Trial | Phase | Enrollment | Study Type | Start Date | Status |
Lung Transplantation Using Hepatitis C Positive Donors to Hepatitis C Negative Recipients: A Pilot Study [NCT03112044] | Early Phase 1 | 26 participants (Actual) | Interventional | 2017-09-19 | Active, not recruiting |
The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4 [NCT03743727] | Phase 4 | 25 participants (Anticipated) | Interventional | 2018-08-01 | Recruiting |
A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study [NCT03236506] | Phase 2 | 129 participants (Actual) | Interventional | 2018-01-19 | Completed |
Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania (CUTTS HepC): a Non-randomised, Quasiexperimental, Prospective Comparative Trial [NCT06159504] | Early Phase 1 | 3,040 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
Management of Hepatitis C Virus (HCV) Infection in Pregnant Women With Opioid Use Disorder (OUD): the Potential of an Integrated Medical Home Model: Phase IV Trial of Sofosbuvir/Velpatasvir (SOF/VEL) in Postpartum Women With Chronic HCV [NCT03057847] | Phase 4 | 32 participants (Actual) | Interventional | 2018-01-30 | Completed |
Pharmacokinetics of Low-dose Sofosbuvir in Dialysis-dependent Patients With Hepatitis C Virus Infection [NCT03883698] | Phase 3 | 30 participants (Actual) | Interventional | 2019-03-15 | Completed |
Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection [NCT03646396] | | 40 participants (Anticipated) | Interventional | 2018-08-01 | Recruiting |
Role of Pegylated Interferon in Combination With Direct Acting Antivirals (DAAs) to Cure Hepatitis C As Soon As Possible (ASAP) - Hepatitis C [ASAP-C] [NCT03480932] | Phase 2/Phase 3 | 150 participants (Actual) | Interventional | 2018-02-02 | Completed |
Evaluation of the Natural History and Vertical Transmission of Chronic Hepatitis C Virus Infection in Pregnancy With Targeted Elimination by Postpartum Treatment [NCT03570112] | | 150 participants (Anticipated) | Observational | 2018-06-08 | Recruiting |
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed [NCT02822794] | Phase 3 | 117 participants (Actual) | Interventional | 2016-07-25 | Completed |
A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations Who Are HCV Treatment Naïve With Evidence of Active HCV Infection: The MINMON Stud [NCT03512210] | Phase 4 | 400 participants (Actual) | Interventional | 2018-10-22 | Completed |
A Phase 3 Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection and Compensated Cirrhosis [NCT04112303] | Phase 3 | 37 participants (Actual) | Interventional | 2019-10-16 | Completed |
The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia [NCT03169348] | | 50 participants (Anticipated) | Interventional | 2017-11-01 | Recruiting |
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis [NCT02994056] | Phase 2 | 32 participants (Actual) | Interventional | 2017-01-23 | Completed |
A Phase IIb/IIIa, Randomized Study to Evaluate the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4 [NCT02371408] | Phase 2/Phase 3 | 300 participants (Anticipated) | Interventional | 2015-01-31 | Active, not recruiting |
A Randomized Study of a Rapid HCV Treatment Initiation Strategy (HCV Seek, Test and Rapid Treatment) Compared to Standard Care in Young People Who Inject Drugs [NCT03627546] | Phase 4 | 39 participants (Actual) | Interventional | 2018-09-18 | Completed |
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease [NCT03036852] | Phase 2 | 59 participants (Actual) | Interventional | 2017-03-22 | Completed |
A Multicenter, Open-label Study of Harvoni ® (Sofosbuvir Ledipasvir Fixed Dose Combination) in Subjects Infected With Chronic Hepatitis C and Advanced Heart Failure or Lung Disease [NCT02858180] | Phase 4 | 15 participants (Actual) | Interventional | 2016-12-31 | Completed |
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection [NCT03074331] | Phase 3 | 130 participants (Actual) | Interventional | 2017-03-23 | Completed |
Bridging Care to HCV Treatment Among Opiate Dependent Patients on Buprenorphine/Naloxone Maintenance Therapy: A Pilot Study of Treating HCV With Epclusa at a Psychiatrist-staffed Outpatient Addiction Clinic [NCT03235154] | Phase 4 | 11 participants (Actual) | Interventional | 2017-10-11 | Completed |
Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin Versus Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin in the Management of Hepatitis C Patients Fauilre to Prior Sofosbuvir/ Daclatasvir (An Open-labeled Randomized Trial) [NCT03549832] | | 40 participants (Actual) | Interventional | 2018-01-01 | Completed |
Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar [NCT03579576] | | 803 participants (Actual) | Observational | 2017-12-20 | Completed |
An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection [NCT02156570] | Phase 4 | 20 participants (Anticipated) | Interventional | 2014-10-31 | Completed |
Multicenter Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir Fix Dose combination_The HepNet Acute HCV-V Study [NCT03818308] | Phase 2 | 20 participants (Actual) | Interventional | 2019-05-28 | Completed |
Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital [NCT03965286] | | 80 participants (Anticipated) | Observational | 2019-06-01 | Not yet recruiting |
Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic G [NCT02483156] | Phase 2/Phase 3 | 80 participants (Actual) | Interventional | 2015-07-31 | Completed |
Outcome of New Direct Acting Agents For Hepatitis C [NCT02485262] | | 340 participants (Anticipated) | Observational [Patient Registry] | 2013-11-30 | Recruiting |
A Randomized, Open-Label, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection (CERTAIN-2) [NCT02723084] | Phase 3 | 136 participants (Actual) | Interventional | 2016-04-08 | Completed |
Effect Of Interferon-Free Direct Acting Antiviral Agents For Treatment Of Hepatitis C Virus Patients On The Normal Kidney [NCT03296930] | Phase 4 | 100 participants (Anticipated) | Interventional | 2017-10-01 | Not yet recruiting |
Generic Velpatasvir Plus Sofosbuvir With or Without Ribavirin for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus [NCT03250910] | Phase 4 | 228 participants (Actual) | Interventional | 2016-08-01 | Completed |
The Relationship Between Direct Acting Antiviral Treatment Effect and Myeloid-Derived Suppressor Cells and NK Cells Activity in Chronic Hepatitis C [NCT03188276] | Early Phase 1 | 52 participants (Actual) | Interventional | 2016-02-01 | Completed |
A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of an 8-Week and 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection With and Witho [NCT02253550] | Phase 2 | 30 participants (Anticipated) | Interventional | 2014-10-31 | Completed |
Evaluation of Vitamin D and Iron Status in Chronic Hepatitis C Virus Patients Before and After Treatment [NCT03166280] | | 87 participants (Anticipated) | Observational | 2017-06-30 | Not yet recruiting |
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects With Genotype 1, 4, 5 and 6 Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease [NCT03036839] | Phase 2 | 95 participants (Actual) | Interventional | 2017-06-27 | Completed |
A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection [NCT03022981] | Phase 2 | 216 participants (Actual) | Interventional | 2017-01-26 | Completed |
A Multicenter, Single-arm, Open-label Study to Investigate the Efficacy and Safety of Yimitasvir Phosphate (DAG181)/Sofosbuvir(SOF) Combination for 12 Weeks in Subjects With Chronic Genotype 1 HCV Infection [NCT03487107] | Phase 3 | 362 participants (Actual) | Interventional | 2018-04-17 | Completed |
Does Directly Acting Antivirals Usage Affect HCV Related Hepatocellular Carcinoma Recurrence After Percutaneous Ablation: A Randomized Controlled Trial [NCT04653818] | Phase 4 | 84 participants (Actual) | Interventional | 2020-10-05 | Completed |
Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet [NCT03389061] | Phase 4 | 0 participants (Actual) | Interventional | 2018-04-01 | Withdrawn(stopped due to Lack of patients who are eligible for inclusion: less patients on treatment and not using epclusa.) |
Efficacy of a Fixed-Dose Combination Pill of Sofosbuvir and Daclatasvir in Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus [NCT03369327] | Phase 3 | 232 participants (Actual) | Interventional | 2017-01-01 | Completed |
A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C [NCT02097966] | | 0 participants | Expanded Access | | No longer available |
Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir (GS-5885) Fixed-dose Combination in NS3/4A Protease Inhibitor-experienced Subjects With HCV Genotype 1 Infection and HIV Co-infection [NCT02125500] | Phase 2 | 68 participants (Actual) | Interventional | 2014-08-31 | Completed |
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Switch Followed by Sofosbuvir/Velpatasvir (SOF/VEL) Antiviral HCV Therapy Followed by Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Simplification in HIV-HCV [NCT03549312] | Phase 4 | 25 participants (Anticipated) | Interventional | 2018-02-01 | Recruiting |
Monitoring of Hepatitis C Therapy Using Telemedicine in a Simplified Protocol With Pangenotypic Regimen in Non-cirrhotic Patients - a Single Group Clinical Trial in the National Public Health System in Brazil [NCT04039698] | | 144 participants (Actual) | Interventional | 2019-08-23 | Active, not recruiting |
A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis [NCT02781558] | Phase 2 | 204 participants (Actual) | Interventional | 2016-07-29 | Completed |
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infect [NCT02639338] | Phase 3 | 220 participants (Actual) | Interventional | 2015-12-23 | Completed |
An Open Label, Pilot Study to Investigate the Safety and Efficacy of 12 Weeks of Simeprevir and Sofosbuvir, for HIV-infected, HCV Genotype 1 Patients With Advanced Fibrosis [NCT02206932] | Phase 4 | 0 participants (Actual) | Interventional | 2014-08-31 | Withdrawn(stopped due to never opened) |
The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin [NCT01329978] | Phase 2 | 332 participants (Actual) | Interventional | 2011-03-31 | Completed |
QUANTUM: An International, Multi-center, Blinded, Randomized Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Administration of Regimens Containing PSI-352938, PSI-7977, and Ribavirin in Patients With Chronic Hepa [NCT01435044] | Phase 2 | 239 participants (Actual) | Interventional | 2011-09-30 | Completed |
Effect of Direct-acting Antiviral Drugs on Erectile Function Among Hepatitis c Patients [NCT03444272] | Phase 3 | 105 participants (Anticipated) | Interventional | 2018-01-01 | Recruiting |
Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine [NCT04038320] | | 868 participants (Actual) | Observational | 2018-03-26 | Completed |
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs [NCT03981211] | | 60 participants (Anticipated) | Interventional | 2021-02-12 | Recruiting |
Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study [NCT02220868] | Phase 4 | 10 participants (Actual) | Interventional | 2014-07-31 | Completed |
Same-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study) [NCT05016609] | Phase 4 | 1,800 participants (Anticipated) | Interventional | 2022-03-09 | Recruiting |
Open Label Study to Evaluate the Safety and Pharmacokinetics of Elpida® in Healthy Subjects and Patients With Hepatic Impairment, as Well as to Assess the Impact of Food Intake and Drug-Drug Interactions in Case of Co-administration With Other Antiviral D [NCT03706898] | Phase 1 | 36 participants (Actual) | Interventional | 2018-10-01 | Completed |
Measuring Inflammation Cells (CD163 and CD206) With the Purpose of Examining Reduction of Fibrosis in the Liver of Chronic Hepatitis C Patients Following Treatment With the Medication Sofosbuvir [NCT02528461] | | 71 participants (Actual) | Observational | 2015-01-31 | Completed |
Evaluation of Efficacy and Safety of KW-136 Capsule Combined With Sofosbuvir Tablet for Treatment of Adult Chronic Hepatitis C: an Open-label, Multi-center, Phase 3 Study [NCT03995485] | Phase 3 | 371 participants (Actual) | Interventional | 2017-06-07 | Completed |
Insulin Resistance and Resistin In Non-Diabetic Patients With Chronic Hepatitis C Before and After Direct-Acting Antiviral Drugs. [NCT04457050] | Phase 4 | 160 participants (Actual) | Interventional | 2017-10-30 | Completed |
PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver [NCT03619837] | Phase 4 | 122 participants (Actual) | Interventional | 2018-07-15 | Completed |
Efficacy of Adding Sofosbuvir/Ledipasvir Combination, or Nitazoxanide to the Standard of Care in Treatment of COVID-19: A Randomized Controlled Trial [NCT04498936] | Phase 4 | 240 participants (Actual) | Interventional | 2020-07-15 | Completed |
Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents [NCT03343444] | Phase 3 | 80 participants (Anticipated) | Interventional | 2017-04-15 | Enrolling by invitation |
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination Therapy in Treatment of Chronic Hepatitis C Infection in Egyptian Children With Gaucher Disease [NCT03721627] | Phase 4 | 10 participants (Anticipated) | Interventional | 2018-04-03 | Recruiting |
An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient [NCT03801707] | Phase 2/Phase 3 | 54 participants (Actual) | Interventional | 2019-03-22 | Completed |
Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland) [NCT02491450] | Phase 1 | 24 participants (Actual) | Interventional | 2015-02-28 | Completed |
Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients [NCT02480686] | Phase 4 | 32 participants (Actual) | Interventional | 2015-01-31 | Completed |
Effect of Triple Direct Acting Antiviral Agents (DAAs) for Non-cirrhotic Subjects With Chronic HCV G1b Infection [NCT02470858] | Phase 2 | 18 participants (Actual) | Interventional | 2015-01-31 | Completed |
Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers [NCT03313414] | Phase 4 | 0 participants (Actual) | Interventional | 2019-08-13 | Withdrawn(stopped due to No participant enrollment, funding withdrawn.) |
Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients [NCT03377478] | Phase 1 | 10 participants (Actual) | Interventional | 2019-07-30 | Completed |
Phase I Pharmacokinetic and Safety Trial of Ledipasvir/Sofosbuvir Fixed Dose Combination in Pregnant Women With Chronic Hepatitis C Virus Infection [NCT02683005] | Phase 1 | 9 participants (Actual) | Interventional | 2016-09-30 | Completed |
Direct Observed Therapy With Ledipasvir/Sofosbuvir in Treatment-naïve Patients With Chronic Genotype 1 HCV (Hepatitis C Virus) Infection Receiving Opiate Substitution Therapy [NCT02638233] | Phase 4 | 40 participants (Anticipated) | Interventional | 2015-09-30 | Recruiting |
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3 [NCT02551861] | Phase 2 | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn |
A Multicenter Study to Evaluate the Anti-viral Activity of an Interferon-free Treatment With Ledipasvir/Sofosbuvir (G1 and G4) and Sofosbuvir/Velpatasvir (G2 and G3) for Patients With Hepatitis C Virus-associated Indolent B-cell Lymphomas [NCT02836925] | Phase 2 | 40 participants (Actual) | Interventional | 2016-03-31 | Completed |
A Prospective, Non-Interventional Cohort Study of Approved Sofosbuvir-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice [NCT02783976] | | 25 participants (Actual) | Observational | 2016-10-28 | Completed |
A Phase IV Open-label Multicentre International Pilot Study of 4-week Treatment With Sofosbuvir (400 mg) Plus Glecaprevir/Pibrentasvir (300mg/120mg) in Chronic HCV Treatment naïve Patients With Early Liver Disease [NCT03855917] | Phase 4 | 30 participants (Anticipated) | Interventional | 2020-02-11 | Recruiting |
A Phase 2 Open-Label Study in Patients With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant to Explore the Safety And Efficacy of Simeprevir and Sofosbuvir With and Without Ribavirin [NCT02165189] | Phase 2 | 46 participants (Actual) | Interventional | 2014-08-31 | Completed |
TAC (Treatment Africa Hepatitis C) : Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus- [NCT02405013] | Phase 2 | 120 participants (Actual) | Interventional | 2015-10-31 | Completed |
The Safety and Efficacy of Ledipasvir/Sofosbuvir in the Treatment of Chronic Hepatitis C Virus Infection in Naïve Children [NCT05091008] | Phase 2 | 50 participants (Actual) | Interventional | 2018-03-01 | Completed |
Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 2 Infection [NCT02482077] | Phase 4 | 112 participants (Actual) | Interventional | 2015-01-31 | Completed |
Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children From 3 to Less Than 18 Years of Age With GT-1 to -6 Chronic Hepatitis C (CHC) Infection [NCT03487848] | Phase 2 | 5 participants (Actual) | Interventional | 2018-06-25 | Terminated(stopped due to Business objectives have changed) |
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection [NCT02472886] | Phase 3 | 153 participants (Actual) | Interventional | 2015-06-17 | Completed |
A Pilot Study to Assess the Feasibility of Hepatitis C Virus (HCV) Treatment as Prevention With Interferon-free Direct Acting Antivirals (DAAs) in the Prison Setting [NCT02064049] | Phase 4 | 3,692 participants (Actual) | Interventional | 2014-10-31 | Completed |
Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient [NCT03093740] | Phase 4 | 0 participants (Actual) | Interventional | 2018-10-01 | Withdrawn(stopped due to Withdrew IRB application, never approved and no subjects enrolled) |
The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China : a Mutil-center,Prospective,Single-arm,Open-label [NCT04997564] | Phase 4 | 120 participants (Anticipated) | Interventional | 2021-08-31 | Recruiting |
Security and Efficacy of Triple Therapy Including Direct-Acting Antivirals Against Chronic Hepatitis C Infection In HIV-Coinfected Patients In Real-Life Conditions: The Prospective HEPAVIR Cohort. [NCT02057003] | | 1,000 participants (Anticipated) | Observational | 2012-01-31 | Recruiting |
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subje [NCT02607800] | Phase 3 | 943 participants (Actual) | Interventional | 2015-11-16 | Completed |
Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, [NCT01359644] | Phase 2 | 350 participants (Actual) | Interventional | 2011-06-30 | Completed |
Real Life Experience in the Management of HCV Related Decompensated Cirrhosis With Direct Antiviral Agents [NCT03547895] | | 80 participants (Actual) | Interventional | 2015-06-01 | Completed |
A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Subjects With Chronic Hepatitis C and Decompensated Cirrhosis or Post-Liver Transplant Subjects With Chronic Hepatitis C Recurrence [NCT02161939] | | 0 participants | Expanded Access | | No longer available |
Therapy for Hepatitis C Virus (HCV) in Primary Treatment Failure in Pakistan [NCT05248919] | | 318 participants (Anticipated) | Interventional | 2023-06-01 | Enrolling by invitation |
Transplantation of Livers of Hepatitis C (HCV) Seropositive Donors to HCV Seronegative Recipients With Subsequent Therapy With Sofosbuvir/Velpatasvir (Epclusa®) [NCT03819322] | Phase 2 | 73 participants (Actual) | Interventional | 2019-08-15 | Active, not recruiting |
The Treatment And Prevention (TAP) Study: Treating People Who Inject Drugs (PWID) in Community-based Settings Using a Social Network Approach [NCT02363517] | Phase 3 | 420 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4 [NCT02772744] | | 250 participants (Anticipated) | Observational | 2017-11-01 | Not yet recruiting |
Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy [NCT03903185] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2019-03-01 | Completed |
Sustained Viral Response Rate in 50 Subjects With Cirrhosis Due to Hepatitis C, Genotype 1, Treated With 12 Weeks of Sofosbuvir, Ledipasvir and Ribavirin [NCT02705534] | Phase 3 | 50 participants (Actual) | Interventional | 2016-09-30 | Completed |
Metabolic Changes in Chronic Hepatitis C Virus Patients Receiving Direct Acting Antivirals [NCT04211844] | | 100 participants (Anticipated) | Observational [Patient Registry] | 2019-10-01 | Recruiting |
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods [NCT02657694] | | 10,000 participants (Anticipated) | Observational [Patient Registry] | 2015-07-01 | Enrolling by invitation |
Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir [NCT02647632] | Phase 2 | 26 participants (Actual) | Interventional | 2016-01-31 | Completed |
Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC [NCT02771405] | Phase 3 | 150 participants (Anticipated) | Interventional | 2016-03-31 | Recruiting |
Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection [NCT02576314] | Phase 3 | 48 participants (Actual) | Interventional | 2015-05-31 | Completed |
A Multi-center, Randomised, Open Label Study of Nitazoxanide (NTZ), or Sofosbuvir and Daclatasvir (SOF/DCV), Compared to no Pharmacological Intervention for the Prevention of COVID-19 Disease in Healthcare Workers and Inner City Inhabitants at High Risk o [NCT04561063] | Phase 2 | 1,950 participants (Actual) | Interventional | 2020-12-08 | Completed |
A Prospective Multicenter Cohort Study: the Efficacy of Vosevi in Treating Direct Antiviral Agent Therapy Failure Patients [NCT06180590] | | 200 participants (Anticipated) | Observational | 2023-02-28 | Recruiting |
A Multicenter, Prospective, Observational, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Patients With Chronic Hepatitis C Virus Infection in India [NCT02592057] | | 532 participants (Actual) | Observational | 2015-11-30 | Completed |
Randomized Clinical Trial to Assess the Effectiveness of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1 (TNT-1 Study) [NCT02624063] | Phase 4 | 121 participants (Actual) | Interventional | 2015-12-31 | Completed |
A Phase IIa, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 2,3,6 Hepatitis C Virus Infection [NCT04111367] | Phase 2 | 36 participants (Anticipated) | Interventional | 2019-04-03 | Recruiting |
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGE [NCT02939989] | Phase 3 | 33 participants (Actual) | Interventional | 2016-11-21 | Completed |
Pharmacokinetics of Sofosbuvir and Ledipasvir in Hepatitis C Virus - Infected Adolescent Patients With Haematological Disorders [NCT04353986] | Phase 3 | 24 participants (Anticipated) | Interventional | 2018-06-11 | Recruiting |
Clinical Pharmacokinetics, Safety and Efficacy Study of Daclatasvir/Sofosbuvir in Adolescents Aged 12 to 18 Years Old With Hepatitis C Virus: A Preliminary Study [NCT03540212] | Phase 2/Phase 3 | 50 participants (Anticipated) | Interventional | 2017-12-10 | Recruiting |
Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients [NCT02555943] | Phase 2/Phase 3 | 23 participants (Actual) | Interventional | 2015-02-28 | Completed |
Comparative Open-label,Randomized, Fasting, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Scien [NCT02953535] | Phase 1 | 36 participants (Actual) | Interventional | 2016-05-31 | Completed |
Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon (Hepatitis Eradication Accuracy Trial of Sofosbuvir): An Observational Non-interventional Real Life Trial [NCT02804386] | Phase 4 | 573 participants (Actual) | Interventional | 2016-06-30 | Completed |
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience [NCT02745535] | Phase 2 | 77 participants (Actual) | Interventional | 2016-05-31 | Completed |
Safety, Tolerability, and Outcomes of Velpatasvir/SofosbuviR in Treatment of Chronic Hepatitis C Virus During Pregnancy (STORC) [NCT05140941] | Phase 4 | 100 participants (Anticipated) | Interventional | 2022-04-04 | Recruiting |
Transplantation of Kidneys of Hepatitis C (HCV) Seropositive Donors to HCV Seronegative Recipients With Subsequent Therapy With Sofosbuvir/Velpatasvir (Epclusa) [NCT03809533] | Phase 2 | 30 participants (Actual) | Interventional | 2019-05-29 | Active, not recruiting |
A Phase Ib/IIa, Single Center, Randomized, Open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability, Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects [NCT04202952] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2020-07-06 | Completed |
Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria. JAILFREE-C [NCT02768961] | Phase 4 | 64 participants (Actual) | Interventional | 2016-05-10 | Completed |
A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 1 Hepatitis C Virus Infection. [NCT04001608] | Phase 3 | 206 participants (Actual) | Interventional | 2018-10-17 | Active, not recruiting |
Evolution of Estimated Glomerular Filtration Rate in Chronic Hepatitis C Patients Receiving Sofosbuvir-based or Sofosbuvir-free Direct Acting Antivirals [NCT04047680] | | 441 participants (Actual) | Observational | 2015-02-28 | Completed |
Efficacy and Safety of Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly Cirrhotic Patients: a Real Life Study [NCT02702739] | Phase 4 | 270 participants (Actual) | Interventional | 2015-01-31 | Completed |
A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1) [NCT02556086] | Phase 2 | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn |
Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication [NCT03823911] | Phase 4 | 87 participants (Actual) | Interventional | 2018-11-18 | Completed |
Evaluation of Liver Fibrosis by Serum Hyalornic Acid Measurement in β-Thalassemic Children Infected With Hepatitis C Virus Before and After Direct-Acting Antiviral Therapy [NCT03961828] | Phase 4 | 50 participants (Actual) | Interventional | 2017-10-01 | Completed |
Open Label Phase II/III, Multicenter, Trial to Assess the Efficacy, Safety, Tolerance, and Pharmacokinetics of Sofosbuvir Plus Ravidasvir in HCV (+/- HIV) Chronically Infected Adults With no or Compensated Cirrhosis in Thailand and Malaysia [NCT02961426] | Phase 2/Phase 3 | 603 participants (Actual) | Interventional | 2016-09-30 | Active, not recruiting |
Evaluation of Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Adults Chronically Infected With Genotype 2 Hepatitis C Virus: an Open-label, Multicenter Confirmatory Study [NCT03453346] | | 136 participants (Actual) | Interventional | 2016-08-05 | Completed |
Newer Direct-Acting Anti-Viral Agents as Sole Therapy of Porphyria Cutanea Tarda in Subjects With Chronic Hepatitis C [NCT03118674] | Phase 2 | 23 participants (Actual) | Interventional | 2017-09-06 | Completed |
A Phase IV, Single Arm, Open-Label Study to Determine the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF) in Treatment-Naive Alcoholic Subjects With Chronic Genotype 1 Hepatitis C Infection [NCT02759861] | Phase 4 | 16 participants (Actual) | Interventional | 2016-08-01 | Completed |
A Phase 2a, Partly Randomized, Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Subjects With Chronic Genotype 4 Hepatitis C Infect [NCT02278419] | Phase 2 | 63 participants (Actual) | Interventional | 2014-12-31 | Completed |
Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment [NCT04530422] | Phase 3 | 250 participants (Actual) | Interventional | 2020-04-15 | Completed |
Phase 2, Exploratory, Single Center, Randomized, Open Label, Adaptive Clinical Trial to Compare Safety and Efficacy of Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19 [NCT04532931] | Phase 2 | 192 participants (Actual) | Interventional | 2020-09-03 | Completed |
Expanding the Pool in Orthotopic Heart Transplantation: The Use of Hepatitis C Positive Donor Hearts in Hepatitis C Negative Recipients [NCT03222531] | Phase 2 | 20 participants (Anticipated) | Interventional | 2017-08-01 | Active, not recruiting |
The Effects of Anti-Viral Therapy on the Clinical Status, Quality of Life, and Survival of Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection [NCT02597166] | Phase 3 | 14 participants (Actual) | Interventional | 2016-01-31 | Completed |
Management of Hepatitis C Virus Infection Among People Who Inject Drugs in a Low-threshold Setting: Efficacy of Direct-acting Antiviral Treatment and the Risk of Reinfection [NCT04063839] | | 300 participants (Anticipated) | Observational | 2015-01-31 | Recruiting |
Hepatitis C Virus Infection Induced Insulin Resistance: Different Contribution From Liver and Extrahepatic Sites as Inferred by Treating Chronic Hepatitis C Patients With an Interferon-free Antiviral Combination [NCT02760355] | | 17 participants (Actual) | Interventional | 2016-03-31 | Completed |
A Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Na [NCT01260350] | Phase 2 | 292 participants (Actual) | Interventional | 2010-12-31 | Completed |
The Renal Safety and Rates of Acute Kidney Injury (AKI) in Patients With Chronic HCV Undergoing Sofosbuvir Containing Direct Acting Antiviral Therapy [NCT04169464] | Phase 4 | 200 participants (Anticipated) | Interventional | 2019-04-01 | Enrolling by invitation |
Role OF OCT-A TO Detect Possible Retinal Vascular Complications of Sofosbuvir (Sovaldi) in Patients With Hepatitis C Virus Infection [NCT04159246] | | 30 participants (Anticipated) | Observational | 2019-02-10 | Active, not recruiting |
Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium [NCT02799355] | | 1,203 participants (Actual) | Observational | 2016-05-31 | Completed |
Transplanting Organs From Hepatitis C Positive Donors to Hepatitis C Uninfected Recipients [NCT03086044] | Phase 4 | 148 participants (Anticipated) | Interventional | 2017-03-01 | Recruiting |
Efficacy and Safety of Interferon Based Therapy and Interferon-free Direct-acting Antivirals in Cirrhotic Patients With Hepatitis C. Impact of Antiviral Therapy on Gastroesophageal Varices. [NCT02758509] | | 237 participants (Actual) | Observational | 2010-01-01 | Completed |
Comparative Open-label,Randomized, Fasting, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (G [NCT02605798] | Phase 1 | 24 participants (Actual) | Interventional | 2015-08-31 | Completed |
Pharmacokinetics, Safety, Efficacy and Acceptability Study of Daclatasvir/Sofosbuvir in Children Weighing 14-35 Kilograms With Chronic Hepatitis C Virus Infection [NCT05854511] | Phase 3 | 30 participants (Anticipated) | Interventional | 2022-06-05 | Recruiting |
New Drugs And New Concerns: Gaining Insight Through Pharmacovigilance Of Direct Acting Anti-Viral's In Chronic HCV Patients [NCT04664894] | | 511 participants (Actual) | Observational | 2018-05-15 | Completed |
Impact of Serum Alpha-fetoprotein Levels on the Response to Direct Antiviral Therapy in Egyptian Patients With Chronic Hepatitis C [NCT03402165] | Phase 4 | 1,200 participants (Anticipated) | Interventional | 2017-01-01 | Recruiting |
Drug Interaction Between RDV and SOF in ASC18 Tablets (RDV/SOF Compound Tablets) and the Influence of Food Effect on the Pharmacokinetics of ASC18 Tablets Were Evaluated in Healthy Subjects. Comparison of the Pharmacokinetic Parameters of ASC18 Tablets(Ra [NCT04358523] | Phase 1 | 50 participants (Actual) | Interventional | 2020-03-20 | Completed |
A Multicenter, Randomized, Parallel Assigned, Open-label Study to Investigate the Efficacy and Safety of Yimitasvir Phosphate (DAG181)/Sofosbuvir(SOF) Combination for 12 Weeks in Subjects With Chronic Genotype 1 HCV Infection [NCT03458481] | Phase 2 | 129 participants (Actual) | Interventional | 2017-07-31 | Completed |
Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks or Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks in DAA Treatment Naïve HCV Subjects With GT3b, Compensated Cirrhosis in China [NCT05467826] | Phase 4 | 100 participants (Anticipated) | Interventional | 2022-09-01 | Not yet recruiting |
A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials [NCT02510300] | | 461 participants (Actual) | Observational [Patient Registry] | 2015-10-21 | Terminated(stopped due to The study stopped early because the study objectives were met.) |
A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve Patie [NCT01188772] | Phase 2 | 147 participants (Actual) | Interventional | 2010-08-31 | Completed |
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Harvoni Treatment Regimen in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea [NCT02951364] | | 1,081 participants (Actual) | Observational | 2016-12-05 | Completed |
Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Daul Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection. A Prospective, Randomized, Multicenter Study [NCT02985281] | Phase 2/Phase 3 | 41 participants (Anticipated) | Interventional | 2016-12-31 | Enrolling by invitation |
The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis [NCT02168361] | Phase 4 | 93 participants (Actual) | Interventional | 2013-12-31 | Completed |
A Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in People Who Inject Drugs and People With HIV Coinfection. [NCT02625909] | Phase 3 | 222 participants (Actual) | Interventional | 2017-03-09 | Completed |
A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection [NCT02250807] | Phase 3 | 40 participants (Actual) | Interventional | 2015-01-31 | Completed |
A Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Standard of Care [NCT01054729] | Phase 2 | 64 participants (Actual) | Interventional | 2010-01-31 | Completed |
Phase 1 Pharmacokinetic Trial of Sofosbuvir/Velpatasvir in Pregnant Women With Chronic Hepatitis C Virus Infection [NCT04382404] | Phase 1 | 11 participants (Actual) | Interventional | 2020-10-22 | Completed |
Sustained Viral Response Rate in 100 Subjects With Cirrhosis Due to Hepatitis C Treated With 12 Weeks of Sofosbuvir, Daclatasvir and Ribavirin [NCT02596880] | Phase 3 | 100 participants (Actual) | Interventional | 2015-09-30 | Completed |
SOF/VEL±RBV: Real-World Efficacy and Safety in GT 3 and 6 HCV Patients in China [NCT04948801] | | 150 participants (Anticipated) | Observational | 2018-12-08 | Recruiting |
A Phase 2 Open- Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naïve Patients With Chronic HCV Genotype 3 Infection [NCT02413593] | Phase 2 | 111 participants (Actual) | Interventional | 2015-04-30 | Completed |
Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection [NCT02457611] | Phase 2 | 26 participants (Actual) | Interventional | 2015-06-30 | Completed |
Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 [NCT04246723] | Phase 2 | 85 participants (Actual) | Interventional | 2019-05-06 | Completed |
A Pilot Study to Evaluate the Safety and Efficacy of Multiple Anti-HCV Combination Therapy in Chronically Infected Hepatitis C Patients [NCT01805882] | Phase 2 | 229 participants (Actual) | Interventional | 2013-01-31 | Completed |
The Safety and Efficacy of Sofosbuvir & Daclatasvir Combined Therapy for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4 [NCT03080415] | Phase 3 | 40 participants (Actual) | Interventional | 2017-03-18 | Completed |
Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World [NCT02964091] | Phase 4 | 300 participants (Actual) | Interventional | 2016-10-31 | Completed |
A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamid [NCT02707601] | Phase 3 | 150 participants (Actual) | Interventional | 2016-04-01 | Completed |
A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Non-Genotype 1 HCV Infection [NCT02378961] | Phase 2 | 128 participants (Actual) | Interventional | 2015-02-16 | Completed |
Eliminación de la infección Por el Virus de la Hepatitis C en PWID en Los Estados Del Norte de México [NCT05503979] | | 1,000 participants (Anticipated) | Observational | 2022-11-15 | Not yet recruiting |
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection [NCT01641640] | Phase 3 | 328 participants (Actual) | Interventional | 2012-06-30 | Completed |
Sofosbuvir in Combination With Ribavirin or Simeprevir: Real-life Study of Patients With Hepatitis C Genotype 4 [NCT04385407] | Phase 2 | 203 participants (Actual) | Interventional | 2015-04-30 | Completed |
A Randomized Study to Evaluate the Safety and Efficacy of Adding Daclatasvir to the Combination of Sofosbuvir (SOF) and Ribavirin (RBV) for 16 Weeks Versus 24 Weeks in Cirrhotic Subjects With Chronic Hepatitis C Infection Genotype 3 [NCT02304159] | Phase 4 | 39 participants (Actual) | Interventional | 2015-01-31 | Completed |
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients [NCT02631772] | Phase 4 | 32 participants (Actual) | Interventional | 2016-06-01 | Completed |
Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination [NCT03776760] | | 600 participants (Anticipated) | Observational | 2019-05-28 | Recruiting |
Simeprevir (SMV) + Sofosbuvir (SOF) With or Without Ribavirin (RBV) for Interferon-intolerant or Ineligible (IFN-II) Patients With Chronic Hepatitis C (CHC) [NCT02214420] | Phase 4 | 24 participants (Actual) | Interventional | 2014-10-31 | Completed |
Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia [NCT02825212] | Phase 2/Phase 3 | 10 participants (Actual) | Interventional | 2016-02-29 | Completed |
Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19) [NCT04535869] | Phase 3 | 50 participants (Anticipated) | Interventional | 2020-12-28 | Recruiting |
A Non-randomized Trial to Evaluate a TEst and Treat Intervention Integrating Novel Point-of-care Hepatitis C RNA Testing, Linkage to Nursing Care, and Peer-supported Delivery of HCV Testing and Treatment aMong Current People Who Inject Drugs With HCV Atte [NCT03492112] | | 101 participants (Actual) | Interventional | 2019-09-10 | Completed |
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting [NCT02350569] | Phase 2 | 17 participants (Actual) | Interventional | 2015-05-22 | Completed |
Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy [NCT05717400] | Phase 4 | 15 participants (Anticipated) | Interventional | 2023-02-07 | Recruiting |
An Open-Label Study to Characterize the Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of PSI-7977 or PSI-352938 in HCV-infected Subjects With Varying Degrees of Hepatic Impairment [NCT01497327] | Phase 1 | 24 participants (Actual) | Interventional | 2011-07-31 | Completed |
A Phase 4, Multicenter, Open Label Study to Investigate the Efficacy and Safety of an All Oral Combination of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis VALOR-HCV: Veterans Affairs alL Oral Regimen of SOF+RBV in GT2 HCV [NCT02128542] | Phase 4 | 66 participants (Actual) | Interventional | 2014-06-30 | Completed |
Efficacy and Safety of Treatment Against Hepatitis C Virus Infection Based on Direct-acting Antivirals in Real-life Conditions: The GEHEP Cohort [NCT02333292] | | 1,128 participants (Actual) | Observational | 2014-12-31 | Completed |
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection [NCT02032901] | Phase 3 | 173 participants (Actual) | Interventional | 2014-01-31 | Completed |
A Phase 2b, Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 and Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 Weeks in Genotype 1 or 4 HCV Infected Subjects With Renal Insufficiency [NCT01958281] | Phase 2 | 38 participants (Actual) | Interventional | 2013-10-07 | Completed |
An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection [NCT01779518] | | 0 participants | Expanded Access | | Approved for marketing |
Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial. [NCT04497649] | Phase 2/Phase 3 | 100 participants (Anticipated) | Interventional | 2020-07-01 | Recruiting |
A Phase 2, Single-Center, Open-Label Pilot Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfe [NCT02480387] | Phase 2 | 20 participants (Actual) | Interventional | 2015-05-31 | Completed |
An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection [NCT01924949] | Phase 2 | 5 participants (Actual) | Interventional | 2013-07-31 | Completed |
An Open-Label, Treatment Duration-Ranging Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/ Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antivira [NCT02399345] | Phase 3 | 10 participants (Actual) | Interventional | 2015-03-31 | Completed |
Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients [NCT04391985] | Phase 1/Phase 2 | 113 participants (Actual) | Interventional | 2017-03-01 | Completed |
A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection [NCT01604850] | Phase 3 | 202 participants (Actual) | Interventional | 2012-06-30 | Completed |
An Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Subjects With Sickle Cell Disease [NCT02301936] | Phase 2 | 10 participants (Actual) | Interventional | 2015-03-02 | Completed |
Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study [NCT02717949] | Phase 4 | 1 participants (Actual) | Interventional | 2016-02-25 | Terminated(stopped due to failure to recruit) |
A Phase 2, Randomized, Open-label Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 6 or 8 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Subjects With Chronic Hepatitis C Virus Genotype 1 I [NCT02349048] | Phase 2 | 68 participants (Actual) | Interventional | 2015-01-31 | Completed |
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection [NCT01910636] | Phase 3 | 153 participants (Actual) | Interventional | 2013-02-28 | Completed |
The Immunologic Effects of HCV Therapy With Fixed Dose Combination Ledipasvir/Sofosbuvir (HARVONI) in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs. [NCT02347345] | Phase 4 | 34 participants (Actual) | Interventional | 2016-11-15 | Completed |
An Exploratory Phase IIa, Randomized, Open-Label Trial to Investigate the Efficacy and Safety of 12 Weeks or 24 Weeks of TMC435 in Combination With PSI-7977 (GS7977) With Or Without Ribavirin in Chronic Hepatitis C Genotype 1-Infected Prior Null Responder [NCT01466790] | Phase 2 | 168 participants (Actual) | Interventional | 2012-01-31 | Completed |
A Phase 3b Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection [NCT04211909] | Phase 3 | 87 participants (Actual) | Interventional | 2020-01-03 | Completed |
An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Stud [NCT01987453] | Phase 2 | 100 participants (Actual) | Interventional | 2014-07-31 | Completed |
Efficacy of Decentralized Care in the Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model [NCT03488485] | | 50,000 participants (Anticipated) | Interventional | 2016-06-18 | Recruiting |
Benefits of Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination [NCT03490097] | Phase 2/Phase 3 | 100 participants (Actual) | Interventional | 2017-12-01 | Completed |
A Phase 2b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders [NCT02120300] | Phase 2 | 122 participants (Actual) | Interventional | 2014-04-30 | Completed |
A Phase 3b, Multicenter, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection. [NCT01896193] | Phase 3 | 127 participants (Actual) | Interventional | 2013-06-30 | Completed |
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant [NCT01687270] | Phase 2 | 40 participants (Actual) | Interventional | 2012-11-30 | Completed |
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (ECF/TAF) Switch Followed by Ledipasvir-Sofosbuvir HCV Therapy in HIV-HCV Co-Infection: A CIHR Canadian HIV Trials Network-Gilead Pilot Trial Proposal [NCT02660905] | Phase 3 | 25 participants (Actual) | Interventional | 2016-04-30 | Completed |
Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection [NCT03061032] | Phase 3 | 200 participants (Anticipated) | Interventional | 2017-03-31 | Not yet recruiting |
Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure. [NCT03063879] | Phase 4 | 95 participants (Actual) | Interventional | 2017-04-01 | Completed |
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection. [NCT01682720] | Phase 3 | 421 participants (Actual) | Interventional | 2012-09-30 | Completed |
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters [NCT05616598] | Phase 2/Phase 3 | 200 participants (Actual) | Interventional | 2022-03-01 | Completed |
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection. [NCT01701401] | Phase 3 | 870 participants (Actual) | Interventional | 2012-09-30 | Completed |
Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study [NCT03949764] | Phase 4 | 374 participants (Actual) | Interventional | 2019-09-23 | Active, not recruiting |
Efficacy and Safety of 8- Versus 12-week Sofosbuvir-ravidasvir Treatment of Non-cirrhotic Chronic Hepatitis C Patients: An Open-label, Randomized, Multicenter Study in Malaysia [NCT04885855] | Phase 2/Phase 3 | 316 participants (Anticipated) | Interventional | 2021-03-23 | Recruiting |
Association of Serum Interleukin -6 and Transforming Growth Factor Beta Levels With Response to Antiviral Therapy for Chronic Hepatitis c Patients [NCT03882307] | Early Phase 1 | 40 participants (Anticipated) | Interventional | 2022-10-31 | Recruiting |
The Role of DAA in Reducing the Risk of Recurrence After Curative Treatment of HCC in Patients With Chronic Hepatitis C and Early Stage HCC [NCT02959359] | Phase 4 | 0 participants (Actual) | Interventional | 2016-11-30 | Withdrawn(stopped due to The supplies of study drug were halted by Gilead Sciences Ltd.) |
The Pulmonary Safety of the New Oral Antihepatitis C Treatment [NCT04122066] | | 50 participants (Anticipated) | Observational | 2020-06-30 | Not yet recruiting |
Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt (Single Center Study) [NCT04773756] | Phase 4 | 54 participants (Actual) | Interventional | 2020-11-01 | Completed |
A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection [NCT02081079] | Phase 2 | 85 participants (Actual) | Interventional | 2014-03-31 | Completed |
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection and Child-Pugh Class B Cirrhosis [NCT02201901] | Phase 3 | 268 participants (Actual) | Interventional | 2014-07-31 | Completed |
A Phase 2, Single-Center, Double-Blind, Placebo-Controlled, Randomized Study to Investigate the Effect of Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Subjects With Chr [NCT02219685] | Phase 2 | 40 participants (Actual) | Interventional | 2014-08-31 | Completed |
A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection [NCT02378935] | Phase 2 | 205 participants (Actual) | Interventional | 2015-02-17 | Completed |
A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen [NCT02536313] | Phase 2 | 49 participants (Actual) | Interventional | 2015-07-29 | Completed |
A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection a [NCT02114151] | Phase 3 | 103 participants (Actual) | Interventional | 2014-04-30 | Completed |
Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4) [NCT02319031] | Phase 3 | 53 participants (Actual) | Interventional | 2015-02-28 | Completed |
A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Sofosbuvir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1, 4 [NCT02358044] | Phase 3 | 257 participants (Actual) | Interventional | 2015-02-27 | Completed |
An Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With or Without Sofosbuvir (SOF) and Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Tre [NCT02356562] | Phase 2 | 29 participants (Actual) | Interventional | 2015-02-03 | Completed |
A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection [NCT02021643] | Phase 3 | 687 participants (Actual) | Interventional | 2013-12-10 | Completed |
A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection. [NCT01838590] | Phase 3 | 103 participants (Actual) | Interventional | 2013-03-31 | Completed |
A Phase 2, Open-Label Study of Sofosbuvir in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3 [NCT01808248] | Phase 2 | 47 participants (Actual) | Interventional | 2013-02-28 | Completed |
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects [NCT01783678] | Phase 3 | 275 participants (Actual) | Interventional | 2013-01-31 | Completed |
An Open Label Trial to Assess Safety, Tolerability, and Efficacy of the Fixed Dose Combination of GS-7977 and GS-5885 in HCV Genotype 1 Subjects Coinfected With HIV [NCT01878799] | Phase 2 | 50 participants (Actual) | Interventional | 2013-06-30 | Completed |
Open-Label Study to Evaluate the Safety and Tolerability of Telaprevir in Combination With Sofosbuvir in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotype 1 [NCT01994486] | Phase 2 | 20 participants (Actual) | Interventional | 2013-12-31 | Completed |
Safety, Tolerability, and Efficacy of Simeprevir 150 mg Daily Plus Sofosbuvir 400 mg Daily for 24 Weeks in Patients With Chronic Hepatitis C Genotype 1 With CPT Score of 6 or Lower Who Are IFN-Intolerant or Unwilling to be Treated With IFN [NCT02485080] | Phase 4 | 0 participants (Actual) | Interventional | 2015-09-30 | Withdrawn(stopped due to Withdrawn due to lack of resources) |
A Phase II Open-Label Study of Ledipasvir/Sofosbuvir for 12 Weeks in Subjects With Hepatitis B Virus Infection [NCT03312023] | Phase 2 | 21 participants (Actual) | Interventional | 2018-02-01 | Completed |
Pilot Therapeutic Study of DAA Treatment for Children and Adolescents With Active HCV Infection in Cambodia [NCT05992077] | | 36,600 participants (Anticipated) | Interventional | 2023-08-07 | Not yet recruiting |
Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C: Multi-center, Prospective, Observational Real-world Study in EASTERN China [NCT04952207] | | 300 participants (Anticipated) | Observational [Patient Registry] | 2019-03-06 | Recruiting |
A Phase 2, 2-panel, Open-label Randomized Study in Hepatitis C Virus Infected Subjects to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir and Ledipasvir in Treatmen [NCT02421211] | Phase 2 | 41 participants (Actual) | Interventional | 2015-05-19 | Completed |
Directly Observed Therapy for the Delivery of HCV Therapy Among HCV-infected Individuals in Chennai, India [NCT02541409] | Phase 2 | 50 participants (Actual) | Interventional | 2015-09-30 | Completed |
Phase II Trial of Retreatment Strategies for Difficult-to-Treat Hepatitis C Virus (HCV)-Infected Individuals Who Have Failed Prior Direct Acting Antiviral (DAA)-Based Regimens [NCT02605304] | Phase 2 | 7 participants (Actual) | Interventional | 2016-02-17 | Terminated(stopped due to The study experienced enrollment difficulties.) |
Effect of Ledipasvir and Sofosbuvir on Proteinuria and Estimated Glomerular Filtration Rate in Patients With Early Stage (1-3) Hepatitis C Associated Chronic Kidney Disease [NCT02503735] | | 14 participants (Actual) | Interventional | 2015-07-15 | Terminated(stopped due to Unable to meet enrollment goal) |
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV [NCT02201940] | Phase 3 | 741 participants (Actual) | Interventional | 2014-07-31 | Completed |
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection [NCT02722837] | Phase 3 | 119 participants (Actual) | Interventional | 2016-04-04 | Completed |
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant [NCT02781571] | Phase 2 | 79 participants (Actual) | Interventional | 2016-07-27 | Completed |
An Open-label Pilot Study to Determine the Tolerability and Efficacy of Fixed-dose Grazoprevir/Elbasvir Treatment in Hepatitis C Uninfected Recipients of Renal Transplants From Hepatitis C Infected Deceased Donors [NCT02781649] | Phase 4 | 10 participants (Actual) | Interventional | 2016-07-20 | Completed |
A Phase 2, Open-label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Subjects Undergoing Cancer Chemotherapy [NCT02868242] | Phase 2 | 19 participants (Actual) | Interventional | 2016-08-28 | Completed |
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis C (FOURward Study) [NCT02175966] | Phase 2 | 35 participants (Actual) | Interventional | 2014-07-28 | Completed |
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV [NCT02671500] | Phase 3 | 375 participants (Actual) | Interventional | 2016-04-19 | Completed |
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects [NCT01667731] | Phase 3 | 224 participants (Actual) | Interventional | 2012-07-31 | Completed |
Towards HCV Elimination: Evaluation of an Integrated Model of HCV Care Targeting People Who Inject Drugs in Hai Phong, Vietnam [NCT03537196] | Phase 4 | 979 participants (Actual) | Interventional | 2018-11-13 | Completed |
Sofosbuvir Plus Daclatasvir With or Without Ribavirin for Chronic Hepatitis C Infection: Impact of Drug Concentration on Viral Load Decay [NCT03318887] | | 130 participants (Actual) | Observational | 2014-02-01 | Completed |
Efficacy and Safety of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection [NCT02473211] | Phase 2/Phase 3 | 106 participants (Actual) | Interventional | 2015-01-31 | Completed |
"To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis - A Randomized Open- Label Study" [NCT02464631] | | 62 participants (Actual) | Interventional | 2015-06-30 | Terminated(stopped due to In view of recent approval of NS5A inhibitors for treatment of hepatitis C such as Declatasvir and Ledipasvir which have proven better efficacy in the HCV cure) |
Dynamic Changes of the Frequency of Classic and Inflammatory Monocytes Subsets and Natural Killer Cells in Chronic Hepatitis C Patients Treated by Direct-acting Antiviral Agents [NCT03063723] | | 25 participants (Actual) | Observational | 2016-01-01 | Completed |
A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HC [NCT02607735] | Phase 3 | 416 participants (Actual) | Interventional | 2015-11-11 | Completed |
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic HCV GT3 Infection [NCT02601573] | Phase 2 | 101 participants (Actual) | Interventional | 2016-01-05 | Completed |
An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies [NCT01625338] | Phase 3 | 534 participants (Actual) | Interventional | 2012-06-30 | Completed |
A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV) [NCT02032888] | Phase 3 | 238 participants (Actual) | Interventional | 2014-02-28 | Completed |
deLIVER: Direct Acting Antiviral Effects on the Liver [NCT02938013] | Phase 4 | 15 participants (Actual) | Interventional | 2017-01-31 | Completed |
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection [NCT02021656] | Phase 3 | 384 participants (Actual) | Interventional | 2013-12-10 | Completed |
A Phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir & Ribavirin) Versus Sofosbuvir + Daclatasvir + Ribavirin (Part A) and a Single Dose of Dactavira (EP [NCT03186313] | Phase 3 | 72 participants (Actual) | Interventional | 2016-09-30 | Completed |
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligib [NCT01542788] | Phase 3 | 278 participants (Actual) | Interventional | 2012-03-31 | Completed |
Assessment of Haematological and Biochemical Effect After New Direct Acting Antiviral Drugs in Chronic Hepatitis c Virus Egyptian Patients in Assiut Province [NCT03163849] | Phase 3 | 50 participants (Anticipated) | Interventional | 2019-09-01 | Active, not recruiting |
A Phase III, Open Label, Multicentric Clinical Trial of a Single Arm of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotype 1,4 Who Have Failed to Treat With a [NCT03105349] | Phase 4 | 0 participants (Actual) | Interventional | 2017-07-01 | Withdrawn(stopped due to No availability of investigational medication.) |
A Sofosbuvir-based Quadruple Regimen is Highly Effective in HCV Type 4-infected Egyptian Patients With DAA Treatment Failure [NCT04387539] | Phase 1/Phase 2 | 94 participants (Actual) | Interventional | 2017-03-01 | Completed |
A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection [NCT02613871] | Phase 3 | 111 participants (Actual) | Interventional | 2015-12-22 | Completed |
A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection [NCT02487030] | Phase 3 | 255 participants (Actual) | Interventional | 2015-09-07 | Completed |
Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial [NCT03032666] | Phase 4 | 7 participants (Actual) | Interventional | 2017-05-01 | Completed |
Reversal of Hepatic Impairment by Achieving Sustained Virologic Response (SVR) With 12 Weeks of Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) in Patients With Hepatitis C Virus (HCV) Genotype 1 Infection and Early Decompensation of Cirrhosis (MELD 10 or [NCT02455167] | Phase 3 | 9 participants (Actual) | Interventional | 2015-05-31 | Terminated(stopped due to Study stopped due to low accrual and availability of other treatment options) |
Sofosbuvir Based Regimens in Treatment of COVID 19 Patients [NCT04460443] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection [NCT02346721] | Phase 3 | 111 participants (Actual) | Interventional | 2015-02-23 | Completed |
An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study [NCT02300103] | Phase 2 | 69 participants (Actual) | Interventional | 2014-12-01 | Completed |
A Phase 2, Multicenter, Open-Label, Randomized Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin Administered for 48 Weeks in Patients Infected With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensatio [NCT01687257] | Phase 2 | 50 participants (Actual) | Interventional | 2012-07-31 | Completed |
A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia [NCT02339038] | Phase 4 | 600 participants (Actual) | Interventional | 2015-01-07 | Completed |
Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection: Real-world Effectiveness and Safety in Taiwan [NCT05092074] | | 100 participants (Anticipated) | Observational | 2021-10-01 | Recruiting |
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection [NCT01713283] | Phase 2 | 60 participants (Actual) | Interventional | 2012-10-31 | Completed |
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant [NCT01938430] | Phase 2 | 339 participants (Actual) | Interventional | 2013-09-30 | Completed |
Comparative Open-label,Randomized, Fed, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sci [NCT03062423] | Phase 1 | 36 participants (Actual) | Interventional | 2016-10-31 | Completed |
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Subjects Who Have Failed Prior Treatment With Sofosbuvir-based Therapies [NCT02600351] | Phase 3 | 87 participants (Actual) | Interventional | 2015-11-11 | Terminated(stopped due to Due to lack of feasibility of enrolling participants, the study was terminated early.) |
A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered With Daclatasvir in Adults With Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3) [NCT02640157] | Phase 3 | 506 participants (Actual) | Interventional | 2015-12-31 | Completed |
Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Egyptian Patients With HCV [NCT03069001] | Phase 4 | 90 participants (Actual) | Interventional | 2015-06-30 | Completed |
Treatment of Recent Injection Drug Use With Chronic HCV Infection in U.S. Liver Referral Clinics: A Prospective, Observational Cohort Study And Contemporaneous Therapy Cohort Without Injection Drug Use [NCT05895448] | Phase 4 | 125 participants (Anticipated) | Interventional | 2018-03-01 | Active, not recruiting |
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naive Subjects W [NCT01851330] | Phase 3 | 647 participants (Actual) | Interventional | 2013-05-31 | Completed |
A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection [NCT02480712] | Phase 3 | 107 participants (Actual) | Interventional | 2015-07-01 | Completed |
Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4 [NCT04387526] | Phase 2/Phase 3 | 946 participants (Actual) | Interventional | 2016-04-01 | Completed |
A Randomized Controlled Study To Assess Safety, Tolerability And Efficacy Of GS-7977 In Combination With Full or Low Dose RBV In HCV Genotype 1, Monoinfected Treatment Naive Participants [NCT01441180] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2011-09-30 | Completed |
A Phase 3b, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 1 HCV Infection [NCT01975675] | Phase 3 | 341 participants (Actual) | Interventional | 2013-10-31 | Completed |
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Sovaldi in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea [NCT02907996] | | 2,033 participants (Actual) | Observational | 2016-09-09 | Completed |
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection [NCT01826981] | Phase 2 | 359 participants (Actual) | Interventional | 2013-04-30 | Completed |
A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir Fixed Dose Combination Administered for Four Weeks in Patients Infected With Chronic HCV in the Peri-Operative Liver Transplantation Setting [NCT02728206] | Phase 2 | 9 participants (Actual) | Interventional | 2016-06-12 | Completed |
Evaluation of Quality of Life, Neurocognitive Performance, Fatigue, and Emotional State in HCV Patients Before, During, and in the (Long-term) Follow-up of an IFN-free Antiviral Therapy [NCT02469012] | | 30 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE) [NCT03282474] | Phase 2 | 10 participants (Actual) | Interventional | 2017-12-07 | Completed |
An Open-Label Study to Explore the Clinical Efficacy of GS-7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant [NCT01559844] | Phase 2 | 61 participants (Actual) | Interventional | 2012-03-31 | Completed |
A Clinical and Pharmacokinetic Study of the Effectiveness of Hepatitis C Treatment (Sofosbuvir+Daclatasvir) in HIV Co-infected and Non HIV Co-infected Patients at the Level of Non-hospital Based Management in Myanmar [NCT03158857] | | 0 participants (Actual) | Observational | 2022-01-31 | Withdrawn(stopped due to Long local IRB process to meet with the treatment deadline) |
A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 [NCT01497366] | Phase 3 | 527 participants (Actual) | Interventional | 2011-12-31 | Completed |
A Phase II, Open-label, Single Arm, Multicentre, International Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use [NCT02336139] | Phase 2 | 103 participants (Actual) | Interventional | 2016-03-16 | Completed |
Investigation of Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816 [NCT02468648] | Phase 2 | 72 participants (Actual) | Interventional | 2015-06-09 | Completed |
THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders [NCT02786537] | Phase 4 | 1,275 participants (Actual) | Interventional | 2016-06-30 | Completed |
A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection [NCT02249182] | Phase 2 | 226 participants (Actual) | Interventional | 2014-11-05 | Completed |
A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection [NCT02738333] | Phase 3 | 239 participants (Actual) | Interventional | 2016-04-12 | Completed |
Evaluation of Efficacy and Safety of KW-136 Plus Sofosbuvir for Treatment-naive Adults Chronically Infected With Hepatitis C Virus: a Randomized, Open-label, Multicenter Phase 2 Trial [NCT03416491] | Phase 2 | 110 participants (Actual) | Interventional | 2017-02-15 | Completed |
Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis [NCT02992457] | Phase 4 | 10,000 participants (Actual) | Interventional | 2015-01-31 | Completed |
A Phase 3b, Multi-Center, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Chronic Genotype 1 or 3 Hepatitis C Virus Infection [NCT02074514] | Phase 3 | 117 participants (Actual) | Interventional | 2014-03-31 | Completed |
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infec [NCT02073656] | Phase 3 | 335 participants (Actual) | Interventional | 2014-02-28 | Completed |
A Phase II Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172, MK-8742, and Sofosbuvir in Treatment-Naïve Subjects With Chronic HCV GT1 or GT3 Infection [NCT02133131] | Phase 2 | 143 participants (Actual) | Interventional | 2014-06-13 | Completed |
Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute HCV in HIV-1 Infected Individuals (SWIFT-C) [NCT02128217] | Phase 1 | 44 participants (Actual) | Interventional | 2014-05-30 | Completed |
The Role of Combined Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in Treatment of Chronic Hepatitis C Non-responders; A Randomized Controlled Trial [NCT04695769] | Phase 4 | 281 participants (Actual) | Interventional | 2020-11-21 | Completed |
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of a 12- or 8-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve and -Experienced Subjects With Chronic Genotype 1 Hepatitis C [NCT02114177] | Phase 3 | 310 participants (Actual) | Interventional | 2014-04-30 | Completed |
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrho [NCT01965535] | Phase 2 | 155 participants (Actual) | Interventional | 2013-10-31 | Completed |
Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT) [NCT02478229] | Phase 3 | 1 participants (Actual) | Interventional | 2015-06-30 | Terminated(stopped due to difficulty recruiting patients) |
Efficacy and Safety of Anti-hepatitis C Drugs in the Treatment of COVID-19 [NCT04443725] | Phase 2/Phase 3 | 100 participants (Anticipated) | Interventional | 2020-07-31 | Not yet recruiting |
A Pilot Phase II Study of New Direct-Acting Antiviral Agent, HARVONI® (Ledipasvir/Sofosbuvir), for the Treatment of Genotype 1 or 2 HCV-Associated Indolent B-Cell Non- Hodgkin's Lymphoma [NCT03261349] | Phase 2 | 21 participants (Anticipated) | Interventional | 2017-09-01 | Not yet recruiting |
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant [NCT02010255] | Phase 2 | 334 participants (Actual) | Interventional | 2014-01-31 | Completed |
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjec [NCT02639247] | Phase 3 | 333 participants (Actual) | Interventional | 2015-12-23 | Completed |
A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection [NCT02292706] | | 1,609 participants (Actual) | Observational [Patient Registry] | 2014-12-29 | Terminated(stopped due to The study stopped early because the study objectives were met.) |
Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir [NCT03247296] | | 200 participants (Actual) | Observational | 2017-02-28 | Active, not recruiting |
[NCT03200184] | Phase 4 | 1,448 participants (Actual) | Interventional | 2016-09-01 | Completed |
A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis [NCT02226549] | Phase 2 | 47 participants (Actual) | Interventional | 2014-07-31 | Completed |
A Phase 3 Evaluation of Daclatasvir, Sofosbuvir, and Ribavirin in Genotype 1-6 Chronic Hepatitis C Infection Subjects With Cirrhosis Who May Require Future Liver Transplant and Subjects Post-Liver Transplant [NCT02032875] | Phase 3 | 116 participants (Actual) | Interventional | 2014-03-31 | Completed |
A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection. [NCT01962441] | Phase 3 | 601 participants (Actual) | Interventional | 2013-09-24 | Completed |
A Phase 2, Open Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection [NCT02251717] | Phase 2 | 114 participants (Actual) | Interventional | 2014-10-14 | Completed |
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection [NCT02201953] | Phase 3 | 558 participants (Actual) | Interventional | 2014-07-31 | Completed |
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus [NCT02292719] | Phase 2 | 70 participants (Actual) | Interventional | 2014-12-19 | Completed |
A Phase 2 Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of 12 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir, Followed by a 5-Year Post-treatment Long-term Follow-up, in Treatment-naïve and Treatment-experienced [NCT02262728] | Phase 2 | 40 participants (Actual) | Interventional | 2014-09-30 | Completed |
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection [NCT02202980] | Phase 2 | 273 participants (Actual) | Interventional | 2014-08-04 | Completed |
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection [NCT02220998] | Phase 3 | 269 participants (Actual) | Interventional | 2014-09-30 | Completed |
A Phase II Open-Label Study of the Clinical Effectiveness of a Human Monoclonal Antibody Against Hepatitis C Virus E2 Glycoprotein (MBL-HCV1) Combined With Oral Direct-Acting Antivirals in Hepatitis C Infected Patients Undergoing Liver Transplantation [NCT01532908] | Phase 2 | 11 participants (Actual) | Interventional | 2012-11-21 | Terminated(stopped due to The study was terminated due to funding constraints) |
A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection [NCT02175758] | Phase 2 | 106 participants (Actual) | Interventional | 2014-07-07 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of GS-331007: Cmax at Day 27 |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0 |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27 |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0 |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of GS-566500: Cmax at Day 27 |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of GS-566500: Cmax at Day 0 |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of GS-331007: Cmax at Day 0 |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27 |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27 |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0 |
NCT01054729 (17) [back to overview] | Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27 |
NCT01054729 (17) [back to overview] | Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0 |
NCT01054729 (17) [back to overview] | Percentage of Participants With Rapid Virologic Response at Week 4 |
NCT01054729 (17) [back to overview] | Percentage of Participants Who Developed Resistance to Sofosbuvir |
NCT01054729 (17) [back to overview] | Change in Circulating HCV RNA at Week 4 |
NCT01054729 (17) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment |
NCT01188772 (14) [back to overview] | Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8) |
NCT01188772 (14) [back to overview] | Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24) |
NCT01188772 (14) [back to overview] | Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period |
NCT01188772 (14) [back to overview] | Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8) |
NCT01188772 (14) [back to overview] | Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29) |
NCT01188772 (14) [back to overview] | Percentage of Participants With Virologic Response at the End of Treatment |
NCT01188772 (14) [back to overview] | Percentage of Participants With Rapid Virologic Response at Week 4 |
NCT01188772 (14) [back to overview] | Percentage of Participants With Extended Rapid Virologic Response |
NCT01188772 (14) [back to overview] | Percentage of Participants With Complete Early Virologic Response at Week 12 |
NCT01188772 (14) [back to overview] | Percentage of Participants Who Developed Resistance to Sofosbuvir |
NCT01188772 (14) [back to overview] | Change in HCV RNA From Baseline to Week 12 |
NCT01188772 (14) [back to overview] | Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29) |
NCT01188772 (14) [back to overview] | Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15) |
NCT01188772 (14) [back to overview] | Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15) |
NCT01260350 (9) [back to overview] | Percentage of Participants With HCV RNA < LOD at Week 12 |
NCT01260350 (9) [back to overview] | Percentage of Participants With HCV RNA < LOD at Week 6 |
NCT01260350 (9) [back to overview] | Percentage of Participants With Virologic Failure |
NCT01260350 (9) [back to overview] | Percentage of Participants Who Experienced Adverse Events |
NCT01260350 (9) [back to overview] | Change From Baseline in HCV RNA at Week 8 |
NCT01260350 (9) [back to overview] | Change From Baseline in HCV RNA at Week 6 |
NCT01260350 (9) [back to overview] | Change From Baseline in HCV RNA at Week 12 |
NCT01260350 (9) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) |
NCT01260350 (9) [back to overview] | Percentage of Participants With HCV RNA < LOD at Week 8 |
NCT01329978 (17) [back to overview] | Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) |
NCT01329978 (17) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) |
NCT01329978 (17) [back to overview] | Percentage of Participants With HCV RNA Below < LOD at Week 8 |
NCT01329978 (17) [back to overview] | Percentage of Participants With HCV RNA Below < LOD at Week 4 |
NCT01329978 (17) [back to overview] | Percentage of Participants With HCV RNA Below < LOD at Week 24 |
NCT01329978 (17) [back to overview] | Percentage of Participants With HCV RNA Below < LOD at Week 12 |
NCT01329978 (17) [back to overview] | Percentage of Participants With HCV RNA < LOD at Week 2 |
NCT01329978 (17) [back to overview] | Percentage of Participants With ALT Normalization at Week 12 |
NCT01329978 (17) [back to overview] | Percentage of Participants With ALT Normalization at Post-treatment Week 4 |
NCT01329978 (17) [back to overview] | Change in HCV RNA at Week 8 |
NCT01329978 (17) [back to overview] | Change in HCV RNA at Week 4 |
NCT01329978 (17) [back to overview] | Percentage of Participants With ALT Normalization at Week 24 |
NCT01329978 (17) [back to overview] | Change in HCV RNA at Week 2 |
NCT01329978 (17) [back to overview] | Change in HCV RNA at Week 12 |
NCT01329978 (17) [back to overview] | Percentage of Participants With Virologic Failure During Treatment |
NCT01329978 (17) [back to overview] | Percentage of Participants Who Experienced Adverse Events |
NCT01329978 (17) [back to overview] | Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). |
NCT01359644 (7) [back to overview] | Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24 |
NCT01359644 (7) [back to overview] | Percentage of Participants With Viral Breakthrough During the Treatment Period |
NCT01359644 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) |
NCT01359644 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) |
NCT01359644 (7) [back to overview] | Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy |
NCT01359644 (7) [back to overview] | Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period |
NCT01359644 (7) [back to overview] | Percentage of Participants Who Experienced Viral Relapse During Follow-up Period |
NCT01441180 (2) [back to overview] | Participants With Adverse Events |
NCT01441180 (2) [back to overview] | Sustained Virologic Response |
NCT01466790 (7) [back to overview] | Number of Participants With Viral Relapse |
NCT01466790 (7) [back to overview] | Number of Participants With Viral Breakthrough |
NCT01466790 (7) [back to overview] | Number of Participants With Inadequate Virologic Response |
NCT01466790 (7) [back to overview] | Number of Participants With a Sustained Virologic Response (SVR) at Week 48 |
NCT01466790 (7) [back to overview] | Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT) |
NCT01466790 (7) [back to overview] | Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT) |
NCT01466790 (7) [back to overview] | Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) |
NCT01497366 (7) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT01497366 (7) [back to overview] | Change From Baseline in HCV RNA |
NCT01497366 (7) [back to overview] | Percentage of Participants With Virologic Failure During Treatment |
NCT01497366 (7) [back to overview] | Percentage of Participants With Viral Relapse Following Treatment |
NCT01497366 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) |
NCT01497366 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) |
NCT01497366 (7) [back to overview] | Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities |
NCT01532908 (6) [back to overview] | Number of Subjects With Undetectable HCV RNA at Day 56 Post Liver Transplantation |
NCT01532908 (6) [back to overview] | Change in Viral Load Between Baseline Pre-transplant HCV RNA Levels and Study Day 7, 10, 14, 28, 35, 42, 49, 56, 70, 84 and 98 in Liver Transplant Recipients |
NCT01532908 (6) [back to overview] | Safety and Tolerability of Study Treatment by Number of Adverse Events Reported |
NCT01532908 (6) [back to overview] | Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 10, 14, 28, 35, 42, 49, 70, 84 and 98 in Liver Transplant Recipients and for Those Subjects Receiving an Additional 4 Weeks of Treatment at Study Day 105, 112 and 126 |
NCT01532908 (6) [back to overview] | Number of Subjects With Sustained Virologic Response (SVR) at Week 12 and Week 24 |
NCT01532908 (6) [back to overview] | Number of Participants With HCV Resistance-associated Variants to MBL-HCV1 and Oral Direct-acting Antivirals Before and After Receipt of Study Treatment |
NCT01542788 (6) [back to overview] | Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug |
NCT01542788 (6) [back to overview] | Percentage of Participants Achieving SVR12 |
NCT01542788 (6) [back to overview] | Percentage of Participants Experiencing Viral Relapse |
NCT01542788 (6) [back to overview] | Percentage of Participants Experiencing Viral Breakthrough |
NCT01542788 (6) [back to overview] | Percentage of Participants Achieving SVR4 |
NCT01542788 (6) [back to overview] | Percentage of Participants Achieving SVR24 |
NCT01559844 (8) [back to overview] | Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48 |
NCT01559844 (8) [back to overview] | Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12 |
NCT01559844 (8) [back to overview] | Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48 |
NCT01559844 (8) [back to overview] | Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant |
NCT01559844 (8) [back to overview] | Percentage of Participants With Graft Loss Following Transplant |
NCT01559844 (8) [back to overview] | HCV RNA and Change From Baseline in HCV RNA Through Week 8 |
NCT01559844 (8) [back to overview] | Number of Participants Who Died |
NCT01559844 (8) [back to overview] | Proportion of Participants With Virologic Failure Prior to Transplant |
NCT01604850 (6) [back to overview] | Percentage of Participants Achieving SVR24 |
NCT01604850 (6) [back to overview] | Percentage of Participants Achieving SVR12 |
NCT01604850 (6) [back to overview] | Adverse Events Leading to Permanent Discontinuation of Study Drug |
NCT01604850 (6) [back to overview] | Percentage of Participants Achieving SVR4 |
NCT01604850 (6) [back to overview] | Percentage of Participants With Viral Breakthrough |
NCT01604850 (6) [back to overview] | Percentage of Participants With Viral Relapse |
NCT01625338 (5) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01625338 (5) [back to overview] | Percentage of Participants With Viral Relapse |
NCT01625338 (5) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT01625338 (5) [back to overview] | Percentage of Participants With On-treatment Virologic Failure |
NCT01625338 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01641640 (6) [back to overview] | Percentage of Participants Achieving SVR4 |
NCT01641640 (6) [back to overview] | Percentage of Participants Achieving SVR24 |
NCT01641640 (6) [back to overview] | Percentage of Participants Achieving Sustained Virologic Response (SVR)12 |
NCT01641640 (6) [back to overview] | Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug |
NCT01641640 (6) [back to overview] | Percentage of Participants With Viral Relapse |
NCT01641640 (6) [back to overview] | Percentage of Participants With Viral Breakthrough |
NCT01667731 (10) [back to overview] | Change From Baseline in HCV RNA at Week 4 |
NCT01667731 (10) [back to overview] | Change From Baseline in HCV RNA at Week 2 |
NCT01667731 (10) [back to overview] | Change From Baseline in HCV RNA at Week 1 |
NCT01667731 (10) [back to overview] | Change From Baseline in HCV RNA at Week 6 |
NCT01667731 (10) [back to overview] | Change From Baseline in HCV RNA at Week 8 |
NCT01667731 (10) [back to overview] | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
NCT01667731 (10) [back to overview] | Percentage of Participants Experiencing On-treatment Virologic Failure |
NCT01667731 (10) [back to overview] | Percentage of Participants Experiencing Viral Relapse |
NCT01667731 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01667731 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01682720 (4) [back to overview] | Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
NCT01682720 (4) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01682720 (4) [back to overview] | Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse |
NCT01682720 (4) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01687257 (7) [back to overview] | Percentage of Participants Experiencing On-Treatment Virologic Failure |
NCT01687257 (7) [back to overview] | Percentage of Participants Experiencing Viral Relapse |
NCT01687257 (7) [back to overview] | Change From Baseline in Child-Pugh-Turcotte (CPT) Score |
NCT01687257 (7) [back to overview] | Change From Baseline in Model for End Stage Liver Disease (MELD) Scores |
NCT01687257 (7) [back to overview] | Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) |
NCT01687257 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01687257 (7) [back to overview] | Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment |
NCT01687270 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) |
NCT01687270 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01687270 (6) [back to overview] | HCV RNA and Change From Baseline at Weeks 2, 4, and 8 |
NCT01687270 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24 |
NCT01687270 (6) [back to overview] | Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event |
NCT01687270 (6) [back to overview] | Percentage of Participants With Virologic Failure |
NCT01701401 (10) [back to overview] | Percentage of Participants With Virologic Failure |
NCT01701401 (10) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug |
NCT01701401 (10) [back to overview] | Change From Baseline in HCV RNA at Week 2 |
NCT01701401 (10) [back to overview] | Change From Baseline in HCV RNA at Week 4 |
NCT01701401 (10) [back to overview] | Change From Baseline in HCV RNA at Week 8 |
NCT01701401 (10) [back to overview] | Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug |
NCT01701401 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 2 |
NCT01701401 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 4 |
NCT01701401 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 8 |
NCT01701401 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12) |
NCT01713283 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01713283 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01713283 (5) [back to overview] | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
NCT01713283 (5) [back to overview] | Percentage of Participants Experiencing On-treatment Virologic Failure |
NCT01713283 (5) [back to overview] | Percentage of Participants Experiencing Viral Relapse |
NCT01783678 (9) [back to overview] | HCV RNA Change From Baseline at Week 6 |
NCT01783678 (9) [back to overview] | HCV RNA Change From Baseline at Week 4 |
NCT01783678 (9) [back to overview] | HCV RNA Change From Baseline at Week 2 |
NCT01783678 (9) [back to overview] | HCV RNA Change From Baseline at Week 1 |
NCT01783678 (9) [back to overview] | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
NCT01783678 (9) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01783678 (9) [back to overview] | Percentage of Participants Experiencing Virologic Failure |
NCT01783678 (9) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01783678 (9) [back to overview] | HCV RNA Change From Baseline at Week 8 |
NCT01805882 (1) [back to overview] | The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs |
NCT01808248 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01808248 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01808248 (5) [back to overview] | Percentage of Participants Experiencing Viral Relapse |
NCT01808248 (5) [back to overview] | Percentage of Participants Experiencing On-treatment Virologic Failure |
NCT01808248 (5) [back to overview] | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
NCT01826981 (11) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01826981 (11) [back to overview] | Percentage of Participants With On-treatment Virologic Failure |
NCT01826981 (11) [back to overview] | Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment |
NCT01826981 (11) [back to overview] | Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment |
NCT01826981 (11) [back to overview] | Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
NCT01826981 (11) [back to overview] | Percentage of Participants Experiencing Viral Relapse |
NCT01826981 (11) [back to overview] | Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment |
NCT01826981 (11) [back to overview] | Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment |
NCT01826981 (11) [back to overview] | Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment |
NCT01826981 (11) [back to overview] | Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24) |
NCT01826981 (11) [back to overview] | For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20) |
NCT01838590 (5) [back to overview] | Percentage of Participants Experiencing On-treatment Virologic Failure |
NCT01838590 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01838590 (5) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT01838590 (5) [back to overview] | Percentage of Participants Experiencing Virologic Relapse |
NCT01838590 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01851330 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01851330 (10) [back to overview] | Percentage of Participants Experiencing Virologic Failure |
NCT01851330 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01851330 (10) [back to overview] | Change From Baseline in HCV RNA at Week 4 |
NCT01851330 (10) [back to overview] | Change From Baseline in HCV RNA at Week 2 |
NCT01851330 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 8 |
NCT01851330 (10) [back to overview] | Change From Baseline in HCV RNA at Week 8 |
NCT01851330 (10) [back to overview] | Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug |
NCT01851330 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 2 |
NCT01851330 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 4 |
NCT01878799 (1) [back to overview] | Percentage of Participants With Achieved SVR12 (HCV RNA |
NCT01896193 (5) [back to overview] | Percentage of Participants Experiencing Virologic Relapse |
NCT01896193 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01896193 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01896193 (5) [back to overview] | Percentage of Participants Experiencing On-treatment Virologic Failure |
NCT01896193 (5) [back to overview] | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
NCT01910636 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01910636 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01910636 (5) [back to overview] | Percentage of Participants Experiencing Viral Relapse |
NCT01910636 (5) [back to overview] | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
NCT01910636 (5) [back to overview] | Percentage of Participants Experiencing Viral Breakthrough |
NCT01924949 (6) [back to overview] | Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event |
NCT01924949 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01924949 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01924949 (6) [back to overview] | HCV RNA Change From Baseline |
NCT01924949 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT01924949 (6) [back to overview] | Percentage of Participants Experiencing Virologic Failure |
NCT01938430 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 24 |
NCT01938430 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 20 |
NCT01938430 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 2 |
NCT01938430 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 16 |
NCT01938430 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 12 |
NCT01938430 (25) [back to overview] | Percentage of Participants With Virologic Failure |
NCT01938430 (25) [back to overview] | HCV RNA and Change From Baseline at Week 1 |
NCT01938430 (25) [back to overview] | HCV RNA and Change From Baseline at Week 8 |
NCT01938430 (25) [back to overview] | HCV RNA and Change From Baseline at Week 6 |
NCT01938430 (25) [back to overview] | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event |
NCT01938430 (25) [back to overview] | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score |
NCT01938430 (25) [back to overview] | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score |
NCT01938430 (25) [back to overview] | HCV RNA and Change From Baseline at Week 2 |
NCT01938430 (25) [back to overview] | HCV RNA and Change From Baseline at Week 12 |
NCT01938430 (25) [back to overview] | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) |
NCT01938430 (25) [back to overview] | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT01938430 (25) [back to overview] | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT01938430 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 1 |
NCT01938430 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 4 |
NCT01938430 (25) [back to overview] | HCV RNA and Change From Baseline at Week 4 |
NCT01938430 (25) [back to overview] | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) |
NCT01938430 (25) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01938430 (25) [back to overview] | Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12 |
NCT01938430 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 8 |
NCT01938430 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 6 |
NCT01958281 (35) [back to overview] | PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) |
NCT01958281 (35) [back to overview] | PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) |
NCT01958281 (35) [back to overview] | PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) |
NCT01958281 (35) [back to overview] | PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) |
NCT01958281 (35) [back to overview] | PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) |
NCT01958281 (35) [back to overview] | Pharmacokinetic (PK) Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT01958281 (35) [back to overview] | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT01958281 (35) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01958281 (35) [back to overview] | Percentage of Participants With Overall Virologic Failure |
NCT01958281 (35) [back to overview] | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities |
NCT01958281 (35) [back to overview] | Percentage of Participants Experiencing Treatment-Emergent Adverse Events Associated With Vital Sign Abnormalities |
NCT01958281 (35) [back to overview] | Percentage of Participants Experiencing Treatment-Emergent Adverse Events |
NCT01958281 (35) [back to overview] | Percentage of Participants Experiencing Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities |
NCT01958281 (35) [back to overview] | PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) |
NCT01958281 (35) [back to overview] | PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) |
NCT01958281 (35) [back to overview] | PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) |
NCT01958281 (35) [back to overview] | PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) |
NCT01958281 (35) [back to overview] | PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) |
NCT01958281 (35) [back to overview] | PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) |
NCT01962441 (10) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT01962441 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01962441 (10) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01962441 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 |
NCT01962441 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 |
NCT01962441 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 |
NCT01962441 (10) [back to overview] | Percentage of Participants Experiencing Viral Relapse |
NCT01962441 (10) [back to overview] | HCV RNA at Weeks 1, 2, 4, 8, and 12 |
NCT01962441 (10) [back to overview] | Percentage of Participants Experiencing On-Treatment Virologic Failure |
NCT01962441 (10) [back to overview] | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 |
NCT01965535 (5) [back to overview] | Percentage of Participants With Virologic Failure |
NCT01965535 (5) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01965535 (5) [back to overview] | Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24 |
NCT01965535 (5) [back to overview] | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 |
NCT01965535 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01975675 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01975675 (5) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT01975675 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants |
NCT01975675 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01975675 (5) [back to overview] | Percentage of Participants Experiencing Virologic Failure |
NCT01987453 (6) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT01987453 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT01987453 (6) [back to overview] | Percentage of Participants With Virologic Failure |
NCT01987453 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT01987453 (6) [back to overview] | Change in HCV RNA From Baseline |
NCT01987453 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment |
NCT01994486 (6) [back to overview] | Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007 |
NCT01994486 (6) [back to overview] | Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose |
NCT01994486 (6) [back to overview] | Proportion of Subjects With Viral Relapse |
NCT01994486 (6) [back to overview] | Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen |
NCT01994486 (6) [back to overview] | Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks |
NCT01994486 (6) [back to overview] | Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir |
NCT02010255 (25) [back to overview] | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) |
NCT02010255 (25) [back to overview] | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02010255 (25) [back to overview] | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT02010255 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 1 |
NCT02010255 (25) [back to overview] | HCV RNA Levels and Change From Baseline at Week 4 |
NCT02010255 (25) [back to overview] | HCV RNA Levels and Change From Baseline at Week 6 |
NCT02010255 (25) [back to overview] | HCV RNA Levels and Change From Baseline at Week 8 |
NCT02010255 (25) [back to overview] | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event |
NCT02010255 (25) [back to overview] | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score |
NCT02010255 (25) [back to overview] | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score |
NCT02010255 (25) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02010255 (25) [back to overview] | Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12 |
NCT02010255 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 8 |
NCT02010255 (25) [back to overview] | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) |
NCT02010255 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 6 |
NCT02010255 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 4 |
NCT02010255 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 24 |
NCT02010255 (25) [back to overview] | HCV RNA Levels and Change From Baseline at Week 2 |
NCT02010255 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 20 |
NCT02010255 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 2 |
NCT02010255 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 16 |
NCT02010255 (25) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 12 |
NCT02010255 (25) [back to overview] | HCV RNA Levels and Change From Baseline at Week 12 |
NCT02010255 (25) [back to overview] | HCV RNA Levels and Change From Baseline at Week 1 |
NCT02010255 (25) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02021643 (8) [back to overview] | Percentage of Participants With Viral Relapse |
NCT02021643 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02021643 (8) [back to overview] | Percentage of Participants With On-Treatment Virologic Failure |
NCT02021643 (8) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02021643 (8) [back to overview] | Change From Baseline in HCV RNA (log10 IU/mL) |
NCT02021643 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02021643 (8) [back to overview] | Change From Baseline in HCV RNA (log10 IU/mL) |
NCT02021643 (8) [back to overview] | Change From Baseline in HCV RNA (log10 IU/mL) |
NCT02021656 (6) [back to overview] | Percentage of Participants Experiencing Viral Breakthrough |
NCT02021656 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02021656 (6) [back to overview] | Percentage of Participants Experiencing Viral Relapse |
NCT02021656 (6) [back to overview] | Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event |
NCT02021656 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02021656 (6) [back to overview] | HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only |
NCT02032875 (8) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death |
NCT02032875 (8) [back to overview] | Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) |
NCT02032875 (8) [back to overview] | Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) |
NCT02032875 (8) [back to overview] | Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12) |
NCT02032875 (8) [back to overview] | Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6 |
NCT02032875 (8) [back to overview] | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment |
NCT02032875 (8) [back to overview] | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24 |
NCT02032875 (8) [back to overview] | Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities |
NCT02032888 (10) [back to overview] | Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) |
NCT02032888 (10) [back to overview] | Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) |
NCT02032888 (10) [back to overview] | Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) |
NCT02032888 (10) [back to overview] | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels |
NCT02032888 (10) [back to overview] | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be |
NCT02032888 (10) [back to overview] | Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) |
NCT02032888 (10) [back to overview] | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results |
NCT02032888 (10) [back to overview] | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period |
NCT02032888 (10) [back to overview] | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period |
NCT02032888 (10) [back to overview] | Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12) |
NCT02032901 (10) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) |
NCT02032901 (10) [back to overview] | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) |
NCT02032901 (10) [back to overview] | Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12) |
NCT02032901 (10) [back to overview] | Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) |
NCT02032901 (10) [back to overview] | Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) |
NCT02032901 (10) [back to overview] | Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) |
NCT02032901 (10) [back to overview] | Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND) |
NCT02032901 (10) [back to overview] | Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND) |
NCT02032901 (10) [back to overview] | Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND) |
NCT02032901 (10) [back to overview] | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND) |
NCT02073656 (12) [back to overview] | Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24 |
NCT02073656 (12) [back to overview] | For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8 |
NCT02073656 (12) [back to overview] | For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24 |
NCT02073656 (12) [back to overview] | For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24) |
NCT02073656 (12) [back to overview] | For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure |
NCT02073656 (12) [back to overview] | Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment |
NCT02073656 (12) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02073656 (12) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02073656 (12) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 |
NCT02073656 (12) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02073656 (12) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02073656 (12) [back to overview] | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8 |
NCT02074514 (4) [back to overview] | Percentage of Participants With Virologic Failure and Viral Relapse |
NCT02074514 (4) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02074514 (4) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02074514 (4) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02081079 (5) [back to overview] | Percentage of Patients With Virologic Failure |
NCT02081079 (5) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02081079 (5) [back to overview] | Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12 |
NCT02081079 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02081079 (5) [back to overview] | Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event |
NCT02114151 (12) [back to overview] | Percentage of Participants With On-treatment Virologic Response |
NCT02114151 (12) [back to overview] | Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24 |
NCT02114151 (12) [back to overview] | Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12 |
NCT02114151 (12) [back to overview] | Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24 |
NCT02114151 (12) [back to overview] | Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24 |
NCT02114151 (12) [back to overview] | Percentage of Participants With Viral Relapse |
NCT02114151 (12) [back to overview] | Percentage of Participants With Viral Breakthrough |
NCT02114151 (12) [back to overview] | Percentage of Participants With On-treatment Failure |
NCT02114151 (12) [back to overview] | Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT) |
NCT02114151 (12) [back to overview] | Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT) |
NCT02114151 (12) [back to overview] | Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT) |
NCT02114151 (12) [back to overview] | Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D) |
NCT02114177 (10) [back to overview] | Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24) |
NCT02114177 (10) [back to overview] | Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4) |
NCT02114177 (10) [back to overview] | Percentage of Participants With Viral Breakthrough |
NCT02114177 (10) [back to overview] | Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24 |
NCT02114177 (10) [back to overview] | Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale |
NCT02114177 (10) [back to overview] | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores |
NCT02114177 (10) [back to overview] | Percentage of Participants With Viral Relapse |
NCT02114177 (10) [back to overview] | Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS) |
NCT02114177 (10) [back to overview] | Percentage of Participants Achieving a On-treatment Virologic Response |
NCT02114177 (10) [back to overview] | Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12) |
NCT02120300 (8) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02120300 (8) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02120300 (8) [back to overview] | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 |
NCT02120300 (8) [back to overview] | Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only) |
NCT02120300 (8) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 |
NCT02120300 (8) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02120300 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02120300 (8) [back to overview] | Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only) |
NCT02128217 (19) [back to overview] | Change in CD4+ Cell Count |
NCT02128217 (19) [back to overview] | Number of Participants Who Had HCV Virologic Relapse |
NCT02128217 (19) [back to overview] | Percentage of HCV Virologic Failure Participants That Developed SOF- or LDV-Associated Resistance Mutations |
NCT02128217 (19) [back to overview] | Percentage of Participants With an Occurrence of a Grade ≥ 2 Adverse Event, Serious AE According to ICH Criteria, or Treatment-limiting AE. |
NCT02128217 (19) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 (SVR12) |
NCT02128217 (19) [back to overview] | Adherence as Measured by LDV/SOF Pill Count |
NCT02128217 (19) [back to overview] | Adherence as Measured by RBV Pill Count |
NCT02128217 (19) [back to overview] | Adherence as Measured by SOF Pill Count |
NCT02128217 (19) [back to overview] | Cellular Concentration of Tenofovir Diphosphate (TFV-DP) |
NCT02128217 (19) [back to overview] | Concentration of Tenofovir (TFV) in Plasma |
NCT02128217 (19) [back to overview] | Concentration of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs) |
NCT02128217 (19) [back to overview] | Count and Percentage of Participants With an Adverse Event by Type. |
NCT02128217 (19) [back to overview] | Percentage of Participants With HCV RNA Undetectable After End of Study Treatment |
NCT02128217 (19) [back to overview] | Percentage of Participants With HCV RNA Undetectable During Study Treatment |
NCT02128217 (19) [back to overview] | Ribavirin Concentration in Plasma |
NCT02128217 (19) [back to overview] | Self-reported Adherence to LDV/SOF |
NCT02128217 (19) [back to overview] | Self-reported Adherence to RBV |
NCT02128217 (19) [back to overview] | Self-reported Adherence to SOF |
NCT02128217 (19) [back to overview] | Count of Participants With HIV-1 RNA <50 Copies/mL |
NCT02128542 (6) [back to overview] | Percentage of Participants Experiencing Viral Relapse |
NCT02128542 (6) [back to overview] | Percentage of Participants Experiencing Viral Breakthrough |
NCT02128542 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02128542 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy |
NCT02128542 (6) [back to overview] | Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment |
NCT02128542 (6) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02133131 (3) [back to overview] | Number of Participants Discontinuing Study Therapy Due to an AE |
NCT02133131 (3) [back to overview] | Number of Participants Experiencing at Least 1 Adverse Event (AE) |
NCT02133131 (3) [back to overview] | Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12) |
NCT02168361 (2) [back to overview] | Proportion of Participants With Sustained Virologic Response 12 (SVR-12) |
NCT02168361 (2) [back to overview] | Serum HCV RNA Level |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Change From Baseline in Weight |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Change From Baseline in HCV RNA |
NCT02175758 (25) [back to overview] | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF) |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair |
NCT02175758 (25) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase |
NCT02175758 (25) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair |
NCT02175758 (25) [back to overview] | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment |
NCT02175758 (25) [back to overview] | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Change From Baseline in HCV RNA |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Change From Baseline in Height |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Change From Baseline in Height |
NCT02175758 (25) [back to overview] | For the Treatment Phase, Change From Baseline in Weight |
NCT02175966 (8) [back to overview] | Percentage of Participants With End of Treatment Response (EOTR) |
NCT02175966 (8) [back to overview] | Percentage of Participants Who Achieved HCV RNA |
NCT02175966 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 (SVR12) |
NCT02175966 (8) [back to overview] | Percentage of Participants Who Achieved HCV RNA < LLOQ TND |
NCT02175966 (8) [back to overview] | Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment |
NCT02175966 (8) [back to overview] | Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b |
NCT02175966 (8) [back to overview] | Number of Participants With Selected Grade 3/4 Laboratory Abnormalities |
NCT02175966 (8) [back to overview] | Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype) |
NCT02201901 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02201901 (8) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
NCT02201901 (8) [back to overview] | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score |
NCT02201901 (8) [back to overview] | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
NCT02201901 (8) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02201901 (8) [back to overview] | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score |
NCT02201901 (8) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02201901 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02201940 (6) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02201940 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 |
NCT02201940 (6) [back to overview] | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12 |
NCT02201940 (6) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02201940 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02201940 (6) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02201953 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
NCT02201953 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02201953 (6) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02201953 (6) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02201953 (6) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02201953 (6) [back to overview] | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
NCT02202980 (10) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02202980 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit |
NCT02202980 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit |
NCT02202980 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit |
NCT02202980 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit |
NCT02202980 (10) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02202980 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit |
NCT02202980 (10) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02202980 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02202980 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit |
NCT02214420 (1) [back to overview] | Sustained Viral Response |
NCT02219685 (22) [back to overview] | Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Motor |
NCT02219685 (22) [back to overview] | Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Memory T Score |
NCT02219685 (22) [back to overview] | Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation |
NCT02219685 (22) [back to overview] | Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed |
NCT02219685 (22) [back to overview] | Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Attention Scaled Score |
NCT02219685 (22) [back to overview] | Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Motor |
NCT02219685 (22) [back to overview] | Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation |
NCT02219685 (22) [back to overview] | Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed |
NCT02219685 (22) [back to overview] | Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Attention Scaled Score |
NCT02219685 (22) [back to overview] | Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by WPAI: Hepatitis C - Activity Impairment |
NCT02219685 (22) [back to overview] | Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Memory T Score |
NCT02219685 (22) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24) |
NCT02219685 (22) [back to overview] | Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Hopelessness Scale (BHS) |
NCT02219685 (22) [back to overview] | Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Depression Inventory-II (BDI-II) |
NCT02219685 (22) [back to overview] | Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol |
NCT02219685 (22) [back to overview] | Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Choline |
NCT02219685 (22) [back to overview] | Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG |
NCT02219685 (22) [back to overview] | Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Work Productivity and Activity Impairment Questionnaire, Hepatitis C (WPAI: Hepatitis C) - Overall Work Impairment |
NCT02219685 (22) [back to overview] | Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Short Form 36 (SF-36) Health Survey Scale - Physical Component Score |
NCT02219685 (22) [back to overview] | Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by SF-36 Health Survey Scale - Mental Component Score |
NCT02219685 (22) [back to overview] | Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) |
NCT02219685 (22) [back to overview] | Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Chronic Liver Disease Questionnaire - HCV (CLDQ-HCV) |
NCT02220998 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 |
NCT02220998 (6) [back to overview] | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12 |
NCT02220998 (6) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02220998 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02220998 (6) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02220998 (6) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02226549 (3) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02226549 (3) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02226549 (3) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment |
NCT02249182 (26) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Change From Baseline in Weight |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Change From Baseline in Weight |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Change From Baseline in Height |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Change From Baseline in HCV RNA |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Change From Baseline in Height |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Change From Baseline in HCV RNA |
NCT02249182 (26) [back to overview] | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF |
NCT02249182 (26) [back to overview] | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA |
NCT02249182 (26) [back to overview] | Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 |
NCT02249182 (26) [back to overview] | Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1 |
NCT02249182 (26) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair |
NCT02249182 (26) [back to overview] | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development |
NCT02250807 (7) [back to overview] | Percentage of Participants With On-Treatment Failure |
NCT02250807 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) |
NCT02250807 (7) [back to overview] | Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
NCT02250807 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24) |
NCT02250807 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4) |
NCT02250807 (7) [back to overview] | Percentage of Participants With Viral Breakthrough |
NCT02250807 (7) [back to overview] | Percentage of Participants With Viral Relapse |
NCT02251717 (4) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02251717 (4) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02251717 (4) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02251717 (4) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02262728 (11) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite) |
NCT02262728 (11) [back to overview] | Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite) |
NCT02262728 (11) [back to overview] | Percentage of Participants With On-treatment Failure |
NCT02262728 (11) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12) |
NCT02262728 (11) [back to overview] | Percentage of Participants With SVR12 Who Maintained to Have HCV RNA |
NCT02262728 (11) [back to overview] | Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite) |
NCT02262728 (11) [back to overview] | Percentage of Participants With On-Treatment Virologic Response |
NCT02262728 (11) [back to overview] | Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite) |
NCT02262728 (11) [back to overview] | Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite) |
NCT02262728 (11) [back to overview] | Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36) |
NCT02262728 (11) [back to overview] | Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24) |
NCT02292706 (6) [back to overview] | Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240 |
NCT02292706 (6) [back to overview] | Number of Participants With Detectable HCV Resistance Mutations Through Week 240 |
NCT02292706 (6) [back to overview] | Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240 |
NCT02292706 (6) [back to overview] | Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 |
NCT02292706 (6) [back to overview] | Percentage of Participants With Any Liver-Associated Events |
NCT02292706 (6) [back to overview] | Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240 |
NCT02292719 (3) [back to overview] | Percentage of Participants With On-treatment Virologic Failure |
NCT02292719 (3) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
NCT02292719 (3) [back to overview] | Percentage of Participants With Post-treatment Relapse |
NCT02300103 (6) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02300103 (6) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02300103 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02300103 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ On-treatment |
NCT02300103 (6) [back to overview] | HCV RNA Change From Baseline |
NCT02300103 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02301936 (14) [back to overview] | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score |
NCT02301936 (14) [back to overview] | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score |
NCT02301936 (14) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02301936 (14) [back to overview] | HCV RNA Change From Baseline |
NCT02301936 (14) [back to overview] | HCV RNA Change From Baseline |
NCT02301936 (14) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02301936 (14) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02301936 (14) [back to overview] | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score |
NCT02301936 (14) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02301936 (14) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02301936 (14) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02301936 (14) [back to overview] | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) |
NCT02301936 (14) [back to overview] | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) |
NCT02301936 (14) [back to overview] | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score |
NCT02304159 (3) [back to overview] | Number of Participants With Abnormal Safety Laboratory Tests (ALT and/or Total Bilirubin) That Required Discontinuing Study Drugs |
NCT02304159 (3) [back to overview] | Number of Participants With Adverse Events |
NCT02304159 (3) [back to overview] | Number of Participants With Undetectable HCV Virus 12 Weeks After Stopping Study Drugs |
NCT02319031 (3) [back to overview] | Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities |
NCT02319031 (3) [back to overview] | Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24) |
NCT02319031 (3) [back to overview] | Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12) |
NCT02339038 (1) [back to overview] | Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs |
NCT02346721 (6) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02346721 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02346721 (6) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02346721 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02346721 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment |
NCT02346721 (6) [back to overview] | HCV RNA Change From Baseline |
NCT02347345 (5) [back to overview] | Gene Expression Profiles |
NCT02347345 (5) [back to overview] | sCD14 (ng/mL) |
NCT02347345 (5) [back to overview] | Virologic Response to Therapy as Measured by HCV RNA |
NCT02347345 (5) [back to overview] | Gene Expression Profiles |
NCT02347345 (5) [back to overview] | sCD14 (ng/mL) |
NCT02349048 (8) [back to overview] | Percentage of Participants With On-treatment Virologic Response |
NCT02349048 (8) [back to overview] | Percentage of Participants With On-Treatment Failure |
NCT02349048 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment |
NCT02349048 (8) [back to overview] | Number of Participants With Late Viral Relapse |
NCT02349048 (8) [back to overview] | Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR |
NCT02349048 (8) [back to overview] | Number of Participants With Viral Relapse |
NCT02349048 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12) |
NCT02349048 (8) [back to overview] | Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR |
NCT02350569 (5) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02350569 (5) [back to overview] | Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event |
NCT02350569 (5) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28 |
NCT02350569 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02350569 (5) [back to overview] | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02356562 (4) [back to overview] | Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment |
NCT02356562 (4) [back to overview] | Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment |
NCT02356562 (4) [back to overview] | Percentage of Participants With On-treatment Virologic Failure |
NCT02356562 (4) [back to overview] | Percentage of Participants With Post-Treatment Relapse |
NCT02358044 (6) [back to overview] | Percentage of Participants Discontinuing Study Treatment Due to an AE |
NCT02358044 (6) [back to overview] | Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days |
NCT02358044 (6) [back to overview] | Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days |
NCT02358044 (6) [back to overview] | Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12) |
NCT02358044 (6) [back to overview] | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24) |
NCT02358044 (6) [back to overview] | Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4) |
NCT02378935 (10) [back to overview] | HCV RNA Change From Baseline |
NCT02378935 (10) [back to overview] | HCV RNA Change From Baseline |
NCT02378935 (10) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02378935 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02378935 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02378935 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02378935 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02378935 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02378935 (10) [back to overview] | HCV RNA Change From Baseline |
NCT02378935 (10) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02378961 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02378961 (10) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02378961 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02378961 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02378961 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02378961 (10) [back to overview] | HCV RNA Change From Baseline |
NCT02378961 (10) [back to overview] | HCV RNA Change From Baseline |
NCT02378961 (10) [back to overview] | HCV RNA Change From Baseline |
NCT02378961 (10) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02378961 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02399345 (3) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment |
NCT02399345 (3) [back to overview] | Percentage of Subjects With On-treatment Virologic Failure |
NCT02399345 (3) [back to overview] | Percentage of Subjects With Post-treatment Relapse |
NCT02413593 (6) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02413593 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02413593 (6) [back to overview] | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 |
NCT02413593 (6) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02413593 (6) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02413593 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12 |
NCT02421211 (19) [back to overview] | Percentage of Participants With Viral Relapse |
NCT02421211 (19) [back to overview] | Percentage of Participants With On-treatment Failure |
NCT02421211 (19) [back to overview] | Minimum Plasma Concentration (Cmin) of Simeprevir (SMV) |
NCT02421211 (19) [back to overview] | Minimum Plasma Concentration (Cmin) of Ledipasvir (LDV) |
NCT02421211 (19) [back to overview] | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT02421211 (19) [back to overview] | Maximum Plasma Concentration (Cmax) of Simeprevir |
NCT02421211 (19) [back to overview] | Maximum Plasma Concentration (Cmax) of Ledipasvir |
NCT02421211 (19) [back to overview] | Fluctuation Index (FI) of Simeprevir |
NCT02421211 (19) [back to overview] | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Ledipasvir |
NCT02421211 (19) [back to overview] | Percentage of Participants With On-treatment Virologic Response |
NCT02421211 (19) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks After the Actual EOT (SVR4) and 12 Weeks After the Actual EOT (SVR12) |
NCT02421211 (19) [back to overview] | Fluctuation Index (FI) of Ledipasvir |
NCT02421211 (19) [back to overview] | Average Plasma Concentration at Steady State (Cavg,ss) of Simeprevir |
NCT02421211 (19) [back to overview] | Average Plasma Concentration at Steady State (Cavg,ss) of Ledipasvir |
NCT02421211 (19) [back to overview] | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Simeprevir |
NCT02421211 (19) [back to overview] | Trough Plasma Concentration (Ctrough) of Simeprevir |
NCT02421211 (19) [back to overview] | Trough Plasma Concentration (Ctrough) of Ledipasvir |
NCT02421211 (19) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir |
NCT02421211 (19) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) of Ledipasvir |
NCT02455167 (3) [back to overview] | Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: 12 Weeks |
NCT02455167 (3) [back to overview] | Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: Baseline |
NCT02455167 (3) [back to overview] | The Sustained Virologic Response (SVR) in Patients Infected With HCV Genotype 1, Cirrhosis, and Early Clinical Decompensation |
NCT02457611 (9) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02457611 (9) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02457611 (9) [back to overview] | Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 |
NCT02457611 (9) [back to overview] | Change From Baseline in HCV RNA at Weeks 2, 4, and 6 |
NCT02457611 (9) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4) |
NCT02457611 (9) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12) |
NCT02457611 (9) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02457611 (9) [back to overview] | Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study. |
NCT02457611 (9) [back to overview] | Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4 |
NCT02468648 (4) [back to overview] | Number of Participants Who Sustained Virologic Response |
NCT02468648 (4) [back to overview] | Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ) |
NCT02468648 (4) [back to overview] | Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ) |
NCT02468648 (4) [back to overview] | Number of Participants With Sustained Virologic Response |
NCT02472886 (8) [back to overview] | Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE) |
NCT02472886 (8) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02472886 (8) [back to overview] | Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 |
NCT02472886 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02472886 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02472886 (8) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02472886 (8) [back to overview] | For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4 |
NCT02472886 (8) [back to overview] | HCV RNA Change From Day 1 |
NCT02480712 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02480712 (8) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02480712 (8) [back to overview] | Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment |
NCT02480712 (8) [back to overview] | HCV RNA Change From Baseline/Day 1 |
NCT02480712 (8) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02480712 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02480712 (8) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02480712 (8) [back to overview] | Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12 |
NCT02487030 (4) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02487030 (4) [back to overview] | Percentage of Participants With Overall Virologic Failure |
NCT02487030 (4) [back to overview] | Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE) |
NCT02487030 (4) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02503735 (6) [back to overview] | The Percent Change in Proteinuria |
NCT02503735 (6) [back to overview] | Change in Urinary β-2microglobulin Levels After Therapy |
NCT02503735 (6) [back to overview] | Number of Participants With ≥25% Reduction in Proteinuria |
NCT02503735 (6) [back to overview] | Median Change in eGFR From Baseline to Timepoint Week 52 |
NCT02503735 (6) [back to overview] | Median Change in eGFR From Baseline to Timepoint Week 24 |
NCT02503735 (6) [back to overview] | Mean Time in Weeks to Maximum Reduction in Proteinuria |
NCT02536313 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT02536313 (6) [back to overview] | HCV RNA Change From Baseline/Day 1 Through Week 12 |
NCT02536313 (6) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02536313 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12) |
NCT02536313 (6) [back to overview] | Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event |
NCT02536313 (6) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02541409 (4) [back to overview] | HCV Treatment Completion |
NCT02541409 (4) [back to overview] | Sustained Virologic Response (SVR) |
NCT02541409 (4) [back to overview] | Serious Adverse Events |
NCT02541409 (4) [back to overview] | Change in Insulin Resistance |
NCT02600351 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation of Therapy (SVR12) |
NCT02600351 (6) [back to overview] | Percentage of Participants With Viral Breakthrough |
NCT02600351 (6) [back to overview] | Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment |
NCT02600351 (6) [back to overview] | Percentage of Participants With Viral Relapse |
NCT02600351 (6) [back to overview] | Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event |
NCT02600351 (6) [back to overview] | Number of Participants With Emerging Resistance |
NCT02601573 (4) [back to overview] | Percentage of Participants Experiencing an Adverse Event (AE) |
NCT02601573 (4) [back to overview] | Percentage of Participants Discontinuing From Study Therapy Due to an AE |
NCT02601573 (4) [back to overview] | Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy) |
NCT02601573 (4) [back to overview] | Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy) |
NCT02605304 (11) [back to overview] | Number of Participants With HIV-1 RNA >50 Copies/mL |
NCT02605304 (11) [back to overview] | Number of Participants With Unquantifiable HCV RNA |
NCT02605304 (11) [back to overview] | Number of Participants With Unquantifiable HCV RNA |
NCT02605304 (11) [back to overview] | Percentage of Participants With Protocol-specified Renal Events |
NCT02605304 (11) [back to overview] | CD4+ T-cell (CD4) Count Change From Baseline |
NCT02605304 (11) [back to overview] | Percentage of Participants With Sustained Virologic Response at 4 Weeks After Treatment Discontinuation (SVR4) |
NCT02605304 (11) [back to overview] | Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12) |
NCT02605304 (11) [back to overview] | CD4+ T-cell (CD4) Count Change From Baseline |
NCT02605304 (11) [back to overview] | Number of Participants With HIV-1 RNA >50 Copies/mL |
NCT02605304 (11) [back to overview] | Percentage of Participants With Grade 3 or Higher Adverse Event (AE), Serious AE (SAE), or AE Reported as the Reason for Permanent Discontinuation of Study Treatment |
NCT02605304 (11) [back to overview] | Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24) |
NCT02607735 (11) [back to overview] | Change From Baseline in HCV RNA (Primary Study) |
NCT02607735 (11) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study) |
NCT02607735 (11) [back to overview] | Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study) |
NCT02607735 (11) [back to overview] | Change From Baseline in HCV RNA (Deferred Treatment Substudy) |
NCT02607735 (11) [back to overview] | Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study) |
NCT02607735 (11) [back to overview] | Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy) |
NCT02607735 (11) [back to overview] | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study) |
NCT02607735 (11) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study) |
NCT02607735 (11) [back to overview] | Percentage of Participants With Virologic Failure (Deferred Treatment Substudy) |
NCT02607735 (11) [back to overview] | Percentage of Participants With Virologic Failure (Primary Study) |
NCT02607735 (11) [back to overview] | Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy) |
NCT02607800 (8) [back to overview] | Change From Baseline in HCV RNA |
NCT02607800 (8) [back to overview] | Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event |
NCT02607800 (8) [back to overview] | Percentage of Participants With HCV RNA < LLOQ On Treatment |
NCT02607800 (8) [back to overview] | Percentage of Participants With HCV RNA < LLOQ On Treatment |
NCT02607800 (8) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02607800 (8) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02607800 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02607800 (8) [back to overview] | Change From Baseline in HCV RNA |
NCT02613871 (16) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02613871 (16) [back to overview] | HCV RNA Change From Baseline While on Treatment |
NCT02613871 (16) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 |
NCT02613871 (16) [back to overview] | Plasma HBV DNA Change From Baseline While on Treatment |
NCT02613871 (16) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment |
NCT02613871 (16) [back to overview] | Serum LOXL-2 Level Change From Baseline While on Treatment |
NCT02613871 (16) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02613871 (16) [back to overview] | Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug |
NCT02613871 (16) [back to overview] | Percentage of Participants That Required HBV Therapy During the Study |
NCT02613871 (16) [back to overview] | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 |
NCT02613871 (16) [back to overview] | Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study |
NCT02613871 (16) [back to overview] | Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36 |
NCT02613871 (16) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02613871 (16) [back to overview] | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 |
NCT02613871 (16) [back to overview] | HBsAg Level Change From Baseline While on Treatment |
NCT02613871 (16) [back to overview] | Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108 |
NCT02625909 (4) [back to overview] | Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Intention-to-treat (ITT) Population |
NCT02625909 (4) [back to overview] | Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Modified Intention-to-treat (ITT) Population |
NCT02625909 (4) [back to overview] | Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Per Protocol (PP) Population |
NCT02625909 (4) [back to overview] | Number of Participants With Undetectable HCV RNA at End of Treatment (ETR) of SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Intention-to-treat (ITT) Population |
NCT02631772 (3) [back to overview] | Number of Participants With Virologic Failure |
NCT02631772 (3) [back to overview] | Treatment Efficacy |
NCT02631772 (3) [back to overview] | Hemoglobin Levels |
NCT02639247 (6) [back to overview] | Percentage of Participants With HCV RNA < LLOQ On Treatment |
NCT02639247 (6) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02639247 (6) [back to overview] | Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event |
NCT02639247 (6) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02639247 (6) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02639247 (6) [back to overview] | Change From Baseline in HCV RNA |
NCT02639338 (8) [back to overview] | Percentage of Participants With HCV RNA < LLOQ On Treatment |
NCT02639338 (8) [back to overview] | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
NCT02639338 (8) [back to overview] | Change From Baseline in HCV RNA |
NCT02639338 (8) [back to overview] | Change From Baseline in HCV RNA |
NCT02639338 (8) [back to overview] | Percentage of Participants With HCV RNA < LLOQ On Treatment |
NCT02639338 (8) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02639338 (8) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02639338 (8) [back to overview] | Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event |
NCT02640157 (5) [back to overview] | Percentage of Participants With On-treatment Virologic Failure |
NCT02640157 (5) [back to overview] | Percentage of Participants With Post-treatment Relapse |
NCT02640157 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B |
NCT02640157 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A |
NCT02640157 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B |
NCT02671500 (7) [back to overview] | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT02671500 (7) [back to overview] | Change From Baseline in HCV RNA |
NCT02671500 (7) [back to overview] | Percentage of Participants With HCV RNA < LLOQ On Treatment |
NCT02671500 (7) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02671500 (7) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02671500 (7) [back to overview] | Percentage of Participants With Overall Virologic Failure |
NCT02671500 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02707601 (4) [back to overview] | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm |
NCT02707601 (4) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4) |
NCT02707601 (4) [back to overview] | Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment |
NCT02707601 (4) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12) |
NCT02722837 (15) [back to overview] | Change From Baseline in HCV RNA at Week 8 |
NCT02722837 (15) [back to overview] | Change From Baseline in HCV RNA at Week 12 |
NCT02722837 (15) [back to overview] | Change From Baseline in HCV RNA at Week 1 |
NCT02722837 (15) [back to overview] | Change From Baseline in HCV RNA at Week 2 |
NCT02722837 (15) [back to overview] | Change From Baseline in HCV RNA at Week 4 |
NCT02722837 (15) [back to overview] | Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event |
NCT02722837 (15) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT02722837 (15) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02722837 (15) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12 |
NCT02722837 (15) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2 |
NCT02722837 (15) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4 |
NCT02722837 (15) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8 |
NCT02722837 (15) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02722837 (15) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02722837 (15) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1 |
NCT02723084 (4) [back to overview] | Percentage of Participants With With On-treatment Virologic Failure |
NCT02723084 (4) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Non-inferiority of Arm A to Arm B |
NCT02723084 (4) [back to overview] | Percentage of Participants With Post-Treatment Relapse |
NCT02723084 (4) [back to overview] | Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
NCT02728206 (5) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02728206 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02728206 (5) [back to overview] | Percentage of Participants With Overall Virologic Failure |
NCT02728206 (5) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02728206 (5) [back to overview] | Percentage of Participants With HCV RNA < LLOQ On Treatment |
NCT02738333 (23) [back to overview] | Change From Baseline in HCV RNA at Week 10 |
NCT02738333 (23) [back to overview] | Change From Baseline in HCV RNA at Week 1 |
NCT02738333 (23) [back to overview] | Change From Baseline in HCV RNA at Week 12 |
NCT02738333 (23) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02738333 (23) [back to overview] | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT02738333 (23) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02738333 (23) [back to overview] | Percentage of Participants With Overall Virologic Failure |
NCT02738333 (23) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 8 |
NCT02738333 (23) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 6 |
NCT02738333 (23) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 5 |
NCT02738333 (23) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 4 |
NCT02738333 (23) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 3 |
NCT02738333 (23) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 2 |
NCT02738333 (23) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 12 |
NCT02738333 (23) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 10 |
NCT02738333 (23) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 1 |
NCT02738333 (23) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02738333 (23) [back to overview] | Change From Baseline in HCV RNA at Week 8 |
NCT02738333 (23) [back to overview] | Change From Baseline in HCV RNA at Week 6 |
NCT02738333 (23) [back to overview] | Change From Baseline in HCV RNA at Week 5 |
NCT02738333 (23) [back to overview] | Change From Baseline in HCV RNA at Week 4 |
NCT02738333 (23) [back to overview] | Change From Baseline in HCV RNA at Week 3 |
NCT02738333 (23) [back to overview] | Change From Baseline in HCV RNA at Week 2 |
NCT02745535 (5) [back to overview] | Number of Participants Who Achieve End of Treatment Virologic Response (ETR) at Completion of Therapy. |
NCT02745535 (5) [back to overview] | Number of Participants Who Achieve Sustained Virologic Response (SVR) 12 Weeks After Completion of Therapy (SVR12) |
NCT02745535 (5) [back to overview] | Number of Participants Who Achieve Sustained Virologic Response (SVR) 24 Weeks After Completion of Therapy. |
NCT02745535 (5) [back to overview] | Number of Participants Who Achieve Sustained Virologic Response (SVR) 4 Weeks After Completion of Therapy. |
NCT02745535 (5) [back to overview] | Number of Participants With Grade 3 and 4 Adverse Events |
NCT02759861 (2) [back to overview] | Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR |
NCT02759861 (2) [back to overview] | The Number of Subjects Who Achieve Negative RNA in Alcoholics |
NCT02781558 (16) [back to overview] | HCV RNA at Week 2 |
NCT02781558 (16) [back to overview] | HCV RNA at Week 12 |
NCT02781558 (16) [back to overview] | Change From Baseline in HCV RNA at Week 8 |
NCT02781558 (16) [back to overview] | Change From Baseline in HCV RNA at Week 4 |
NCT02781558 (16) [back to overview] | Change From Baseline in HCV RNA at Week 2 |
NCT02781558 (16) [back to overview] | Change From Baseline in HCV RNA at Week 12 |
NCT02781558 (16) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02781558 (16) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12) |
NCT02781558 (16) [back to overview] | HCV RNA at Week 4 |
NCT02781558 (16) [back to overview] | Percentage of Participants Who Have HCV RNA < LLOQ at Week 8 |
NCT02781558 (16) [back to overview] | Percentage of Participants Who Have HCV RNA < LLOQ at Week 4 |
NCT02781558 (16) [back to overview] | Percentage of Participants Who Have HCV RNA < LLOQ at Week 2 |
NCT02781558 (16) [back to overview] | Percentage of Participants Who Have HCV RNA < LLOQ at Week 12 |
NCT02781558 (16) [back to overview] | Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4) |
NCT02781558 (16) [back to overview] | HCV RNA at Week 8 |
NCT02781558 (16) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event |
NCT02781571 (16) [back to overview] | Change From Baseline in HCV RNA at Week 4 |
NCT02781571 (16) [back to overview] | Change From Baseline in HCV RNA at Week 2 |
NCT02781571 (16) [back to overview] | Change From Baseline in HCV RNA at Week 12 |
NCT02781571 (16) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02781571 (16) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4) |
NCT02781571 (16) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12) |
NCT02781571 (16) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 8 |
NCT02781571 (16) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 4 |
NCT02781571 (16) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 2 |
NCT02781571 (16) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 12 |
NCT02781571 (16) [back to overview] | Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event |
NCT02781571 (16) [back to overview] | HCV RNA at Week 8 |
NCT02781571 (16) [back to overview] | HCV RNA at Week 4 |
NCT02781571 (16) [back to overview] | HCV RNA at Week 2 |
NCT02781571 (16) [back to overview] | HCV RNA at Week 12 |
NCT02781571 (16) [back to overview] | Change From Baseline in HCV RNA at Week 8 |
NCT02781649 (6) [back to overview] | Number of Participants With Grade 3 or Higher Treatment-related Adverse Events as US Department of Health and Human Services Common Terminology of Adverse Events (CTCAE) Version 4 |
NCT02781649 (6) [back to overview] | Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Mutations in the HCV Population From the Deceased Donors |
NCT02781649 (6) [back to overview] | Viral Response |
NCT02781649 (6) [back to overview] | Kidney Function at 12 Months |
NCT02781649 (6) [back to overview] | Kidney Function at 6 Months |
NCT02781649 (6) [back to overview] | Antibody Development |
NCT02786537 (28) [back to overview] | HCV SVR Durability -No Cirrhosis |
NCT02786537 (28) [back to overview] | HCV SVR Durability-Patients With Cirrhosis |
NCT02786537 (28) [back to overview] | Median Change in Fatigue-Phase 2 |
NCT02786537 (28) [back to overview] | Median Change in Fatigue -Phase 1 |
NCT02786537 (28) [back to overview] | Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF |
NCT02786537 (28) [back to overview] | Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF |
NCT02786537 (28) [back to overview] | Mean Change in Nausea/Vomiting PRO Score -Phase 1 |
NCT02786537 (28) [back to overview] | Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2 |
NCT02786537 (28) [back to overview] | Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation |
NCT02786537 (28) [back to overview] | Change in Functional Status (HCV-PRO) Within Treatment |
NCT02786537 (28) [back to overview] | Treatment Non-Adherence Probability Estimates |
NCT02786537 (28) [back to overview] | Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV |
NCT02786537 (28) [back to overview] | Post-treatment Progression/Regression of Liver Disease-Fib-4 |
NCT02786537 (28) [back to overview] | Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) |
NCT02786537 (28) [back to overview] | Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation |
NCT02786537 (28) [back to overview] | Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) |
NCT02786537 (28) [back to overview] | Mean Change in Headache-PRO Scores -Phase 1 |
NCT02786537 (28) [back to overview] | Median Change in Nausea PROMIS Score-EBR/GZR SOF/LDV |
NCT02786537 (28) [back to overview] | Median Change in Nausea PRO Score -Phase 1 |
NCT02786537 (28) [back to overview] | Mean Change in Headache-EBR/GZR and SOF/LDV |
NCT02786537 (28) [back to overview] | Median Change in Headache -Phase 1 |
NCT02786537 (28) [back to overview] | Median Change in HCV-PRO (Overall Well Being) -Phase 1 |
NCT02786537 (28) [back to overview] | Mean Change in HCV-PRO (Functional Well-being) EBR/GZR vs. SOF/LDV Score-Phase 2 |
NCT02786537 (28) [back to overview] | Mean Change in HCV- PRO- Phase 1 |
NCT02786537 (28) [back to overview] | Median Change in Headache-Phase 2 |
NCT02786537 (28) [back to overview] | Mean Change in Fatigue PRO Score -Phase 1 |
NCT02786537 (28) [back to overview] | Mean Change in Fatigue PRO -EBR/GZR vs SOF/LDV |
NCT02786537 (28) [back to overview] | 16 Wk EBR/GZR With RBV Efficacy on Patients With HCV RASs |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 12 |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 16 |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 2 |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 20 |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 24 |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 3 |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 4 |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 5 |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 6 |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 8 |
NCT02822794 (29) [back to overview] | Percentage of Participants With Overall Virologic Failure |
NCT02822794 (29) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02822794 (29) [back to overview] | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT02822794 (29) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 1 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 10 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 12 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 16 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 2 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 20 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 24 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 3 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 4 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 5 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 6 |
NCT02822794 (29) [back to overview] | Change From Baseline in HCV RNA at Week 8 |
NCT02822794 (29) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 1 |
NCT02822794 (29) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at Week 10 |
NCT02825212 (2) [back to overview] | Response in Patients With Mixed Cryoglobulinemia (MC) |
NCT02825212 (2) [back to overview] | Sustained Virologic Response (SVR) |
NCT02858180 (4) [back to overview] | Number of Subjects With Sustained Virologic Response (SVR) 4 |
NCT02858180 (4) [back to overview] | Number of Subjects With Sustained Virologic Response (SVR) 12 |
NCT02858180 (4) [back to overview] | Number of Subjects Who Completed 24 Weeks of Therapy |
NCT02858180 (4) [back to overview] | Discontinuation for Adverse Events and Serious Adverse Events |
NCT02868242 (7) [back to overview] | Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event |
NCT02868242 (7) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT02868242 (7) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02868242 (7) [back to overview] | Percentage of Participants With Virologic Failure |
NCT02868242 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02868242 (7) [back to overview] | HCV RNA Change From Baseline/Day 1 |
NCT02868242 (7) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Treatment |
NCT02938013 (4) [back to overview] | Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy. |
NCT02938013 (4) [back to overview] | Reduction Over the First Week in Plasma HCV RNA |
NCT02938013 (4) [back to overview] | Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy |
NCT02938013 (4) [back to overview] | Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM). |
NCT02939989 (3) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
NCT02939989 (3) [back to overview] | Percentage of Participants With Post-treatment Relapse |
NCT02939989 (3) [back to overview] | Percentage of Participants With On-treatment Virologic Failure |
NCT02994056 (10) [back to overview] | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment |
NCT02994056 (10) [back to overview] | Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score |
NCT02994056 (10) [back to overview] | Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event |
NCT02994056 (10) [back to overview] | Absolute HCV RNA Level Through Week 12 |
NCT02994056 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT02994056 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT02994056 (10) [back to overview] | Number of Participants With Virologic Failure |
NCT02994056 (10) [back to overview] | Change From Baseline in HCV RNA |
NCT02994056 (10) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT02994056 (10) [back to overview] | Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class |
NCT03022981 (22) [back to overview] | Treatment Phase: Percentage of Participants With Virologic Failure |
NCT03022981 (22) [back to overview] | Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT03022981 (22) [back to overview] | Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT03022981 (22) [back to overview] | Treatment Phase: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT03022981 (22) [back to overview] | Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE) |
NCT03022981 (22) [back to overview] | Treatment Phase: Growth and Development as Measured by Parental Height |
NCT03022981 (22) [back to overview] | PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE) |
NCT03022981 (22) [back to overview] | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL) |
NCT03022981 (22) [back to overview] | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF) |
NCT03022981 (22) [back to overview] | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF) |
NCT03022981 (22) [back to overview] | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment |
NCT03022981 (22) [back to overview] | Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline |
NCT03022981 (22) [back to overview] | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey |
NCT03022981 (22) [back to overview] | Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment |
NCT03022981 (22) [back to overview] | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 |
NCT03022981 (22) [back to overview] | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 |
NCT03022981 (22) [back to overview] | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline |
NCT03022981 (22) [back to overview] | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 |
NCT03022981 (22) [back to overview] | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles |
NCT03022981 (22) [back to overview] | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles |
NCT03022981 (22) [back to overview] | Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age |
NCT03022981 (22) [back to overview] | PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7 |
NCT03036839 (20) [back to overview] | PK Parameter: AUCtau of SOF |
NCT03036839 (20) [back to overview] | PK Parameter: Cmax of SOF |
NCT03036839 (20) [back to overview] | HCV RNA |
NCT03036839 (20) [back to overview] | HCV RNA |
NCT03036839 (20) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT03036839 (20) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT03036839 (20) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT03036839 (20) [back to overview] | Change From Baseline in HCV RNA |
NCT03036839 (20) [back to overview] | Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event |
NCT03036839 (20) [back to overview] | Change From Baseline in HCV RNA |
NCT03036839 (20) [back to overview] | Change From Baseline in HCV RNA |
NCT03036839 (20) [back to overview] | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT03036839 (20) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT03036839 (20) [back to overview] | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT03036839 (20) [back to overview] | Percentage of Participants With Virologic Failure |
NCT03036839 (20) [back to overview] | Pharmacokinetics (PK) Parameter: AUCtau of LDV |
NCT03036839 (20) [back to overview] | PK Parameter: AUCtau of GS-331007 (Metabolite of SOF) |
NCT03036839 (20) [back to overview] | HCV RNA |
NCT03036839 (20) [back to overview] | PK Parameter: Cmax of GS-331007 (Metabolite of SOF) |
NCT03036839 (20) [back to overview] | PK Parameter: Cmax of LDV |
NCT03036852 (15) [back to overview] | Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment |
NCT03036852 (15) [back to overview] | Percentage of Participants With Virologic Failure |
NCT03036852 (15) [back to overview] | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) |
NCT03036852 (15) [back to overview] | Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) |
NCT03036852 (15) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT03036852 (15) [back to overview] | PK Parameter: Cmax of SOF |
NCT03036852 (15) [back to overview] | PK Parameter: Cmax of VEL |
NCT03036852 (15) [back to overview] | PK Parameter: Ctau of VEL |
NCT03036852 (15) [back to overview] | Change From Baseline in HCV RNA |
NCT03036852 (15) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT03036852 (15) [back to overview] | Pharmacokinetic (PK) Parameter: AUCtau of SOF |
NCT03036852 (15) [back to overview] | PK Parameter: AUCtau of VEL |
NCT03036852 (15) [back to overview] | PK Parameter: Cmax of GS-331007 (Metabolite of SOF) |
NCT03036852 (15) [back to overview] | Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event |
NCT03036852 (15) [back to overview] | PK Parameter: AUCtau of GS-331007 (Metabolite of SOF) |
NCT03057847 (6) [back to overview] | Number of Participants Achieving Sustained Virologic Response (SVR) |
NCT03057847 (6) [back to overview] | Number of Missed Treatment Doses |
NCT03057847 (6) [back to overview] | Number of Participants Reporting Treatment Side Effects |
NCT03057847 (6) [back to overview] | Intravenous Drug Use Recidivism |
NCT03057847 (6) [back to overview] | Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment |
NCT03057847 (6) [back to overview] | HCV Reinfection |
NCT03074331 (3) [back to overview] | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
NCT03074331 (3) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
NCT03074331 (3) [back to overview] | Percentage of Participants With Virologic Failure |
NCT03118674 (4) [back to overview] | Number of Participants With Resolution of Active PCT by 7 Months After Start of Therapy |
NCT03118674 (4) [back to overview] | Number of Participants With Complete Biochemical Remission of PCT |
NCT03118674 (4) [back to overview] | Number of Participants With Cure of CHC |
NCT03118674 (4) [back to overview] | Time to Resolution of Active PCT |
NCT03235154 (3) [back to overview] | Adherence to Study Treatment |
NCT03235154 (3) [back to overview] | Health-Related Quality of Life |
NCT03235154 (3) [back to overview] | Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment (SVR-12) |
NCT03236506 (1) [back to overview] | Adherence as Assessed by the Total Percentage of Tablets Taken (Out of Those Dispensed) During the Treatment Period |
NCT03312023 (3) [back to overview] | Change of Serum Hepatitis B Surface Antigen (HBsAg as Measured in log10 IU/mL) Level as an Indicator of Antiviral Activity of Ledipasvir and/or Sofosbuvir in Subjects With Chronic Hepatitis B From Baseline to End of 12 Weeks Treatment. |
NCT03312023 (3) [back to overview] | Changes in Serum Hepatitis B Virus DNA Levels (HBV DNA as Measured in IU/mL) With Treatment of Ledipasvir and/or Sofosbuvir From Baseline to End of 12 Weeks of Treatment in Subjects With Chronic Hepatitis B Infection. |
NCT03312023 (3) [back to overview] | Incidence of Adverse Events Leading to Permanent Discontinuation of Ledipasvir and/or Sofosbuvir Treatment in Subjects With Chronic Hepatitis B Infection. |
NCT03480932 (3) [back to overview] | Medication Adherence |
NCT03480932 (3) [back to overview] | Serious Adverse Events |
NCT03480932 (3) [back to overview] | SVR12 |
NCT03487848 (9) [back to overview] | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12 |
NCT03487848 (9) [back to overview] | Apparent Total Body Clearance (CLT/F) for Daclatasvir |
NCT03487848 (9) [back to overview] | Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir |
NCT03487848 (9) [back to overview] | Maximum Observed Plasma Concentration (Cmax) for Daclatasvir |
NCT03487848 (9) [back to overview] | Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis |
NCT03487848 (9) [back to overview] | Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir |
NCT03487848 (9) [back to overview] | Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis |
NCT03487848 (9) [back to overview] | Number of Participants Experiencing Adverse Events |
NCT03487848 (9) [back to overview] | Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir |
NCT03512210 (5) [back to overview] | Percentage of Participants Who Prematurely Discontinued HCV Study Medications |
NCT03512210 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response 12 (SVR12) |
NCT03512210 (5) [back to overview] | Percentage of Participants With at Least One Unplanned Clinic Visit Prior to SVR12 Evaluation |
NCT03512210 (5) [back to overview] | Percentage of Participants With an Occurrence of Serious Adverse Events According to International Council for Harmonization (ICH) Criteria |
NCT03512210 (5) [back to overview] | Percentage of Participants With an Occurrence of One or More Non-serious, Grade >= 3 Adverse Event (AE), or Treatment Limiting AE. |
NCT03619837 (3) [back to overview] | Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ) |
NCT03619837 (3) [back to overview] | Survival Rate of Patients and Their Allografts 6 Months Post Transplant |
NCT03619837 (3) [back to overview] | Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment |
NCT03801707 (4) [back to overview] | Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant |
NCT03801707 (4) [back to overview] | Graft Survival at 6 and 12 Months |
NCT03801707 (4) [back to overview] | Patient's Survival at 6 and 12 Months |
NCT03801707 (4) [back to overview] | Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment |
NCT03823911 (1) [back to overview] | Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein |
NCT04112303 (5) [back to overview] | Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug |
NCT04112303 (5) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24) |
NCT04112303 (5) [back to overview] | Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4) |
NCT04112303 (5) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12) |
NCT04112303 (5) [back to overview] | Percentage of Participants With Virologic Failure |
NCT04211909 (7) [back to overview] | Number of Participants With Alanine Aminotransferase (ALT) Normalization |
NCT04211909 (7) [back to overview] | Change From Baseline in HCV RNA |
NCT04211909 (7) [back to overview] | Percentage of Participants With Virologic Failure |
NCT04211909 (7) [back to overview] | Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment |
NCT04211909 (7) [back to overview] | Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment |
NCT04211909 (7) [back to overview] | Percentage of Participants With HCV RNA < LLOQ on Treatment |
NCT04211909 (7) [back to overview] | Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event |
Plasma Pharmacokinetics of GS-331007: Cmax at Day 27
The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir. (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Intervention | ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 233.79 |
Sofosbuvir 200 mg+PEG+RBV | 357.38 |
Sofosbuvir 400 mg+PEG+RBV | 717.23 |
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Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0
"The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir.~Cmax is defined as the maximum concentration of drug." (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Intervention | ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 218.08 |
Sofosbuvir 200 mg+PEG+RBV | 332.26 |
Sofosbuvir 400 mg+PEG+RBV | 1257.50 |
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Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27
"The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir).~AUCtau is defined as the concentration of drug (area under the plasma concentration versus time curve) over the dosing interval." (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Intervention | h*ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 375.70 |
Sofosbuvir 200 mg+PEG+RBV | 732.27 |
Sofosbuvir 400 mg+PEG+RBV | 2011.23 |
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Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0
"The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir).~AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time." (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Intervention | h*ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 280.19 |
Sofosbuvir 200 mg+PEG+RBV | 585.56 |
Sofosbuvir 400 mg+PEG+RBV | 1867.24 |
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Plasma Pharmacokinetics of GS-566500: Cmax at Day 27
The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir. (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Intervention | ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 64.75 |
Sofosbuvir 200 mg+PEG+RBV | 132.72 |
Sofosbuvir 400 mg+PEG+RBV | 237.46 |
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Plasma Pharmacokinetics of GS-566500: Cmax at Day 0
The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir. GS-566500 is one of the major metabolites of sofosbuvir. (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Intervention | ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 69.99 |
Sofosbuvir 200 mg+PEG+RBV | 145.51 |
Sofosbuvir 400 mg+PEG+RBV | 293.35 |
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Plasma Pharmacokinetics of GS-331007: Cmax at Day 0
The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir. GS-331007 is the predominant circulating metabolite of sofosbuvir. (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Intervention | ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 197.32 |
Sofosbuvir 200 mg+PEG+RBV | 357.33 |
Sofosbuvir 400 mg+PEG+RBV | 662.13 |
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Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27
The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir. (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Intervention | ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 253.54 |
Sofosbuvir 200 mg+PEG+RBV | 475.14 |
Sofosbuvir 400 mg+PEG+RBV | 1355.65 |
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Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27
The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir). (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Intervention | h*ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 262.00 |
Sofosbuvir 200 mg+PEG+RBV | 571.95 |
Sofosbuvir 400 mg+PEG+RBV | 1072.91 |
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Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0
The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir). (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Intervention | h*ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 266.22 |
Sofosbuvir 200 mg+PEG+RBV | 645.95 |
Sofosbuvir 400 mg+PEG+RBV | 1315.94 |
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Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event. (NCT01054729)
Timeframe: Baseline to Week 4
Intervention | percentage of participants (Number) |
---|
| Any AE | Drug-related AE | Grade 3 or higher AE | AE leading to drug discontinuation/interruption | Serious AE |
---|
Placebo+PEG+RBV | 85.7 | 42.9 | 0.0 | 0.0 | 0.0 |
,Sofosbuvir 100 mg+PEG+RBV | 87.5 | 12.5 | 0.0 | 0.0 | 0.0 |
,Sofosbuvir 200 mg+PEG+RBV | 83.3 | 27.8 | 0.0 | 0.0 | 0.0 |
,Sofosbuvir 400 mg+PEG+RBV | 86.7 | 33.3 | 0.0 | 0.0 | 0.0 |
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Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27
The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir). (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Intervention | h*ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 2256.81 |
Sofosbuvir 200 mg+PEG+RBV | 3389.23 |
Sofosbuvir 400 mg+PEG+RBV | 7398.99 |
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Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0
The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir). (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Intervention | h*ng/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | 2173.18 |
Sofosbuvir 200 mg+PEG+RBV | 3984.88 |
Sofosbuvir 400 mg+PEG+RBV | 7559.91 |
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Percentage of Participants With Rapid Virologic Response at Week 4
Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4. (NCT01054729)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
Sofosbuvir 100 mg+PEG+RBV | 87.5 |
Sofosbuvir 200 mg+PEG+RBV | 94.4 |
Sofosbuvir 400 mg+PEG+RBV | 93.3 |
Placebo+PEG+RBV | 21.4 |
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Percentage of Participants Who Developed Resistance to Sofosbuvir
(NCT01054729)
Timeframe: Baseline to Week 4
Intervention | percentage of participants (Number) |
---|
Sofosbuvir 100 mg+PEG+RBV | 0.0 |
Sofosbuvir 200 mg+PEG+RBV | 0.0 |
Sofosbuvir 400 mg+PEG+RBV | 0.0 |
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Change in Circulating HCV RNA at Week 4
(NCT01054729)
Timeframe: Baseline to Week 4
Intervention | log10 IU/mL (Mean) |
---|
Sofosbuvir 100 mg+PEG+RBV | -5.323 |
Sofosbuvir 200 mg+PEG+RBV | -5.081 |
Sofosbuvir 400 mg+PEG+RBV | -5.346 |
Placebo+PEG+RBV | -2.8 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment
SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA < LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV). (NCT01054729)
Timeframe: Post-treatment Weeks 12 and 24
Intervention | percentage of participants (Number) |
---|
| SVR12 | SVR24 |
---|
Placebo+PEG+RBV | 50.0 | 42.9 |
,Sofosbuvir 100 mg+PEG+RBV | 56.3 | 56.3 |
,Sofosbuvir 200 mg+PEG+RBV | 72.2 | 83.3 |
,Sofosbuvir 400 mg+PEG+RBV | 86.7 | 80.0 |
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Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose
Intervention | ng•h/mL (Mean) |
---|
Sofosbuvir 200 mg (Genotype 1) | 3020.30 |
Sofosbuvir 400 mg (Genotype 1) | 8620.07 |
Sofosbuvir 400 mg (Genotype 2/3) | 5738.61 |
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Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)
SVR12 and SVR24 were defined as HCV RNA below the limit of detection (< 15 IU/mL) at post-treatment Weeks 12 and 24, respectively. (NCT01188772)
Timeframe: Post-treatment Weeks 12 and 24
Intervention | percentage of participants (Number) |
---|
| SVR12 | SVR24 |
---|
Placebo (Genotype 1) | 57.7 | 57.7 |
,Sofosbuvir 200 mg (Genotype 1) | 89.6 | 89.6 |
,Sofosbuvir 400 mg (Genotype 1) | 91.5 | 91.5 |
,Sofosbuvir 400 mg (Genotype 2/3) | 92.0 | 92.0 |
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Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event. (NCT01188772)
Timeframe: Baseline to Week 12 plus 30 days
Intervention | percentage of participants (Number) |
---|
| Any AE | Drug-related AE | Grade 3 or higher AE | AE leading to drug discontinuation | Serious AE |
---|
Placebo (Genotype 1) | 100.0 | 100.0 | 11.5 | 11.5 | 3.8 |
,Sofosbuvir 200 mg (Genotype 1) | 97.9 | 97.9 | 10.4 | 4.2 | 2.1 |
,Sofosbuvir 400 mg (Genotype 1) | 97.9 | 95.7 | 21.3 | 6.4 | 6.4 |
,Sofosbuvir 400 mg (Genotype 2/3) | 96.0 | 96.0 | 12.0 | 0.0 | 0.0 |
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Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose
Intervention | ng/mL (Mean) |
---|
Sofosbuvir 200 mg (Genotype 1) | 331.48 |
Sofosbuvir 400 mg (Genotype 1) | 750.78 |
Sofosbuvir 400 mg (Genotype 2/3) | 518.18 |
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Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose
Intervention | ng/mL (Mean) |
---|
Sofosbuvir 200 mg (Genotype 1) | 285.77 |
Sofosbuvir 400 mg (Genotype 1) | 897.41 |
Sofosbuvir 400 mg (Genotype 2/3) | 574.13 |
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Percentage of Participants With Virologic Response at the End of Treatment
End-of-treatment virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at the last on-treatment visit. (NCT01188772)
Timeframe: Week 48 (genotype 1) or Week 12 (genotype 2/3)
Intervention | percentage of participants (Number) |
---|
Sofosbuvir 200 mg (Genotype 1) | 93.8 |
Sofosbuvir 400 mg (Genotype 1) | 100.0 |
Placebo (Genotype 1) | 61.5 |
Sofosbuvir 400 mg (Genotype 2/3) | 100.0 |
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Percentage of Participants With Rapid Virologic Response at Week 4
Rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) (NCT01188772)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
Sofosbuvir 200 mg (Genotype 1) | 97.9 |
Sofosbuvir 400 mg (Genotype 1) | 97.9 |
Placebo (Genotype 1) | 19.2 |
Sofosbuvir 400 mg (Genotype 2/3) | 96.0 |
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Percentage of Participants With Extended Rapid Virologic Response
Extended rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) which was maintained through Week 12. (NCT01188772)
Timeframe: Week 4 to Week 12
Intervention | percentage of participants (Number) |
---|
Sofosbuvir 200 mg (Genotype 1) | 97.9 |
Sofosbuvir 400 mg (Genotype 1) | 91.5 |
Placebo (Genotype 1) | 19.2 |
Sofosbuvir 400 mg (Genotype 2/3) | 96.0 |
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Percentage of Participants With Complete Early Virologic Response at Week 12
Complete early virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 12 (NCT01188772)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Sofosbuvir 200 mg (Genotype 1) | 100.0 |
Sofosbuvir 400 mg (Genotype 1) | 91.5 |
Placebo (Genotype 1) | 61.5 |
Sofosbuvir 400 mg (Genotype 2/3) | 96.0 |
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Percentage of Participants Who Developed Resistance to Sofosbuvir
Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24. (NCT01188772)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
Sofosbuvir 200 mg (Genotype 1) | 0.0 |
Sofosbuvir 400 mg (Genotype 1) | 0.0 |
Sofosbuvir 400 mg (Genotype 2/3) | 0.0 |
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Change in HCV RNA From Baseline to Week 12
(NCT01188772)
Timeframe: Baseline to Week 12
Intervention | log10 IU/mL (Mean) |
---|
Sofosbuvir 200 mg (Genotype 1) | -5.39 |
Sofosbuvir 400 mg (Genotype 1) | -5.20 |
Placebo (Genotype 1) | -4.16 |
Sofosbuvir 400 mg (Genotype 2/3) | -4.95 |
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Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose
Intervention | ng•h/mL (Mean) |
---|
Sofosbuvir 200 mg (Genotype 1) | 2789.62 |
Sofosbuvir 400 mg (Genotype 1) | 9191.86 |
Sofosbuvir 400 mg (Genotype 2/3) | 5874.52 |
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Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose
Intervention | ng•h/mL (Mean) |
---|
Sofosbuvir 200 mg (Genotype 1) | 3178.53 |
Sofosbuvir 400 mg (Genotype 1) | 11245.43 |
Sofosbuvir 400 mg (Genotype 2/3) | 5465.41 |
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Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose
Intervention | ng/mL (Mean) |
---|
Sofosbuvir 200 mg (Genotype 1) | 269.93 |
Sofosbuvir 400 mg (Genotype 1) | 1087.21 |
Sofosbuvir 400 mg (Genotype 2/3) | 515.13 |
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Percentage of Participants With HCV RNA < LOD at Week 12
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. (NCT01260350)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN | 100.0 |
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN | 100.0 |
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN | 100.0 |
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN | 100.0 |
Group 5: SOF 12 wk: GT 2 or 3, TN | 100.0 |
Group 7: SOF+RBV 12 wk: GT 1, TE | 100.0 |
Group 8: SOF+RBV 12 wk: GT 1, TN | 100.0 |
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE | 100.0 |
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN | 100.0 |
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE | 100.0 |
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN | 100.0 |
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE | 100.0 |
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN | 100.0 |
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis | 100.0 |
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis | 100.0 |
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN | 100.0 |
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac | 100.0 |
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Percentage of Participants With HCV RNA < LOD at Week 6
(NCT01260350)
Timeframe: Week 6
Intervention | percentage of participants (Number) |
---|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN | 100.0 |
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN | 100.0 |
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN | 100.0 |
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN | 100.0 |
Group 5: SOF 12 wk: GT 2 or 3, TN | 100.0 |
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN | 100.0 |
Group 7: SOF+RBV 12 wk: GT 1, TE | 100.0 |
Group 8: SOF+RBV 12 wk: GT 1, TN | 100.0 |
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE | 100.0 |
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN | 100.0 |
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN | 100.0 |
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE | 100.0 |
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN | 100.0 |
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE | 100.0 |
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN | 100.0 |
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis | 100.0 |
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis | 100.0 |
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN | 100.0 |
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac | 100.0 |
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN | 100.0 |
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Percentage of Participants With Virologic Failure
"The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.~On-treatment virologic failure was defined as:~Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment),~Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or~Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)~Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit." (NCT01260350)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| On-treatment virologic failure | Viral relapse |
---|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN | 0.0 | 0.0 |
,Group 10: SOF+RBV 8 wk: GT 2 or 3, TN | 0.0 | 36.0 |
,Group 11: SOF+RBV 12 wk: GT 2 or 3, TN | 0.0 | 40.0 |
,Group 12: SOF+RBV+LDV 12 wk: GT 1, TE | 0.0 | 0.0 |
,Group 13: SOF+RBV+LDV 12 wk: GT 1, TN | 0.0 | 0.0 |
,Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE | 0.0 | 0.0 |
,Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN | 0.0 | 8.0 |
,Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis | 0.0 | 30.0 |
,Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis | 0.0 | 0.0 |
,Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN | 0.0 | 20.0 |
,Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN | 0.0 | 0.0 |
,Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac | 0.0 | 0.0 |
,Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN | 0.0 | 32.0 |
,Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN | 0.0 | 0.0 |
,Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN | 0.0 | 0.0 |
,Group 5: SOF 12 wk: GT 2 or 3, TN | 0.0 | 40.0 |
,Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN | 0.0 | 0.0 |
,Group 7: SOF+RBV 12 wk: GT 1, TE | 0.0 | 90.0 |
,Group 8: SOF+RBV 12 wk: GT 1, TN | 0.0 | 16.0 |
,Group 9: SOF+RBV 12 wk: GT 2 or 3, TE | 0.0 | 32.0 |
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Percentage of Participants Who Experienced Adverse Events
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event. (NCT01260350)
Timeframe: Up to 12 weeks plus 30 days
Intervention | Percentage of participants (Number) |
---|
| Any AE | Drug-related AE | Grade 3 or higher AE | AE leading to drug discontinuation | Serious AE |
---|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN | 10 | 8 | 0 | 0 | 1 |
,Group 10: SOF+RBV 8 wk: GT 2 or 3, TN | 25 | 21 | 1 | 0 | 2 |
,Group 11: SOF+RBV 12 wk: GT 2 or 3, TN | 10 | 7 | 0 | 0 | 0 |
,Group 12: SOF+RBV+LDV 12 wk: GT 1, TE | 9 | 9 | 0 | 0 | 0 |
,Group 13: SOF+RBV+LDV 12 wk: GT 1, TN | 24 | 24 | 3 | 1 | 2 |
,Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE | 10 | 10 | 0 | 0 | 0 |
,Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN | 25 | 21 | 2 | 0 | 0 |
,Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis | 7 | 5 | 0 | 0 | 0 |
,Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis | 8 | 8 | 1 | 0 | 0 |
,Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN | 7 | 6 | 0 | 0 | 0 |
,Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN | 9 | 9 | 2 | 0 | 0 |
,Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac | 13 | 12 | 1 | 3 | 2 |
,Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN | 22 | 19 | 0 | 2 | 0 |
,Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN | 10 | 10 | 0 | 0 | 0 |
,Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN | 11 | 11 | 1 | 1 | 0 |
,Group 5: SOF 12 wk: GT 2 or 3, TN | 10 | 7 | 0 | 0 | 0 |
,Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN | 10 | 10 | 3 | 0 | 1 |
,Group 7: SOF+RBV 12 wk: GT 1, TE | 10 | 10 | 0 | 0 | 0 |
,Group 8: SOF+RBV 12 wk: GT 1, TN | 25 | 25 | 1 | 0 | 1 |
,Group 9: SOF+RBV 12 wk: GT 2 or 3, TE | 24 | 20 | 0 | 0 | 0 |
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Change From Baseline in HCV RNA at Week 8
Data are not presented for Group 21 which ended treatment after Week 6. (NCT01260350)
Timeframe: Baseline to Week 8
Intervention | log10 IU/mL (Mean) |
---|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN | -5.52 |
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN | -5.44 |
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN | -5.23 |
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN | -5.20 |
Group 5: SOF 12 wk: GT 2 or 3, TN | -4.59 |
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN | -4.94 |
Group 7: SOF+RBV 12 wk: GT 1, TE | -5.70 |
Group 8: SOF+RBV 12 wk: GT 1, TN | -4.95 |
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE | -5.38 |
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN | -4.92 |
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN | -5.01 |
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE | -5.74 |
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN | -4.80 |
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE | -5.84 |
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN | -5.19 |
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis | -5.36 |
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis | -5.18 |
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN | -4.93 |
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac | -5.35 |
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Change From Baseline in HCV RNA at Week 6
(NCT01260350)
Timeframe: Baseline to Week 6
Intervention | log10 IU/mL (Mean) |
---|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN | -5.52 |
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN | -5.44 |
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN | -5.23 |
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN | -5.20 |
Group 5: SOF 12 wk: GT 2 or 3, TN | -6.23 |
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN | -4.94 |
Group 7: SOF+RBV 12 wk: GT 1, TE | -5.70 |
Group 8: SOF+RBV 12 wk: GT 1, TN | -4.95 |
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE | -5.38 |
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN | -4.92 |
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN | -5.01 |
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE | -5.74 |
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN | -4.80 |
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE | -5.84 |
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN | -5.19 |
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis | -5.36 |
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis | -5.18 |
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN | -4.93 |
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac | -5.35 |
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN | -5.39 |
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Change From Baseline in HCV RNA at Week 12
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules. (NCT01260350)
Timeframe: Baseline to Week 12
Intervention | log10 IU/mL (Mean) |
---|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN | -5.52 |
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN | -5.44 |
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN | -5.23 |
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN | -5.20 |
Group 5: SOF 12 wk: GT 2 or 3, TN | -4.59 |
Group 7: SOF+RBV 12 wk: GT 1, TE | -5.70 |
Group 8: SOF+RBV 12 wk: GT 1, TN | -4.95 |
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE | -5.39 |
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN | -2.01 |
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE | -5.74 |
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN | -4.85 |
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE | -5.84 |
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN | -5.19 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug. (NCT01260350)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN | 100.0 |
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN | 100.0 |
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN | 100.0 |
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN | 100.0 |
Group 5: SOF 12 wk: GT 2 or 3, TN | 60.0 |
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN | 100.0 |
Group 7: SOF+RBV 12 wk: GT 1, TE | 10.0 |
Group 8: SOF+RBV 12 wk: GT 1, TN | 84.0 |
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE | 68.0 |
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN | 64.0 |
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN | 60.0 |
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE | 100.0 |
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN | 100.0 |
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE | 100.0 |
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN | 92.0 |
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis | 70.0 |
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis | 100.0 |
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN | 80.0 |
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac | 100.0 |
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN | 68.0 |
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Percentage of Participants With HCV RNA < LOD at Week 8
Data are not presented for Group 21 which ended treatment after Week 6. (NCT01260350)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN | 100.0 |
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN | 100.0 |
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN | 100.0 |
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN | 100.0 |
Group 5: SOF 12 wk: GT 2 or 3, TN | 100.0 |
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN | 100.0 |
Group 7: SOF+RBV 12 wk: GT 1, TE | 100.0 |
Group 8: SOF+RBV 12 wk: GT 1, TN | 100.0 |
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE | 100.0 |
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN | 100.0 |
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN | 100.0 |
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE | 100.0 |
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN | 100.0 |
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE | 100.0 |
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN | 100.0 |
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis | 100.0 |
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis | 100.0 |
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN | 100.0 |
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac | 100.0 |
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Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug. (NCT01329978)
Timeframe: Post-treatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 12 Weeks | 90.4 |
SOF+PEG+RBV 24 Weeks | 92.7 |
SOF+PEG+RBV 12 Week/Rerandomization Group | 91.0 |
SOF Rerandomization Group | 93.3 |
SOF+RBV Rerandomization Group | 94.7 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug. (NCT01329978)
Timeframe: Post-treatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 12 Weeks | 90.4 |
SOF+PEG+RBV 24 Weeks | 92.0 |
SOF+PEG+RBV 12 Week/Rerandomization Group | 91.0 |
SOF Rerandomization Group | 93.3 |
SOF+RBV Rerandomization Group | 94.7 |
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Percentage of Participants With HCV RNA Below < LOD at Week 8
(NCT01329978)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 12 Weeks | 100.0 |
SOF+PEG+RBV 24 Weeks | 100.0 |
SOF+PEG+RBV 12 Week/Rerandomization Group | 99.3 |
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Percentage of Participants With HCV RNA Below < LOD at Week 4
(NCT01329978)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 12 Weeks | 98.0 |
SOF+PEG+RBV 24 Weeks | 100.0 |
SOF+PEG+RBV 12 Week/Rerandomization Group | 98.7 |
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Percentage of Participants With HCV RNA Below < LOD at Week 24
(NCT01329978)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 24 Weeks | 100.0 |
SOF Rerandomization Group | 100.0 |
SOF+RBV Rerandomization Group | 98.6 |
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Percentage of Participants With HCV RNA Below < LOD at Week 12
(NCT01329978)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 12 Weeks | 100.0 |
SOF+PEG+RBV 24 Weeks | 100.0 |
SOF+PEG+RBV 12 Week/Rerandomization Group | 100.0 |
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Percentage of Participants With HCV RNA < LOD at Week 2
(NCT01329978)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 12 Weeks | 68.6 |
SOF+PEG+RBV 24 Weeks | 85.5 |
SOF+PEG+RBV 12 Week/Rerandomization Group | 77.1 |
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Percentage of Participants With ALT Normalization at Week 12
ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12. (NCT01329978)
Timeframe: Baseline (Day 1) to Week 12
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 12 Weeks | 78.3 |
SOF+PEG+RBV 24 Weeks | 76.6 |
SOF+PEG+RBV 12 Week/Rerandomization Group | 67.6 |
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Percentage of Participants With ALT Normalization at Post-treatment Week 4
ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4. (NCT01329978)
Timeframe: Baseline (Day 1) to Post-treatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 12 Weeks | 89.5 |
SOF+PEG+RBV 24 Weeks | 87.2 |
SOF+PEG+RBV 12 Week/Rerandomization Group | 95.2 |
SOF Rerandomization Group | 91.7 |
SOF+RBV Rerandomization Group | 100.0 |
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Change in HCV RNA at Week 8
(NCT01329978)
Timeframe: Baseline (Day 1) to Week 8
Intervention | log10 IU/mL (Mean) |
---|
SOF+PEG+RBV 12 Weeks | -5.34 |
SOF+PEG+RBV 24 Weeks | -5.17 |
SOF+PEG+RBV 12 Week/Rerandomization Group | -5.25 |
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Change in HCV RNA at Week 4
(NCT01329978)
Timeframe: Baseline (Day 1) to Week 4
Intervention | log10 IU/mL (Mean) |
---|
SOF+PEG+RBV 12 Weeks | -5.33 |
SOF+PEG+RBV 24 Weeks | -5.19 |
SOF+PEG+RBV 12 Week/Rerandomization Group | -5.24 |
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Percentage of Participants With ALT Normalization at Week 24
ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24. (NCT01329978)
Timeframe: Baseline (Day 1) to Week 24
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 24 Weeks | 78.9 |
SOF Rerandomization Group | 94.3 |
SOF+RBV Rerandomization Group | 100.0 |
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Change in HCV RNA at Week 2
(NCT01329978)
Timeframe: Baseline (Day 1) to Week 2
Intervention | log10 IU/mL (Mean) |
---|
SOF+PEG+RBV 12 Weeks | -5.12 |
SOF+PEG+RBV 24 Weeks | -5.07 |
SOF+PEG+RBV 12 Week/Rerandomization Group | -5.13 |
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Change in HCV RNA at Week 12
(NCT01329978)
Timeframe: Baseline (Day 1) to Week 12
Intervention | log10 IU/mL (Mean) |
---|
SOF+PEG+RBV 12 Weeks | -5.36 |
SOF+PEG+RBV 24 Weeks | -5.20 |
SOF+PEG+RBV 12 Week/Rerandomization Group | -5.25 |
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Percentage of Participants With Virologic Failure During Treatment
"Virologic failure was defined as either~HCV RNA ≥ 15 IU/mL after having previously had HCV RNA < 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or~HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)~Baseline was Day 1 for all groups." (NCT01329978)
Timeframe: Baseline (Day 1) to Week 24
Intervention | percentage of participants (Number) |
---|
| Viral breakthrough | Viral rebound | Non-response |
---|
SOF Rerandomization Group | 0.0 | 0.0 | 0.0 |
,SOF+PEG+RBV 12 Week/Rerandomization Group | 0.0 | 0.0 | 0.0 |
,SOF+PEG+RBV 12 Weeks | 0.0 | 0.0 | 0.0 |
,SOF+PEG+RBV 24 Weeks | 0.0 | 0.0 | 0.0 |
,SOF+RBV Rerandomization Group | 0.0 | 0.0 | 0.0 |
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Percentage of Participants Who Experienced Adverse Events
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event. (NCT01329978)
Timeframe: Baseline (Day 1) to post-treatment Day 30
Intervention | percentage of participants (Number) |
---|
| Any AE | Drug-related AE | Grade 3 or higher AE | AE leading to drug discontinuation | Serious AE |
---|
SOF Rerandomization Group | 98.7 | 98.7 | 14.7 | 5.3 | 2.7 |
,SOF+PEG+RBV 12 Week/Rerandomization Group | 98.7 | 97.4 | 14.2 | 4.5 | 2.6 |
,SOF+PEG+RBV 12 Weeks | 98.1 | 96.2 | 15.4 | 5.8 | 3.8 |
,SOF+PEG+RBV 24 Weeks | 96.8 | 94.4 | 17.6 | 16.0 | 4.8 |
,SOF+RBV Rerandomization Group | 100.0 | 97.3 | 13.3 | 4.0 | 2.7 |
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Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).
Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement. (NCT01329978)
Timeframe: End of treatment to Post-treatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 12 Weeks | 5.9 |
SOF+PEG+RBV 24 Weeks | 1.6 |
SOF+PEG+RBV 12 Week/Rerandomization Group | 3.9 |
SOF Rerandomization Group | 2.7 |
SOF+RBV Rerandomization Group | 2.7 |
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Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
Change from baseline in log10 HCV RNA at scheduled sampling time. (NCT01359644)
Timeframe: Baseline, Follow-up week 24
Intervention | IU/mL (Mean) |
---|
| Baseline | Change at Follow-up week 24 |
---|
Treatment A: Sofosbuvir + Daclatasvir | 1.28 | -5.19 |
,Treatment B: Sofosbuvir + Daclatasvir | 0.95 | -5.23 |
,Treatment C: Sofosbuvir + Daclatasvir | 0.95 | -5.67 |
,Treatment D: Sofosbuvir + Daclatasvir | 0.98 | -5.83 |
,Treatment E: Sofosbuvir + Daclatasvir + Ribavirin | 0.95 | -5.77 |
,Treatment F: Sofosbuvir + Daclatasvir + Ribavirin | 0.95 | -5.61 |
,Treatment G: Sofosbuvir + Daclatasvir | 0.95 | -5.19 |
,Treatment H: Sofosbuvir + Daclatasvir + Ribavirin | 0.95 | -5.48 |
,Treatment I: Sofosbuvir + Daclatasvir | 0.95 | -5.39 |
,Treatment J: Sofosbuvir + Daclatasvir + Ribavirin | 0.95 | -5.36 |
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Percentage of Participants With Viral Breakthrough During the Treatment Period
Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8. (NCT01359644)
Timeframe: First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Intervention | Percentage of participants (Number) |
---|
| DCV/SOF with ribavirin (n=56, 14, 20) | DCV/SOF without ribavirin (n=70, 30, 21) |
---|
Telaprevir or Boceprevir Failures With Genotype 1 | 0 | 0 |
,Treatment-naive Participants With Genotype 1 | 0 | 0 |
,Treatment-naive Participants With Genotype 2 or 3 | 0 | 3.3 |
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Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir. (NCT01359644)
Timeframe: Follow-up Week 24
Intervention | Percentage of participants (Number) |
---|
| DCV/SOF with ribavirin (n=56, 14, 20) | DCV/SOF without ribavirin (n=70, 30, 21) | DCV/SOF All |
---|
Telaprevir/Boceprevir Failures With Genotype 1 | 100.0 | 100.0 | 100.0 |
,Treatment-naive Participants With Genotype 1 | 94.6 | 95.7 | 95.2 |
,Treatment-naive Participants With Genotype 2 or 3 | 92.9 | 93.3 | 93.2 |
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Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir. (NCT01359644)
Timeframe: Follow-up Week 12
Intervention | Percentage of participants (Number) |
---|
| DCV/SOF with ribavirin (n=56, 14, 20) | DCV/SOF without ribavirin (n=70, 30, 21) | DCF/SOF All |
---|
Telaprevir or Boceprevir Failures With Genotype 1 | 95.0 | 100.0 | 97.6 |
,Treatment-naive Participants With Genotype 1 | 96.4 | 100.0 | 98.4 |
,Treatment-naive Participants With Genotype 2 or 3 | 85.7 | 93.3 | 90.9 |
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Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe. (NCT01359644)
Timeframe: First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
Intervention | Participants (Number) |
---|
| Deaths | SAEs | AEs leading to discontinuation | Gr 3 Phosporus | Gr 3 Fasting serum glucose | Gr 3 Serum glucose | Gr 3 Total cholesterol | Gr 3 Uric acid |
---|
Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks) | 0 | 1 | 0 | 3 | 0 | 0 | 1 | 1 |
,Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks) | 0 | 6 | 1 | 1 | 1 | 2 | 0 | 0 |
,Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks) | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks) | 0 | 7 | 1 | 1 | 2 | 1 | 1 | 0 |
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Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe (NCT01359644)
Timeframe: AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)
Intervention | Participants (Number) |
---|
| Deaths | SAEs | Grade 3-4 Lab Abnormalities: Serum glucose |
---|
Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks) | 0 | 2 | 1 |
,Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks) | 0 | 4 | 0 |
,Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks) | 0 | 2 | 0 |
,Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks) | 0 | 4 | 0 |
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Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment. (NCT01359644)
Timeframe: Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Intervention | Percentage of participants (Number) |
---|
| DCV/SOF with ribavirin (n=56, 14, 20) | DCV/SOF without ribavirin (n=70, 30, 21) |
---|
Telaprevir or Boceprevir Failures With Genotype 1 | 0 | 0 |
,Treatment-naive Participants With Genotype 1 | 0 | 1.4 |
,Treatment-naive Participants With Genotype 2 or 3 | 0 | 3.3 |
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Participants With Adverse Events
Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability. (NCT01441180)
Timeframe: 24 weeks
Intervention | partipants (Number) |
---|
| Any grade 3-4 event | Any Serious Adverse Event | Death | Discontinuation owing to an adverse event |
---|
Phase 1 | 1 | 0 | 0 | 0 |
,Phase 2 Arm A (Sofosbuvir + Weight Based RBV) | 1 | 0 | 0 | 0 |
,Phase 2 Arm B (Sofosbuvir + Low-dose RBV) | 5 | 1 | 0 | 0 |
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Sustained Virologic Response
Sustained virology response at 24 weeks post treatment completion (NCT01441180)
Timeframe: 24 weeks post treatment completion
Intervention | percentage of total participants (Number) |
---|
Phase 1 | 100 |
Phase 2 Arm A | 71 |
Phase 2 Arm B | 55 |
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Number of Participants With Viral Relapse
Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period. (NCT01466790)
Timeframe: During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]
Intervention | Participants (Number) |
---|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 1 |
Cohort 1: TMC435 and PSI-7977 for 24 Weeks | 0 |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 1 |
Cohort 1: TMC435 and PSI-7977 for 12 Weeks | 1 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 0 |
Cohort 2: TMC435 and PSI-7977 for 24 Weeks | 0 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 2 |
Cohort 2: TMC435 and PSI-7977 for 12 Weeks | 1 |
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Number of Participants With Viral Breakthrough
Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions. (NCT01466790)
Timeframe: Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]
Intervention | Participants (Number) |
---|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 0 |
Cohort 1: TMC435 and PSI-7977 for 24 Weeks | 0 |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 0 |
Cohort 1: TMC435 and PSI-7977 for 12 Weeks | 0 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 0 |
Cohort 2: TMC435 and PSI-7977 for 24 Weeks | 0 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 0 |
Cohort 2: TMC435 and PSI-7977 for 12 Weeks | 0 |
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Number of Participants With Inadequate Virologic Response
Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition. (NCT01466790)
Timeframe: Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]
Intervention | Participants (Number) |
---|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 0 |
Cohort 1: TMC435 and PSI-7977 for 24 Weeks | 0 |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 0 |
Cohort 1: TMC435 and PSI-7977 for 12 Weeks | 0 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 0 |
Cohort 2: TMC435 and PSI-7977 for 24 Weeks | 0 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 0 |
Cohort 2: TMC435 and PSI-7977 for 12 Weeks | 0 |
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Number of Participants With a Sustained Virologic Response (SVR) at Week 48
Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48. (NCT01466790)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 19 |
Cohort 1: TMC435 and PSI-7977 for 24 Weeks | 14 |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 26 |
Cohort 1: TMC435 and PSI-7977 for 12 Weeks | 13 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 27 |
Cohort 2: TMC435 and PSI-7977 for 24 Weeks | 16 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 24 |
Cohort 2: TMC435 and PSI-7977 for 12 Weeks | 13 |
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Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment. (NCT01466790)
Timeframe: Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)
Intervention | Participants (Number) |
---|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 20 |
Cohort 1: TMC435 and PSI-7977 for 24 Weeks | 14 |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 26 |
Cohort 1: TMC435 and PSI-7977 for 12 Weeks | 13 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 28 |
Cohort 2: TMC435 and PSI-7977 for 24 Weeks | 16 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 26 |
Cohort 2: TMC435 and PSI-7977 for 12 Weeks | 14 |
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Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)
Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment. (NCT01466790)
Timeframe: Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)
Intervention | Participants (Number) |
---|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 19 |
Cohort 1: TMC435 and PSI-7977 for 24 Weeks | 14 |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 26 |
Cohort 1: TMC435 and PSI-7977 for 12 Weeks | 13 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 28 |
Cohort 2: TMC435 and PSI-7977 for 24 Weeks | 16 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 25 |
Cohort 2: TMC435 and PSI-7977 for 12 Weeks | 13 |
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Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment. (NCT01466790)
Timeframe: Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)
Intervention | Participants (Number) |
---|
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 19 |
Cohort 1: TMC435 and PSI-7977 for 24 Weeks | 14 |
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 26 |
Cohort 1: TMC435 and PSI-7977 for 12 Weeks | 13 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | 28 |
Cohort 2: TMC435 and PSI-7977 for 24 Weeks | 16 |
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | 25 |
Cohort 2: TMC435 and PSI-7977 for 12 Weeks | 13 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT01497366)
Timeframe: Up to 12 Weeks
Intervention | percentage of participants (Number) |
---|
| Week 1 (SOF+RBV, n = 252; PEG+RBV, n = 243) | Week 2 (SOF+RBV, n = 251; PEG+RBV, n = 241) | Week 4 (SOF+RBV, n = 250; PEG+RBV, n = 236) | Week 8 (SOF+RBV, n = 248; PEG+RBV, n = 231) | Week 12 (SOF+RBV, n = 244; PEG+RBV, n = 224) |
---|
PEG+RBV | 6.6 | 31.5 | 66.9 | 85.7 | 92.4 |
,Sofosbuvir+RBV | 43.7 | 92.0 | 99.6 | 99.6 | 99.2 |
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Change From Baseline in HCV RNA
(NCT01497366)
Timeframe: Baseline to Week 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 (SOF+RBV, n = 239; PEG+RBV, n = 236) | Week 2 (SOF+RBV, n = 246; PEG+RBV, n = 233) | Week 4 (SOF+RBV, n = 250; PEG+RBV, n = 235) | Week 8 (SOF+RBV, n = 248; PEG+RBV, n = 228) | Week 12 (SOF+RBV, n = 243; PEG+RBV, n = 222) |
---|
PEG+RBV | -2.19 | -3.19 | -4.04 | -4.42 | -4.45 |
,Sofosbuvir+RBV | -4.26 | -4.60 | -4.64 | -4.63 | -4.65 |
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Percentage of Participants With Virologic Failure During Treatment
"Virologic failure was defined as either~Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement~Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)" (NCT01497366)
Timeframe: Baseline up to Week 24
Intervention | percentage of participants (Number) |
---|
Sofosbuvir+RBV | 0.4 |
PEG+RBV | 7.4 |
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Percentage of Participants With Viral Relapse Following Treatment
Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement. (NCT01497366)
Timeframe: Up to Post-treatment Week 24
Intervention | percentage of participants (Number) |
---|
Sofosbuvir+RBV | 30.5 |
PEG+RBV | 22.6 |
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Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)
SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation. (NCT01497366)
Timeframe: Post-treatment Week 24
Intervention | percentage of participants (Number) |
---|
Sofosbuvir+RBV | 66.8 |
PEG+RBV | 65.4 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation. (NCT01497366)
Timeframe: Post-treatment Week 12
Intervention | percentage of participants (Number) |
---|
Sofosbuvir+RBV | 67 |
PEG+RBV | 67 |
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Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
(NCT01497366)
Timeframe: Up to 24 weeks plus 30 days following the last dose of study drug
Intervention | participants (Number) |
---|
| AEs leading to discontinuation of any study drug | Serious AEs | Grade 3 laboratory abnormalities | Grade 4 laboratory abnormalities | Deaths |
---|
PEG+RBV | 29 | 3 | 80 | 21 | 0 |
,Sofosbuvir+RBV | 3 | 7 | 33 | 3 | 1 |
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Number of Subjects With Undetectable HCV RNA at Day 56 Post Liver Transplantation
The primary outcome was to determine if MBL-HCV1 in combination with the oral direct-acting antiviral could reduce HCV viral RNA to undetectable at day 56 post transplant and prevent the new liver from becoming productively infected. Undetectable HCV RNA was defined as the level below the lower limit of detection (LLOD) of an FDA-approved polymerase chain reaction (PCR) assay. HCV RNA was quantified by PCR (e.g., COBAS®AmpliPrep/ COBAS® TaqMan® HCV Test manufactured by Roche or equivalent) at each study site (NCT01532908)
Timeframe: Day 56
Intervention | Participants (Count of Participants) |
---|
Part 1: MBL-HCV1 and Telaprevir | 4 |
Part 2: MBL-HCV1 and Sofosbuvir | 2 |
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Change in Viral Load Between Baseline Pre-transplant HCV RNA Levels and Study Day 7, 10, 14, 28, 35, 42, 49, 56, 70, 84 and 98 in Liver Transplant Recipients
"Serum HCV RNA was measured by quantitative RT-PCR. The change in log 10 IU/mL HCV viral load from baseline was compared with pre-transplant HCV RNA level and evaluated for each subject at each study visit.~Change in the level of HCV RNA in serum, log10(IU/mL), is defined as the difference between the level measured at Baseline and the specified time point. If HCV RNA was not detected by the PCR assay, the lower level of detection of the PCR assay was used for the calculation" (NCT01532908)
Timeframe: Baseline pre-transplant and study Day 7, 10, 14, 28, 35, 42, 49, 56, 70, 84 and 98
Intervention | Log10 IU/mL (Mean) |
---|
| Day 7 | Day 10 | Day 14 | Day 28 | Day 35 | Day 42 | Day 49 | Day 56 | Day 70 | Day 84 | Day 98 |
---|
Part 1: MBL-HCV1 and Telaprevir | -2.97 | -3.35 | -3.58 | -2.94 | -3.01 | -2.94 | -2.89 | -2.28 | -2.62 | -2.53 | -0.76 |
,Part 2: MBL-HCV1 and Sofosbuvir | -3.46 | -3.99 | -4.32 | -5.29 | -5.29 | -5.29 | -5.29 | -5.29 | -5.29 | -5.29 | -5.29 |
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Safety and Tolerability of Study Treatment by Number of Adverse Events Reported
Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms and/or required therapy that was new or enhanced from baseline. Solicited adverse reactions included the occurrence of the following during or immediately after the infusion: arthralgia, chills, dyspnea, fatigue, fever, headache, nausea, hives, or rash. The presence of any of these symptoms (new or worsening from baseline) was documented as an adverse event. In addition, subjects were asked at all scheduled study visits to report any other adverse events. Adverse events were summarized by System Organ Class (SOC) using MedDRA (version 14.1) (NCT01532908)
Timeframe: Day 0 start of first infusion through Day 56 or six weeks after last dose of study treatment whichever is later, up to approximately 126 days
Intervention | Events (Number) |
---|
| Blood And Lymphatic System Disorders | Cardiac Disorders | Eye Disorders | Gastrointestinal Disorders | General Disorders And Administration Site Conditions | Hepatobiliary Disorders | Immune System Disorders | Infections And Infestations | Injury, Poisoning And Procedural Complications | Investigations | Metabolism And Nutrition Disorders | Musculoskeletal And Connective Tissue Disorders | Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) | Nervous System Disorders | Psychiatric Disorders | Renal And Urinary Disorders | Reproductive System And Breast Disorders | Respiratory, Thoracic And Mediastinal Disorders | Skin And Subcutaneous Tissue Disorders | Surgical And Medical Procedures | Vascular Disorders |
---|
Part 1: MBL-HCV1 and Telaprevir | 6 | 0 | 1 | 9 | 12 | 3 | 2 | 6 | 11 | 3 | 14 | 1 | 0 | 6 | 5 | 1 | 1 | 10 | 2 | 0 | 5 |
,Part 2: MBL-HCV1 and Sofosbuvir | 0 | 1 | 0 | 3 | 0 | 0 | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 2 | 0 | 2 | 0 | 1 | 1 | 1 |
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Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 10, 14, 28, 35, 42, 49, 70, 84 and 98 in Liver Transplant Recipients and for Those Subjects Receiving an Additional 4 Weeks of Treatment at Study Day 105, 112 and 126
"The number of subjects with undetectable HCV RNA by study visit day was analyzed utilizing a last value carried forward (LVCF) strategy so that each study visit day had data from (8 subjects in Part 1 and 2 subjects in Part 2), effectively imputing the information for the subjects who had missing data due to a missed study visit, HCV RNA measured with a non-FDA approved assay, or completion of all required post-treatment study visits. The last recorded HCV RNA status for a subject (detectable vs undetectable) was used for the next missing level (in ascending visit number order) until a new HCV RNA level was recorded at a later visit. Serum HCV RNA was measured by Quantitative RT-PCR using an FDA-approved quantitative assay" (NCT01532908)
Timeframe: Day 7, 10, 14, 28, 35, 42, 49, 70, 84, 98, 105, 112 and 126
Intervention | participants (Number) |
---|
| Day 7 | Day 10 | Day 14 | Day 28 | Day 35 | Day 42 | Day 49 | Day 70 | Day 84 | Day 98 | Day 105 | Day 112 | Day 126 |
---|
Part 1: MBL-HCV1 and Telaprevir | 0 | 2 | 2 | 4 | 5 | 5 | 5 | 3 | 2 | 2 | 2 | 2 | 2 |
,Part 2: MBL-HCV1 and Sofosbuvir | 0 | 0 | 0 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
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Number of Subjects With Sustained Virologic Response (SVR) at Week 12 and Week 24
"Number of subjects with sustained virologic response (defined as HCV RNA concentration below the limit of detection) at 12 and 24 weeks post-treatment was examined as an exploratory endpoint in subjects whose HCV RNA remained undetectable at the 6 week post-treatment safety follow-up visit.~Those subjects that had detectable HCV RNA at the end of safety follow-up period were not assessed for SVR 12 and SVR 24. Those subjects achieving an SVR12 were assessed for the durability of the response at 24 weeks after the end of treatment" (NCT01532908)
Timeframe: 12 weeks after the end of treatment (SVR12) and 24 weeks after the end of treatment 12 weeks and 24 weeks post-treatment
Intervention | participants (Number) |
---|
| Post Treatment Week 12 | Post Treatment Week 24 |
---|
Part 1: MBL-HCV1 and Telaprevir | 1 | 1 |
,Part 2: MBL-HCV1 and Sofosbuvir | 2 | 2 |
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Number of Participants With HCV Resistance-associated Variants to MBL-HCV1 and Oral Direct-acting Antivirals Before and After Receipt of Study Treatment
Conventional sequencing was performed on HCV RNA isolated from a subset of serum samples obtained at baseline, at the time of viral rebound, and at the end of study in subjects who did not achieve a sustained virologic response. The targets of both the MBL-HCV1 antibody (E1/E2 glycoprotein) and telaprevir (NS3) were sequenced. The data displays the number of subjects with > 20% resistance associated variants (RAV) reported for the target MBL-HCV1 and/or Direct-acting Antiviral (DAA) (NCT01532908)
Timeframe: Pre-transplant, time of viral rebound (assessed from Day 7-Day 56 of treatment), end of study (up to day 126) in subjects who did not achieve a sustained virologic response (SVR)
Intervention | Participants with > 20 % RAV (Number) |
---|
| Pre-transplant | Viral Rebound | End of Study |
---|
Part 1: MBL-HCV1 and Telaprevir | 4 | 4 | 7 |
,Part 2: MBL-HCV1 and Sofosbuvir | NA | NA | NA |
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Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. (NCT01542788)
Timeframe: Baseline to Week 12
Intervention | participants (Number) |
---|
| No adverse event leading to discontinuation | Abdominal pain upper | Alanine aminotransferase increased | Anaemia | Anxiety | Chest discomfort | Injury | Insomnia | Muscle spasms | Oedema peripheral | Pancreatitis | Rash | Road traffic accident |
---|
Placebo | 68 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
,SOF+RBV | 202 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 1 |
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Percentage of Participants Achieving SVR12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy (NCT01542788)
Timeframe: Post-treatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 78 |
Placebo | 0 |
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Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement (NCT01542788)
Timeframe: End of treatment to post-treatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 20.5 |
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Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values (NCT01542788)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 0.0 |
Placebo | 0.0 |
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Percentage of Participants Achieving SVR4
SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy (NCT01542788)
Timeframe: Post-treatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 83.1 |
Placebo | 0.0 |
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Percentage of Participants Achieving SVR24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy (NCT01542788)
Timeframe: Post-treatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 77.8 |
Placebo | 0.0 |
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Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48
pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at the relevant time point after transplant. (NCT01559844)
Timeframe: Up to 48 weeks following transplant
Intervention | percentage of participants (Number) |
---|
| Posttransplant Week 1 (N = 32) | Posttransplant Week 2 (N = 32) | Posttransplant Week 4 (N = 32) | Posttransplant Week 8 (N = 32) | Posttransplant Week 24 (N = 32) | Posttransplant Week 48 (N = 30) |
---|
SOF+RBV | 87.5 | 81.3 | 75.0 | 75.0 | 75.0 | 66.7 |
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Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at Week 12 after transplant. (NCT01559844)
Timeframe: Posttransplant Week 12
Intervention | percentage of participants (Number) |
---|
| Transplant after ≥ 12 weeks of treatment (N=32) | Transplant after any duration of treatment (N=43) |
---|
SOF+RBV | 75.0 | 69.8 |
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Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48
(NCT01559844)
Timeframe: Up to 48 weeks prior to transplant
Intervention | percentage of participants (Number) |
---|
| Week 1 (N = 61) | Week 2 (N = 61) | Week 3 (N = 60) | Week 4 (N = 58) | Week 8 (N = 54) | Week 12 (N = 48) | Week 24 (N = 30) | Week 36 (N = 9) | Week 48 (N = 8) |
---|
SOF+RBV | 13.1 | 57.4 | 81.7 | 93.1 | 90.7 | 93.8 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant
(NCT01559844)
Timeframe: Up to 48 weeks prior to transplant
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 3.3 |
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Percentage of Participants With Graft Loss Following Transplant
(NCT01559844)
Timeframe: Up to 48 weeks following transplant
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 6.5 |
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HCV RNA and Change From Baseline in HCV RNA Through Week 8
(NCT01559844)
Timeframe: Up to 8 weeks prior to transplant
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 (N = 59) | Week 2 (N = 61) | Week 3 (N = 60) | Week 4 (N = 58) | Week 8 (N = 53) |
---|
SOF+RBV | -3.87 | -4.43 | -4.64 | -4.69 | -4.66 |
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Number of Participants Who Died
"Treatment-emergent deaths were those that occurred while taking study drug or to the minimum of 1) date of transplantation, 2) retreatment 1st dose date, or 3) last dose date + 30 days.~Only those participants who underwent liver transplantation were analyzed for death post-transplantation." (NCT01559844)
Timeframe: Up to 48 weeks following transplant
Intervention | participants (Number) |
---|
| All Deaths | Treatment-Emergent Death (N = 61) | Death Following Transplant (N = 46) | Death Not Meeting Either Criteria (N = 61) |
---|
SOF+RBV | 5 | 1 | 3 | 1 |
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Proportion of Participants With Virologic Failure Prior to Transplant
"Virologic failure (VF) in the pretransplant phase was defined by:~Breakthrough (HCV RNA ≥ 25 IU/ml after having previously had HCV RNA < 25 IU/ml, while on treatment)~Rebound (breakthrough or > 1 log10 IU/ml increase in HCV RNA from nadir while on treatment)~Non-response (HCV RNA ≥ 25 IU/ml through 8 weeks of treatment)~Pre-transplant relapse (HCV RNA ≥ 25 IU/ml during the Pre-Transplant off-treatment follow-up period after having achieved HCV RNA < 25 IU/ml at last observed HCV RNA on treatment)" (NCT01559844)
Timeframe: Up to 48 weeks prior to transplant
Intervention | percentage of participants (Number) |
---|
| On-treatment VF (N = 61) | Posttreatment/Pretransplant VF - 24 Weeks (N = 15) | Posttreatment/Pretransplant VF - 48 Weeks (N = 8) |
---|
SOF+RBV | 8.2 | 73.3 | 37.5 |
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Percentage of Participants Achieving SVR24
"SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)." (NCT01604850)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV+Placebo | 50.0 |
SOF+RBV | 71.6 |
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Percentage of Participants Achieving SVR12
"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)." (NCT01604850)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV+Placebo | 51.0 |
SOF+RBV | 72.6 |
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Adverse Events Leading to Permanent Discontinuation of Study Drug
Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment. (NCT01604850)
Timeframe: Baseline to Week 16
Intervention | participants (Number) |
---|
SOF+RBV+Placebo | 1 |
SOF+RBV | 0 |
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Percentage of Participants Achieving SVR4
"SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)." (NCT01604850)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF+RBV+Placebo | 56.0 |
SOF+RBV | 76.8 |
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Percentage of Participants With Viral Breakthrough
"Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.~For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)." (NCT01604850)
Timeframe: Up to 16 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV+Placebo | 0.0 |
SOF+RBV | 0.0 |
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Percentage of Participants With Viral Relapse
"Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)." (NCT01604850)
Timeframe: End of treatment to posttreatment Week 24
Intervention | participants (Number) |
---|
SOF+RBV+Placebo | 47 |
SOF+RBV | 26 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT01625338)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF+RBV 12 Weeks | 73.7 | 71.9 |
,SOF+RBV 24 Weeks | 81.5 | 76.0 |
,SOF+RBV+Peg-IFN 12 Weeks | 87.2 | 82.6 |
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Percentage of Participants With Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. (NCT01625338)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Weeks | 25.7 |
SOF+RBV 24 Weeks | 20.6 |
SOF+RBV+Peg-IFN 12 Weeks | 16.4 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT01625338)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Weeks | 0.9 |
SOF+RBV 24 Weeks | 1.0 |
SOF+RBV+Peg-IFN 12 Weeks | 3.7 |
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Percentage of Participants With On-treatment Virologic Failure
"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)" (NCT01625338)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Weeks | 0.9 |
SOF+RBV 24 Weeks | 0.5 |
SOF+RBV+Peg-IFN 12 Weeks | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01625338)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Weeks | 71.9 |
SOF+RBV 24 Weeks | 77.5 |
SOF+RBV+Peg-IFN 12 Weeks | 82.6 |
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Percentage of Participants Achieving SVR4
SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy (NCT01641640)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
Sofosbuvir+PEG+RBV | 92.4 |
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Percentage of Participants Achieving SVR24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy (NCT01641640)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
Sofosbuvir+PEG+RBV | 90.5 |
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Percentage of Participants Achieving Sustained Virologic Response (SVR)12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy. (NCT01641640)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
Sofosbuvir+PEG+RBV | 91 |
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Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments. (NCT01641640)
Timeframe: Baseline to Week 12
Intervention | participants (Number) |
---|
| Anaemia | Haemolytic anaemia | Neutropenia | Vision blurred | Blood creatinine increased | Haemoglobin abnormal | Dermatitis |
---|
Sofosbuvir+PEG+RBV | 2 | 1 | 1 | 1 | 1 | 1 | 1 |
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Percentage of Participants With Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. (NCT01641640)
Timeframe: End of treatment to post-treatment Week 24
Intervention | percentage of participants (Number) |
---|
Sofosbuvir+PEG+RBV | 8.6 |
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Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. (NCT01641640)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
Sofosbuvir+PEG+RBV | 0.0 |
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Change From Baseline in HCV RNA at Week 4
(NCT01667731)
Timeframe: Baseline; Week 4
Intervention | log10 IU/mL (Mean) |
---|
SOF+RBV 12 Wk GT 2 TN | -5.04 |
SOF+RBV 12 Wk GT 3 TN | -4.86 |
SOF+RBV 24 Wk GT 2 TE | -5.16 |
SOF+RBV 24 Wk GT 3 TE | -5.06 |
SOF+RBV 24 Wk GT 1 TN | -5.12 |
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Change From Baseline in HCV RNA at Week 2
(NCT01667731)
Timeframe: Baseline; Week 2
Intervention | log10 IU/mL (Mean) |
---|
SOF+RBV 12 Wk GT 2 TN | -5.11 |
SOF+RBV 12 Wk GT 3 TN | -4.84 |
SOF+RBV 24 Wk GT 2 TE | -5.15 |
SOF+RBV 24 Wk GT 3 TE | -5.06 |
SOF+RBV 24 Wk GT 1 TN | -5.00 |
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Change From Baseline in HCV RNA at Week 1
(NCT01667731)
Timeframe: Baseline; Week 1
Intervention | log10 IU/mL (Mean) |
---|
SOF+RBV 12 Wk GT 2 TN | -4.69 |
SOF+RBV 12 Wk GT 3 TN | -4.52 |
SOF+RBV 24 Wk GT 2 TE | -4.63 |
SOF+RBV 24 Wk GT 3 TE | -4.78 |
SOF+RBV 24 Wk GT 1 TN | -4.42 |
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Change From Baseline in HCV RNA at Week 6
(NCT01667731)
Timeframe: Baseline; Week 6
Intervention | log10 IU/mL (Mean) |
---|
SOF+RBV 12 Wk GT 2 TN | -5.13 |
SOF+RBV 12 Wk GT 3 TN | -4.86 |
SOF+RBV 24 Wk GT 2 TE | -5.16 |
SOF+RBV 24 Wk GT 3 TE | -5.06 |
SOF+RBV 24 Wk GT 1 TN | -5.20 |
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Change From Baseline in HCV RNA at Week 8
(NCT01667731)
Timeframe: Baseline; Week 8
Intervention | log10 IU/mL (Mean) |
---|
SOF+RBV 12 Wk GT 2 TN | -5.13 |
SOF+RBV 12 Wk GT 3 TN | -4.83 |
SOF+RBV 24 Wk GT 2 TE | -5.16 |
SOF+RBV 24 Wk GT 3 TE | -5.06 |
SOF+RBV 24 Wk GT 1 TN | -5.20 |
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Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants discontinuing any study drug due to an adverse event was summarized. (NCT01667731)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Wk GT 2/3 TN | 4.4 |
SOF+RBV 24 Wk GT 2/3 TE | 2.4 |
SOF+RBV 24 Wk GT 1 TN | 2.6 |
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Percentage of Participants Experiencing On-treatment Virologic Failure
"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment" (NCT01667731)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Wk GT 2 TN | 3.8 |
SOF+RBV 12 Wk GT 3 TN | 0 |
SOF+RBV 24 Wk GT 2 TE | 0 |
SOF+RBV 24 Wk GT 3 TE | 0 |
SOF+RBV 24 Wk GT 1 TN | 0.9 |
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Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. (NCT01667731)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Wk GT 2 TN | 0 |
SOF+RBV 12 Wk GT 3 TN | 28.6 |
SOF+RBV 24 Wk GT 2 TE | 4.2 |
SOF+RBV 24 Wk GT 3 TE | 5.9 |
SOF+RBV 24 Wk GT 1 TN | 22.1 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01667731)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Wk GT 2 TN | 88.5 |
SOF+RBV 12 Wk GT 3 TN | 66.7 |
SOF+RBV 24 Wk GT 2 TE | 91.7 |
SOF+RBV 24 Wk GT 3 TE | 94.1 |
SOF+RBV 24 Wk GT 1 TN | 76.3 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01667731)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF+RBV 12 Wk GT 2 TN | 88.5 | 88.5 |
,SOF+RBV 12 Wk GT 3 TN | 71.4 | 66.7 |
,SOF+RBV 24 Wk GT 1 TN | 80.7 | 75.4 |
,SOF+RBV 24 Wk GT 2 TE | 95.8 | 91.7 |
,SOF+RBV 24 Wk GT 3 TE | 94.1 | 88.2 |
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Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed. (NCT01682720)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
Placebo 12 Weeks (GT2/3) | 1.2 |
SOF 12 Weeks (GT2/3) | 1.2 |
SOF 24 Weeks (GT3) | 0.4 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group. (NCT01682720)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF 12 Weeks (GT2) | 93.2 |
SOF 12 Weeks (GT3) | 27.3 |
SOF 24 Weeks (GT3) | 85.2 |
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Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.~Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.~Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group." (NCT01682720)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| Viral breakthrough | Viral relapse |
---|
SOF 12 Weeks (GT2) | 0 | 6.8 |
,SOF 12 Weeks (GT3) | 0 | 54.5 |
,SOF 24 Weeks (GT3) | 0.4 | 14.0 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group. (NCT01682720)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF 12 Weeks (GT2) | 93.2 | 93.2 |
,SOF 12 Weeks (GT3) | 45.5 | 27.3 |
,SOF 24 Weeks (GT3) | 87.2 | 84.4 |
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Percentage of Participants Experiencing On-Treatment Virologic Failure
"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)" (NCT01687257)
Timeframe: Up to 48 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV (Group 1) | 8.0 |
SOF+RBV (Group 2) | 0 |
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Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. (NCT01687257)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV (Group 1) | 17.4 |
SOF+RBV (Group 2) | 23.8 |
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Change From Baseline in Child-Pugh-Turcotte (CPT) Score
"CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. Data are presented as improvement, no change, or worsening in CPT scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).~Improvement in CPT score was defined as having a decrease in CPT score from baseline, no change in CPT score was defined as having no change in CPT score from baseline, and worsening in CPT score was defined as having an increase in CPT score from baseline.~Baseline values were the last available values on or prior to first dose date of any study drug." (NCT01687257)
Timeframe: Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)
Intervention | percentage of participants (Number) |
---|
| Improvement in CPT Score | No Change in CPT Score | Worsening in CPT Score |
---|
All SOF+RBV (Groups 1 and 2) | 53.7 | 36.6 | 9.8 |
,Observation Period (Group 2) | 10.0 | 75.0 | 15.0 |
,SOF+RBV (Group 1) | 65.2 | 26.1 | 8.7 |
,SOF+RBV (Group 2) | 38.9 | 50.0 | 11.1 |
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Change From Baseline in Model for End Stage Liver Disease (MELD) Scores
"MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. Data are presented as improvement, no change, or worsening in MELD scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).~Improvement in MELD score was defined as having a baseline MELD score of 11-15 or 16-20 that changed to 0-10, or a baseline MELD score of 16-20 that changed to 11-15; no change in MELD score was defined as having no change in score group (0-10, 11-15, or 16-20) from baseline; and worsening in MELD score was defined as having a baseline MELD score of 0-10 that changed to 11-15 or 16-20, or a baseline MELD score of 11-15 that changed to 16-20.~Baseline values were the last available values on or prior to first dose date of any study drug." (NCT01687257)
Timeframe: Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)
Intervention | percentage of participants (Number) |
---|
| Improvement in MELD Score | No Change in MELD Score | Worsening in MELD Score |
---|
All SOF+RBV (Groups 1 and 2) | 22.0 | 68.3 | 9.8 |
,Observation Period (Group 2) | 20.0 | 75.0 | 5.0 |
,SOF+RBV (Group 1) | 33.3 | 54.2 | 12.5 |
,SOF+RBV (Group 2) | 5.9 | 88.2 | 5.9 |
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Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
SVR4, SVR24, and SVR48 were defined as HCV RNA < LLOQ at 4, 24, and 48 weeks after stopping study treatment, respectively. (NCT01687257)
Timeframe: Posttreatment Weeks 4, 24, and 48
Intervention | percentage of participants (Number) |
---|
| SVR4 (Group 1: N = 25; Group 2: N = 21) | SVR24 (Group 1: N = 25; Group 2: N = 21) | SVR48 (Group 1: N = 17; Group 2: N = 13) |
---|
SOF+RBV (Group 1) | 72.0 | 68.0 | 94.1 |
,SOF+RBV (Group 2) | 76.2 | 71.4 | 100.0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. For the Observation/SOF+RBV group, SVR12 during the observational period was defined as HCV RNA < LLOQ for 12 consecutive weeks, any time during the observational period. (NCT01687257)
Timeframe: Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)
Intervention | percentage of participants (Number) |
---|
SOF+RBV (Group 1) | 72.0 |
Observation Period (Group 2) | 0 |
SOF+RBV (Group 2) | 71.4 |
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Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment
HVPG closely reflects the degree of portal hypertension in patients with cirrhosis. The end of treatment for the Observation group was defined as the end of the observation period. The treatment period for Group 2 was defined as the end of the observation period to the end of the treatment. Baseline values were the last available values on or prior to first dose date of any study drug. (NCT01687257)
Timeframe: Baseline; Week 24 (Observation) and Week 48 (SOF+RBV)
Intervention | mmHg (Mean) |
---|
SOF+RBV (Group 1) | -1.6 |
Observation Period (Group 2) | 0.5 |
SOF+RBV (Group 2) | -0.4 |
All SOF+RBV (Groups 1 and 2) | -1.0 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively. (NCT01687270)
Timeframe: Posttreatment Weeks 4, 24, and 48
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 | SVR48 |
---|
SOF+RBV | 72.5 | 70.0 | 70.0 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug. (NCT01687270)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 70.0 |
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HCV RNA and Change From Baseline at Weeks 2, 4, and 8
(NCT01687270)
Timeframe: Baseline; Weeks 2, 4, and 8
Intervention | log10 IU/mL (Mean) |
---|
| Week 2 (n = 39) | Change from baseline at Week 2 (n = 39) | Week 4 (n = 40) | Change from baseline at Week 4 (n = 40) | Week 8 (n = 40) | Change from baseline at Week 8 (n = 40) |
---|
SOF+RBV | 1.65 | -4.89 | 1.38 | -5.17 | 1.38 | -5.17 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24
(NCT01687270)
Timeframe: Weeks 12 and 24
Intervention | percentage of participants (Number) |
---|
| Week 12 (n = 40) | Week 24 (n = 38) |
---|
SOF+RBV | 100.00 | 100.00 |
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Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event
(NCT01687270)
Timeframe: Baseline to Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 5.0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment~Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)" (NCT01687270)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| On-treatment virologic failure | Virologic relapse |
---|
SOF+RBV | 0 | 30.0 |
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Percentage of Participants With Virologic Failure
"On-treatment virologic failure was defined as:~Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR~Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment~Virologic relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement" (NCT01701401)
Timeframe: Baseline to posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| On-treatment virologic failure | Virologic relapse |
---|
LDV/SOF 12 Weeks | 0 | 0.5 |
,LDV/SOF 24 Weeks | 0.5 | 0.5 |
,LDV/SOF+RBV 12 Weeks | 0 | 0 |
,LDV/SOF+RBV 24 Weeks | 0 | 0 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug
SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively. (NCT01701401)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF 12 Weeks | 98.6 | 98.6 |
,LDV/SOF 24 Weeks | 99.1 | 98.2 |
,LDV/SOF+RBV 12 Weeks | 98.2 | 97.2 |
,LDV/SOF+RBV 24 Weeks | 99.1 | 99.1 |
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Change From Baseline in HCV RNA at Week 2
(NCT01701401)
Timeframe: Baseline; Week 2
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF 12 Weeks | -4.90 |
LDV/SOF+RBV 12 Weeks | -4.94 |
LDV/SOF 24 Weeks | -4.86 |
LDV/SOF+RBV 24 Weeks | -4.89 |
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Change From Baseline in HCV RNA at Week 4
(NCT01701401)
Timeframe: Baseline; Week 4
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF 12 Weeks | -4.99 |
LDV/SOF+RBV 12 Weeks | -5.02 |
LDV/SOF 24 Weeks | -4.93 |
LDV/SOF+RBV 24 Weeks | -4.96 |
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Change From Baseline in HCV RNA at Week 8
(NCT01701401)
Timeframe: Baseline; Week 8
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF 12 Weeks | -4.99 |
LDV/SOF+RBV 12 Weeks | -5.02 |
LDV/SOF 24 Weeks | -4.91 |
LDV/SOF+RBV 24 Weeks | -4.96 |
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Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized. (NCT01701401)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 0 |
LDV/SOF+RBV 12 Weeks | 0.5 |
LDV/SOF 24 Weeks | 1.8 |
LDV/SOF+RBV 24 Weeks | 3.7 |
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Percentage of Participants With HCV RNA < LLOQ at Week 2
(NCT01701401)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 82.2 |
LDV/SOF+RBV 12 Weeks | 83.4 |
LDV/SOF 24 Weeks | 82.9 |
LDV/SOF+RBV 24 Weeks | 82.9 |
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Percentage of Participants With HCV RNA < LLOQ at Week 4
(NCT01701401)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 100 |
LDV/SOF+RBV 12 Weeks | 99.1 |
LDV/SOF 24 Weeks | 100 |
LDV/SOF+RBV 24 Weeks | 100 |
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Percentage of Participants With HCV RNA < LLOQ at Week 8
(NCT01701401)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 99.5 |
LDV/SOF+RBV 12 Weeks | 100 |
LDV/SOF 24 Weeks | 99.5 |
LDV/SOF+RBV 24 Weeks | 100 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)
SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug. (NCT01701401)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 98.6 |
LDV/SOF+RBV 12 Weeks | 97.2 |
LDV/SOF 24 Weeks | 98.2 |
LDV/SOF+RBV 24 Weeks | 99.1 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01713283)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Wk TN | 78.6 |
SOF+RBV 12 Wk TE | 58.8 |
SOF+RBV 24 Wk TN | 100.0 |
SOF+RBV 24 Wk TE | 86.7 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01713283)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF+RBV 12 Wk TE | 58.8 | 58.8 |
,SOF+RBV 12 Wk TN | 78.6 | 78.6 |
,SOF+RBV 24 Wk TE | 93.3 | 86.7 |
,SOF+RBV 24 Wk TN | 100.0 | 100.0 |
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Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants discontinuing any study drug due to an adverse event was summarized. (NCT01713283)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Wk | 0 |
SOF+RBV 24 Wk | 3.4 |
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Percentage of Participants Experiencing On-treatment Virologic Failure
"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment" (NCT01713283)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Wk TN | 7.1 |
SOF+RBV 12 Wk TE | 0 |
SOF+RBV 24 Wk TN | 0 |
SOF+RBV 24 Wk TE | 0 |
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Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. (NCT01713283)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Wk TN | 15.4 |
SOF+RBV 12 Wk TE | 41.2 |
SOF+RBV 24 Wk TN | 0 |
SOF+RBV 24 Wk TE | 13.3 |
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HCV RNA Change From Baseline at Week 6
(NCT01783678)
Timeframe: Baseline; Week 6
Intervention | log10 IU/mL (Mean) |
---|
Genotype 2 Treatment-naive | -5.33 |
All Genotype 1 Treatment-naive | -4.95 |
Genotype 1a Treatment-naive | -5.01 |
Genotype 1b Treatment-naive | -4.55 |
Genotype 2 Treatment-experienced | -5.05 |
Genotype 3 Treatment-naive | -4.89 |
Genotype 3 Treatment-experienced | -4.91 |
Genotype 4 Treatment-naive | -4.57 |
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HCV RNA Change From Baseline at Week 4
(NCT01783678)
Timeframe: Baseline; Week 4
Intervention | log10 IU/mL (Mean) |
---|
Genotype 2 Treatment-naive | -5.33 |
All Genotype 1 Treatment-naive | -4.95 |
Genotype 1a Treatment-naive | -5.01 |
Genotype 1b Treatment-naive | -4.55 |
Genotype 2 Treatment-experienced | -5.05 |
Genotype 3 Treatment-naive | -4.89 |
Genotype 3 Treatment-experienced | -4.84 |
Genotype 4 Treatment-naive | -4.57 |
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HCV RNA Change From Baseline at Week 2
(NCT01783678)
Timeframe: Baseline; Week 2
Intervention | log10 IU/mL (Mean) |
---|
Genotype 2 Treatment-naive | -5.29 |
All Genotype 1 Treatment-naive | -4.92 |
Genotype 1a Treatment-naive | -4.97 |
Genotype 1b Treatment-naive | -4.55 |
Genotype 2 Treatment-experienced | -4.98 |
Genotype 3 Treatment-naive | -4.86 |
Genotype 3 Treatment-experienced | -4.89 |
Genotype 4 Treatment-naive | -4.52 |
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HCV RNA Change From Baseline at Week 1
(NCT01783678)
Timeframe: Baseline; Week 1
Intervention | log10 IU/mL (Mean) |
---|
Genotype 2 Treatment-naive | -4.72 |
All Genotype 1 Treatment-naive | -4.54 |
Genotype 1a Treatment-naive | -4.57 |
Genotype 1b Treatment-naive | -4.35 |
Genotype 2 Treatment-experienced | -4.34 |
Genotype 3 Treatment-naive | -4.41 |
Genotype 3 Treatment-experienced | -4.33 |
Genotype 4 Treatment-naive | -4.21 |
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Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized. (NCT01783678)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
Genotype 2 Treatment-naive | 0 |
Genotype 2/3 Treatment-experienced | 1.8 |
Genotype 1/3/4 Treatment-naive | 3.5 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively. (NCT01783678)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
All Genotype 1 Treatment-naive | 87.5 | 83.0 |
,Genotype 1a Treatment-naive | 87.0 | 82.0 |
,Genotype 1b Treatment-naive | 90.9 | 90.9 |
,Genotype 2 Treatment-experienced | 83.3 | 83.3 |
,Genotype 2 Treatment-naive | 89.5 | 89.5 |
,Genotype 3 Treatment-experienced | 87.8 | 83.7 |
,Genotype 3 Treatment-naive | 91.2 | 91.2 |
,Genotype 4 Treatment-naive | 90.3 | 80.6 |
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Percentage of Participants Experiencing Virologic Failure
"On-treatment virologic failure was defined as either:~Virologic breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment).~Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01783678)
Timeframe: Baseline up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| On-Treatment Virologic Failure | Virologic Relapse |
---|
All Genotype 1 Treatment-naive | 0 | 12.5 |
,Genotype 1a Treatment-naive | 0 | 13.0 |
,Genotype 1b Treatment-naive | 0 | 9.1 |
,Genotype 2 Treatment-experienced | 0 | 16.7 |
,Genotype 2 Treatment-naive | 0 | 5.3 |
,Genotype 3 Treatment-experienced | 2.0 | 12.5 |
,Genotype 3 Treatment-naive | 0 | 7.0 |
,Genotype 4 Treatment-naive | 0 | 16.1 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. (NCT01783678)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
Genotype 2 Treatment-naive | 89.5 |
All Genotype 1 Treatment-naive | 84.8 |
Genotype 1a Treatment-naive | 84.0 |
Genotype 1b Treatment-naive | 90.9 |
Genotype 2 Treatment-experienced | 83.3 |
Genotype 3 Treatment-naive | 91.2 |
Genotype 3 Treatment-experienced | 85.7 |
Genotype 4 Treatment-naive | 83.9 |
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HCV RNA Change From Baseline at Week 8
(NCT01783678)
Timeframe: Baseline; Week 8
Intervention | log10 IU/mL (Mean) |
---|
Genotype 2 Treatment-naive | -5.33 |
All Genotype 1 Treatment-naive | -4.95 |
Genotype 1a Treatment-naive | -5.01 |
Genotype 1b Treatment-naive | -4.55 |
Genotype 2 Treatment-experienced | -5.05 |
Genotype 3 Treatment-naive | -4.88 |
Genotype 3 Treatment-experienced | -4.86 |
Genotype 4 Treatment-naive | -4.57 |
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The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
The primary outcome was the proportion of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification. (NCT01805882)
Timeframe: 12 weeks after stop of treatment
Intervention | percentage of subjects (Number) |
---|
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir | 100 |
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669 | 95 |
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451 | 95 |
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir | 91.2 |
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir | 100 |
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir | 95 |
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451 | 76 |
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451 | 40 |
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669 | 20 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01808248)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
Genotype 2 | 95.7 | 95.7 |
,Genotype 3 | 87.5 | 83.3 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 15 IU/mL) at 12 weeks after stopping study treatment. (NCT01808248)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
Genotype 2 | 95.7 |
Genotype 3 | 83.3 |
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Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. (NCT01808248)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
Genotype 2 | 0 |
Genotype 3 | 8.7 |
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Percentage of Participants Experiencing On-treatment Virologic Failure
"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment" (NCT01808248)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
Genotype 2 | 0 |
Genotype 3 | 0 |
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Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants discontinuing any study drug due to an adverse event was summarized. (NCT01808248)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV | 8.5 |
[back to top]
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment. (NCT01826981)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) | 100 |
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) | 90 |
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) | 100 |
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease | 100 |
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) | 64.0 |
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) | 100 |
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) | 96.0 |
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) | 82.0 |
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) | 65.0 |
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) | 100 |
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) | 87.5 |
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) | 96.3 |
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) | 100.0 |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) | 75 |
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) | 100 |
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Percentage of Participants With On-treatment Virologic Failure
"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)" (NCT01826981)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) | 0 |
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) | 0 |
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) | 0 |
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease | 0 |
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) | 0 |
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) | 0 |
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) | 0 |
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) | 0 |
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) | 0 |
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) | 0 |
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) | 0 |
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) | 0 |
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) | 0 |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) | 0 |
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) | 0 |
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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
(NCT01826981)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) | 100.0 |
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) | 100.0 |
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) | 100.0 |
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease | 100.0 |
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) | 100.0 |
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) | 100.0 |
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) | 100.0 |
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) | 98.0 |
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) | 100.0 |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) | 100.0 |
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
(NCT01826981)
Timeframe: Week 10
Intervention | percentage of participants (Number) |
---|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) | 100.0 |
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) | 100.0 |
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) | 100.0 |
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease | 100.0 |
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) | 100.0 |
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) | 100.0 |
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) | 100.0 |
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) | 98.0 |
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) | 100.0 |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) | 100.0 |
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) | 100.0 |
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Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
(NCT01826981)
Timeframe: Up to 24 weeks plus 30 days
Intervention | Percentage of participants (Number) |
---|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) | 0 |
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) | 0 |
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) | 4.0 |
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease | 0 |
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) | 4.0 |
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) | 0 |
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) | 0 |
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) | 2.0 |
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) | 0 |
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) | 0 |
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) | 4.2 |
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) | 0 |
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) | 3.8 |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) | 5.0 |
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) | 0 |
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Percentage of Participants Experiencing Viral Relapse
Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. (NCT01826981)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) | 0 |
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) | 10.0 |
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) | 0 |
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease | 0 |
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) | 33.3 |
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) | 0 |
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) | 4.0 |
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) | 16.3 |
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) | 35.0 |
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) | 0 |
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) | 8.7 |
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) | 0 |
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) | 0 |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) | 15.0 |
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) | 0 |
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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
(NCT01826981)
Timeframe: Weeks 1 and 2
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 |
---|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) | 15.8 | 63.2 |
,Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) | 30.0 | 50.0 |
,Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) | 4.0 | 44.0 |
,Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease | 11.5 | 53.8 |
,Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) | 20.0 | 64.0 |
,Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) | 11.5 | 61.5 |
,Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) | 12.0 | 56.0 |
,Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) | 12.0 | 52.0 |
,Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) | 0 | 25.0 |
,Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) | 33.3 | 70.4 |
,Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) | 4.2 | 66.7 |
,Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) | 26.9 | 65.4 |
,Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) | 19.2 | 69.2 |
,Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) | 15.0 | 45.0 |
,Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) | 12.5 | 75.0 |
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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
(NCT01826981)
Timeframe: Weeks 4, 6, and 8
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 6 | Week 8 |
---|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) | 100.0 | 100.0 | 100.0 |
,Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) | 100.0 | 100.0 | 100.0 |
,Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) | 84.0 | 100.0 | 100.0 |
,Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease | 92.3 | 100.0 | 100.0 |
,Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) | 95.8 | 100.0 | 100.0 |
,Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) | 88.5 | 100.0 | 100.0 |
,Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) | 96.0 | 96.0 | 100.0 |
,Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) | 96.0 | 100.0 | 100.0 |
,Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) | 75.0 | 100.0 | 100.0 |
,Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) | 96.3 | 100.0 | 100.0 |
,Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) | 95.7 | 100.0 | 100.0 |
,Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) | 92.3 | 100.0 | 100.0 |
,Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) | 96.2 | 100.0 | 100.0 |
,Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) | 75.0 | 90.0 | 90.0 |
,Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) | 87.5 | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
(NCT01826981)
Timeframe: Weeks 16, 20, and 24
Intervention | percentage of participants (Number) |
---|
| Week 16 | Week 20 | Week 24 |
---|
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
(NCT01826981)
Timeframe: Posttreatment Weeks 2, 4, 8, and 24
Intervention | percentage of participants (Number) |
---|
| SVR2 | SVR4 | SVR8 | SVR24 |
---|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) | 100.0 | 100.0 | 100.0 | 100.0 |
,Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) | 100.0 | 100.0 | 90.0 | 90.0 |
,Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) | 100.0 | 84.0 | 100.0 | 100.0 |
,Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease | 100.0 | 92.3 | 100.0 | 100.0 |
,Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) | 72.0 | 95.8 | 64.0 | 64.0 |
,Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) | 100.0 | 88.5 | 100.0 | 100.0 |
,Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) | 100.0 | 96.0 | 96.0 | 96.0 |
,Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) | 90.0 | 96.0 | 82.0 | 82.0 |
,Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) | 95.0 | 75.0 | 65.0 | 65.0 |
,Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) | 100.0 | 96.3 | 100.0 | 100.0 |
,Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) | 87.5 | 95.7 | 87.5 | 87.5 |
,Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) | 96.3 | 92.3 | 96.3 | 96.3 |
,Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) | 100.0 | 96.2 | 100.0 | 100.0 |
,Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) | 95.0 | 75.0 | 80.0 | 75.0 |
,Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) | 100.0 | 87.5 | 100.0 | 100.0 |
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For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)
(NCT01826981)
Timeframe: Posttreatment Weeks 16 and 20
Intervention | percentage of participants (Number) |
---|
| SVR16 | SVR20 |
---|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) | 100 | 100 |
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Percentage of Participants Experiencing On-treatment Virologic Failure
"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)" (NCT01838590)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Weeks, TN | 0 |
SOF+RBV 12 Weeks, TE | 0 |
SOF+RBV 24 Weeks, TN | 0 |
SOF+RBV 24 Weeks, TE | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01838590)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Weeks, TN | 84.0 |
SOF+RBV 12 Weeks, TE | 70.4 |
SOF+RBV 24 Weeks, TN | 91.7 |
SOF+RBV 24 Weeks, TE | 88.9 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT01838590)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Weeks | 0 |
SOF+RBV 24 Weeks | 0 |
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Percentage of Participants Experiencing Virologic Relapse
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT01838590)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Weeks, TN | 16.0 |
SOF+RBV 12 Weeks, TE | 29.6 |
SOF+RBV 24 Weeks, TN | 4.2 |
SOF+RBV 24 Weeks, TE | 11.1 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01838590)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF+RBV 12 Weeks, TE | 74.1 | 70.4 |
,SOF+RBV 12 Weeks, TN | 88.0 | 84.0 |
,SOF+RBV 24 Weeks, TE | 88.9 | 88.9 |
,SOF+RBV 24 Weeks, TN | 91.7 | 91.7 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug. (NCT01851330)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 Week | 94.0 |
LDV/SOF+RBV 8 Week | 93.1 |
LDV/SOF 12 Week | 96.3 |
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Percentage of Participants Experiencing Virologic Failure
"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-Treatment Virologic Failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01851330)
Timeframe: Baseline to posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| On-treatment virologic failure | Virologic relapse |
---|
LDV/SOF 12 Week | 0 | 1.4 |
,LDV/SOF 8 Week | 0 | 5.1 |
,LDV/SOF+RBV 8 Week | 0 | 4.2 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01851330)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF 12 Week | 96.3 | 96.3 |
,LDV/SOF 8 Week | 96.3 | 94.0 |
,LDV/SOF+RBV 8 Week | 94.9 | 93.1 |
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Change From Baseline in HCV RNA at Week 4
(NCT01851330)
Timeframe: Baseline; Week 4
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF 8 Week | -5.12 |
LDV/SOF+RBV 8 Week | -5.05 |
LDV/SOF 12 Week | -5.05 |
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Change From Baseline in HCV RNA at Week 2
(NCT01851330)
Timeframe: Baseline; Week 2
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF 8 Week | -5.06 |
LDV/SOF+RBV 8 Week | -5.01 |
LDV/SOF 12 Week | -4.99 |
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Percentage of Participants With HCV RNA < LLOQ at Week 8
(NCT01851330)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 Week | 100.0 |
LDV/SOF+RBV 8 Week | 100.0 |
LDV/SOF 12 Week | 99.5 |
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Change From Baseline in HCV RNA at Week 8
(NCT01851330)
Timeframe: Baseline; Week 8
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF 8 Week | -5.12 |
LDV/SOF+RBV 8 Week | -5.05 |
LDV/SOF 12 Week | -5.04 |
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Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized. (NCT01851330)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 Week | 0 |
LDV/SOF+RBV 8 Week | 0.9 |
LDV/SOF 12 Week | 0.9 |
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Percentage of Participants With HCV RNA < LLOQ at Week 2
(NCT01851330)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 Week | 88.4 |
LDV/SOF+RBV 8 Week | 91.1 |
LDV/SOF 12 Week | 91.2 |
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Percentage of Participants With HCV RNA < LLOQ at Week 4
(NCT01851330)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 Week | 100.0 |
LDV/SOF+RBV 8 Week | 99.1 |
LDV/SOF 12 Week | 100.0 |
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Percentage of Participants With Achieved SVR12 (HCV RNA The primary end point was sustained virologic response [plasma HCV RNA level <12 IU/mL by real-time HCV assay (Abbott)] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study. (NCT01878799)
Timeframe: 12 weeks after completion of treatment
Intervention | percentage of participants (Number) |
---|
Subjects With HIV and HCV on Antiretroviral Agents | 97 |
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents | 100 |
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Percentage of Participants Experiencing Virologic Relapse
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT01896193)
Timeframe: Up to Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV 16 Weeks, GT1 | 50.0 |
SOF+RBV 24 Weeks, GT1 | 23.5 |
SOF+RBV 16 Weeks, GT3 | 13.3 |
SOF+RBV 24 Weeks, GT3 | 9.7 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01896193)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV 16 Weeks, GT1 | 50.0 |
SOF+RBV 24 Weeks, GT1 | 76.5 |
SOF+RBV 16 Weeks, GT3 | 86.7 |
SOF+RBV 24 Weeks, GT3 | 90.3 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01896193)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF+RBV 16 Weeks, GT1 | 53.1 | 46.9 |
,SOF+RBV 16 Weeks, GT3 | 90.0 | 86.7 |
,SOF+RBV 24 Weeks, GT1 | 76.5 | 76.5 |
,SOF+RBV 24 Weeks, GT3 | 90.3 | 90.3 |
[back to top]
Percentage of Participants Experiencing On-treatment Virologic Failure
"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)" (NCT01896193)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 16 Weeks, GT1 | 0 |
SOF+RBV 24 Weeks, GT1 | 0 |
SOF+RBV 16 Weeks, GT3 | 0 |
SOF+RBV 24 Weeks, GT3 | 0 |
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Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized. (NCT01896193)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 16 Weeks, GT1 | 0 |
SOF+RBV 24 Weeks, GT1 | 0 |
SOF+RBV 16 Weeks, GT3 | 0 |
SOF+RBV 24 Weeks, GT3 | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01910636)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV Treatment Naive | 97.8 |
SOF+RBV Treatment Experienced | 95.2 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01910636)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF+RBV Treatment Experienced | 95.2 | 95.2 |
,SOF+RBV Treatment Naive | 98.9 | 97.8 |
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Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. (NCT01910636)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV Treatment Naive | 2.2 |
SOF+RBV Treatment Experienced | 4.8 |
[back to top]
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized. (NCT01910636)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 0 |
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Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values. (NCT01910636)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV Treatment Naive | 0 |
SOF+RBV Treatment Experienced | 0 |
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Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event
(NCT01924949)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01924949)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 100.0 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT01924949)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF 12 Weeks | 100.0 | 100.0 |
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HCV RNA Change From Baseline
(NCT01924949)
Timeframe: Baseline; Weeks 1, 4, and 8
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 4 | Change at Week 8 |
---|
LDV/SOF 12 Weeks | -4.36 | -4.56 | -4.56 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT01924949)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 4 | Week 8 | Week 12 |
---|
LDV/SOF 12 Weeks | 60.0 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants Experiencing Virologic Failure
"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01924949)
Timeframe: Baseline to posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 24
(NCT01938430)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 20
(NCT01938430)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 2
(NCT01938430)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 36.7 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 41.4 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 39.1 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 38.5 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 49.1 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 41.8 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 34.6 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 28.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 8.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 42.3 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 40.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 25.0 |
Cohort B, Group 7 (12 wk): FCH | 50.0 |
Cohort B, Group 7 (24 wk): FCH | 0.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 16
(NCT01938430)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 12
(NCT01938430)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 96.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01938430)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 10.0 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 3.7 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 4.5 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 8.7 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 3.6 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 0.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 0.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 0.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 3.8 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 0.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 40.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 25.0 |
Cohort B, Group 7 (12 wk): FCH | 3.6 |
Cohort B, Group 7 (24 wk): FCH | 0.0 |
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HCV RNA and Change From Baseline at Week 1
(NCT01938430)
Timeframe: Baseline; Week 1
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Change at Week 1 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 2.26 | -3.59 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 2.49 | -3.34 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 2.11 | -3.47 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 2.46 | -3.32 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 2.33 | -4.14 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 2.42 | -3.98 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 2.40 | -3.80 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 2.86 | -3.86 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 2.84 | -3.41 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 2.56 | -3.68 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 2.76 | -3.75 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 2.75 | -3.52 |
,Cohort B, Group 7 (12 wk): FCH | 2.28 | -4.22 |
,Cohort B, Group 7 (24 wk): FCH | 4.30 | -2.76 |
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HCV RNA and Change From Baseline at Week 8
(NCT01938430)
Timeframe: Baseline; Week 8
Intervention | log10 IU/mL (Mean) |
---|
| Week 8 | Change at Week 8 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 1.15 | -4.70 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 1.15 | -4.67 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 1.15 | -4.47 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 1.16 | -4.61 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.15 | -5.33 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 1.15 | -5.25 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 1.15 | -5.05 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 1.15 | -5.60 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 1.15 | -5.11 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 1.15 | -5.10 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 1.15 | -5.21 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 1.15 | -5.12 |
,Cohort B, Group 7 (12 wk): FCH | 1.15 | -5.36 |
,Cohort B, Group 7 (24 wk): FCH | 1.22 | -5.83 |
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HCV RNA and Change From Baseline at Week 6
(NCT01938430)
Timeframe: Baseline; Week 6
Intervention | log10 IU/mL (Mean) |
---|
| Week 6 | Change at Week 6 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 1.15 | -4.70 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 1.15 | -4.69 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 1.15 | -4.47 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 1.15 | -4.61 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.15 | -5.32 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 1.15 | -5.25 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 1.15 | -5.05 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 1.15 | -5.60 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 1.15 | -5.10 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 1.15 | -5.09 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 1.15 | -5.21 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 1.15 | -5.12 |
,Cohort B, Group 7 (12 wk): FCH | 1.15 | -5.36 |
,Cohort B, Group 7 (24 wk): FCH | 1.15 | -5.28 |
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Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
(NCT01938430)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
| Discontinued LDV/SOF | Discontinued Any Study Drug |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 0.0 | 0.0 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 6.9 | 13.8 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 4.3 | 13.0 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 7.7 | 34.6 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 0.0 | 10.9 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 3.6 | 17.9 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 3.8 | 15.4 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 0.0 | 8.0 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 7.7 | 23.1 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 11.5 | 34.6 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 0.0 | 40.0 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 0.0 | 25.0 |
,Cohort B, Group 7 (12 wk): FCH | 0.0 | 25.0 |
,Cohort B, Group 7 (24 wk): FCH | 0.0 | 0.0 |
[back to top]
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline. (NCT01938430)
Timeframe: Baseline to Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Decrease | No Change | Increase |
---|
Cohort A: Baseline CPT Class A (24 wk) | 0.0 | 0.0 | 100.0 |
,Cohort A: Baseline CPT Class B (12 wk) | 63.3 | 23.3 | 13.3 |
,Cohort A: Baseline CPT Class B (24 wk) | 50.0 | 38.5 | 11.5 |
,Cohort A: Baseline CPT Class C (12 wk) | 89.5 | 10.5 | 0.0 |
,Cohort A: Baseline CPT Class C (24 wk) | 72.2 | 27.8 | 0.0 |
,Cohort B: Baseline CPT Class A (12 wk) | 18.2 | 68.2 | 13.6 |
,Cohort B: Baseline CPT Class A (24 wk) | 47.8 | 52.2 | 0.0 |
,Cohort B: Baseline CPT Class B (12 wk) | 56.5 | 34.8 | 8.7 |
,Cohort B: Baseline CPT Class B (24 wk) | 59.1 | 31.8 | 9.1 |
,Cohort B: Baseline CPT Class C (12 wk) | 50.0 | 50.0 | 0.0 |
,Cohort B: Baseline CPT Class C (24 wk) | 100.0 | 0.0 | 0.0 |
[back to top]
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. (NCT01938430)
Timeframe: Baseline to Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Decrease | No Change | Increase |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 60.7 | 17.9 | 21.4 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 68.0 | 20.0 | 12.0 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 61.9 | 9.5 | 28.6 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 80.0 | 15.0 | 5.0 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 30.4 | 39.1 | 30.4 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 52.0 | 16.0 | 32.0 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 66.7 | 19.0 | 14.3 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 70.0 | 5.0 | 25.0 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 40.0 | 20.0 | 40.0 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 66.7 | 0.0 | 33.3 |
[back to top]
HCV RNA and Change From Baseline at Week 2
(NCT01938430)
Timeframe: Baseline; Week 2
Intervention | log10 IU/mL (Mean) |
---|
| Week 2 | Change at Week 2 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 1.60 | -4.25 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 1.67 | -4.16 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 1.49 | -4.09 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 1.82 | -3.98 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.64 | -4.83 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 1.59 | -4.79 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 1.73 | -4.48 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 1.91 | -4.84 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 2.03 | -4.22 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 1.76 | -4.47 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 1.80 | -4.56 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 2.00 | -4.26 |
,Cohort B, Group 7 (12 wk): FCH | 1.66 | -4.85 |
,Cohort B, Group 7 (24 wk): FCH | 1.61 | -4.81 |
[back to top]
HCV RNA and Change From Baseline at Week 12
(NCT01938430)
Timeframe: Baseline; Week 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 12 | Change at Week 12 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 1.15 | -4.70 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 1.15 | -4.70 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 1.15 | -4.44 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 1.15 | -4.62 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.15 | -5.33 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 1.15 | -5.25 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 1.15 | -5.09 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 1.15 | -5.60 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 1.15 | -5.14 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 1.15 | -5.10 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 1.15 | -5.21 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 1.15 | -5.12 |
,Cohort B, Group 7 (12 wk): FCH | 1.15 | -5.36 |
,Cohort B, Group 7 (24 wk): FCH | 1.15 | -5.91 |
[back to top]
Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment. (NCT01938430)
Timeframe: Posttreatment Week 8
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 86.7 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 88.9 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 86.4 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 95.7 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 96.4 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 98.2 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 96.2 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 88.5 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 88.5 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 60.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 75.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT01938430)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 90.0 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 88.9 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 90.9 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 95.7 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 96.4 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 98.2 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 96.2 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 88.5 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 92.3 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 75.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT01938430)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 86.7 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 88.9 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 85.7 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 87.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 96.4 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 98.2 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 96.2 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 96.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 84.6 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 88.5 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 60.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 75.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 1
(NCT01938430)
Timeframe: Week 1
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 6.7 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 6.9 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 13.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 3.8 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 16.4 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 12.5 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 15.4 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 4.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 3.8 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 7.7 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 0.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 0.0 |
Cohort B, Group 7 (12 wk): FCH | 25.0 |
Cohort B, Group 7 (24 wk): FCH | 0.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 4
(NCT01938430)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 83.3 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 82.8 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 84.6 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 87.3 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 90.9 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 88.5 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 80.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 72.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 88.5 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 50.0 |
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HCV RNA and Change From Baseline at Week 4
(NCT01938430)
Timeframe: Baseline; Week 4
Intervention | log10 IU/mL (Mean) |
---|
| Week 4 | Change at Week 4 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 1.20 | -4.65 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 1.21 | -4.63 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 1.15 | -4.44 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 1.23 | -4.56 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.24 | -5.23 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 1.16 | -5.24 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 1.18 | -5.01 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 1.23 | -5.52 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 1.24 | -5.01 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 1.18 | -5.05 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 1.15 | -5.21 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 1.15 | -5.12 |
,Cohort B, Group 7 (12 wk): FCH | 1.15 | -5.36 |
,Cohort B, Group 7 (24 wk): FCH | 1.67 | -5.39 |
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Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment. (NCT01938430)
Timeframe: Posttreatment Week 2
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 96.7 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 92.6 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 95.5 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 95.8 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 98.2 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 96.2 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 88.5 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 92.3 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 75.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT01938430)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 86.7 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 88.9 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 86.4 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 87.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 96.4 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 98.2 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 96.2 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 96.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 84.6 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 88.5 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 60.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 75.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant. (NCT01938430)
Timeframe: Posttransplant Week 12
Intervention | percentage of participants (Number) |
---|
All LDV/SOF+RBV | 85.7 |
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Percentage of Participants With HCV RNA < LLOQ at Week 8
(NCT01938430)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 96.6 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 92.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 96.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 96.2 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 50.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 6
(NCT01938430)
Timeframe: Week 6
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 96.2 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 96.4 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 50.0 |
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT01958281)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF 200 mg + RBV 200 mg (Cohort 1) | 40.0 |
SOF 400 mg + RBV 200 mg (Cohort 2) | 60.0 |
LDV/SOF (Cohort 3) | 100.0 |
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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR4 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT01958281)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF 200 mg + RBV 200 mg (Cohort 1) | 40.0 |
SOF 400 mg + RBV 200 mg (Cohort 2) | 60.0 |
LDV/SOF (Cohort 3) | 100.0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT01958281)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF 200 mg + RBV 200 mg (Cohort 1) | 40.0 |
SOF 400 mg + RBV 200 mg (Cohort 2) | 60.0 |
LDV/SOF (Cohort 3) | 100.0 |
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Percentage of Participants With Overall Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01958281)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF 200 mg + RBV 200 mg (Cohort 1) | 50.0 |
SOF 400 mg + RBV 200 mg (Cohort 2) | 40.0 |
LDV/SOF (Cohort 3) | 0 |
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Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any time postbaseline up to the date of last dose of study drug plus 30 days. (NCT01958281)
Timeframe: Up to 24 weeks plus 30 days
Intervention | percentage of participants (Number) |
---|
SOF 200 mg + RBV 200 mg (Cohort 1) | 100.0 |
SOF 400 mg + RBV 200 mg (Cohort 2) | 100.0 |
LDV/SOF (Cohort 3) | 100.0 |
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events Associated With Vital Sign Abnormalities
(NCT01958281)
Timeframe: Up to 24 weeks plus 30 days
Intervention | percentage of participants (Number) |
---|
SOF 200 mg + RBV 200 mg (Cohort 1) | 10.0 |
SOF 400 mg + RBV 200 mg (Cohort 2) | 0 |
LDV/SOF (Cohort 3) | 0 |
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events
(NCT01958281)
Timeframe: Up to 24 weeks plus 30 days
Intervention | percentage of participants (Number) |
---|
SOF 200 mg + RBV 200 mg (Cohort 1) | 100.0 |
SOF 400 mg + RBV 200 mg (Cohort 2) | 90.0 |
LDV/SOF (Cohort 3) | 72.2 |
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Percentage of Participants Experiencing Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
(NCT01958281)
Timeframe: Up to 24 weeks plus 30 days
Intervention | percentage of participants (Number) |
---|
SOF 200 mg + RBV 200 mg (Cohort 1) | 0 |
SOF 400 mg + RBV 200 mg (Cohort 2) | 0 |
LDV/SOF (Cohort 3) | 5.6 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT01962441)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 16 Weeks | 1.5 |
SOF+RBV 24 Weeks | 1.5 |
SOF+RBV+Peg-IFN 12 Weeks | 1.5 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT01962441)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+RBV 16 Weeks | 71.9 |
SOF+RBV 24 Weeks | 85.4 |
SOF+RBV+Peg-IFN 12 Weeks | 92.9 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT01962441)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF+RBV 16 Weeks | 73.0 | 71.9 |
,SOF+RBV 24 Weeks | 85.9 | 84.4 |
,SOF+RBV+Peg-IFN 12 Weeks | 95.9 | 93.4 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
(NCT01962441)
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
SOF+RBV 24 Weeks | 20.1 | 53.5 | 91.9 | 99.5 | 98.5 | 99.5 | 99.5 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
(NCT01962441)
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 |
---|
SOF+RBV 16 Weeks | 14.8 | 53.3 | 86.6 | 99.5 | 100.0 | 99.0 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
(NCT01962441)
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF+RBV+Peg-IFN 12 Weeks | 25.9 | 67.0 | 97.4 | 99.5 | 100.0 |
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Percentage of Participants Experiencing Viral Relapse
Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. (NCT01962441)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF+RBV 16 Weeks | 26.7 |
SOF+RBV 24 Weeks | 12.3 |
SOF+RBV+Peg-IFN 12 Weeks | 4.6 |
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HCV RNA at Weeks 1, 2, 4, 8, and 12
(NCT01962441)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF+RBV 16 Weeks | 2.13 | 1.44 | 1.19 | 1.15 | 1.15 |
,SOF+RBV 24 Weeks | 2.08 | 1.45 | 1.21 | 1.15 | 1.17 |
,SOF+RBV+Peg-IFN 12 Weeks | 1.81 | 1.32 | 1.16 | 1.15 | 1.15 |
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Percentage of Participants Experiencing On-Treatment Virologic Failure
"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)" (NCT01962441)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV 16 Weeks | 0 |
SOF+RBV 24 Weeks | 1.5 |
SOF+RBV+Peg-IFN 12 Weeks | 0 |
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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
(NCT01962441)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF+RBV 16 Weeks | -4.18 | -4.86 | -5.11 | -5.16 | -5.15 |
,SOF+RBV 24 Weeks | -4.15 | -4.78 | -5.02 | -5.08 | -5.05 |
,SOF+RBV+Peg-IFN 12 Weeks | -4.46 | -4.96 | -5.12 | -5.12 | -5.12 |
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Percentage of Participants With Virologic Failure
"Virologic failure is defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01965535)
Timeframe: Baseline to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| On-Treatment Virologic Failure | Virologic Relapse |
---|
LDV/SOF | 0 | 2.6 |
,LDV/SOF + RBV | 0 | 3.9 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01965535)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF | 97.4 | 97.4 |
,LDV/SOF + RBV | 97.4 | 96.1 |
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Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24
(NCT01965535)
Timeframe: Weeks 1, 2, 4, 8, 12, and 24
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 24 |
---|
LDV/SOF | 7.8 | 50.6 | 97.4 | 98.7 | 100.0 | 100.0 |
,LDV/SOF + RBV | 9.1 | 59.7 | 97.4 | 100.0 | 100.0 | 100.0 |
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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
(NCT01965535)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 (LDV/SOF: n = 75; LDV/SOF + RBV: n = 75) | Week 2 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77) | Week 4 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77) | Week 8 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77) | Week 12 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77) |
---|
LDV/SOF | -4.10 | -4.74 | -5.10 | -5.11 | -5.11 |
,LDV/SOF + RBV | -4.27 | -4.94 | -5.19 | -5.20 | -5.20 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.~1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set.~1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set)." (NCT01965535)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 97.4 |
LDV/SOF + RBV | 96.1 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT01975675)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF (Treatment Experienced) | 100.0 | 100.0 |
,LDV/SOF (Treatment Naive) | 100.0 | 100.0 |
,LDV/SOF+RBV (Treatment Experienced) | 100.0 | 100.0 |
,LDV/SOF+RBV (Treatment Naive) | 96.4 | 96.4 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT01975675)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 0 |
LDV/SOF+RBV | 1.8 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01975675)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Treatment Naive) | 100.0 |
LDV/SOF+RBV (Treatment Naive) | 97.2 |
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Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01975675)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Treatment Naive) | 100.0 |
LDV/SOF+RBV (Treatment Naive) | 96.4 |
LDV/SOF (Treatment Experienced) | 100.0 |
LDV/SOF+RBV (Treatment Experienced) | 100.0 |
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Percentage of Participants Experiencing Virologic Failure
"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01975675)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| On-treatment virologic failure | Virologic relapse |
---|
LDV/SOF (Treatment Experienced) | 0 | 0 |
,LDV/SOF (Treatment Naive) | 0 | 0 |
,LDV/SOF+RBV (Treatment Experienced) | 0 | 0 |
,LDV/SOF+RBV (Treatment Naive) | 0 | 1.2 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT01987453)
Timeframe: Up to 24 Weeks
Intervention | Percentage of participants (Number) |
---|
LDV/SOF + RBV 12 Weeks (Group 1) | 5.9 |
LDV/SOF 24 Weeks (Group 2) | 0 |
LDV/SOF + RBV 24 Weeks (Group 3) | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively. (NCT01987453)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | Percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF + RBV 12 Weeks (Group 1) | 98.0 | 98.0 |
,LDV/SOF + RBV 24 Weeks (Group 3) | 100.0 | 100.0 |
,LDV/SOF 24 Weeks (Group 2) | 73.2 | 70.7 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit confirmed with 2 consecutive values or last available posttreatment measurement" (NCT01987453)
Timeframe: Up to posttreatment Week 24
Intervention | Percentage of participants (Number) |
---|
| On treatment Virologic Failure | Relapse |
---|
LDV/SOF + RBV 12 Weeks (Group 1) | 0 | 2.0 |
,LDV/SOF + RBV 24 Weeks (Group 3) | 0 | 0 |
,LDV/SOF 24 Weeks (Group 2) | 2.4 | 27.5 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. (NCT01987453)
Timeframe: Post-treatment Week 12
Intervention | Percentage of participants (Number) |
---|
LDV/SOF + RBV 12 Weeks (Group 1) | 98.0 |
LDV/SOF 24 Weeks (Group 2) | 70.7 |
LDV/SOF + RBV 24 Weeks (Group 3) | 100.0 |
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Change in HCV RNA From Baseline
(NCT01987453)
Timeframe: Baseline to Week 8
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 4 | Week 8 |
---|
LDV/SOF + RBV 12 Weeks (Group 1) | -4.47 | -5.07 | -5.09 |
,LDV/SOF + RBV 24 Weeks (Group 3) | -3.75 | -4.47 | -4.47 |
,LDV/SOF 24 Weeks (Group 2) | -4.40 | -5.06 | -5.08 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment
(NCT01987453)
Timeframe: Baseline to Week 24
Intervention | Percentage of participants (Number) |
---|
| Week 1 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
LDV/SOF + RBV 12 Weeks (Group 1) | 23.5 | 98.0 | 100.0 | 100.0 | NA | NA | NA |
,LDV/SOF + RBV 24 Weeks (Group 3) | 0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,LDV/SOF 24 Weeks (Group 2) | 31.7 | 95.1 | 100.0 | 100.0 | 97.6 | 97.6 | 100.0 |
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Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose
Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment (NCT01994486)
Timeframe: 4/22/2014-5/6/2014
Intervention | participants (Number) |
---|
Telaprevir and Sofosbuvir | 19 |
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Proportion of Subjects With Viral Relapse
Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point. (NCT01994486)
Timeframe: 1/3/2014-9/8/2014
Intervention | participants (Number) |
---|
Telaprevir and Sofosbuvir | 1 |
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Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen
Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL) (NCT01994486)
Timeframe: 6/16/2014-7/2/2014
Intervention | participants (Number) |
---|
Telaprevir and Sofosbuvir | 19 |
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Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks
The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period. (NCT01994486)
Timeframe: 1/3/2014-4/10/2014
Intervention | participants (Number) |
---|
Telaprevir and Sofosbuvir | 1 |
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Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir
Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported. (NCT01994486)
Timeframe: 12 weeks-January 3, 2014- April 10, 2014
Intervention | participants (Number) |
---|
Telaprevir and Sofosbuvir | 0 |
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Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment. (NCT02010255)
Timeframe: Posttreatment Week 8
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 84.6 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 96.2 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 81.8 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 80.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 94.2 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 97.1 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 97.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 95.5 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 33.3 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 80.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02010255)
Timeframe: Posttreatment Week 4
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 88.5 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 90.9 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 80.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 94.2 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 97.1 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 97.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 95.5 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 80.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02010255)
Timeframe: Posttreatment Week 24
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 84.0 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 96.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 80.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 76.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 94.2 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 97.1 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 97.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 95.5 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 33.3 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 80.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 1
(NCT02010255)
Timeframe: Week 1
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 3.8 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 3.7 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 12.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 3.8 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 9.6 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 6.1 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 5.9 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 3.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 0.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 8.7 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 0.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 0.0 |
Cohort B, Group 7 (12 wk): FCH | 0.0 |
Cohort B, Group 7 (24 wk): FCH | 0.0 |
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HCV RNA Levels and Change From Baseline at Week 4
(NCT02010255)
Timeframe: Baseline; Week 4
Intervention | log10 IU/mL (Mean) |
---|
| Week 4 | Change at Week 4 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 1.26 | -4.78 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 1.20 | -4.66 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 1.23 | -4.45 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 1.18 | -4.52 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.23 | -5.13 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 1.18 | -5.32 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 1.29 | -5.05 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 1.21 | -5.25 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 1.25 | -4.88 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 1.32 | -4.87 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 1.15 | -4.89 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 1.56 | -4.91 |
,Cohort B, Group 7 (12 wk): FCH | 1.15 | -6.16 |
,Cohort B, Group 7 (24 wk): FCH | 1.15 | -4.89 |
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HCV RNA Levels and Change From Baseline at Week 6
(NCT02010255)
Timeframe: Baseline; Week 6
Intervention | log10 IU/mL (Mean) |
---|
| Week 6 | Change at Week 6 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 1.15 | -4.90 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 1.15 | -4.72 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 1.17 | -4.51 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 1.15 | -4.56 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.15 | -5.21 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 1.15 | -5.35 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 1.15 | -5.19 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 1.15 | -5.31 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 1.15 | -4.98 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 1.15 | -5.05 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 1.15 | -4.89 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 1.15 | -5.33 |
,Cohort B, Group 7 (12 wk): FCH | 1.15 | -6.16 |
,Cohort B, Group 7 (24 wk): FCH | 1.15 | -4.89 |
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HCV RNA Levels and Change From Baseline at Week 8
(NCT02010255)
Timeframe: Baseline; Week 8
Intervention | log10 IU/mL (Mean) |
---|
| Week 8 | Change at Week 8 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 1.15 | -4.90 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 1.15 | -4.72 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 1.15 | -4.53 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 1.15 | -4.60 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.15 | -5.21 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 1.15 | -5.35 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 1.15 | -5.19 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 1.15 | -5.31 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 1.15 | -4.98 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 1.15 | -5.05 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 1.15 | -4.89 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 1.15 | -5.33 |
,Cohort B, Group 7 (12 wk): FCH | 1.15 | -6.16 |
,Cohort B, Group 7 (24 wk): FCH | 1.15 | -4.89 |
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Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
(NCT02010255)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
| Discontinued LDV/SOF | Discontinued Any Study Drug |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 3.6 | 3.6 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 3.6 | 7.1 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 0.0 | 16.0 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 7.7 | 23.1 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.9 | 5.8 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 0.0 | 6.1 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 0.0 | 0.0 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 3.0 | 15.2 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 0.0 | 18.2 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 0.0 | 17.4 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 0.0 | 33.3 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 20.0 | 20.0 |
,Cohort B, Group 7 (12 wk): FCH | 0.0 | 0.0 |
,Cohort B, Group 7 (24 wk): FCH | 0.0 | 0.0 |
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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline. (NCT02010255)
Timeframe: Baseline to Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Decrease | No Change | Increase |
---|
Cohort A: Baseline CPT Class B (12 wk) | 64.3 | 28.6 | 7.1 |
,Cohort A: Baseline CPT Class B (24 wk) | 87.0 | 13.0 | 0.0 |
,Cohort A: Baseline CPT Class C (12 wk) | 82.4 | 11.8 | 5.9 |
,Cohort A: Baseline CPT Class C (24 wk) | 73.7 | 26.3 | 0.0 |
,Cohort B: Baseline CPT Class A (12 wk) | 28.6 | 68.6 | 2.9 |
,Cohort B: Baseline CPT Class A (24 wk) | 23.5 | 61.8 | 14.7 |
,Cohort B: Baseline CPT Class B (12 wk) | 61.1 | 33.3 | 5.6 |
,Cohort B: Baseline CPT Class B (24 wk) | 85.0 | 10.0 | 5.0 |
,Cohort B: Baseline CPT Class C (12 wk) | 100.0 | 0.0 | 0.0 |
,Cohort B: Baseline CPT Class C (24 wk) | 80.0 | 20.0 | 0.0 |
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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. (NCT02010255)
Timeframe: Baseline to Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Decrease | No Change | Increase |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 70.8 | 12.5 | 16.7 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 77.3 | 9.1 | 13.6 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 81.0 | 14.3 | 4.8 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 70.0 | 5.0 | 25.0 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 28.1 | 31.3 | 40.6 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 62.5 | 18.8 | 18.8 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 66.7 | 14.3 | 19.0 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 65.2 | 17.4 | 17.4 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 50.0 | 50.0 | 0.0 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 75.0 | 0.0 | 25.0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02010255)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 84.6 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 96.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 81.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 76.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 94.2 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 97.1 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 97.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 95.5 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 33.3 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 80.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant. (NCT02010255)
Timeframe: Posttreatment Week 12
Intervention | Percentage of participants (Number) |
---|
All LDV/SOF+RBV | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 8
(NCT02010255)
Timeframe: Week 8
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 96.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 96.9 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment. (NCT02010255)
Timeframe: Posttreatment Week 2
Intervention | percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 96.2 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 91.3 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 80.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 98.1 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 97.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 95.5 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 80.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 6
(NCT02010255)
Timeframe: Week 6
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 91.7 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 98.1 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 97.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 4
(NCT02010255)
Timeframe: Week 4
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 76.9 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 81.5 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 80.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 84.6 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 84.6 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 91.8 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 67.6 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 81.8 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 72.7 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 82.6 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 25 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 24
(NCT02010255)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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HCV RNA Levels and Change From Baseline at Week 2
(NCT02010255)
Timeframe: Baseline; Week 2
Intervention | log10 IU/mL (Mean) |
---|
| Week 2 | Change at Week 2 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 1.76 | -4.29 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 1.70 | -4.17 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 1.71 | -3.92 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 1.72 | -3.99 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.62 | -4.74 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 1.49 | -5.00 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 1.92 | -4.42 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 1.97 | -4.48 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 1.86 | -4.26 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 2.00 | -4.20 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 2.08 | -3.95 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 2.81 | -3.66 |
,Cohort B, Group 7 (12 wk): FCH | 1.85 | -5.46 |
,Cohort B, Group 7 (24 wk): FCH | 1.65 | -4.38 |
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Percentage of Participants With HCV RNA < LLOQ at Week 20
(NCT02010255)
Timeframe: Week 20
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 2
(NCT02010255)
Timeframe: Week 2
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 26.9 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 37.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 40.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 38.5 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 48.1 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 44.9 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 26.5 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 21.2 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 31.8 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 30.4 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 0.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 0.0 |
Cohort B, Group 7 (12 wk): FCH | 33.3 |
Cohort B, Group 7 (24 wk): FCH | 0.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 16
(NCT02010255)
Timeframe: Week 16
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 12
(NCT02010255)
Timeframe: Week 12
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 100.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 100.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 95.5 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 100.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 100.0 |
Cohort B, Group 7 (12 wk): FCH | 100.0 |
Cohort B, Group 7 (24 wk): FCH | 100.0 |
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HCV RNA Levels and Change From Baseline at Week 12
(NCT02010255)
Timeframe: Baseline; Week 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 12 | Change at Week 12 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 1.15 | -4.90 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 1.15 | -4.72 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 1.15 | -4.53 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 1.15 | -4.60 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.15 | -5.21 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 1.15 | -5.35 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 1.15 | -5.19 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 1.15 | -5.30 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 1.15 | -4.98 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 1.15 | -5.05 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 1.15 | -4.89 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 1.15 | -5.33 |
,Cohort B, Group 7 (12 wk): FCH | 1.15 | -6.16 |
,Cohort B, Group 7 (24 wk): FCH | 1.15 | -4.89 |
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HCV RNA Levels and Change From Baseline at Week 1
(NCT02010255)
Timeframe: Baseline; Week 1
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Change at Week 1 |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 2.44 | -3.60 |
,Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 2.47 | -3.39 |
,Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 2.32 | -3.28 |
,Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 2.50 | -3.20 |
,Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 2.38 | -3.98 |
,Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 2.38 | -4.12 |
,Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 2.64 | -3.70 |
,Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 2.81 | -3.65 |
,Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 2.63 | -3.50 |
,Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 2.75 | -3.44 |
,Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 2.97 | -3.06 |
,Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 3.73 | -2.74 |
,Cohort B, Group 7 (12 wk): FCH | 2.91 | -4.40 |
,Cohort B, Group 7 (24 wk): FCH | 2.28 | -3.76 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02010255)
Timeframe: Up to Posttreatment Week 24
Intervention | Percentage of participants (Number) |
---|
Cohort A, Group 1 (12 wk): CPT Class B (7-9) | 15.4 |
Cohort A, Group 1 (24 wk): CPT Class B (7-9) | 4.0 |
Cohort A, Group 2 (12 wk): CPT Class C (10-12) | 9.5 |
Cohort A, Group 2 (24 wk): CPT Class C (10-12) | 4.0 |
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | 1.9 |
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | 0.0 |
Cohort B, Group 4 (12 wk): CPT Class A (5-6) | 0.0 |
Cohort B, Group 4 (24 wk): CPT Class A (5-6) | 0.0 |
Cohort B, Group 5 (12 wk): CPT Class B (7-9) | 0.0 |
Cohort B, Group 5 (24 wk): CPT Class B (7-9) | 0.0 |
Cohort B, Group 6 (12 wk): CPT Class C (10-12) | 33.3 |
Cohort B, Group 6 (24 wk): CPT Class C (10-12) | 0.0 |
Cohort B, Group 7 (12 wk): FCH | 0.0 |
Cohort B, Group 7 (24 wk): FCH | 0.0 |
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Percentage of Participants With Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. (NCT02021643)
Timeframe: Up to Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | 7 |
SOF+RBV 12 Weeks (GT1 and GT6) | 0 |
SOF+RBV 16 Weeks (GT1 and GT6) | 0 |
SOF+RBV 24 Weeks (GT1 and GT6) | 6 |
SOF+RBV 12 Weeks (GT2) | 6 |
SOF+RBV 24 Weeks (GT3) | 6 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug. (NCT02021643)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | 95.5 |
SOF+RBV 12 Weeks (GT1 and GT6) | 100 |
SOF+RBV 16 Weeks (GT1 and GT6) | 100 |
SOF+RBV 24 Weeks (GT1 and GT6) | 94.2 |
SOF+RBV 12 Weeks (GT2) | 96.8 |
SOF+RBV 24 Weeks (GT3) | 95.2 |
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Percentage of Participants With On-Treatment Virologic Failure
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment. (NCT02021643)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | 0 |
SOF+RBV 12 Weeks (GT1 and GT6) | 0 |
SOF+RBV 16 Weeks (GT1 and GT6) | 0 |
SOF+RBV 24 Weeks (GT1 and GT6) | 0 |
SOF+RBV 12 Weeks (GT2) | 1 |
SOF+RBV 24 Weeks (GT3) | 0 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02021643)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
SOF+PEG+RBV 12 Weeks | 1 |
SOF+RBV 12 Weeks | 1 |
SOF+RBV 16 Weeks | 0 |
SOF+RBV 24 Weeks | 2 |
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Change From Baseline in HCV RNA (log10 IU/mL)
(NCT02021643)
Timeframe: Up to 24 weeks
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 10 | Change at Week 12 | Change at Week 16 |
---|
SOF+RBV 16 Weeks (GT1 and GT6) | -4.36 | -4.79 | -4.82 | -4.82 | -4.82 | -4.82 | -4.82 | -4.82 |
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Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02021643)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | 96.8 | 95.5 |
,SOF+RBV 12 Weeks (GT1 and GT6) | 100 | 100 |
,SOF+RBV 12 Weeks (GT2) | 97.5 | 96.8 |
,SOF+RBV 16 Weeks (GT1 and GT6) | 100 | 90.9 |
,SOF+RBV 24 Weeks (GT1 and GT6) | 94.2 | 94.2 |
,SOF+RBV 24 Weeks (GT3) | 97.6 | 95.2 |
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Change From Baseline in HCV RNA (log10 IU/mL)
(NCT02021643)
Timeframe: Up to 24 weeks
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 10 | Change at Week 12 |
---|
SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | -4.81 | -5.11 | -5.12 | -5.12 | -5.12 | -5.12 | -5.12 |
,SOF+RBV 12 Weeks (GT1 and GT6) | -4.59 | -4.89 | -4.89 | -4.89 | -4.89 | -4.89 | -4.89 |
,SOF+RBV 12 Weeks (GT2) | -4.46 | -4.78 | -4.81 | -4.80 | -4.83 | -4.83 | -4.83 |
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Change From Baseline in HCV RNA (log10 IU/mL)
(NCT02021643)
Timeframe: Up to 24 weeks
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 10 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 |
---|
SOF+RBV 24 Weeks (GT1 and GT6) | -4.61 | -5.04 | -5.12 | -5.12 | -5.12 | -5.12 | -5.12 | -5.12 | -5.14 | -5.14 |
,SOF+RBV 24 Weeks (GT3) | -4.52 | -4.86 | -4.87 | -4.87 | -4.87 | -4.87 | -4.84 | -4.87 | -4.87 | -4.87 |
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Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). (NCT02021656)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF: China | 0 |
LDF/SOF: Overall | 0 |
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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02021656)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDF/SOF: Overall | 99.2 | 99.0 |
,LDV/SOF: China | 100.0 | 100.0 |
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Percentage of Participants Experiencing Viral Relapse
Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR. (NCT02021656)
Timeframe: Week 12 to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF: China | 0 |
LDF/SOF: Overall | 0.5 |
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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
(NCT02021656)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF: China | 0 |
LDV/SOF: Overall | 0.5 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL in Korea and Taiwan and < 15 IU/mL in China) 12 weeks following the last dose of study drug. (NCT02021656)
Timeframe: Posttreatment Week 12
Intervention | Percentage of participants (Number) |
---|
LDV/SOF: China | 100.0 |
LDV/SOF: Overall | 99.2 |
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HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only
(NCT02021656)
Timeframe: Baseline; Week 12
Intervention | log10 IU/mL (Mean) |
---|
| Baseline | Change at Week 12 |
---|
LDV/SOF: China | 6.31 | -5.16 |
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Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. (NCT02032875)
Timeframe: Post-treatment follow-up Week 12
Intervention | Percentage of participants (Number) |
---|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 82.2 |
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Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (NCT02032875)
Timeframe: Post-treatment follow-up Week 12
Intervention | Percentage of participants (Number) |
---|
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 95.1 |
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Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)
Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be NCT02032875)
Timeframe: Post-treatment follow-up Week 12
Intervention | Percentage of participants (Number) |
---|
| CC type (n = 13, 13) | Non-CC type (n = 40, 47) |
---|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 84.6 | 78.7 |
,Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 100 | 92.5 |
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Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6
SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. (NCT02032875)
Timeframe: Post-treatment follow-up Week 12
Intervention | Percentage of participants (Number) |
---|
| All Genotypes (n =53, 60) | HCV Genotype 2 (n =0, 5) | HCV Genotype 3 (n =11, 6) | HCV Genotype 4 (n =0, 4) | HCV Genotype 6 (n =1, 0) |
---|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 83.3 | 80 | 83.3 | 100 | NA |
,Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 94.3 | NA | 90.9 | NA | 100 |
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Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit. (NCT02032875)
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment
Intervention | Percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | End of treatment |
---|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 1.7 | 11.7 | 53.3 | 76.7 | 93.3 | 93.3 | 96.7 |
,Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 3.8 | 13.2 | 56.6 | 84.9 | 98.1 | 98.1 | 100.0 |
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Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit. (NCT02032875)
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24
Intervention | Percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | End of treatment | Follow-up Week 4 (SVR4) | Follow-up Week 8 (SVR8) | Follow-up Week 24 (SVR24) |
---|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 15.0 | 45.0 | 95.0 | 91.7 | 95.0 | 93.3 | 96.7 | 88.3 | 86.7 | 80.0 |
,Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 22.6 | 67.9 | 94.3 | 96.2 | 98.1 | 98.1 | 100.0 | 98.1 | 96.2 | 94.3 |
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Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50-7.4 g/dL for grade 3 and/or < 6.5 g/dL for grade 4, Platelet count as 25*10^9-50*10^9 /L for grade 3 and/or < 25.000*10^9 /L for grade 4, International normalized ratio as 2.1-3.0*upper limit of normal (ULN) > 3.0*ULN for grade 3 and/or > 3.0*ULN for grade 4, Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and/or <1.0*10^9/L for grade 4, Lymphocytes (Absolute) as 0.350*109-0.499*10^9 /L for grade 3 and/or < 0.350*10^9 /L for grade 4, Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Alkaline phosphatase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Bilirubin (Total) as 2.6-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, Albumin as < 20 g/L, Lipase (Total) as 3.1-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, and Creatinine as 1.9-3.4*ULN for grade 3 and/or ≥ 3.5*ULN for grade 4. (NCT02032875)
Timeframe: From start of study treatment up to 7 days post last dose of study treatment
Intervention | participants (Number) |
---|
| Hemoglobin | Platelet count | International normalized ratio | Leukocytes | Lymphocytes (Absolute) | Alanine aminotransferase | Aspartate aminotransferase | Alkaline phosphatase | Bilirubin (Total) | Albumin | Lipase (Total) | Creatinine |
---|
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 5 | 4 | 1 | 0 | 6 | 2 | 3 | 0 | 9 | 1 | 3 | 2 |
,Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin | 2 | 0 | 0 | 2 | 3 | 0 | 0 | 1 | 2 | 0 | 2 | 2 |
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Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as HCV RNANCT02032888)
Timeframe: At follow-up Week 12
Intervention | Percentage of participants (Number) |
---|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 75.6 |
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Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as HCV RNA NCT02032888)
Timeframe: At follow-up Week 12
Intervention | Percentage of participants (Number) |
---|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 97.7 |
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Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as HCV RNA NCT02032888)
Timeframe: At follow-up Week 12
Intervention | Percentage of participants (Number) |
---|
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 96.4 |
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Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA LevelsParticipants with HCV RNA levels NCT02032888)
Timeframe: At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
Intervention | Percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | End of treatment |
---|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 5.8 | 23.1 | 63.5 | 94.2 | 100.0 | 98.1 | 100.0 |
,Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 9.9 | 33.7 | 70.3 | 89.1 | 98.0 | 96.0 | 99.0 |
,Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 6.0 | 34.0 | 78.0 | 90.0 | 96.0 | NA | 100.0 |
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Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be Participants with hepatitis C virus CV) levels to be NCT02032888)
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24
Intervention | Percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | End of treatment | Follow-up Week 4 | Follow-up Week 24 |
---|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 34.6 | 71.2 | 92.3 | 98.1 | 100.0 | 98.1 | 100.0 | 96.2 | 92.3 |
,Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 34.7 | 77.2 | 93.1 | 99.0 | 98.0 | 96.0 | 99.0 | 98.0 | 92.1 |
,Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 44.0 | 78.0 | 98.0 | 98.0 | 96.0 | NA | 100.0 | 82.0 | 72.0 |
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Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR is defined as hepatitis C virus RNA NCT02032888)
Timeframe: At Follow-up Week 12
Intervention | Percentage of participants (Number) |
---|
| CC Genotype (n=28,13,13) | Non-CC Genotype (n=73,37, 39) |
---|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 100.0 | 97.4 |
,Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 100.0 | 95.9 |
,Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 69.2 | 78.4 |
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Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. (NCT02032888)
Timeframe: From screening up to week 24 of post treatment follow--up
Intervention | Participants (Number) |
---|
| International normalized ratio | Leukocytes | Aspartate aminotransferase | Bilirubin (total) | Lipase (total) | Alanine aminotransferase |
---|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 1 | 1 | 1 | 2 | 1 | 1 |
,Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 1 | 0 | 0 | 5 | 5 | 0 |
,Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 0 | 0 | 1 | 1 | 1 | 1 |
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Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)
SVR12 was defined as HCV RNA levels NCT02032888)
Timeframe: At follow-up Week 12
Intervention | Percentage of participants (Number) |
---|
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 97.0 |
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 76.0 |
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 98.1 |
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Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. (NCT02032901)
Timeframe: From Day 1 first dose to last dose plus 7 days
Intervention | Participants (Number) |
---|
| SAEs | Discontinuations Due to AEs |
---|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 0 | 0 |
,Daclatasvir + Sofosbuvir in Treatment-naive Participants | 1 | 0 |
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Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
Percentage of participants who achieved HCV RNA NCT02032901)
Timeframe: Week 1, 2, 6, 8 (treatment period)
Intervention | Percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 6 | Week 8 |
---|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 2.0 | 29.4 | 90.2 | 98.0 |
,Daclatasvir + Sofosbuvir in Treatment-naive Participants | 11.9 | 34.7 | 86.1 | 95.0 |
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Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)
Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12 (Follow-up period)
Intervention | Percentage of participants (Number) |
---|
| Genotype: CC (n=40, 20) | Genotype: Non-CC (n=61, 31) |
---|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 95.0 | 80.6 |
,Daclatasvir + Sofosbuvir in Treatment-naive Participants | 90.0 | 90.2 |
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Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse. (NCT02032901)
Timeframe: Baseline, Week 12 (Follow-up period)
Intervention | Percentage of participants (Number) |
---|
| With cirrhosis (n= 19, 13) | Without cirrhosis (n= 75, 34) |
---|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 69.2 | 94.1 |
,Daclatasvir + Sofosbuvir in Treatment-naive Participants | 57.9 | 97.3 |
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Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12 (Follow-up period)
Intervention | Percentage of participants (Number) |
---|
Daclatasvir + Sofosbuvir in Treatment-naive Participants | 90.1 |
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Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12 (Follow-up period)
Intervention | percentage of participants (Number) |
---|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 86.3 |
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Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 4
Intervention | Percentage of participants (Number) |
---|
Daclatasvir + Sofosbuvir in Treatment-naive Participants | 63.4 |
Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 72.5 |
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Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)
EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Up to the end of treatment (up to 24 weeks)
Intervention | percentage of participants (Number) |
---|
Daclatasvir + Sofosbuvir in Treatment-naive Participants | 99.0 |
Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 100.0 |
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Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)
cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12
Intervention | Percentage of participants (Number) |
---|
Daclatasvir + Sofosbuvir in Treatment-naive Participants | 98.0 |
Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 100.0 |
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Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Percentage of participants who achieved HCV RNA NCT02032901)
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
Intervention | Percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | End of treatment | Follow-up Week 4 | Follow-up Week 24 |
---|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 23.5 | 68.6 | 98.0 | 98.0 | 100.0 | 100.0 | 100.0 | 86.3 | 82.4 |
,Daclatasvir + Sofosbuvir in Treatment-naive Participants | 39.6 | 77.2 | 94.1 | 100.0 | 100.0 | 98.0 | 99.0 | 91.1 | 89.1 |
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Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24
(NCT02073656)
Timeframe: Baseline; Week 12, Posttreatment Weeks 12 and 24
Intervention | mg/dL (Mean) |
---|
| Change at Week 12 (N = 320) | Change at Posttreatment Week 12 (N = 325) | Change at Posttreatment Week 24 (N = 313) |
---|
LDV/SOF 12 Weeks | 0.05 | 0.03 | -0.02 |
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For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8
(NCT02073656)
Timeframe: Baseline; Weeks 2, 4, and 8 of Retreatment Substudy
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 2 Retreatment | Change at Week 4 Retreatment | Change at Week 8 Retreatment |
---|
LDV/SOF+RBV 24 Weeks (Retreatment Substudy) | -5.01 | -5.04 | -5.04 |
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For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
(NCT02073656)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy
Intervention | percentage of participants (Number) |
---|
| Week 2 Retreatment | Week 4 Retreatment | Week 8 Retreatment | Week 12 Retreatment | Week 16 Retreatment | Week 20 Retreatment | Week 24 Retreatment |
---|
LDV/SOF+RBV 24 Weeks (Retreatment Substudy) | 88.9 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively. (NCT02073656)
Timeframe: Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR12 | SVR24 |
---|
LDV/SOF+RBV 24 Weeks (Retreatment Substudy) | 88.9 | 88.9 | 88.9 |
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For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02073656)
Timeframe: Up to Posttreatment Week 24 of Retreatment Substudy
Intervention | percentage of participants (Number) |
---|
| On-Treatment Virologic Failure | Virologic Relapse |
---|
LDV/SOF+RBV 24 Weeks (Retreatment Substudy) | 0 | 11.1 |
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Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment
(NCT02073656)
Timeframe: Weeks 4, 8, and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 (N = 335) | Week 8 (N = 334) | Week 12 (N = 334) |
---|
LDV/SOF 12 Weeks | 98.5 | 98.2 | 97.9 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02073656)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF 12 Weeks | 96.7 | 96.1 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02073656)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| On-Treatment Virologic Failure (N = 335) | Virologic Relapse (N = 333) |
---|
LDV/SOF 12 Weeks | 0.6 | 3.0 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
(NCT02073656)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 (N = 335) | Week 2 (N = 335) | Week 4 (N = 335) | Week 6 (N = 335) | Week 8 (N = 334) | Week 10 (N = 332) | Week 12 (N = 332) |
---|
LDV/SOF 12 Weeks | 29.3 | 81.2 | 98.8 | 99.1 | 99.4 | 100.0 | 100.0 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02073656)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT02073656)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 96.1 |
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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
(NCT02073656)
Timeframe: Baseline; Weeks 1, 2, 4, 6, and 8
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 (N = 331) | Change at Week 2 (N = 334) | Change at Week 4 (N = 335) | Change at Week 6 (N = 334) | Change at Week 8 (N = 333) |
---|
LDV/SOF 12 Weeks | -4.68 | -5.21 | -5.30 | -5.30 | -5.33 |
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Percentage of Participants With Virologic Failure and Viral Relapse
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02074514)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| Overall Virologic Failure | Relapse |
---|
SOF + RBV 16 Weeks GT1 | 10.0 | 10.0 |
,SOF + RBV 16 Weeks GT3 | 0 | 0 |
,SOF + RBV 24 Weeks GT1 | 3.6 | 3.6 |
,SOF + RBV 24 Weeks GT3 | 3.3 | 3.3 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug. (NCT02074514)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF + RBV 16 Weeks GT1 | 90 |
SOF + RBV 24 Weeks GT1 | 96.4 |
SOF + RBV 16 Weeks GT3 | 100.0 |
SOF + RBV 24 Weeks GT3 | 93.3 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02074514)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF + RBV 16 Weeks GT1 | 90.0 | 90.0 |
,SOF + RBV 16 Weeks GT3 | 100.0 | 100.0 |
,SOF + RBV 24 Weeks GT1 | 96.4 | 96.4 |
,SOF + RBV 24 Weeks GT3 | 96.7 | 93.3 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02074514)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF + RBV 16 Weeks | 0 |
SOF + RBV 24 Weeks | 3.4 |
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Percentage of Patients With Virologic Failure
"Virologic failure was defined as either:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); or~Relapse:~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment" (NCT02081079)
Timeframe: Up to posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| On-treatment Virologic Failure | Relapse |
---|
Genotype 4: Treatment-experienced | 0 | 9.1 |
,Genotype 4: Treatment-naive | 0 | 4.5 |
,Genotype 5: Treatment-experienced | 0 | 5.0 |
,Genotype 5: Treatment-naive | 0 | 4.8 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02081079)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
Genotype 4: Treatment-experienced | 90.9 | 90.9 |
,Genotype 4: Treatment-naive | 95.5 | 95.5 |
,Genotype 5: Treatment-experienced | 95.0 | 95.0 |
,Genotype 5: Treatment-naive | 95.2 | 95.2 |
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Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12
(NCT02081079)
Timeframe: Baseline; Weeks 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
Genotype 4: Treatment-experienced | -4.77 | -5.17 | -5.18 | -5.18 |
,Genotype 4: Treatment-naive | -4.65 | -4.86 | -4.88 | -4.88 |
,Genotype 5: Treatment-experienced | -4.94 | -5.39 | -5.45 | -5.45 |
,Genotype 5: Treatment-naive | -4.97 | -5.07 | -5.07 | -5.07 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02081079)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
Genotype 4: Treatment-naive | 95.5 |
Genotype 4: Treatment-experienced | 90.9 |
Genotype 5: Treatment-naive | 95.2 |
Genotype 5: Treatment-experienced | 95.0 |
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Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event
(NCT02081079)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
Genotype 4 | 0 |
Genotype 5 | 0 |
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Percentage of Participants With On-treatment Virologic Response
On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. NCT02114151)
Timeframe: Week 2, 4 and End of Treatment (Week 12)
Intervention | Percentage of Participants (Number) |
---|
| Week 2: < 100 IU/mL (n=102) | Week 2: < 25 IU/mL (n=102) | Week 2: < 25 IU/mL Detectable (n=102) | Week 2: < 25 IU/mL Undetectable (n=102) | Week 4: < 100 IU/mL (n=102) | Week 4: < 25 IU/mL (n=102) | Week 4: < 25 IU/mL Detectable (n=102) | Week 4: < 25 IU/mL Undetectable (n=102) | EOT (Week 12): < 100 IU/mL (n=103) | EOT (Week 12): < 25 IU/mL (n=103) | EOT (Week 12): < 25 IU/mL Detectable (n=103) | EOT (Week 12): < 25 IU/mL Undetectable (n=103) |
---|
Simeprevir Plus Sofosbuvir | 90.2 | 68.6 | 44.1 | 24.5 | 99.0 | 99.0 | 15.7 | 83.3 | 97.1 | 97.1 | 0 | 97.1 |
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Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24
Sequencing of the HCV nonstructural protein 3/4A (NS3/4A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. Sequencing data is available for 16 participants. (NCT02114151)
Timeframe: Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24
Intervention | Participants (Number) |
---|
| HCV NS3 | NS5B |
---|
Simeprevir Plus Sofosbuvir | 13 | 0 |
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Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12
The HCV-SIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively. (NCT02114151)
Timeframe: Baseline, Week 4, Week 12 and Follow-Up Week 12
Intervention | Units on a Scale (Mean) |
---|
| Baseline (n=98) | Change at Week 4 (n=96) | Change at Week 12 (n=89) | Change at Follow-up Week 12 (n=94) |
---|
Simeprevir Plus Sofosbuvir | 17.4 | -4.9 | -4.7 | -5.8 |
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Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24
The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue. (NCT02114151)
Timeframe: Baseline, Week 12, Follow-up Week 12 and 24
Intervention | Units on a Scale (Mean) |
---|
| Baseline (n=96) | Change at Week 12 (n=86) | Change at Follow-up Week 12 (n=92) | Change at Follow-up Week 24 (n=86) |
---|
Simeprevir Plus Sofosbuvir | 3.4 | -0.4 | -0.6 | -0.8 |
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Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24
"The EQ-5D questionnaire was a brief, generic health-related quality of life (HRQOL) assessment that could also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assessed HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health)." (NCT02114151)
Timeframe: Baseline, Follow-up Week 12 and 24
Intervention | Units on a Scale (Mean) |
---|
| Baseline (n=96) | Change at Follow-up Week 12 (n=92) | Change at Follow-up Week 24 (n=86) |
---|
Simeprevir Plus Sofosbuvir | 70.1 | 9.8 | 9.5 |
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Percentage of Participants With Viral Relapse
Viral relapse was defined as participants who did not achieve SVR12 and had HCV RNA < LLOQ (25 IU/mL) undetectable at EOT and had HCV RNA >= LLOQ (25 IU/mL) during the follow-up period. (NCT02114151)
Timeframe: During the Follow-up (Week 24)
Intervention | Percentage of Participants (Number) |
---|
Simeprevir Plus Sofosbuvir | 13.1 |
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Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as confirmed greater than (>) 1 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA < LLOQ (25 IU/mL). (NCT02114151)
Timeframe: Up to End of Treatment (Week 12)
Intervention | Percentage of Participants (Number) |
---|
Simeprevir Plus Sofosbuvir | 1.9 |
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Percentage of Participants With On-treatment Failure
On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment. (NCT02114151)
Timeframe: Week 12
Intervention | Percentage of Participants (Number) |
---|
Simeprevir Plus Sofosbuvir | 2.9 |
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Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the actual end of treatment. (NCT02114151)
Timeframe: Week 16
Intervention | Percentage of Participants (Number) |
---|
Simeprevir Plus Sofosbuvir | 86.4 |
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Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 24 weeks after the actual end of treatment. (NCT02114151)
Timeframe: Week 36
Intervention | Percentage of Participants (Number) |
---|
Simeprevir Plus Sofosbuvir | 82.5 |
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Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment. (NCT02114151)
Timeframe: Week 24
Intervention | Percentage of Participants (Number) |
---|
Simeprevir Plus Sofosbuvir | 83.5 |
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Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D Scale assessed how often during the past week participants experienced 20 symptoms commonly associated with major depression. The CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5 to 7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores >=23 indicate probable major depressive illness. (NCT02114151)
Timeframe: Baseline, Week 12, Follow-up Week 12 and 24
Intervention | Percentage of Participants (Number) |
---|
| Baseline: No Depression (n=96) | Baseline: Mild to Moderate Depression (n=96) | Baseline: Severe Depression (n=96) | Week 12: No Depression (n=88) | Week 12: Mild to Moderate Depression (n=88) | Week 12: Severe Depression (n=88) | Follow-up Week 12: No Depression (n=94) | Follow-up Week12:Mild to Moderate Depression(n=94) | Follow-up Week 12: Severe Depression (n=94) | Follow-up Week 24: No Depression (n=88) | Follow-up Week24:Mild to Moderate Depression(n=88) | Follow-up Week 24: Severe Depression (n=88) |
---|
Simeprevir Plus Sofosbuvir | 67.7 | 16.7 | 15.6 | 77.3 | 15.9 | 6.8 | 79.8 | 6.4 | 13.8 | 79.5 | 10.2 | 10.2 |
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Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)
Participants considered to have achieved SVR24, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 24 weeks after the Actual end of study drug treatment. (NCT02114177)
Timeframe: 24 weeks after the end of treatment (EOT) (Week 32 or Week 36)
Intervention | Percentage of participants (Number) |
---|
Simeprevir and Sofosbuvir for 8 Weeks | 82.6 |
Simeprevir and Sofosbuvir for 12 Weeks | 96.8 |
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Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
Participants considered to have achieved SVR4, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 4 weeks after the actual end of study drug treatment. (NCT02114177)
Timeframe: 4 weeks after the end of treatment (EOT) (Week 12 or Week 16)
Intervention | Percentage of Participants (Number) |
---|
Simeprevir and Sofosbuvir for 8 Weeks | 83.9 |
Simeprevir and Sofosbuvir for 12 Weeks | 96.8 |
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Percentage of Participants With Viral Breakthrough
Percentage of participants with greater than 1 log10 IU/mL increase in plasma Hepatitis C virus ribonucleic acid level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been less than 25 IU/mL. (NCT02114177)
Timeframe: Up to Week 24
Intervention | Percentage of participants (Number) |
---|
Simeprevir and Sofosbuvir for 8 Weeks | 0 |
Simeprevir and Sofosbuvir for 12 Weeks | 0 |
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Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24
The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue. (NCT02114177)
Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24
Intervention | units on a scale (Mean) |
---|
| Baseline (n=144, 149) | Change at Week 4 (n=142, 142) | Change at Week 8 (n=142, 144) | Change at Week 12 (n=0, 140) | Change at Follow-up Week 4 (n=141, 148) | Change at Follow-up Week 12 (n=140, 145) | Change at Follow-up Week 24 (n=132, 143) |
---|
Simeprevir and Sofosbuvir for 12 Weeks | 3.2 | -0.1 | -0.2 | -0.1 | -0.4 | -0.4 | -0.5 |
,Simeprevir and Sofosbuvir for 8 Weeks | 2.9 | -0.1 | -0.1 | NA | -0.4 | -0.5 | -0.6 |
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Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale
"The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening." (NCT02114177)
Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24
Intervention | units on a scale (Mean) |
---|
| Baseline (N=144, 149) | Change at Week 4 (n=142, 141) | Change at Week 8 (n=142, 144) | Change at Week 12 (n=0, 140) | Change at Follow-up Week 4 (n=141, 148) | Change at Follow-up Week 12 (n=138, 145) | Change at Follow-up Week 24 (n=131, 143) |
---|
Simeprevir and Sofosbuvir for 12 Weeks | 76.7 | 2.4 | 2.7 | 2.5 | 4.4 | 3.9 | 5.3 |
,Simeprevir and Sofosbuvir for 8 Weeks | 79.3 | 4.6 | 4.0 | NA | 6.9 | 5.5 | 6.2 |
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Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores
The CES-D scale assesses how often during the past week participants experienced 20 symptoms commonly associated with major depression. CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5-7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores greater than or equal to 23 indicate probable major depressive illness. (NCT02114177)
Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24
Intervention | units on a scale (Mean) |
---|
| Baseline (n=144, 149) | Change at Week 4 (n=139, 140) | Change at Week 8 (n=141, 144) | Change at Week 12 (n=141, 144) | Change at Follow-up Week 4 (n=141, 148) | Change at Follow-up Week 12 (n=140, 145) | Change at Follow-up Week 24 (n=131, 143) |
---|
Simeprevir and Sofosbuvir for 12 Weeks | 10.2 | -0.8 | -0.3 | 1.0 | -0.6 | -0.1 | -1.0 |
,Simeprevir and Sofosbuvir for 8 Weeks | 8.8 | -0.6 | -0.6 | NA | -2.6 | -1.5 | -2.8 |
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Percentage of Participants With Viral Relapse
Percentage of participants who did not achieve sustained virologic response 12, have less than 25 IU/mL undetectable plasma HCV RNA at end of treatment, and greater than or equal to 25 IU/mL plasma HCV RNA during the follow-up phase. (NCT02114177)
Timeframe: Up to Week 24
Intervention | Percentage of participants (Number) |
---|
Simeprevir and Sofosbuvir for 8 Weeks | 17.4 |
Simeprevir and Sofosbuvir for 12 Weeks | 2.6 |
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Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS)
HCVSIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively. (NCT02114177)
Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24
Intervention | units on a scale (Mean) |
---|
| Baseline (n=145, 149) | Change at Week 4 (n=145, 146) | Change at Week 8 (n=144, 146) | Change at Week 12 (n=0, 141) | Change at Follow-up Week 4 (n=142, 148) | Change at Follow-up Week 12 (n=141, 145) | Change at Follow-up Week 24 (n=133, 143) |
---|
Simeprevir and Sofosbuvir for 12 Weeks | 13.3 | -0.9 | -0.4 | 0.1 | -3.0 | -3.5 | -4.4 |
,Simeprevir and Sofosbuvir for 8 Weeks | 10.8 | -0.4 | -0.2 | NA | -3.5 | -2.0 | -3.6 |
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Percentage of Participants Achieving a On-treatment Virologic Response
Ontreatment virologic response was determined by HCV RNA results satisfying a specified threshold. NCT02114177)
Timeframe: Day 14, Day 28, End of treatment (Week 8 or Week 12)
Intervention | Percentage of participants (Number) |
---|
| Day 14: < 100 IU/mL (n=154, 152) | Day 14: < 25 IU/mL (n=154, 152) | Day 14: < 25 IU/mL detectable (n=154, 152) | Day 14: < 25 IU/mL undetectable (n=154, 152) | Day 28: < 100 IU/mL (n=154, 153) | Day 28: < 25 IU/mL (n=154, 153) | Day 28: < 25 IU/mL detectable (n=154, 153) | Day 28: < 25 IU/mL undetectable (n=154, 153) | EOT: < 100 IU/mL (n=155, 155) | EOT: < 25 IU/mL (n=155, 155) | EOT: < 25 IU/mL undetectable (n=155, 155) |
---|
Simeprevir and Sofosbuvir for 12 Weeks | 93.4 | 79.6 | 45.4 | 34.2 | 100 | 98.7 | 11.1 | 87.6 | 100 | 100 | 100 |
,Simeprevir and Sofosbuvir for 8 Weeks | 90.9 | 77.92 | 40.26 | 37.66 | 100 | 98.7 | 16.2 | 82.5 | 100 | 100 | 100 |
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Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)
Participants considered to have achieved SVR12, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the actual end of study drug treatment. (NCT02114177)
Timeframe: 12 weeks after the end of treatment (EOT) (Week 20 or Week 24)
Intervention | Percentage of participants (Number) |
---|
Simeprevir and Sofosbuvir for 8 Weeks | 82.6 |
Simeprevir and Sofosbuvir for 12 Weeks | 96.8 |
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02120300)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks GT1 or GT4 | 99.0 |
LDV/SOF 24 Weeks GT1 (TE) | 100.0 |
SOF+RBV 12 Weeks GT2 | 100.0 |
SOF+RBV 24 Weeks GT3 | 83.3 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02120300)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks GT1 or GT4 | 0 |
LDV/SOF 24 Weeks GT1 (TE) | 0 |
SOF+RBV 12 Weeks GT2 | 0 |
SOF+RBV 24 Weeks GT3 | 16.7 |
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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
(NCT02120300)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Intervention | log10 IU/mL (Mean) |
---|
| Baseline | Week 1 (LDV/SOF 12 Weeks: n= 98) | Week 2 (LDV/SOF 24 Week: n=4) | Week 4 | Week 8 | Week 12 (LDV/SOF 12 Weeks: n= 98) | Week 16 | Week 20 | Week 24 |
---|
LDV/SOF 12 Weeks GT1 or GT4 | 6.21 | -4.41 | -4.87 | -5.05 | -5.06 | -5.06 | NA | NA | NA |
,LDV/SOF 24 Weeks GT1 (TE) | 6.02 | -4.32 | -4.65 | -4.87 | -4.87 | -4.87 | -4.87 | -4.87 | -4.87 |
,SOF+RBV 12 Weeks GT2 | 6.20 | -4.39 | -5.01 | -5.05 | -5.05 | -5.05 | NA | NA | NA |
,SOF+RBV 24 Weeks GT3 | 6.6 | -3.95 | -4.76 | -5.26 | -5.45 | -5.45 | -5.45 | -5.45 | -5.45 |
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Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)
(NCT02120300)
Timeframe: Baseline; Weeks 12, 24, and Posttreatment Week 12
Intervention | mg/dL (Mean) |
---|
| Baseline | Week 12 | Week 24 | Posttreatment Week12 |
---|
LDV/SOF 12 Weeks GT1 or GT4 | 0.94 | 0.04 | NA | -0.01 |
,SOF+RBV 12 Weeks GT2 | 1.01 | -0.03 | NA | -0.08 |
,SOF+RBV 24 Weeks GT3 | 0.94 | -0.03 | -0.08 | -0.02 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
(NCT02120300)
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
LDV/SOF 12 Weeks GT1 or GT4 | 28.3 | 68.7 | 94.9 | 100.0 | 99.0 | NA | NA | NA |
,LDV/SOF 24 Weeks GT1 (TE) | 20.0 | 40.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,SOF+RBV 12 Weeks GT2 | 20.0 | 70.0 | 100.0 | 100.0 | 100.0 | NA | NA | NA |
,SOF+RBV 24 Weeks GT3 | 16.7 | 33.3 | 66.7 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02120300)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks GT1 or GT4 | 0 |
LDV/SOF 24 Weeks GT1 (TE) | 0 |
SOF+RBV 12 Weeks GT2 | 0 |
SOF+RBV 24 Weeks GT3 | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02120300)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks GT1 or GT4 | 99.0 |
LDV/SOF 24 Weeks GT1 (TE) | 100.0 |
SOF+RBV 12 Weeks GT2 | 100.0 |
SOF+RBV 24 Weeks GT3 | 83.3 |
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Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)
(NCT02120300)
Timeframe: Weeks 4, 8, 12, 16, 20, and 24
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
LDV/SOF 12 Weeks GT1 or GT4 | 100 | 100 | 100 | NA | NA | NA |
,SOF+RBV 12 Weeks GT2 | 100 | 100 | 100 | NA | NA | NA |
,SOF+RBV 24 Weeks GT3 | 100 | 100 | 100 | 100 | 100 | 66.7 |
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Change in CD4+ Cell Count
The change in CD4+ cell count from baseline to 12 weeks after the end of study treatment. (NCT02128217)
Timeframe: Baseline to 12 weeks after end of study treatment. Duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Intervention | cells/mm^3 (Mean) |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 11 |
Cohort 2: LDV/SOF for 8 Wks | 61 |
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Number of Participants Who Had HCV Virologic Relapse
HCV virologic relapse was defined as HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable. (NCT02128217)
Timeframe: From end of study treatment through to 24 weeks after end of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Intervention | Participants (Count of Participants) |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 7 |
Cohort 2: LDV/SOF for 8 Wks | 0 |
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Percentage of HCV Virologic Failure Participants That Developed SOF- or LDV-Associated Resistance Mutations
Percentage of participants who developed SOF- or LDV-associated resistance mutation found within HCV Virologic Failure participants. HCV virologic failure was defined as HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable. (NCT02128217)
Timeframe: At time of HCV virologic failure; any time from start of study treatment to 24 weeks after end of study treatment. Duration of study treatment for Cohort 1 and 2 were 12 and 8 weeks, respectively.
Intervention | Percentage of participants (Number) |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 0.00 |
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Percentage of Participants With an Occurrence of a Grade ≥ 2 Adverse Event, Serious AE According to ICH Criteria, or Treatment-limiting AE.
"Any adverse event occurring after initiation of study treatment through to 28 days after the date of last dose of study treatment was included (except that an event that was ongoing at the same grade from before start of study treatment was excluded). Adverse events consisted of Grade ≥ 2 primary diagnosis, primary sign/symptoms, and primary laboratory abnormality. It also included any serious adverse event according to ICH criteria and any treatment-limiting AE (ie, an AE reported as the reason for permanent discontinuation of study treatment).~A two-sided 90% confidence interval was calculated for the percentage using the Blyth-Still-Casella method." (NCT02128217)
Timeframe: From initiation of study treatment to 28 days after last dose of study treatment. The duration for study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Intervention | Percentage of participants (Number) |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 47.1 |
Cohort 2: LDV/SOF for 8 Wks | 33.3 |
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Percentage of Participants With Sustained Virologic Response 12 (SVR12)
"SVR12 was defined as HCV RNA undetectable less than the lower limit of quantification, Target Not Detected (NCT02128217)
Timeframe: At 12 weeks after date of last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Intervention | Percentage of participants (Number) |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 58.8 |
Cohort 2: LDV/SOF for 8 Wks | 100.0 |
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Adherence as Measured by LDV/SOF Pill Count
The count and percentage of participants who had a pill count consistent with 100% of LDV/SOF doses taken.. This outcome measure was evaluated in Cohort 2 only. (NCT02128217)
Timeframe: 8 weeks after starting study treatment.
Intervention | Participants (Count of Participants) |
---|
| Pill count not available | Pill count consistent with 100% of doses taken | Pill count indicates <100% of doses taken |
---|
Cohort 2: LDV/SOF for 8 Wks | 7 | 17 | 3 |
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Adherence as Measured by RBV Pill Count
The count and percentage of participants who had a pill count consistent with 100% of RBV doses taken. This outcome measure was evaluated in Cohort 1 only. (NCT02128217)
Timeframe: 12 weeks after starting study treatment.
Intervention | Participants (Count of Participants) |
---|
| Pill count not available | Pill count consistent with 100% of doses taken | Pill count indicates <100% of doses taken |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 12 | 1 | 4 |
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Adherence as Measured by SOF Pill Count
The count and percentage of participants who had a pill count consistent with 100% of SOF doses taken. This outcome measure was evaluated in Cohort 1 only. (NCT02128217)
Timeframe: 12 weeks after starting study treatment.
Intervention | Participants (Count of Participants) |
---|
| Pill count not available | Pill count consistent with 100% of doses taken | Pill count indicates <100% of doses taken |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 12 | 4 | 1 |
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Cellular Concentration of Tenofovir Diphosphate (TFV-DP)
Cellular concentration of tenofovir diphosphate (TFV-DP) from dried blood spot samples. (NCT02128217)
Timeframe: Baseline (before HCV study treatment), EOT (end of trial dosing), 12 weeks after end of HCV study treatment. The duration of HCV study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Intervention | fmol/punch (Geometric Mean) |
---|
| Baseline | End of treatment | 12 Weeks after end of HCV study treatment |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 1687 | 6607 | 2100 |
,Cohort 2: LDV/SOF for 8 Wks | 1516 | 26846 | 1644 |
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Concentration of Tenofovir (TFV) in Plasma
Concentration of tenofovir (TFV) in plasma among participants who took TFV for treatment of HIV infection. (NCT02128217)
Timeframe: Baseline (before HCV study treatment), EOT (end of trial dosing), 12 weeks after end of HCV study treatment. The duration of HCV study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Intervention | ng/mL (Geometric Mean) |
---|
| Baseline | End of treatment | 12 Weeks after end of HCV study treatment |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 98 | 96 | 94 |
,Cohort 2: LDV/SOF for 8 Wks | 87 | 155 | 76 |
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Concentration of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs)
Concentration of tenofovir diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs). This outcome is measured in Cohort 1 only. (NCT02128217)
Timeframe: Baseline (before SOF + RBV dosing), EOT (end of study treatment), 12 weeks after end of HCV study treatment.
Intervention | fmol/10^6 cells (Geometric Mean) |
---|
| Baseline | End of treatment | 12 Weeks after end of HCV study treatment |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 79 | 149 | 81 |
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Count and Percentage of Participants With an Adverse Event by Type.
The adverse events considered were Grade 2 or higher adverse events (primary diagnosis, primary sign and symptom, or a primary lab), SAE according to ICH criteria, or treatment-limiting adverse events. Participants may experience more than one type of adverse event. (NCT02128217)
Timeframe: Any time from start of treatment to 28 days after date of last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Intervention | Participants (Count of Participants) |
---|
| Primary Diagnosis | Primary Sign/Symptom | Primary Lab | Serious Adverse Event | Treatment-Limiting Adverse Event |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 0 | 5 | 5 | 0 | 0 |
,Cohort 2: LDV/SOF for 8 Wks | 2 | 4 | 6 | 1 | 0 |
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Percentage of Participants With HCV RNA Undetectable After End of Study Treatment
"HCV RNA undetectable is defined as an HCV RNA measurement NCT02128217)
Timeframe: 2, 4, 8 and 24 weeks after last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Intervention | Percentage of participants (Number) |
---|
| SVR2 | SVR4 | SVR8 | SVR24 |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 64.7 | 58.8 | 58.8 | 64.7 |
,Cohort 2: LDV/SOF for 8 Wks | 100.0 | 96.3 | 96.3 | 96.3 |
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Percentage of Participants With HCV RNA Undetectable During Study Treatment
"HCV RNA undetectable was defined as an HCV RNA measurement NCT02128217)
Timeframe: 1, 2, 4, 8 and, for the 12-week regimen, 12 weeks after starting study treatment.
Intervention | Percentage of participants (Number) |
---|
| On-treatment Week 1 | On Treatment Week 2 | On-treatment Week 4 | On-treatment Week 8 | On-treatment Week 12 |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 11.8 | 29.4 | 70.6 | 100.0 | 100.0 |
,Cohort 2: LDV/SOF for 8 Wks | 18.5 | 44.4 | 81.5 | 92.6 | NA |
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Ribavirin Concentration in Plasma
Ribavirin concentration in plasma. This outcome was evaluated in Cohort 1 only. (NCT02128217)
Timeframe: 4, 8, and 12 weeks after starting study treatment.
Intervention | ng/mL (Geometric Mean) |
---|
| Week 4 | week 8 | Week 12 |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 1803 | 2122 | 2013 |
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Self-reported Adherence to LDV/SOF
Count and percentage of participants who reported having taken all doses of LDV/SOF. This outcome measure was evaluated in Cohort 2 only. (NCT02128217)
Timeframe: 1, 2, 4, and 8 weeks after starting study treatment.
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 |
---|
Cohort 2: LDV/SOF for 8 Wks | 25 | 25 | 27 | 18 |
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Self-reported Adherence to RBV
Count and percentage of participants who reported having taken all doses of RBV. This outcome measure was evaluated in Cohort 1 only. (NCT02128217)
Timeframe: 1, 2, 4, 8 and 12 weeks after starting study treatment.
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 16 | 15 | 15 | 16 | 15 |
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Self-reported Adherence to SOF
Count and percentage of participants who reported having taken all doses of SOF. This outcome measure was evaluated in Cohort 1 only. (NCT02128217)
Timeframe: 1, 2, 4, 8 and 12 weeks after starting study treatment.
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 17 | 16 | 16 | 16 | 15 |
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Count of Participants With HIV-1 RNA <50 Copies/mL
Because all except one participant had HIV-1 RNA < 50 copies/mL, participants were categorized according to whether or not their HIV-1 RNA was <5 copies/mL at each follow-up evaluation. (NCT02128217)
Timeframe: 4 and 12 weeks after start of study treatment for Cohort 1. 4 and 8 weeks after start of study treatment for the 8-week regimen used in Cohort 2)
Intervention | Participants (Count of Participants) |
---|
| On-treatment Week 471972119 | On-treatment Week 471972120 | On-treatment Week 871972119 | On-treatment Week 871972120 | On-treatment Week 1271972119 | On-treatment Week 1271972120 |
---|
| ≥50 copies/mL | <50 copies/mL |
---|
Cohort 1: SOF+Weight-based RBV for 12 Wks | 17 |
Cohort 2: LDV/SOF for 8 Wks | 27 |
Cohort 2: LDV/SOF for 8 Wks | 0 |
Cohort 1: SOF+Weight-based RBV for 12 Wks | 0 |
Cohort 2: LDV/SOF for 8 Wks | 23 |
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Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment. (NCT02128542)
Timeframe: Up to Posttreatment Week 12
Intervention | Percentage of participants (Number) |
---|
SOF+RBV 12 Weeks (TN) | 17.4 |
SOF+RBV 12 Weeks (TE) | 15.8 |
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Percentage of Participants Experiencing Viral Breakthrough
"Viral breakthrough was defined as either:~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment~HCV RNA ≥ LLOQ at the last available on-treatment measurement with no subsequent follow-up values" (NCT02128542)
Timeframe: Up to Posttreatment Weak 12
Intervention | Percentage of participants (Number) |
---|
SOF+RBV 12 Weeks (TN) | 0 |
SOF+RBV 12 Weeks (TE) | 0 |
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Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug. (NCT02128542)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF+RBV 12 Weeks (TN) | 78.7 |
SOF+RBV 12 Weeks (TE) | 89.5 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT02128542)
Timeframe: Posttreatment Week 12
Intervention | Percentage of participants (Number) |
---|
SOF+RBV 12 Weeks (TN) | 76.6 |
SOF+RBV 12 Weeks (TE) | 84.2 |
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Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment
Deep sequencing of the HCV NS5B gene was attempted for all participants who had virologic failure at pretreatment and posttreatment time points if the level of HCV RNA in the plasma sample was ≥ 1000 IU/L. (NCT02128542)
Timeframe: Pretreatment and Posttreatment Week 12
Intervention | participants (Number) |
---|
| NS5B NI RAV Pretreatment | NS5B NI RAV Posttreatment | NS5B RBV RAV Pretreatment | NS5B RBV RAV Posttreatment |
---|
SOF+RBV 12 Weeks (All) | 2 | 5 | 0 | 0 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02128542)
Timeframe: Up to 12 weeks
Intervention | Percentage of participants (Number) |
---|
SOF+RBV 12 Weeks (All) | 4.5 |
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Number of Participants Discontinuing Study Therapy Due to an AE
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02133131)
Timeframe: Up to Week 12
Intervention | Number of participants (Number) |
---|
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks | 0 |
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks | 0 |
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks | 0 |
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks | 1 |
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks | 0 |
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks | 0 |
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks | 0 |
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Number of Participants Experiencing at Least 1 Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02133131)
Timeframe: Up to Week 14
Intervention | Number of participants (Number) |
---|
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks | 5 |
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks | 7 |
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks | 7 |
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks | 4 |
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks | 4 |
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks | 3 |
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks | 3 |
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Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)
The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0. (NCT02133131)
Timeframe: Up to 24 weeks
Intervention | Percentage of participants (Number) |
---|
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks | 33.3 |
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks | 89.3 |
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks | 80.0 |
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks | 89.5 |
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks | 93.3 |
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks | 100.0 |
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks | 90.9 |
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Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy (NCT02168361)
Timeframe: 12 weeks post-therapy
Intervention | participants (Number) |
---|
All Oral Therapy | 54 |
Interferon-containing Arm | 18 |
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Serum HCV RNA Level
(NCT02168361)
Timeframe: 4 and 12 weeks into therapy
Intervention | IU/ml (Median) |
---|
| Serum HCV RNA level at 4 weeks | Serum HCV RNA level at 8 weeks |
---|
All Oral Therapy | 154 | 31 |
,Interferon-containing Arm | 880 | 740 |
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For the Treatment Phase, Change From Baseline in Weight
(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Intervention | kilograms (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 24 |
---|
12 to < 18 Years Old - SOF+RBV 12 Weeks | -0.7 | -0.2 | -0.2 | -0.5 | -0.4 | -0.3 | 0.9 | 2.5 |
,3 to < 6 Years Old - SOF+RBV 12 Weeks | 0.2 | 0.5 | 0.0 | 0.3 | 0.3 | 0.5 | 1.0 | 1.3 |
,6 to < 12 Years Old - SOF+RBV 12 Weeks | 0.2 | 0.3 | 0.4 | 0.6 | 0.9 | 1.2 | 2.1 | 3.8 |
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For the Treatment Phase, Change From Baseline in HCV RNA
(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 |
---|
12 to < 18 Years Old - SOF+RBV 24 Weeks | -4.12 | -4.86 | -5.01 | -5.02 | -5.02 | -5.02 | -5.02 | -5.02 |
,3 to < 6 Years Old - SOF+RBV 24 Weeks | -3.53 | -3.94 | -3.97 | -3.97 | -3.97 | -3.97 | -3.97 | -3.97 |
,6 to < 12 Years Old - SOF+RBV 24 Weeks | -3.88 | -4.51 | -4.56 | -4.54 | -4.57 | -4.57 | -4.57 | -4.57 |
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For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment. (NCT02175758)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - SOF+RBV 12 Weeks | 0 |
12 to < 18 Years Old - SOF+RBV 24 Weeks | 0 |
6 to < 12 Years Old - SOF+RBV 12 Weeks | 0 |
6 to < 12 Years Old - SOF+RBV 24 Weeks | 0 |
3 to < 6 Years Old - SOF+RBV 12 Weeks | 0 |
3 to < 6 Years Old - SOF+RBV 24 Weeks | 0 |
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For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT02175758)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - SOF+RBV 12 Weeks | 0 |
12 to < 18 Years Old - SOF+RBV 24 Weeks | 0 |
6 to < 12 Years Old - SOF+RBV 12 Weeks | 0 |
6 to < 12 Years Old - SOF+RBV 24 Weeks | 0 |
3 to < 6 Years Old - SOF+RBV 12 Weeks | 0 |
3 to < 6 Years Old - SOF+RBV 24 Weeks | 0 |
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For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02175758)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - SOF+RBV 12 Weeks | 100.0 |
12 to < 18 Years Old - SOF+RBV 24 Weeks | 100.0 |
6 to < 12 Years Old - SOF+RBV 12 Weeks | 100.0 |
6 to < 12 Years Old - SOF+RBV 24 Weeks | 100.0 |
3 to < 6 Years Old - SOF+RBV 12 Weeks | 80.0 |
3 to < 6 Years Old - SOF+RBV 24 Weeks | 100.0 |
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For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
(NCT02175758)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
12 to < 18 Years Old - SOF+RBV 12 Weeks | 30.8 | 100.0 | 100.0 | 100.0 | 100.0 |
,3 to < 6 Years Old - SOF+RBV 12 Weeks | 50.0 | 75.0 | 75.0 | 100.0 | 100.0 |
,6 to < 12 Years Old - SOF+RBV 12 Weeks | 46.2 | 76.9 | 100.0 | 100.0 | 100.0 |
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For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02175758)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old (Total) - SOF+RBV 12 or 24 Weeks | 98.1 |
3 to < 12 Years Old (Total) - SOF+RBV 12 or 24 Weeks | 98.1 |
12 to < 18 Years Old - SOF+RBV 12 Weeks | 100.0 |
12 to < 18 Years Old - SOF+RBV 24 Weeks | 97.4 |
6 to < 12 Years Old - SOF+RBV 12 Weeks | 100.0 |
6 to < 12 Years Old - SOF+RBV 24 Weeks | 100.0 |
3 to < 6 Years Old - SOF+RBV 12 Weeks | 80.0 |
3 to < 6 Years Old - SOF+RBV 24 Weeks | 100.0 |
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For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules
Participants were asked if they were able to taste the SOF oral granules. (NCT02175758)
Timeframe: Day 1
Intervention | percentage of participants (Number) |
---|
| Able to Taste SOF Granules: Yes | Able to Taste SOF Granules: No |
---|
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 0 | 100.0 |
,3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 75.0 | 25.0 |
,6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 42.9 | 57.1 |
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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data. (NCT02175758)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Posttreatment Week 4 |
---|
12 to < 18 Years Old - SOF+RBV 12 Weeks | 50.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,6 to < 12 Years Old - SOF+RBV 12 Weeks | 25.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data. (NCT02175758)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Posttreatment Week 4 |
---|
12 to < 18 Years Old - SOF+RBV 24 Weeks | 63.6 | 90.9 | 95.5 | 95.5 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,3 to < 6 Years Old - SOF+RBV 24 Weeks | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,6 to < 12 Years Old - SOF+RBV 24 Weeks | 75.0 | 93.3 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02175758)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
| End of Treatment71966064 | End of Treatment71966065 | End of Treatment71966066 | Posttreatment Week 1271966064 | Posttreatment Week 1271966065 | Posttreatment Week 1271966066 | Posttreatment Week 2471966064 | Posttreatment Week 2471966065 | Posttreatment Week 2471966066 |
---|
| No Change | Increase | Decrease |
---|
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 24 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 11 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 7 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 21 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 10 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 9 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 1 |
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 20 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 9 |
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 3 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 11 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 2 |
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For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02175758)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - SOF+RBV 12 Weeks | 100.0 |
12 to < 18 Years Old - SOF+RBV 24 Weeks | 97.4 |
6 to < 12 Years Old - SOF+RBV 12 Weeks | 100.0 |
6 to < 12 Years Old - SOF+RBV 24 Weeks | 100.0 |
3 to < 6 Years Old - SOF+RBV 12 Weeks | 80.0 |
3 to < 6 Years Old - SOF+RBV 24 Weeks | 100.0 |
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For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02175758)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
| End of Treatment71966064 | End of Treatment71966065 | End of Treatment71966066 | Posttreatment Week 1271966064 | Posttreatment Week 1271966065 | Posttreatment Week 1271966066 | Posttreatment Week 2471966064 | Posttreatment Week 2471966065 | Posttreatment Week 2471966066 |
---|
| No Change | Increase | Decrease |
---|
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 23 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 10 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 8 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 1 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 10 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 20 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 9 |
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 3 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 11 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 2 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
(NCT02175758)
Timeframe: Up to Day 7
Intervention | percentage of participants (Number) |
---|
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
(NCT02175758)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - SOF+RBV 12 Weeks | 0 |
12 to < 18 Years Old - SOF+RBV 24 Weeks | 0 |
6 to < 12 Years Old - SOF+RBV 12 Weeks | 0 |
6 to < 12 Years Old - SOF+RBV 24 Weeks | 0 |
3 to < 6 Years Old - SOF+RBV 12 Weeks | 20.0 |
3 to < 6 Years Old - SOF+RBV 24 Weeks | 0 |
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For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02175758)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
| End of Treatment71966067 | End of Treatment71966068 | End of Treatment71966069 | Posttreatment Week 1271966067 | Posttreatment Week 1271966068 | Posttreatment Week 1271966069 | Posttreatment Week 2471966068 | Posttreatment Week 2471966069 | Posttreatment Week 2471966067 |
---|
| No Change | Increase | Decrease |
---|
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 20 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 24 |
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 8 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 1 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 6 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 18 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 23 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 2 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 22 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 8 |
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For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 Weeks | -3.98 | -4.84 | -4.84 | -4.84 | -4.84 |
,PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks | -4.12 | -4.31 | -4.42 | -4.52 | -4.52 |
,PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 Weeks | -3.82 | -4.92 | -4.92 | -4.92 | -4.92 |
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For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02175758)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
| End of Treatment71966068 | End of Treatment71966069 | End of Treatment71966067 | Posttreatment Week 1271966068 | Posttreatment Week 1271966069 | Posttreatment Week 1271966067 | Posttreatment Week 2471966069 | Posttreatment Week 2471966067 | Posttreatment Week 2471966068 |
---|
| No Change | Increase | Decrease |
---|
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 20 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 24 |
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 8 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 1 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 5 |
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 1 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 17 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 3 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 16 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 19 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 4 |
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 11 |
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 0 |
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For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
(NCT02175758)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
12 to < 18 Years Old - SOF+RBV 24 Weeks | 30.8 | 74.4 | 92.3 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,3 to < 6 Years Old - SOF+RBV 24 Weeks | 37.5 | 87.5 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,6 to < 12 Years Old - SOF+RBV 24 Weeks | 39.3 | 78.6 | 96.4 | 96.4 | 100.0 | 100.0 | 100.0 | 100.0 |
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For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 |
---|
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks | -4.23 | -4.34 | -4.34 | -4.34 | -4.34 | -4.34 | -4.34 | -4.34 |
,PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks | -3.53 | -3.94 | -3.97 | -3.97 | -3.97 | -3.97 | -3.97 | -3.97 |
,PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks | -3.78 | -4.56 | -4.60 | -4.61 | -4.61 | -4.61 | -4.61 | -4.61 |
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For the Treatment Phase, Change From Baseline in HCV RNA
(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
12 to < 18 Years Old - SOF+RBV 12 Weeks | -4.25 | -4.74 | -4.74 | -4.74 | -4.74 |
,3 to < 6 Years Old - SOF+RBV 12 Weeks | -4.12 | -4.31 | -4.42 | -4.52 | -4.52 |
,6 to < 12 Years Old - SOF+RBV 12 Weeks | -4.12 | -4.55 | -4.68 | -4.68 | -4.68 |
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For the Treatment Phase, Change From Baseline in Height
(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Intervention | centimeters (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 | Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 24 |
---|
12 to < 18 Years Old - SOF+RBV 24 Weeks | 0.0 | -0.1 | 0.2 | 0.2 | 0.3 | 0.4 | 0.5 | 0.8 | 0.9 | 1.3 | 1.8 |
,3 to < 6 Years Old - SOF+RBV 24 Weeks | 0.3 | 0.3 | 0.5 | 0.8 | 1.7 | 1.8 | 2.5 | 2.7 | 3.5 | 4.0 | 5.7 |
,6 to < 12 Years Old - SOF+RBV 24 Weeks | 0.0 | 0.0 | 0.4 | 0.4 | 0.7 | 1.1 | 1.6 | 2.1 | 2.6 | 3.8 | 5.1 |
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For the Treatment Phase, Change From Baseline in Height
(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Intervention | centimeters (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 24 |
---|
12 to < 18 Years Old - SOF+RBV 12 Weeks | 0.1 | 0.1 | 0.2 | 0.3 | 0.5 | 0.5 | 1.4 | 1.6 |
,6 to < 12 Years Old - SOF+RBV 12 Weeks | 0.0 | 0.1 | 0.3 | 1.0 | 0.8 | 1.4 | 2.4 | 4.2 |
,3 to < 6 Years Old - SOF+RBV 12 Weeks | 0.3 | 0.7 | 0.9 | 0.9 | 1.5 | 1.6 | 2.8 | 5.0 |
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For the Treatment Phase, Change From Baseline in Weight
(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Intervention | kilograms (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 | Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 24 |
---|
12 to < 18 Years Old - SOF+RBV 24 Weeks | -0.4 | -0.3 | -0.1 | 0.0 | -0.1 | 0.2 | 0.1 | 0.5 | 0.9 | 2.1 | 3.0 |
,3 to < 6 Years Old - SOF+RBV 24 Weeks | -0.2 | -0.1 | -0.1 | 0.0 | 0.1 | 0.1 | 0.4 | 0.4 | 0.7 | 0.9 | 1.7 |
,6 to < 12 Years Old - SOF+RBV 24 Weeks | 0.0 | 0.0 | 0.1 | 0.1 | 0.5 | 0.6 | 0.9 | 1.2 | 1.3 | 2.2 | 3.5 |
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Percentage of Participants With End of Treatment Response (EOTR)
EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment. (NCT02175966)
Timeframe: End of the treatment
Intervention | Percentage of participants (Number) |
---|
4 Weeks DCV 3DAA + SOF | 92.9 |
6 Weeks DCV 3DAA + SOF | 100.0 |
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Percentage of Participants Who Achieved HCV RNA Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24). (NCT02175966)
Timeframe: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)
Intervention | Percentage of Participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Follow-Up Week 2 | Follow-Up Week 4 | Follow-Up Week 12 | Follow-Up Week 24 |
---|
4 Weeks DCV 3DAA + SOF | 35.7 | 78.6 | 100.0 | NA | 78.6 | 42.9 | 28.6 | 28.6 |
,6 Weeks DCV 3DAA + SOF | 71.4 | 100.0 | 100.0 | 100.0 | 100.0 | 78.6 | 57.1 | 57.1 |
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Percentage of Participants With Sustained Virologic Response 12 (SVR12)
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach. (NCT02175966)
Timeframe: 12 Weeks after treatment discontinuation (Follow-up Week 12)
Intervention | Percentage of participants (Number) |
---|
4 Weeks DCV 3DAA + SOF | 28.6 |
6 Weeks DCV 3DAA + SOF | 57.1 |
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Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24). (NCT02175966)
Timeframe: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24
Intervention | Percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Follow-Up Week 2 | Follow-Up Week 4 | Follow-Up Week 12 | Follow-Up Week 24 |
---|
4 Weeks DCV 3DAA + SOF | 21.4 | 42.9 | 92.9 | NA | 71.4 | 42.9 | 28.6 | 28.6 |
,6 Weeks DCV 3DAA + SOF | 7.1 | 64.3 | 100.0 | 100.0 | 92.9 | 71.4 | 57.1 | 57.1 |
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Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect. (NCT02175966)
Timeframe: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Intervention | Participants (Count of Participants) |
---|
| Death | Serious Adverse Events | AEs Leading to Discontinuation |
---|
4 Weeks DCV 3DAA + SOF | 0 | 1 | 0 |
,6 Weeks DCV 3DAA + SOF | 0 | 0 | 0 |
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Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b
Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b (NCT02175966)
Timeframe: Post-treatment Week 12
Intervention | Percentage of Participants (Number) |
---|
| Genotype 1a | Genotype 1b |
---|
4 Weeks DCV 3DAA + SOF | 27.3 | 33.3 |
,6 Weeks DCV 3DAA + SOF | 54.5 | 66.7 |
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Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. (NCT02175966)
Timeframe: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Intervention | Participants (Count of Participants) |
---|
4 Weeks DCV 3DAA + SOF | 0 |
6 Weeks DCV 3DAA + SOF | 0 |
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Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype)
Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported. (NCT02175966)
Timeframe: Post-treatment Week 12
Intervention | Percentage of Participants (Number) |
---|
| CC genotype | Non-CC Genotype |
---|
4 Weeks DCV 3DAA + SOF | 40.0 | 22.2 |
,6 Weeks DCV 3DAA + SOF | 66.7 | 50.0 |
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Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02201901)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF/VEL 12 Weeks (Group 1) | 92.2 | 83.3 |
,SOF/VEL 24 Weeks (Group 3) | 90.0 | 87.8 |
,SOF/VEL+RBV 12 Weeks (Group 2) | 95.4 | 94.3 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
(NCT02201901)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Intervention | percentage of participants (Number) |
---|
| Wk 1(Group 1: N=90; Group 2: N=87; Group 3: N=90) | Wk 2 (Group 1: N=90; Group 2: N=87;Group 3: N=89) | Wk 4 (Group 1: N=90; Group 2: N=87; Group 3: N=89) | Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88) | Wk 8(Group 1: N=89; Group 2: N=84; Group 3: N=87) | Wk 10(Group 1: N=89; Group 2: N=84; Group 3: N=87) | Wk 12(Group 1: N=89; Group 2: N=83; Group 3: N=87) | Wk 16(Group 1: N=0; Group 2: N=0; Group 3: N=86) | Wk 20(Group 1: N=0; Group 2: N=0;Group 3: N=84) | Wk 24(Group 1: N=0; Group 2: N=0; Group 3: N=84) |
---|
SOF/VEL 12 Weeks (Group 1) | 2.2 | 34.4 | 81.1 | 98.9 | 98.9 | 100.0 | 100.0 | NA | NA | NA |
,SOF/VEL 24 Weeks (Group 3) | 11.1 | 39.3 | 91.0 | 98.9 | 100.0 | 100.0 | 97.7 | 97.7 | 100.0 | 100.0 |
,SOF/VEL+RBV 12 Weeks (Group 2) | 14.9 | 49.4 | 80.5 | 97.6 | 98.8 | 98.8 | 98.8 | NA | NA | NA |
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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. (NCT02201901)
Timeframe: Baseline to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| Decrease (Improvement) | No Change | Increase (Worsening) |
---|
SOF/VEL 12 Weeks (Group 1) | 55.1 | 20.3 | 24.6 |
,SOF/VEL 24 Weeks (Group 3) | 50.7 | 21.7 | 27.5 |
,SOF/VEL+RBV 12 Weeks (Group 2) | 49.3 | 25.3 | 25.3 |
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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
(NCT02201901)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Intervention | log10 IU/mL (Mean) |
---|
| Wk 1(Group 1: N=89; Group 2: N=83; Group 3: N=88) | Wk 2(Group 1: N=89; Group 2: N=87; Group 3: N=88) | Wk 4(Group 1: N=88; Group 2: N=86; Group 3: N=88) | Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88) | Wk 8(Group 1: N=89; Group 2: N=83; Group 3: N=87) | Wk 10(Group 1: N=89; Group 2: N=84; Group 3, N=87) | Wk 12(Group 1: N=89; Group 2: N=82; Group 3: N=86) | Wk 16 (Group 1: N=0; Group 2: N=0; Group 3: N=85) | Wk 20 (Group 1: N=0; Group 2: N=0; Group 3: N =84) | Wk 24 (Group 1: N=0; Group 2: N=0; Group 3: N =84) |
---|
SOF/VEL 12 Weeks (Group 1) | -3.51 | -4.24 | -4.78 | -4.87 | -4.87 | -4.87 | -4.87 | NA | NA | NA |
,SOF/VEL 24 Weeks (Group 3) | -3.72 | -4.38 | -4.70 | -4.74 | -4.76 | -4.76 | -4.75 | -4.76 | -4.77 | -4.77 |
,SOF/VEL+RBV 12 Weeks (Group 2) | -3.63 | -4.17 | -4.58 | -4.68 | -4.68 | -4.67 | -4.68 | NA | NA | NA |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as~On-treatment virologic failure~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,~HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement" (NCT02201901)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks (Group 1) | 12.2 |
SOF/VEL+RBV 12 Weeks (Group 2) | 3.4 |
SOF/VEL 24 Weeks (Group 3) | 8.9 |
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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease. (NCT02201901)
Timeframe: Baseline to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| Decrease (Improvement) | No Change | Increase (Worsening) |
---|
SOF/VEL 12 Weeks (Group 1) | 44.9 | 43.5 | 11.6 |
,SOF/VEL 24 Weeks (Group 3) | 63.8 | 27.5 | 8.7 |
,SOF/VEL+RBV 12 Weeks (Group 2) | 53.3 | 37.3 | 9.3 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02201901)
Timeframe: Up to 24 weeks plus 30 days
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks (Group 1) | 1.1 |
SOF/VEL+RBV 12 Weeks (Group 2) | 16.1 |
SOF/VEL 24 Weeks (Group 3) | 4.4 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02201901)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks (Group 1) | 83.3 |
SOF/VEL+RBV 12 Weeks (Group 2) | 94.3 |
SOF/VEL 24 Weeks (Group 3) | 87.8 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02201940)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
Placebo | 0 | 0 |
,SOF/VEL | 99.2 | 99.0 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
(NCT02201940)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 (SOF/VEL: N = 624; Placebo: N = 116) | Week 2 (SOF/VEL: N = 624; Placebo: N = 116) | Week 4 (SOF/VEL: N = 623; Placebo: N = 116) | Week 6 (SOF/VEL: N = 623; Placebo: N = 115) | Week 8 (SOF/VEL: N = 622; Placebo: N = 114) | Week 10 (SOF/VEL: N = 622; Placebo: N = 114) | Week 12 (SOF/VEL: N = 622; Placebo: N = 113) |
---|
Placebo | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,SOF/VEL | 18.8 | 56.9 | 90.5 | 98.9 | 99.7 | 100.0 | 100.0 |
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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
(NCT02201940)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Wk 1 (SOF/VEL: N= 617; Placebo: N= 114) | Change at Wk 2 (SOF/VEL: N= 622; Placebo: N= 116) | Change at Wk 4 (SOF/VEL: N= 617; Placebo: N= 114) | Change at Wk 6 (SOF/VEL: N= 623; Placebo: N= 115) | Change at Wk 8 (SOF/VEL: N= 622; Placebo: N= 113) | Change at Wk 10 (SOF/VEL: N= 622; Placebo: N= 112) | Change at Wk 12 (SOF/VEL: N= 622; Placebo: N= 111) |
---|
Placebo | -0.05 | 0.01 | -0.01 | 0.07 | 0.05 | 0.05 | -0.06 |
,SOF/VEL | -4.29 | -4.82 | -5.08 | -5.11 | -5.11 | -5.12 | -5.12 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02201940)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 0.3 |
Placebo | 100 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02201940)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 99.0 |
Placebo | 0 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02201940)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 0.2 |
Placebo | 1.7 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
(NCT02201953)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Intervention | percentage of participants (Number) |
---|
| Week 1 (SOF/VEL: N = 277; SOF+RBV: N = 275) | Week 2 (SOF/VEL: N = 276; SOF+RBV: N = 274) | Week 4 (SOF/VEL: N = 276; SOF+RBV: N = 272) | Week 6 (SOF/VEL: N = 276; SOF+RBV: N = 269) | Week 8 (SOF/VEL: N = 276; SOF+RBV: N = 269) | Week 10 (SOF/VEL: N = 276; SOF+RBV: N = 268) | Week 12 (SOF/VEL: N = 275; SOF+RBV: N = 265) | Week 16 (SOF/VEL: N = 0; SOF+RBV: N = 262) | Week 20 (SOF/VEL: N = 0; SOF+RBV: N = 260) | Week 24 (SOF/VEL: N = 0; SOF+RBV: N = 255) |
---|
SOF/VEL 12 Weeks | 18.4 | 62.0 | 91.7 | 96.7 | 99.6 | 100.0 | 100.0 | NA | NA | NA |
,SOF+RBV 24 Weeks | 17.5 | 50.0 | 88.2 | 98.9 | 99.3 | 99.3 | 99.6 | 98.9 | 99.6 | 100.0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02201953)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 95.3 |
SOF+RBV 24 Weeks | 80.7 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02201953)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 0 |
SOF+RBV 24 Weeks | 3.3 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02201953)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 4.0 |
SOF+RBV 24 Weeks | 14.2 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug. (NCT02201953)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF/VEL 12 Weeks | 96.8 | 95.3 |
,SOF+RBV 24 Weeks | 82.2 | 80.7 |
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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
(NCT02201953)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Intervention | log10 IU/mL (Mean) |
---|
| Change at Wk 1 (SOF/VEL: N =272; SOF+RBV: N =268) | Change at Wk 2 (SOF/VEL: N =274; SOF+RBV: N =272) | Change at Wk 4 (SOF/VEL: N =276; SOF+RBV: N =270) | Change at Wk 6 (SOF/VEL: N =275; SOF+RBV: N =269) | Change at Wk 8 (SOF/VEL: N =276; SOF+RBV: N =269) | Change at Wk 10 (SOF/VEL: N =276; SOF+RBV: N =267) | Change at Wk 12 (SOF/VEL: N =275; SOF+RBV: N =264) | Change at Wk 16 (SOF/VEL: N = 0; SOF+RBV: N = 262) | Change at Wk 20 (SOF/VEL: N = 0; SOF+RBV: N = 259) | Change at Wk 24 (SOF/VEL: N = 0; SOF+RBV: N = 255) |
---|
SOF/VEL 12 Weeks | -4.26 | -4.82 | -5.02 | -5.06 | -5.07 | -5.07 | -5.08 | NA | NA | NA |
,SOF+RBV 24 Weeks | -4.16 | -4.79 | -5.09 | -5.13 | -5.13 | -5.14 | -5.14 | -5.11 | -5.14 | -5.14 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02202980)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) | 7.1 |
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) | 0 |
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) | 0 |
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) | 0 |
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) | 0 |
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) | 0 |
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) | 0 |
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) | 0 |
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) | 0 |
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) | 0 |
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) | 0 |
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) | 0 |
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) | 0 |
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) | 0 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 |
---|
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) | 7.4 | 40.7 | 92.6 | 96.3 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) | 9.4 | 53.1 | 87.5 | 100.0 | 100.0 |
,LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) | 28.0 | 60.0 | 92.0 | 100.0 | 100.0 |
,LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) | 7.7 | 7.7 | 84.6 | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 |
---|
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) | 26.7 | 66.7 | 100.0 | 100.0 |
,SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) | 26.7 | 66.7 | 100.0 | 100.0 |
,SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) | 13.3 | 43.3 | 93.3 | 96.7 |
,SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) | 16.7 | 88.9 | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 |
---|
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) | 26.7 | 53.3 | 100.0 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02202980)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) | 100.0 | 100.0 |
,LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) | 96.2 | 96.2 |
,LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) | 76.9 | 76.9 |
,LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) | 81.5 | 74.1 |
,LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) | 92.9 | 92.9 |
,SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) | 73.3 | 20.0 |
,SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) | 100.0 | 93.3 |
,SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) | 86.7 | 86.7 |
,SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) | 86.7 | 66.7 |
,SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) | 88.9 | 83.3 |
,SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) | 100.0 | 100.0 |
,SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) | 92.9 | 89.3 |
,SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) | 100.0 | 100.0 |
,SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 |
---|
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) | 5.9 | 41.2 | 76.5 | 100.0 | 100.0 |
,SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) | 7.1 | 60.7 | 85.7 | 96.4 | 100.0 |
,SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) | 5.3 | 42.1 | 84.2 | 94.7 | 100.0 |
,SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) | 0 | 25.0 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02202980)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) | 7.1 |
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) | 0 |
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) | 22.2 |
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) | 0 |
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) | 23.1 |
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) | 6.7 |
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) | 73.3 |
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) | 13.3 |
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) | 11.1 |
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) | 0 |
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) | 0 |
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) | 10.7 |
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) | 30.0 |
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02202980)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) | 92.9 |
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) | 96.2 |
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) | 74.1 |
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) | 100.0 |
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) | 76.9 |
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) | 93.3 |
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) | 26.7 |
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) | 86.7 |
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) | 83.3 |
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) | 100.0 |
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) | 100.0 |
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) | 89.3 |
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) | 66.7 |
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) | 7.1 | 64.3 | 100.0 | 100.0 | 100.0 | 92.9 | 92.9 | 100.0 |
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Sustained Viral Response
Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured. (NCT02214420)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
SMV+SOF | 13 |
SMV+SOF+RBV | 8 |
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Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Motor
"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).~For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4
Intervention | units on a scale (Mean) |
---|
Blinded Phase: LDV/SOF | -10.00 |
Blinded Phase: Placebo | -6.00 |
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Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Memory T Score
"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).~For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4
Intervention | units on a scale (Mean) |
---|
Blinded Phase: LDV/SOF | -3.88 |
Blinded Phase: Placebo | 7.93 |
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Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation
"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).~For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4
Intervention | units on a scale (Mean) |
---|
Blinded Phase: LDV/SOF | -13.04 |
Blinded Phase: Placebo | -12.43 |
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Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed
"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).~For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4
Intervention | units on a scale (Mean) |
---|
Blinded Phase: LDV/SOF | 1.96 |
Blinded Phase: Placebo | 4.00 |
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Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Attention Scaled Score
"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).~For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4
Intervention | units on a scale (Mean) |
---|
Blinded Phase: LDV/SOF | 0.73 |
Blinded Phase: Placebo | 1.43 |
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Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Motor
"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).~For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 24
Intervention | units on a scale (Mean) |
---|
Blinded Phase: LDV/SOF | -9.21 |
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Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation
"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).~For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 24
Intervention | units on a scale (Mean) |
---|
Blinded Phase: LDV/SOF | -16.67 |
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Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed
"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).~For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 24
Intervention | units on a scale (Mean) |
---|
Blinded Phase: LDV/SOF | 4.00 |
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Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Attention Scaled Score
"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).~For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 24
Intervention | units on a scale (Mean) |
---|
Blinded Phase: LDV/SOF | 1.42 |
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Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Memory T Score
"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).~For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 24
Intervention | units on a scale (Mean) |
---|
Blinded Phase: LDV/SOF | -17.42 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
SVR4, SVR12, and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4, 12, and 24 weeks after stopping study treatment with LDV/SOF, respectively. (NCT02219685)
Timeframe: Posttreatment Weeks 4, 12, and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR12 | SVR24 |
---|
Blinded Phase: LDV/SOF | 96.2 | 92.3 | 92.3 |
,Open-Label Phase: LDV/SOF | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
(NCT02220998)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 2 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 4 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 6 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 8 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 10 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 12 (SOF/VEL: N = 133; SOF+RBV: N = 131) |
---|
SOF/VEL | 12.8 | 57.1 | 90.2 | 97.7 | 100.0 | 100.0 | 100.0 |
,SOF+RBV | 22.7 | 59.8 | 90.2 | 99.2 | 100.0 | 100.0 | 100.0 |
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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
(NCT02220998)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Wk 1 (SOF/VEL: N= 132; SOF+RBV: N= 131) | Change at Wk 2 (SOF/VEL: N= 132; SOF+RBV: N= 131) | Change at Wk 4 (SOF/VEL: N= 132; SOF+RBV: N= 131) | Change at Wk 6 (SOF/VEL: N= 133; SOF+RBV: N= 131) | Change at Wk 8 (SOF/VEL: N= 133; SOF+RBV: N= 132) | Change at Wk 10 (SOF/VEL: N= 133; SOF+RBV: N= 132) | Change at Wk 12 (SOF/VEL: N= 133; SOF+RBV: N= 131) |
---|
SOF/VEL | -4.51 | -5.08 | -5.29 | -5.31 | -5.32 | -5.32 | -5.32 |
,SOF+RBV | -4.51 | -5.04 | -5.24 | -5.27 | -5.27 | -5.27 | -5.26 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02220998)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 0 |
SOF+RBV | 4.5 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02220998)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 99.3 |
SOF+RBV | 93.9 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02220998)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 0.7 |
SOF+RBV | 0 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02220998)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF/VEL | 99.3 | 99.3 |
,SOF+RBV | 96.2 | 93.9 |
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02226549)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF+VDV | 95.5 |
LDV/SOF+VDV+RBV | 95.8 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02226549)
Timeframe: Up to 8 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF+VDV | 0 |
LDV/SOF+VDV+RBV | 8.3 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02226549)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF+VDV | 95.5 |
LDV/SOF+VDV+RBV | 87.5 |
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For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
(NCT02249182)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
6 to < 12 Years Old - LDV/SOF 24 Weeks | 0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
(NCT02249182)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 0 |
6 to < 12 Years Old - LDV/SOF 12 Weeks | 0 |
6 to < 12 Years Old - LDV/SOF 24 Weeks | 0 |
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 0 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 2.9 |
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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. (NCT02249182)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Posttreatment Week 4 |
---|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 50.0 | 50.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. (NCT02249182)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
6 to < 12 Years Old - LDV/SOF 24 Weeks | 0 | 0 | 0 | 0 | 100.0 | 100.0 | 100.0 | 100.0 |
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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. (NCT02249182)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Posttreatment Week 4 |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 72.3 | 89.8 | 93.8 | 91.3 | 93.3 | 90.2 |
,3 to < 6 Years Old - LDV/SOF 12 Weeks | 63.0 | 84.0 | 96.0 | 92.0 | 91.7 | 91.3 |
,6 to < 12 Years Old - LDV/SOF 12 Weeks | 75.7 | 84.8 | 93.1 | 90.1 | 95.5 | 98.4 |
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For the Treatment Phase, Change From Baseline in Weight
(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Intervention | kilograms (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 24 |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 0.1 | 0.3 | 0.4 | 0.5 | 0.6 | 0.9 | 1.6 | 3.2 |
,3 to < 6 Years Old - LDV/SOF 12 Weeks | 0.1 | 0.2 | 0.3 | 0.5 | 0.6 | 1.1 | 1.2 | 2.0 |
,6 to < 12 Years Old - LDV/SOF 12 Weeks | 0.3 | 0.4 | 0.5 | 0.8 | 1.1 | 1.4 | 2.1 | 3.5 |
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For the Treatment Phase, Change From Baseline in Weight
(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Intervention | kilograms (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 | Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 24 |
---|
6 to < 12 Years Old - LDV/SOF 24 Weeks | -0.5 | 0.0 | 0.5 | 1.3 | 2.1 | 1.6 | 2.2 | 3.1 | 1.8 | 3.1 | 4.5 |
,6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 0.3 | 0.3 | 0.7 | 0.6 | 0.9 | 1.2 | 1.8 | 2.4 | 2.2 | 3.7 | 5.7 |
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For the Treatment Phase, Change From Baseline in Height
(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Intervention | centimeters (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 24 |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 0.1 | 0.0 | 0.1 | 0.4 | 0.5 | 0.8 | 1.2 | 1.8 |
,3 to < 6 Years Old - LDV/SOF 12 Weeks | 0.2 | 0.3 | 0.7 | 1.0 | 1.6 | 2.1 | 3.3 | 4.7 |
,6 to < 12 Years Old - LDV/SOF 12 Weeks | 0.1 | 0.3 | 0.5 | 0.8 | 1.3 | 1.8 | 2.7 | 4.1 |
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For the Treatment Phase, Change From Baseline in HCV RNA
(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | -4.34 | -4.74 | -4.84 | -4.85 | -4.85 |
,3 to < 6 Years Old - LDV/SOF 12 Weeks | -4.25 | -4.80 | -4.85 | -4.86 | -4.86 |
,6 to < 12 Years Old - LDV/SOF 12 Weeks | -4.27 | -4.73 | -4.87 | -4.89 | -4.89 |
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For the Treatment Phase, Change From Baseline in Height
(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Intervention | centimeters (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 | Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 24 |
---|
6 to < 12 Years Old - LDV/SOF 24 Weeks | 0.3 | 0.5 | 1.2 | 1.3 | 2.1 | 3.2 | 4.3 | 4.3 | 4.3 | 5.0 | 7.6 |
,6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 0.7 | 0.5 | 0.6 | 0.8 | 1.1 | 1.4 | 1.6 | 2.5 | 2.4 | 3.4 | 5.6 |
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For the Treatment Phase, Change From Baseline in HCV RNA
(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 |
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6 to < 12 Years Old - LDV/SOF 24 Weeks | -4.30 | -5.09 | -5.09 | -5.09 | -5.09 | -5.09 | -5.09 | -5.09 |
,6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | -4.54 | -4.54 | -4.54 | -4.54 | -4.54 | -4.54 | -4.54 | -4.54 |
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For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | -4.34 | -4.71 | -4.73 | -4.73 | -4.73 |
,PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | -4.32 | -4.87 | -4.92 | -4.92 | -4.92 |
,PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | -4.29 | -4.55 | -4.75 | -4.76 | -4.76 |
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Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1
Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to < 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to < 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet. (NCT02249182)
Timeframe: Day 1
Intervention | percentage of participants (Number) |
---|
| Able to Swallow 90/400 mg Placebo Tablet | Unable to Swallow 90/400 mg Placebo Tablet | Able to Swallow 22.5/100 mg Placebo Tablet | Unable to Swallow 22.5/100 mg Placebo Tablet |
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12 to < 18 Years Old - LDV/SOF 12 Weeks | 89.0 | 11.0 | 72.7 | 27.3 |
,6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 100.0 | 0 | 98.8 | 1.2 |
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Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score > 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to < 40. (NCT02249182)
Timeframe: Day 1
Intervention | percentage of participants (Number) |
---|
| Did not taste the study drug | Tasted drug with score > 60 to 100 | Tasted drug with score 40 to 60 | Tasted drug with score of 0 to < 40 |
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3 to < 6 Years Old - LDV/SOF 12 Weeks | 41.2 | 17.6 | 11.8 | 29.4 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
(NCT02249182)
Timeframe: Up to Day 10
Intervention | percentage of participants (Number) |
---|
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | 0 |
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | 0 |
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | 5.9 |
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For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02249182)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 98.0 |
6 to < 12 Years Old - LDV/SOF 12 Weeks | 98.9 |
6 to < 12 Years Old - LDV/SOF 24 Weeks | 100.0 |
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 100.0 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 97.1 |
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For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment. (NCT02249182)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 98.0 |
6 to < 12 Years Old - LDV/SOF 12 Weeks | 98.9 |
6 to < 12 Years Old - LDV/SOF 24 Weeks | 100.0 |
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 100.0 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 97.1 |
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For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment. (NCT02249182)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 98.0 |
6 to < 12 Years Old - LDV/SOF 12 Weeks | 98.9 |
6 to < 12 Years Old - LDV/SOF 24 Weeks | 100.0 |
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 100.0 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 97.1 |
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For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT02249182)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 0 |
6 to < 12 Years Old - LDV/SOF 12 Weeks | 1.1 |
6 to < 12 Years Old - LDV/SOF 24 Weeks | 0 |
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 0 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 0 |
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For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment. (NCT02249182)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 0 |
6 to < 12 Years Old - LDV/SOF 12 Weeks | 0 |
6 to < 12 Years Old - LDV/SOF 24 Weeks | 0 |
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 0 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 0 |
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For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
(NCT02249182)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 40.0 | 75.0 | 97.0 | 100.0 | 100.0 |
,3 to < 6 Years Old - LDV/SOF 12 Weeks | 29.4 | 78.8 | 97.0 | 100.0 | 100.0 |
,6 to < 12 Years Old - LDV/SOF 12 Weeks | 30.3 | 71.9 | 96.6 | 100.0 | 100.0 |
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For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02249182)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
| End of Treatment71908377 | End of Treatment71908376 | End of Treatment71908378 | Posttreatment Week 1271908377 | Posttreatment Week 1271908376 | Posttreatment Week 1271908378 | Posttreatment Week 2471908378 | Posttreatment Week 2471908376 | Posttreatment Week 2471908377 |
---|
| No Change | Increase | Decrease |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 35 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 52 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 10 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 1 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 1 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 32 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 51 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 3 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 2 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 28 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 48 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 9 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 7 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 4 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 1 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 0 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 0 |
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For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02249182)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
| End of Treatment71908376 | End of Treatment71908377 | End of Treatment71908378 | Posttreatment Week 1271908377 | Posttreatment Week 1271908376 | Posttreatment Week 1271908378 | Posttreatment Week 2471908376 | Posttreatment Week 2471908377 | Posttreatment Week 2471908378 |
---|
| Decrease | No Change | Increase |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 34 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 52 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 1 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 1 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 33 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 50 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 9 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 2 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 4 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 0 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 29 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 47 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 10 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 6 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 6 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 0 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 0 |
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For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02249182)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
| End of Treatment71908380 | End of Treatment71908381 | End of Treatment71908379 | Posttreatment Week 1271908380 | Posttreatment Week 1271908379 | Posttreatment Week 1271908381 | Posttreatment Week 2471908379 | Posttreatment Week 2471908380 | Posttreatment Week 2471908381 |
---|
| No Change | Increase | Decrease |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 52 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 34 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 21 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 9 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 2 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 1 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 0 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 0 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 45 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 31 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 22 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 15 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 3 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 40 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 27 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 21 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 8 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 0 |
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For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02249182)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
| End of Treatment71908379 | End of Treatment71908380 | End of Treatment71908381 | Posttreatment Week 1271908380 | Posttreatment Week 1271908381 | Posttreatment Week 1271908379 | Posttreatment Week 2471908380 | Posttreatment Week 2471908381 | Posttreatment Week 2471908379 |
---|
| Increase | Decrease | No Change |
---|
12 to < 18 Years Old - LDV/SOF 12 Weeks | 53 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 31 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 8 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 5 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 0 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 1 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 0 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 49 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 25 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 21 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 11 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 8 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 0 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 1 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 43 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 21 |
12 to < 18 Years Old - LDV/SOF 12 Weeks | 18 |
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | 14 |
3 to < 6 Years Old - LDV/SOF 12 Weeks | 1 |
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Percentage of Participants With On-Treatment Failure
Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., =LLOQ. (NCT02250807)
Timeframe: through 12 weeks (EOT)
Intervention | percentage of participants (Number) |
---|
SMV+SOF 12 Weeks | 0 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT. (NCT02250807)
Timeframe: 12 weeks after EOT
Intervention | percentage of participants (Number) |
---|
SMV+SOF 12 Weeks | 100 |
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Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Percentage of participants with HCV RNA less than (<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed. (NCT02250807)
Timeframe: Week 2, 3, 4, 12 and EOT
Intervention | percentage of participants (Number) |
---|
| Week 2: < 100 IU/mL | Week 2: < 15 IU/mL undetectable/detectable | Week 2: < 15 IU/mL undetectable | Week 3: < 100 IU/mL | Week 3: < 15 IU/mL undetectable/detectable | Week 3: < 15 IU/mL undetectable | Week 4: < 100 IU/mL | Week 4: < 15 IU/mL undetectable/detectable | Week 4: < 15 IU/mL undetectable (RVR) | Week 12: < 100 IU/mL | Week 12: < 15 IU/mL undetectable/detectable | Week 12: < 15 IU/mL undetectable | End of Treatment (EOT): < 100 IU/mL | EOT: < 15 IU/mL undetectable/detectable | EOT: < 15 IU/mL undetectable |
---|
SMV+SOF 12 Weeks | 87.5 | 40.0 | 17.5 | 100.0 | 82.5 | 40.0 | 100.0 | 87.5 | 65.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)
Participants were considered to have reached SVR24, if at the time point of SVR24 (that is [i.e.], 24 weeks after the end of treatment [EOT]) the following condition has been met: HCV RNA < lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable. (NCT02250807)
Timeframe: At 24 weeks after EOT
Intervention | percentage of participants (Number) |
---|
SMV+SOF 12 Weeks | 100 |
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Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)
SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 4 weeks after actual EOT. (NCT02250807)
Timeframe: 4 weeks after EOT
Intervention | percentage of participants (Number) |
---|
SMV+SOF 12 Weeks | 100 |
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Percentage of Participants With Viral Breakthrough
Participants with confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA NCT02250807)
Timeframe: Up to follow-up Week 24
Intervention | percentage of participants (Number) |
---|
SMV+SOF 12 Weeks | 0 |
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Percentage of Participants With Viral Relapse
Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (>=)LLOQ. (NCT02250807)
Timeframe: Up to follow-up week 24
Intervention | percentage of participants (Number) |
---|
SMV+SOF 12 Weeks | 0 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02251717)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF 12 Weeks | 100.0 | 100.0 |
,LDV/SOF 24 Weeks | 100.0 | 100.0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02251717)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 0 |
LDV/SOF 24 Weeks | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02251717)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 100.0 |
LDV/SOF 24 Weeks | 100.0 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02251717)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 1.8 |
LDV/SOF 24 Weeks | 0 |
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Percentage of Participants With On-treatment Failure
On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment. (NCT02262728)
Timeframe: Week 12
Intervention | Percentage of Participants (Number) |
---|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 0 |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 0 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)
Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment. (NCT02262728)
Timeframe: Week 24
Intervention | Percentage of Participants (Number) |
---|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 100 |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 100 |
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Percentage of Participants With SVR12 Who Maintained to Have HCV RNA Percentage of participants with SVR12 who maintained to have HCV RNA NCT02262728)
Timeframe: Week 24 post treatment until the end of 3-year follow-up
Intervention | Percentage of participants (Number) |
---|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 78.9 |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 85.7 |
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Percentage of Participants With On-Treatment Virologic Response
On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. The following thresholds were considered at any time point: NCT02262728)
Timeframe: Week 1, 2, 4, 6, 8, 10, 12
Intervention | Percentage of Participants (Number) |
---|
| Week 1 : >= 15 IU/mL | Week 1 : < 100 IU/mL | Week 1: < 15 IU/mL undetect/detectable | Week 1 : < 15 IU/mL detectable | Week 1 : < 15 IU/mL Undetectable | Week 2 : >= 15 IU/mL | Week 2 : < 100 IU/mL | Week 2: < 15 IU/mL undetect/detectable | Week 2 : < 15 IU/mL detectable | Week 2: < 15 IU/mL undetectable (vRVR) | Week 4 : >= 15 IU/mL | Week 4 : < 100 IU/mL | Week 4: < 15 IU/mL undetect/detectable | Week 4 : < 15 IU/mL detectable | Week 4 : < 15 IU/mL undetectable (RVR) | Week 6 : >= 15 IU/mL | Week 6 : < 100 IU/mL | Week 6: < 15 IU/mL undetect/detectable | Week 6 : < 15 IU/mL detectable | Week 6 : < 15 IU/mL undetectable | Week 8 : >= 15 IU/mL | Week 8 : < 100 IU/mL | Week 8: < 15 IU/mL undetect/detectable | Week 8 : < 15 IU/mL detectable | Week 8 : < 15 IU/mL undetectable | Week 10 : >= 15 IU/mL | Week 10 : < 100 IU/mL | Week 10: < 15 IU/mL undetect/detectable | Week 10 : < 15 IU/mL detectable | Week 10 : < 15 IU/mL undetectable | Week 12 : >= 15 IU/mL | Week 12 :< 100 IU/mL | Week 12: < 15 IU/mL undetect/detectable | Week 12 : < 15 IU/mL detectable | Week 12 : < 15 IU/mL undetectable |
---|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 72.2 | 61.1 | 27.8 | 11.1 | 16.7 | 10.5 | 94.7 | 89.5 | 36.8 | 52.6 | 0 | 100.0 | 100.0 | 5.6 | 94.4 | 0 | 100.0 | 100.0 | 5.3 | 94.7 | 0 | 100.0 | 100.0 | 0 | 100.0 | 0 | 100.0 | 100.0 | 0 | 100.0 | 0 | 100.0 | 100.0 | 0 | 100.0 |
,SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 76.2 | 38.1 | 23.8 | 19.0 | 4.8 | 47.6 | 71.4 | 52.4 | 19.0 | 33.3 | 9.5 | 100.0 | 90.5 | 28.6 | 61.9 | 0 | 100.0 | 100.0 | 20.0 | 80.0 | 0 | 100.0 | 100.0 | 4.8 | 95.2 | 0 | 100.0 | 100.0 | 0 | 100.0 | 0 | 100.0 | 100.0 | 0 | 100.0 |
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Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)
(NCT02262728)
Timeframe: Follow-up Week 24 (Week 36)
Intervention | Units per Liter (U/L) (Mean) |
---|
| Baseline : ALT | Baseline : AST | Follow-Up Week 24 : ALT | Follow-Up Week 24 : AST |
---|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 137.8 | 119.1 | 34.8 | 39.2 |
,SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 60.9 | 83.5 | 32.3 | 35.0 |
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Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24)
Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was NCT02262728)
Timeframe: Week 16 and Week 36
Intervention | Percentage of Participants (Number) |
---|
| SVR 4 | SVR 24 |
---|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 100 | 100 |
,SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 100 | 100 |
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Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240
(NCT02292706)
Timeframe: Enrollment up to 240 weeks
Intervention | Participants (Count of Participants) |
---|
SOF+RBV | 0 |
LDV/SOF | 0 |
LDV/SOF+RBV | 0 |
SOF/VEL | 0 |
SOF/VEL+RBV | 0 |
SOF/VEL/VOX | 0 |
Other SOF-Based | 0 |
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Number of Participants With Detectable HCV Resistance Mutations Through Week 240
(NCT02292706)
Timeframe: Enrollment up to 240 weeks
Intervention | Participants (Count of Participants) |
---|
SOF+RBV | 0 |
LDV/SOF | 0 |
LDV/SOF+RBV | 1 |
SOF/VEL | 0 |
SOF/VEL+RBV | 0 |
SOF/VEL/VOX | 1 |
Other SOF-Based | 0 |
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Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240
Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model. (NCT02292706)
Timeframe: Enrollment up to 240 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 11.8 |
LDV/SOF | 5.01 |
LDV/SOF+RBV | 10.8 |
SOF/VEL | 10.8 |
SOF/VEL+RBV | 15.3 |
SOF/VEL/VOX | 12.4 |
Other SOF-Based | 11.2 |
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Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240
SVR at Week 240 was defined as HCV RNA< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter [IU/mL]) or last available HCV RNA< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model. (NCT02292706)
Timeframe: Week 240
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 98.9 |
LDV/SOF | 100 |
LDV/SOF+RBV | 99.6 |
SOF/VEL | 99.7 |
SOF/VEL+RBV | 100 |
SOF/VEL/VOX | 99.6 |
Other SOF-Based | 100 |
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Percentage of Participants With Any Liver-Associated Events
The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model. (NCT02292706)
Timeframe: Enrollment up to 240 weeks
Intervention | percentage of participants (Number) |
---|
SOF+RBV | 18.7 |
LDV/SOF | 15.0 |
LDV/SOF+RBV | 24.8 |
SOF/VEL | 18.1 |
SOF/VEL+RBV | 37.6 |
SOF/VEL/VOX | 16.1 |
Other SOF-Based | 18.2 |
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Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240
Reinfection was defined as HCV RNA > LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study. (NCT02292706)
Timeframe: Enrollment up to 240 weeks
Intervention | Participants (Count of Participants) |
---|
SOF+RBV | 0 |
LDV/SOF | 0 |
LDV/SOF+RBV | 0 |
SOF/VEL | 1 |
SOF/VEL+RBV | 0 |
SOF/VEL/VOX | 1 |
Other SOF-Based | 0 |
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Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment. (NCT02292719)
Timeframe: Up to Week 12
Intervention | percentage of participants (Number) |
---|
Arm A (Genotype [GT]3, Noncirrhotic) | 0 |
Arm B (GT3, Noncirrhotic) | 0 |
Arm C (GT2, Noncirrhotic) | 0 |
Arm D (GT2, Noncirrhotic) | 0 |
Arm E (GT3, Cirrhotic) | 0 |
Arm F (GT3, Noncirrhotic) | 0 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02292719)
Timeframe: 12 weeks after the last actual dose of study drug
Intervention | percentage of participants (Number) |
---|
Arm A (Genotype [GT]3, Noncirrhotic) | 100 |
Arm B (GT3, Noncirrhotic) | 90.9 |
Arm C (GT2, Noncirrhotic) | 90.0 |
Arm D (GT2, Noncirrhotic) | 44.4 |
Arm E (GT3, Cirrhotic) | 100 |
Arm F (GT3, Noncirrhotic) | 100 |
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Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02292719)
Timeframe: Up to 12 weeks after the last actual dose of active study drug
Intervention | percentage of participants (Number) |
---|
Arm A (Genotype [GT]3, Noncirrhotic) | 0 |
Arm B (GT3, Noncirrhotic) | 0 |
Arm C (GT2, Noncirrhotic) | 10.0 |
Arm D (GT2, Noncirrhotic) | 55.6 |
Arm E (GT3, Cirrhotic) | 0 |
Arm F (GT3, Noncirrhotic) | 0 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02300103)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV | 5.8 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT02300103)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV | 7.2 |
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Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug. (NCT02300103)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF/VEL+RBV | 92.8 | 89.9 |
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Percentage of Participants With HCV RNA < LLOQ On-treatment
(NCT02300103)
Timeframe: Baseline to Week 24
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
SOF/VEL+RBV | 15.9 | 60.9 | 91.3 | 98.5 | 97.1 | 98.5 | 100.0 | 100.0 | 100.0 |
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HCV RNA Change From Baseline
(NCT02300103)
Timeframe: Baseline to Week 24
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
SOF/VEL+RBV | -4.45 | -5.04 | -5.18 | -5.23 | -5.23 | -5.23 | -5.23 | -5.23 | -5.23 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02300103)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV | 91.3 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02301936)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 0 |
LDV/SOF 24 Weeks | 0 |
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HCV RNA Change From Baseline
(NCT02301936)
Timeframe: Up to 24 weeks
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
LDV/SOF 12 Weeks | -4.20 | -3.86 | -3.98 | -4.47 | -4.61 |
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HCV RNA Change From Baseline
(NCT02301936)
Timeframe: Up to 24 weeks
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 |
---|
LDV/SOF 24 Weeks | -3.86 | -4.63 | -5.05 | -5.05 | -5.05 | -5.05 | -5.05 | -5.05 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02301936)
Timeframe: Weeks 1, 2, 4, 8,12, 16, 20, and 24
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
LDV/SOF 12 Weeks | 33.3 | 66.7 | 88.9 | 88.9 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02301936)
Timeframe: Weeks 1, 2, 4, 8,12, 16, 20, and 24
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
LDV/SOF 24 Weeks | 0 | 0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02301936)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 88.9 |
LDV/SOF 24 Weeks | 100.0 |
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Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < the LLOQ 4 weeks following the last dose of study drug. (NCT02301936)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 88.9 |
LDV/SOF 24 Weeks | 100.0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as~On-treatment virologic failure~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement" (NCT02301936)
Timeframe: Up to Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks | 11.1 |
LDV/SOF 24 Weeks | 0 |
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Number of Participants With Abnormal Safety Laboratory Tests (ALT and/or Total Bilirubin) That Required Discontinuing Study Drugs
This field states the number of participants who had an abnormal ALT that required discontinuing study drugs and/or abnormal Total Bilirubin that required discontinuing study drugs. (NCT02304159)
Timeframe: From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.
Intervention | Participants (Count of Participants) |
---|
Group A - 16 Weeks | 0 |
Group B - 24 Weeks | 0 |
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Number of Participants With Adverse Events
This field states the number of participants who had an adverse event (NCT02304159)
Timeframe: From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.
Intervention | Participants (Count of Participants) |
---|
Group A - 16 Weeks | 21 |
Group B - 24 Weeks | 18 |
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Number of Participants With Undetectable HCV Virus 12 Weeks After Stopping Study Drugs
Sustained Virologic Response (SVR) defined as undetectable HCV RNA 12 weeks after stopping study drugs. (NCT02304159)
Timeframe: From baseline (start of study drugs) until 12 weeks after stopping study drugs
Intervention | Participants (Count of Participants) |
---|
Group A - 16 Weeks | 19 |
Group B - 24 Weeks | 16 |
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Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities
Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. The degree of the adverse event or laboratory abnormality are evaluated by grades: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Grading as per using National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0 criteria. (NCT02319031)
Timeframe: Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group)
Intervention | participants (Number) |
---|
| Death | SAEs | Discontinuation due to AEs | Grade 3/4 AEs | Grade 3/4 Laboratory Abnormalities |
---|
Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks) | 1 | 2 | 0 | 2 | 1 |
,Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks) | 0 | 3 | 0 | 2 | 2 |
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Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)
SVR4, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 4. SVR24, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 24. SVR4 imputation was based on Next Value Carried Backwards (NVCB) approach. SVR24 imputation was based on missing being treated as non-responder. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up. (NCT02319031)
Timeframe: Follow-up Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| Follow-up Week 4 (SVR4) | Follow-up Week 24 (SVR24) |
---|
Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks) | 87.5 | 87.5 |
,Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks) | 96.2 | 92.3 |
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Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)
SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up. (NCT02319031)
Timeframe: Follow-up Week 12
Intervention | percentage of participants (Number) |
---|
Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks) | 87.5 |
Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks) | 92.3 |
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Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (<15IU/mL). (NCT02339038)
Timeframe: At least 12 weeks after completion of medication
Intervention | Participants (Count of Participants) |
---|
Standard of Care | 516 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02346721)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 0.9 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02346721)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 97.3 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02346721)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 0.9 |
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Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02346721)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF/VEL 12 Weeks | 98.2 | 97.3 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment
(NCT02346721)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 |
---|
SOF/VEL 12 Weeks | 18.0 | 55.0 | 94.6 | 99.1 | 100.0 | 100.0 | 100.0 |
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HCV RNA Change From Baseline
(NCT02346721)
Timeframe: Baseline to Week 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 10 | Change at Week 12 |
---|
SOF/VEL 12 Weeks | -4.23 | -4.79 | -5.10 | -5.11 | -5.11 | -5.11 | -5.11 |
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Gene Expression Profiles
Gene expression profiles in PBMC will be determined using RNA Seq (NCT02347345)
Timeframe: 24 weeks
Intervention | RNA seq different from active IDU (Number) |
---|
| baseline |
---|
Healthy Volunteers | 12 |
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sCD14 (ng/mL)
Marker of immune activation as measured by levels of soluble CD14. Note that the levels of sCD14 were only measured at baseline in the Healthy Volunteers group and therefore there are no data for weeks 4, 12, or 24 entered. (NCT02347345)
Timeframe: 24 weeks
Intervention | ng/mL (Mean) |
---|
| baseline | week 4 | week 12 | week 24 |
---|
Active Injection Drug Use (IDU) | 1986 | 2060 | 2036 | 1973 |
,Former Injection Drug Use (Former IDU) | 1918 | 1805 | 1782 | 1819 |
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Virologic Response to Therapy as Measured by HCV RNA
HCV RNA levels in plasma (IU/mL) (NCT02347345)
Timeframe: 24 weeks
Intervention | HCV RNA copies/mL plasma (Mean) |
---|
| baseline | week 12 | week 24 |
---|
Active Injection Drug Use (IDU) | 7781148 | 0 | 0 |
,Former Injection Drug Use (Former IDU) | 2320026 | 0 | 0 |
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Gene Expression Profiles
Gene expression profiles in PBMC will be determined using RNA Seq (NCT02347345)
Timeframe: 24 weeks
Intervention | RNA seq different from active IDU (Number) |
---|
| baseline | 4 weeks | 12 weeks | 24 weeks |
---|
Active Injection Drug Use (IDU) | 9 | 9 | 9 | 9 |
,Former Injection Drug Use (Former IDU) | 11 | 11 | 11 | 11 |
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sCD14 (ng/mL)
Marker of immune activation as measured by levels of soluble CD14. Note that the levels of sCD14 were only measured at baseline in the Healthy Volunteers group and therefore there are no data for weeks 4, 12, or 24 entered. (NCT02347345)
Timeframe: 24 weeks
Intervention | ng/mL (Mean) |
---|
| baseline |
---|
Healthy Volunteers | 1542 |
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Percentage of Participants With On-treatment Virologic Response
"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point: NCT02349048)
Timeframe: Day 2, Day 3, Week 1, 2, 3, 4, 6 (for Arm A) and 8 (for Arm B only)
Intervention | Percentage of Participants (Number) |
---|
| Day 2 : >= 15 IU/mL (n = 56, 9) | Day 2 : < 100 IU/mL (n = 56, 9) | Day 2 : < 15 IU/mL undetect/detectable (n = 56, 9) | Day 2 : < 15 IU/mL detectable (n = 56, 9) | Day 2: < 15 IU/mL undetectable (n = 56, 9) | Day 3 : >= 15 IU/mL (n = 58, 9) | Day 3 : < 100 IU/mL (n = 58, 9) | Day 3 : < 15 IU/mL undetect/detectable (n = 58, 9) | Day 3 : < 15 IU/mL detectable (n = 58, 9) | Day 3 : < 15 IU/mL undetectable (n = 58, 9) | Week 1: >= 15 IU/mL (n = 58, 9) | Week 1: < 100 IU/mL (n = 58, 9) | Week 1: < 15 IU/mL undetect/detectable (n = 58, 9) | Week 1 : < 15 IU/mL detectable (n = 58, 9) | Week 1 : < 15 IU/mL undetectable (n = 58, 9) | Week 2 : >= 15 IU/mL (n = 56, 9) | Week 2: < 100 IU/mL (n = 56, 9) | Week 2: < 15 IU/mL undetect/detectable (n = 56, 9) | Week 2 : < 15 IU/mL detectable (n = 56, 9) | Week 2: < 15 IU/mL undetectable (vRVR) (n = 56, 9) | Week 3: >= 15 IU/mL (n = 56, 9) | Week 3: < 100 IU/mL (n = 56, 9) | Week 3: < 15 IU/mL undetect/detectable (n = 56, 9) | Week 3 : < 15 IU/mL detectable (n = 56, 9) | Week 3 : < 15 IU/mL undetectable (n = 56, 9) | Week 4 : >= 15 IU/mL (n = 58, 9) | Week 4: < 100 IU/mL (n = 58, 9) | Week 4: < 15 IU/mL undetect/detectable (n = 58, 9) | Week 4 : < 15 IU/mL detectable ( n = 58, 9) | Week 4 : < 15 IU/mL undetectable (RVR) (n = 58, 9) | Week 6 : >= 15 IU/mL (n = 58, 9) | Week 6: < 100 IU/mL ( n = 58, 9) | Week 6: < 15 IU/mL undetect/detectable (n = 58, 9) | Week 6 : < 15 IU/mL detectable (n = 58, 9) | Week 6 : < 15 IU/mL undetectable (n= 58, 9) | Week 8 : >= 15 IU/ml (n = 0, 9) | Week 8: < 100 IU/mL (n = 0, 9) | Week 8: < 15 IU/mL undetect/detectable (n = 0, 9) | Week 8: < 15 IU/mL detectable (n = 0, 9) | Week 8: < 15 IU/mL undetectable (n = 0, 9) |
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Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 96.4 | 7.1 | 3.6 | 3.6 | 0 | 94.8 | 19.0 | 5.2 | 5.2 | 0 | 58.6 | 75.9 | 41.4 | 36.2 | 5.2 | 19.6 | 94.6 | 80.4 | 41.1 | 39.3 | 7.1 | 100 | 92.9 | 21.4 | 71.4 | 3.4 | 98.3 | 96.6 | 8.6 | 87.9 | 0 | 100 | 100 | 6.9 | 93.1 | NA | NA | NA | NA | NA |
,Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 100 | 0 | 0 | 0 | 0 | 100 | 11.1 | 0 | 0 | 0 | 66.7 | 33.3 | 33.3 | 33.3 | 0 | 66.7 | 77.8 | 33.3 | 0 | 33.3 | 33.3 | 100 | 66.7 | 22.2 | 44.4 | 11.1 | 100 | 88.9 | 33.3 | 55.6 | 0 | 100 | 100 | 0 | 100 | 0 | 100 | 100 | 0 | 100 |
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Percentage of Participants With On-Treatment Failure
Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. Includes participants with: 1) viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA 2) confirmed detectable HCV RNA at the actual end of treatment (example, completed treatment, discontinued due to adverse events, withdrawal of consent) of >100 IU/mL in participants whose HCV RNA had previously been NCT02349048)
Timeframe: Baseline up to End of Treatment (Week 6 for Arm A and Week 8 for Arm B)
Intervention | Percentage of Participants (Number) |
---|
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 1.7 |
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 0 |
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Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment
Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was NCT02349048)
Timeframe: 4 weeks after end of study drug treatment (week 10 for Arm A and 12 for Arm B); 24 weeks after end of study drug treatment (week 30 for Arm A and 32 for Arm B)
Intervention | Percentage of Participants (Number) |
---|
| SVR4 | SVR24 |
---|
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 93.2 | 84.7 |
,Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 100 | 100 |
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Number of Participants With Late Viral Relapse
Late Viral Relapse: Participant who achieved SVR12 and the post treatment HCV RNA measurement fulfilled 1 the following conditions: a) at least 2 consecutive measurements not lesser than (<)15 IU/mL undetectable, of which at least the second measurement was >=15 IU/mL quantifiable or b) the last available measurement was >=15 IU/mL quantifiable. (NCT02349048)
Timeframe: From Week 18 to Week 30 (for Arm A), From Week 20 to Week 32 (for Arm B)
Intervention | Participants (Number) |
---|
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 1 |
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 0 |
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Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR
The Q80K polymorphism, associated with low level SMV in vitro resistance. Percentage of participants who achieved SVR with or without an NS3 Q80K polymorphism at baseline were reported. (NCT02349048)
Timeframe: up to Week 30 for Arm A and Week 32 for Arm B
Intervention | Percentage of Participants (Number) |
---|
| With NS3 Q80K polymorphism at baseline (n=25,9) | Without NS3 Q80K polymorphism at baseline (n=23,9) |
---|
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 88.0 | 78.3 |
,Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 100 | 100 |
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Number of Participants With Viral Relapse
Viral Relapse: Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during followup. (NCT02349048)
Timeframe: From Week 6 to Week 18 (for Arm A) and From Week 8 to Week 20 (for Arm B)
Intervention | Participants (Number) |
---|
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 7 |
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12)
Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment. (NCT02349048)
Timeframe: 12 weeks after end of study drug treatment (week 18 for Arm A and week 20 for Arm B)
Intervention | Percentage of Participants (Number) |
---|
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 86.4 |
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 100 |
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Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR
Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify preexisting sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. (NCT02349048)
Timeframe: Up to Week 30 for Arm A and up to Week 32 for Arm B
Intervention | Participants (Number) |
---|
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 8 |
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~End of treatment virologic failure:~Completed 28 days LDV/SOF treatment and had HCV RNA ≥ LLOQ at last measurement on treatment~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment HCV RNA measurement." (NCT02350569)
Timeframe: Up to Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
Main Study (LDV/SOF 4 Weeks) | 6.3 |
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Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event
(NCT02350569)
Timeframe: Up to 4 weeks
Intervention | percentage of participants (Number) |
---|
Main Study (LDV/SOF 4 Weeks) | 0 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28
(NCT02350569)
Timeframe: Days 1, 3, 5, 7, 14, 21, and 28
Intervention | percentage of participants (Number) |
---|
| Day 1 | Day 3 | Day 5 | Day 7 | Day 14 | Day 21 | Day 28 |
---|
Main Study (LDV/SOF 4 Weeks) | 0 | 12.5 | 18.8 | 33.3 | 93.3 | 100.0 | 100.0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02350569)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
Main Study (LDV/SOF 4 Weeks) | 87.5 |
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Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02350569)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
Main Study (LDV/SOF 4 Weeks) | 87.5 |
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Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
SVR12 was defined as plasma HCV RNA level NCT02356562)
Timeframe: 12 weeks after the last dose of active drug
Intervention | percentage of participants (Number) |
---|
Part 2, 3-DAA With RBV | 85.7 |
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Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02356562)
Timeframe: 12 weeks after the last dose of active drug
Intervention | percentage of participants (Number) |
---|
Part 1, 3-DAA With SOF With or Without RBV | 95.5 |
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Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. (NCT02356562)
Timeframe: Up to week 24
Intervention | percentage of participants (Number) |
---|
Part 1, 3-DAA With SOF With or Without RBV | 0.0 |
Part 2, 3-DAA With RBV | 14.3 |
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Percentage of Participants With Post-Treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. (NCT02356562)
Timeframe: Within 12 weeks after the last actual dose of active study drug
Intervention | percentage of participants (Number) |
---|
Part 1, 3-DAA With SOF With or Without RBV | 4.8 |
Part 2, 3-DAA With RBV | 0.0 |
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Percentage of Participants Discontinuing Study Treatment Due to an AE
"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.~The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial." (NCT02358044)
Timeframe: Up to Week 12
Intervention | percentage of participants (Number) |
---|
Grazoprevir + Elbasvir | 0.8 |
SOF + PR | 0.8 |
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Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm. (NCT02358044)
Timeframe: Treatment + First 14 days of follow-up (Up to Week 14)
Intervention | percentage of participants (Number) |
---|
Grazoprevir + Elbasvir | 51.9 |
SOF + PR | 93.7 |
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Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days
Tier 1 safety events were pre-specified by the protocol to evaluate safety and test the safety superiority hypothesis. Tier 1 safety events were chosen to assess broad tolerability, hematological side effects and liver-related laboratory abnormalities. For this study, Tier 1 safety events included: any serious drug-related AE, any drug-related AE leading to permanent discontinuation (DC) of all study drugs, neutrophil count <0.75 x 10^9/L, hemoglobin <10 g/dL, severe depression, hepatic events of clinical interest (defined by abnormal increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]), or events meeting stopping rule criteria for DC from trial (due to abnormal increases of ALT, AST, or ALP with/without pre-specified related AEs). The percentage of participants who experienced each individual event that was defined as a Tier 1 safety event during the study treatment period was reported for each treatment arm. (NCT02358044)
Timeframe: Treatment + First 14 days of follow-up (Up to Week 14)
Intervention | percentage of participants (Number) |
---|
| Total Tier 1 AEs | Tier 1 AE: Serious drug-related AE | Tier 1 AE: DC due to drug-related AE | Tier 1 AE: Neutrophil count <0.75 x 10^9/L | Tier 1 AE: Hemoglobin <10 g/dL | Tier 1 AE: Severe depression | Tier 1 AE: Hepatic event of clinical interest | Tier 1 AE: Trial DC due to stopping rule |
---|
Grazoprevir + Elbasvir | 0.8 | 0.0 | 0.0 | 0.0 | 0.8 | 0.0 | 0.0 | 0.0 |
,SOF + PR | 27.8 | 2.4 | 0.8 | 12.7 | 14.3 | 0.0 | 0.0 | 0.0 |
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Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12)
Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (NCT02358044)
Timeframe: 12 weeks after end of all therapy (Study Week 24)
Intervention | percentage of participants (Number) |
---|
Grazoprevir + Elbasvir | 99.2 |
SOF + PR | 90.5 |
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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)
HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR24 was defined as HCV RNA NCT02358044)
Timeframe: 24 weeks after end of all therapy (Study Week 36)
Intervention | percentage of participants (Number) |
---|
Grazoprevir + Elbasvir | 98.4 |
SOF + PR | 89.7 |
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Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4)
HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR4 was defined as HCV RNA NCT02358044)
Timeframe: 4 weeks after end of all therapy (Study Week 16)
Intervention | percentage of participants (Number) |
---|
Grazoprevir + Elbasvir | 99.2 |
SOF + PR | 92.1 |
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HCV RNA Change From Baseline
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 |
---|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | -4.15 | -4.57 | -4.81 | -4.84 | -4.85 |
,VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | -4.60 | -4.98 | -5.06 | -5.08 | -5.08 |
,VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | -4.31 | -4.85 | -5.17 | -5.16 | -5.16 |
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HCV RNA Change From Baseline
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 |
---|
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | -4.64 | -5.00 | -5.07 | -5.07 |
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Percentage of Participants With Virologic Failure
"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02378935)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 29.4 |
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | 0 |
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 6.1 |
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | 19.4 |
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | 0 |
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | 0 |
VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | 0 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. (NCT02378935)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 70.6 |
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | 100.0 |
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 93.9 |
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | 80.6 |
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | 100 |
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | 100.0 |
VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 |
---|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | 12.5 | 75.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | 28.1 | 62.5 | 96.9 | 100.0 | 100.0 | 100.0 | 100.0 |
,VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | 22.6 | 58.1 | 93.5 | 100.0 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 |
---|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 33.3 | 63.6 | 90.9 | 97.0 | 100.0 |
,VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | 38.9 | 75.0 | 94.4 | 100.0 | 100.0 |
,VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | 16.1 | 54.8 | 96.8 | 100.0 | 100.0 |
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Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02378935)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | 100.0 | 100.0 |
,VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | 100.0 | 100.0 |
,VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | 100.0 | 100.0 |
,VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 88.2 | 70.6 |
,VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 93.9 | 93.9 |
,VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | 100.0 | 100.0 |
,VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | 87.1 | 80.6 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 |
---|
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 23.5 | 79.4 | 100.0 | 100.0 |
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HCV RNA Change From Baseline
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 10 | Change at Week 12 |
---|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | -4.19 | -4.66 | -4.84 | -4.84 | -4.84 | -4.84 | -4.84 |
,VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | -4.40 | -4.97 | -5.22 | -5.24 | -5.24 | -5.24 | -5.24 |
,VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | -4.71 | -5.27 | -5.35 | -5.35 | -5.35 | -5.35 | -5.35 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02378935)
Timeframe: Up to 12 Weeks
Intervention | percentage of participants (Number) |
---|
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 0 |
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | 0 |
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 0 |
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | 6.5 |
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | 0 |
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | 0 |
VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | 0 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. (NCT02378961)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 87.9 |
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 93.3 |
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | 100.0 |
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 96.6 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02378961)
Timeframe: Up to 12 Weeks
Intervention | percentage of participants (Number) |
---|
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 0 |
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 6.7 |
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | 0 |
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 3.4 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 |
---|
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 33.3 | 81.8 | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 |
---|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 20.0 | 73.3 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 |
---|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 10. | 58.6 | 89.7 | 96.6 | 100.0 | 100.0 | 100.0 |
,VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | 33.3 | 72.2 | 88.9 | 97.2 | 100.0 | 100.0 | 100.0 |
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HCV RNA Change From Baseline
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 |
---|
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | -4.51 | -4.91 | -5.01 | -5.01 |
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HCV RNA Change From Baseline
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 |
---|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | -4.28 | -4.84 | -4.99 | -4.99 | -4.98 |
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HCV RNA Change From Baseline
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 10 | Change at Week 12 |
---|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | -4.24 | -4.96 | -5.25 | -5.29 | -5.30 | -5.30 | -5.32 |
,VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | -4.51 | -4.95 | -5.14 | -5.19 | -5.19 | -5.19 | -5.19 |
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Percentage of Participants With Virologic Failure
"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02378961)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 12.1 |
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 6.7 |
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | 0 |
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 3.4 |
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Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively. (NCT02378961)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 100.0 | 96.6 |
,VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | 100.0 | 100.0 |
,VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 90.9 | 87.9 |
,VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 96.7 | 93.3 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. (NCT02399345)
Timeframe: 12 weeks after the last actual dose of study drug
Intervention | percentage of participants (Number) |
---|
Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV | 80 |
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Percentage of Subjects With On-treatment Virologic Failure
Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment). (NCT02399345)
Timeframe: 6 weeks
Intervention | percentage of participants (Number) |
---|
Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV | 0 |
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Percentage of Subjects With Post-treatment Relapse
Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment (NCT02399345)
Timeframe: Up to 12 weeks after last actual dose of active study drug
Intervention | percentage of participants (Number) |
---|
Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV | 20 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02413593)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF+RBV | 0.9 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02413593)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF+RBV | 89.2 |
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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
(NCT02413593)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
LDV/SOF+RBV | -4.33 | -4.85 | -5.05 | -5.06 | -5.06 |
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02413593)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF+RBV | 91.9 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02413593)
Timeframe: Up to Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF+RBV | 7.2 |
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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12
(NCT02413593)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
LDV/SOF+RBV | 20.7 | 64.9 | 97.3 | 100.0 | 99.1 |
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Percentage of Participants With Viral Relapse
Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up. (NCT02421211)
Timeframe: Up to Week 12 follow-up phase after EOT
Intervention | percentage of participants (Number) |
---|
Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks]) | 0 |
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks) | 0 |
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Percentage of Participants With On-treatment Failure
On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of >100 IU/mL in participants whose HCV RNA had previously been NCT02421211)
Timeframe: Day 70 in Panel 1 and Day 56 in Panel 2
Intervention | percentage of participants (Number) |
---|
Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks]) | 0 |
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks) | 0 |
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Minimum Plasma Concentration (Cmin) of Simeprevir (SMV)
The Cmin is the minimum observed plasma concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | nanogram per Milliliters (ng/mL) (Mean) |
---|
Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 2411 |
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 6701 |
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Minimum Plasma Concentration (Cmin) of Ledipasvir (LDV)
The Cmin is the minimum observed plasma concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | ng/mL (Mean) |
---|
Panel 2: LDV 90mg/SOF 400mg (Day 14) | 319 |
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 557 |
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. (NCT02421211)
Timeframe: Up to 10 Weeks for Panel 1 and 8 Weeks for Panel 2
Intervention | number of participants (Number) |
---|
| Adverse events | Serious adverse events |
---|
Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks]) | 17 | 2 |
,Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks) | 15 | 0 |
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Maximum Plasma Concentration (Cmax) of Simeprevir
The Cmax is the maximum observed plasma concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | ng/mL (Mean) |
---|
Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 6767 |
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 13691 |
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Maximum Plasma Concentration (Cmax) of Ledipasvir
The Cmax is the maximum observed plasma concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | ng/mL (Mean) |
---|
Panel 2: LDV 90mg/SOF 400mg (Day 14) | 556 |
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 930 |
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Fluctuation Index (FI) of Simeprevir
Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg). (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | percentage fluctuation (Mean) |
---|
Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 144 |
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 84.4 |
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Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Ledipasvir
AUCtau is defined as area under the analyte concentration versus time curve during dosing interval tau, calculated by linear-linear trapezoidal summation. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | ng*h/mL (Mean) |
---|
Panel 2: LDV 90mg/SOF 400mg (Day 14) | 9868 |
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 17435 |
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Percentage of Participants With On-treatment Virologic Response
"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point: less than (<) lower limit of quantification (LLOQ) undetectable, NCT02421211)
Timeframe: Week 1, up to EOT (Week 10 in Panel 1 and Week 8 in Panel 2)
Intervention | percentage of participants (Number) |
---|
| Week 1: >= 15 IU/mL | Week 1: < 15 IU/mL undetectable/detectable | Week 1: < 15 IU/mL detectable | Week 1: < 15 IU/mL undetectable | Week 2: >= 15 IU/mL | Week 2: < 15 IU/mL undetectable/detectable | Week 2: < 15 IU/mL detectable | Week 2: < 15 IU/mL undetectable (vRVR) | Week 4: >= 15 IU/mL | Week 4: < 15 IU/mL undetectable/detectable | Week 4: < 15 IU/mL detectable | Week 4: < 15 IU/mL undetectable (RVR) | Week 6: >= 15 IU/mL | Week 6: < 15 IU/mL undetectable/detectable | Week 6: < 15 IU/mL detectable | Week 6: < 15 IU/mL undetectable | Week 8: >= 15 IU/mL | Week 8: < 15 IU/mL undetectable/detectable | Week 8: < 15 IU/mL detectable | Week 8: < 15 IU/mL undetectable | Week 10: >= 15 IU/mL | Week 10: < 15 IU/mL undetectable/detectable | Week 10: < 15 IU/mL detectable | Week 10: < 15 IU/mL undetectable |
---|
Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks]) | 65.0 | 35.0 | 15.0 | 20.0 | 25.0 | 75.0 | 30.0 | 45.0 | 0 | 100.0 | 15.0 | 85.0 | 0 | 100.0 | 0 | 100.0 | 0 | 100.0 | 0 | 100.0 | 0 | 100.0 | 0 | 100.0 |
,Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks) | 60.0 | 40.0 | 35.0 | 5.0 | 35.0 | 65.0 | 30.0 | 35.0 | 5.0 | 95.0 | 5.0 | 90.0 | 0 | 100.0 | 5.0 | 95.0 | 0 | 100.0 | 0 | 100.0 | NA | NA | NA | NA |
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Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks After the Actual EOT (SVR4) and 12 Weeks After the Actual EOT (SVR12)
SVR4 or SVR12 is defined as sustained virologic response 4 or 12 weeks after the actual EOT the participant has HCV RNA NCT02421211)
Timeframe: 4 weeks after EOT (Week 4 of follow-up phase in Panel 1 and Panel 2) and 12 weeks after EOT (Week 12 of follow-up phase in Panel 1 and Panel 2)
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR12 |
---|
Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks]) | 100 | 100 |
,Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks) | 100 | 100 |
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Fluctuation Index (FI) of Ledipasvir
Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg). (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | percentage fluctuation (Mean) |
---|
Panel 2: LDV 90mg/SOF 400mg (Day 14) | 60.6 |
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 51.2 |
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Average Plasma Concentration at Steady State (Cavg,ss) of Simeprevir
The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau). (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | ng/mL (Mean) |
---|
Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 4196 |
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 10139 |
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Average Plasma Concentration at Steady State (Cavg,ss) of Ledipasvir
The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau). (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | ng/mL (Mean) |
---|
Panel 2: LDV 90mg/SOF 400mg (Day 14) | 411 |
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 725 |
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Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Simeprevir
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | nanogram hour per Milliliters (ng*h/mL) (Mean) |
---|
Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 100492 |
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 243564 |
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Trough Plasma Concentration (Ctrough) of Simeprevir
The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen. (NCT02421211)
Timeframe: Pre-dose on Day 14 and Day 28
Intervention | nanogram per Milliliters (ng/mL) (Mean) |
---|
Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 3059 |
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 8453 |
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Trough Plasma Concentration (Ctrough) of Ledipasvir
The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen. (NCT02421211)
Timeframe: Pre-dose on Day 14 and Day 28
Intervention | ng/mL (Mean) |
---|
Panel 2: LDV 90mg/SOF 400mg (Day 14) | 376 |
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 659 |
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Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | hour (H) (Median) |
---|
Panel 1: SMV 150 mg + SOF 400 mg (Day 14) | 6.00 |
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 6.00 |
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Time to Reach Maximum Plasma Concentration (Tmax) of Ledipasvir
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28
Intervention | Hour (Median) |
---|
Panel 2: LDV 90mg/SOF 400mg (Day 14) | 4.07 |
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28) | 6.00 |
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Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: 12 Weeks
Liver function as assessed via MELD score. The Model For End-Stage Liver Disease (MELD) score assesses the severity of patient liver disease. Possible scores range from 6 to 40, with higher scores indicating more severe liver disease and a worse outcome. (NCT02455167)
Timeframe: 12 Weeks
Intervention | score on a scale (Mean) |
---|
HCV Positive Group | 7.25 |
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Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: Baseline
Liver function as assessed via MELD score. The Model For End-Stage Liver Disease (MELD) score assesses the severity of patient liver disease. Possible scores range from 6 to 40, with higher scores indicating more severe liver disease and a worse outcome. (NCT02455167)
Timeframe: Baseline
Intervention | score on a scale (Mean) |
---|
HCV Positive Group | 8 |
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The Sustained Virologic Response (SVR) in Patients Infected With HCV Genotype 1, Cirrhosis, and Early Clinical Decompensation
"Number of participants who cleared Hepatitis C (HCV) after 12 weeks was collected (HCV RNA level was Not Detected." (NCT02455167)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
HCV Positive Group | 4 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),~HCV RNA persistently ≥ LLOQ through end of treatment (ie, nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement" (NCT02457611)
Timeframe: Up to Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 15.4 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02457611)
Timeframe: Weeks 2, 4, and 6
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 6 |
---|
LDV/SOF | 73.1 | 88.5 | 96.2 |
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Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
(NCT02457611)
Timeframe: Weeks 2, 4, 6, and Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 6 | Posttreatment Week 4 |
---|
LDV/SOF | 100.0 | 100.0 | 95.2 | 100.0 |
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Change From Baseline in HCV RNA at Weeks 2, 4, and 6
(NCT02457611)
Timeframe: Baseline; Weeks 2, 4, and 6
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 6 |
---|
LDV/SOF | -4.01 | -4.16 | -4.17 |
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Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)
SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug. (NCT02457611)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 84.6 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02457611)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 76.9 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02457611)
Timeframe: Up to 6 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 0 |
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Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.
Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates. (NCT02457611)
Timeframe: Day 1; Week 6
Intervention | Participants (Count of Participants) |
---|
LDV/SOF | 0 |
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Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4
(NCT02457611)
Timeframe: Baseline; Week 6; Posttreatment Week 4
Intervention | percent change (Mean) |
---|
| Change at Week 6 | Change at Posttreatment Week 4 |
---|
LDV/SOF | -0.3 | 0.4 |
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Number of Participants Who Sustained Virologic Response
Absence of detectable virus 24 weeks after completion of antiviral therapy (NCT02468648)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
Combination of Sofosbuvir and GS-5816 | 70 |
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Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)
(NCT02468648)
Timeframe: 4 weeks
Intervention | Participants (Count of Participants) |
---|
Combination of Sofosbuvir and GS-5816 | 55 |
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Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)
(NCT02468648)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
Combination of Sofosbuvir and GS-5816 | 70 |
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Number of Participants With Sustained Virologic Response
Absence of detectable virus 12 weeks after completion of antiviral therapy (NCT02468648)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
Combination of Sofosbuvir and GS-5816 | 70 |
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Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)
(NCT02472886)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 Weeks (TN, HCV-monoinfected) | 0 |
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | 0 |
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | 0 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02472886)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | 3.7 | 59.3 | 88.9 | 100.0 | 100.0 |
,LDV/SOF 8 Weeks (TN, HCV-monoinfected) | 20.9 | 65.7 | 100.0 | 100.0 | NA |
,LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | 39.0 | 69.5 | 96.6 | 98.3 | NA |
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Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
(NCT02472886)
Timeframe: Up to Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Posttreatment Week 4 |
---|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | 100.0 | 100.0 | 97.2 |
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Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02472886)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | 96.3 | 96.3 |
,LDV/SOF 8 Weeks (TN, HCV-monoinfected) | 100.0 | 100.0 |
,LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | 96.6 | 96.6 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02472886)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 Weeks (TN, HCV-monoinfected) | 100.0 |
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | 96.6 |
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | 96.3 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement" (NCT02472886)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 Weeks (TN, HCV-monoinfected) | 0 |
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | 3.4 |
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | 3.7 |
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For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4
(NCT02472886)
Timeframe: Up to Posttreatment Week 4
Intervention | cells/µL (Mean) |
---|
| Change at Week 4 | Change at Week 8 | Change at Posttreatment Week 4 |
---|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV Experienced) | 159 | 202 | 172 |
,LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV- Naive) | 47 | 45 | 74 |
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HCV RNA Change From Day 1
(NCT02472886)
Timeframe: Up to 12 weeks
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | -4.12 | -4.83 | -5.08 | -5.11 | -5.11 |
,LDV/SOF 8 Weeks (TN, HCV-monoinfected) | -3.97 | -4.50 | -4.74 | -4.74 | NA |
,LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | -4.34 | -4.76 | -4.89 | -4.91 | NA |
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Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02480712)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF/VEL 12 Weeks | 95.3 | 95.3 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02480712)
Timeframe: Up to 12 Weeks
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 |
---|
SOF/VEL 12 Weeks | 25.7 | 68.0 | 92.2 | 99.0 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment
(NCT02480712)
Timeframe: Up to 12 Weeks
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 |
---|
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens) | 94.4 | 96.3 | 96.2 |
,SOF/VEL 12 Weeks (Non TDF Containing Regimens) | 100 | 100 | 92.9 |
,SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens) | 97.1 | 97.1 | 100 |
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HCV RNA Change From Baseline/Day 1
(NCT02480712)
Timeframe: Baseline to Week 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 10 | Change at Week 12 |
---|
SOF/VEL 12 Weeks | -4.47 | -4.97 | -5.15 | -5.18 | -5.17 | -5.17 | -5.17 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT02480712)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 1.9 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02480712)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 95.3 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02480712)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 1.9 |
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Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12
(NCT02480712)
Timeframe: Week 12; Posttreatment Week 12
Intervention | mg/dL (Mean) |
---|
| Change at Week 12 | Change at Posttreatment Week 12 |
---|
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens) | 0.09 | 0.04 |
,SOF/VEL 12 Weeks (Non TDF Containing Regimens) | 0.00 | -0.06 |
,SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens) | 0.04 | 0.02 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02487030)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 wk TN (Cohort 1, Group 1) | 95.3 |
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2) | 90.5 |
LDV/SOF 12 wk TN (Cohort 1, Group 3) | 97.7 |
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) | 97.6 |
LDV/SOF 12 wk TE (Cohort 3, Group 1) | 94.4 |
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) | 100.0 |
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2) | 100.0 |
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Percentage of Participants With Overall Virologic Failure
"Virologic failure was defined as~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),~HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement" (NCT02487030)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 wk TN (Cohort 1, Group 1) | 4.7 |
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2) | 9.5 |
LDV/SOF 12 wk TN (Cohort 1, Group 3) | 2.3 |
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) | 0.0 |
LDV/SOF 12 wk TE (Cohort 3, Group 1) | 2.8 |
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) | 0.0 |
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2) | 0.0 |
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Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)
(NCT02487030)
Timeframe: 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 8 Weeks | 0 |
LDV/SOF + RBV 8 Weeks | 0 |
LDV/SOF 12 Weeks | 0 |
LDV/SOF + RBV 12 Weeks | 1.1 |
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Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively. (NCT02487030)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2) | 100.0 | 100.0 |
,LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) | 100.0 | 100.0 |
,LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) | 97.6 | 97.6 |
,LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2) | 95.2 | 90.5 |
,LDV/SOF 12 wk TE (Cohort 3, Group 1) | 100.0 | 94.4 |
,LDV/SOF 12 wk TN (Cohort 1, Group 3) | 97.7 | 97.7 |
,LDV/SOF 8 wk TN (Cohort 1, Group 1) | 95.3 | 95.3 |
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The Percent Change in Proteinuria
% change in proteinuria from baseline (timepoint week 0) through timepoint week 24, which was 12 weeks after completion of Harvoni. (NCT02503735)
Timeframe: Baseline and 24 weeks (12 weeks after completion of Harvoni)
Intervention | percentage change from baseline (Median) |
---|
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg) | -14 |
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Change in Urinary β-2microglobulin Levels After Therapy
"Change in urinary β-2microglobulin levels after therapy with ledipasvir/sofosbuvir fixed dose combination pill~β-2microglobulin (mcg/L) levels were assessed at baseline (timepoint week 0) and at timepoint week 24. Change was recorded for each patient, and presented as a median with IQR." (NCT02503735)
Timeframe: 24 weeks
Intervention | mcg/L (Median) |
---|
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg) | 57 |
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Number of Participants With ≥25% Reduction in Proteinuria
Number of participants with at least -25% change in proteinuria, calculated from baseline (timepoint week 0) to timepoint week 24, which is 12 weeks after completion of Harvoni. (NCT02503735)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg) | 3 |
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Mean Time in Weeks to Maximum Reduction in Proteinuria
This outcome evaluated all post-baseline proteinuria values through the 52 week followup, and determined which demonstrated the greatest negative change (reduction) from baseline. We then calculate the mean time to maximum reduction of proteinuria. (NCT02503735)
Timeframe: 52 weeks
Intervention | weeks (Mean) |
---|
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg) | 39.4 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT02536313)
Timeframe: Weeks 1, 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL/VOX | 54.2 | 79.2 | 100 | 100.0 | 100.0 |
,SOF/VEL/VOX + RBV | 40 | 60.0 | 92.0 | 100.0 | 100.0 |
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HCV RNA Change From Baseline/Day 1 Through Week 12
(NCT02536313)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
SOF/VEL/VOX | -4.63 | -4.97 | -5.10 | -5.10 | -5.10 |
,SOF/VEL/VOX + RBV | -4.53 | -4.95 | -5.14 | -5.18 | -5.18 |
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Percentage of Participants With Virologic Failure
"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02536313)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX | 0 |
SOF/VEL/VOX + RBV | 4.0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02536313)
Timeframe: Posttreatment Week 12
Intervention | percentage of particpants (Number) |
---|
SOF/VEL/VOX | 100.0 |
SOF/VEL/VOX + RBV | 96.0 |
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Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event
(NCT02536313)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX | 0 |
SOF/VEL/VOX + RBV | 0 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02536313)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF/VEL/VOX | 100.0 | 100.0 |
,SOF/VEL/VOX + RBV | 96.0 | 96.0 |
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HCV Treatment Completion
The percentage of subjects that complete their course of treatment (NCT02541409)
Timeframe: 12 weeks from baseline for SOF+PEG+RBV and 24 weeks from baselne for SOF+RBV
Intervention | Participants (Count of Participants) |
---|
SOF+PEG+RBV | 22 |
SOF+RBV | 22 |
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Sustained Virologic Response (SVR)
The percentage of participants who achieve SVR as assessed by undetectable HCV RNA measured 12 weeks after treatment completion (NCT02541409)
Timeframe: 24 weeks from baseline for SOF+PEG+RBV and 36 weeks from baseline for SOF+RBV
Intervention | Participants (Count of Participants) |
---|
SOF+PEG+RBV | 22 |
SOF+RBV | 15 |
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Serious Adverse Events
Number of participants with treatment-related serious adverse events by laboratory tests and physician examination (NCT02541409)
Timeframe: 24 weeks from baseline SOF+PEG+RBV and 36 weeks from baseline for SOF+RBV
Intervention | Participants (Count of Participants) |
---|
SOF+PEG+RBV | 0 |
SOF+RBV | 0 |
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Change in Insulin Resistance
Change in insulin resistance while on treatment by the homeostasis model assessment - insulin resistance (HOMA-IR). HOMA-IR is calculated according to the formula (fasting insulin (microU/L)+fasting glucose (nmol/L)/22.5. Fasting insulin and glucose measurements are obtained using whole blood. (NCT02541409)
Timeframe: Difference from entry to 24 weeks for SOF+PEG+RBV and difference from entry to 36 weeks for SOF+RBV
Intervention | HOMA-IR (Median) |
---|
SOF+PEG+RBV | 1.2 |
SOF+RBV | 0.2 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02600351)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks, Without Cirrhosis | 81.3 |
LDV/SOF + RBV 12 Weeks, Without Cirrhosis | 100.0 |
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis | 80.0 |
LDV/SOF 24 Weeks, With Compensated Cirrhosis | 91.7 |
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Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment. (NCT02600351)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks, Without Cirrhosis | 0 |
LDV/SOF + RBV 12 Weeks, Without Cirrhosis | 0 |
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis | 0 |
LDV/SOF 24 Weeks, With Compensated Cirrhosis | 0 |
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Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02600351)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis | 88.0 | 80.0 |
,LDV/SOF + RBV 12 Weeks, Without Cirrhosis | 100.0 | 100.0 |
,LDV/SOF 12 Weeks, Without Cirrhosis | 93.8 | 81.3 |
,LDV/SOF 24 Weeks, With Compensated Cirrhosis | 95.8 | 91.7 |
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Percentage of Participants With Viral Relapse
Viral relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA NCT02600351)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks, Without Cirrhosis | 18.8 |
LDV/SOF + RBV 12 Weeks, Without Cirrhosis | 0 |
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis | 20.0 |
LDV/SOF 24 Weeks, With Compensated Cirrhosis | 8.3 |
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Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event
(NCT02600351)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF 12 Weeks, Without Cirrhosis | 0 |
LDV/SOF + RBV 12 Weeks, Without Cirrhosis | 0 |
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis | 0 |
LDV/SOF 24 Weeks, With Compensated Cirrhosis | 0 |
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Number of Participants With Emerging Resistance
The full-length NS3, NS5A, and NS5B coding regions were deep sequenced at pretreatment (baseline) for all participants included in the Full Analysis Set, and at posttreatment for all participants who relapsed. (NCT02600351)
Timeframe: Up to Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
LDV/SOF 12 Weeks, Without Cirrhosis | 3 |
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis | 5 |
LDV/SOF 24 Weeks, With Compensated Cirrhosis | 2 |
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Percentage of Participants Experiencing an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02601573)
Timeframe: Up to 18 weeks (up to 2 weeks after completion of study treatment)
Intervention | Percentage of Participants (Number) |
---|
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks | 87.0 |
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks | 87.5 |
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks | 82.4 |
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks | 94.4 |
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks | 94.4 |
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Percentage of Participants Discontinuing From Study Therapy Due to an AE
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02601573)
Timeframe: Up to 16 weeks
Intervention | Percentage of Participants (Number) |
---|
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks | 0.0 |
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks | 0.0 |
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks | 0.0 |
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks | 0.0 |
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks | 5.6 |
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Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy)
The percentage of participants achieving SVR12 (i.e., HCV ribnonucleic acid [RNA] < Lower Limit of Quantification [LLOQ] 12 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. (NCT02601573)
Timeframe: Up to Week 28
Intervention | Percentage of Participants (Number) |
---|
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks | 91.3 |
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks | 100.0 |
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks | 100.0 |
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks | 100.0 |
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks | 94.4 |
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Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy)
The percentage of participants achieving SVR24 (i.e., HCV RNA < LLOQ 24 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. (NCT02601573)
Timeframe: Up to Week 40
Intervention | Percentage of Participants (Number) |
---|
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks | 91.3 |
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks | 100.0 |
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks | 100.0 |
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks | 100.0 |
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks | 93.8 |
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Number of Participants With HIV-1 RNA >50 Copies/mL
HIV-1 RNA testing was performed at a central laboratory using Abbott RealTime HIV-1 assay (Abbott Laboratories, Lake Bluff, IL, USA). (NCT02605304)
Timeframe: Entry (Week 0); at 4, 12 (and 24 in Arm B) weeks after study entry, and at 4 weeks after treatment discontinuation
Intervention | Participants (Count of Participants) |
---|
| Week 0: HIV-1 RNA >50 copies/mL | Week 4: HIV-1 RNA >50 copies/mL | Week 12: HIV-1 RNA >50 copies/mL | Week 24: HIV-1 RNA >50 copies/mL | Post treatment Week 4: HIV-1 RNA >50 copies/mL |
---|
Arm B: LDV/SOF | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Unquantifiable HCV RNA
Unquantifiable HCV was defined as HCV RNA below the LLOQ of the assay (15 IU/mL), either TD or TND. HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). (NCT02605304)
Timeframe: Entry (Week 0); at 1, 4, 8, 12 (and 16, 20, 24 in Arm B) weeks after study entry
Intervention | Participants (Count of Participants) |
---|
| Week 0: unquantifiable HCV RNA | Week 1: unquantifiable HCV RNA | Week 4: unquantifiable HCV RNA | Week 8: unquantifiable HCV RNA | Week 12: unquantifiable HCV RNA |
---|
Arm A: LDV/SOF + RBV | 0 | 1 | 4 | 4 | 4 |
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Number of Participants With Unquantifiable HCV RNA
Unquantifiable HCV was defined as HCV RNA below the LLOQ of the assay (15 IU/mL), either TD or TND. HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). (NCT02605304)
Timeframe: Entry (Week 0); at 1, 4, 8, 12 (and 16, 20, 24 in Arm B) weeks after study entry
Intervention | Participants (Count of Participants) |
---|
| Week 0: unquantifiable HCV RNA | Week 1: unquantifiable HCV RNA | Week 4: unquantifiable HCV RNA | Week 8: unquantifiable HCV RNA | Week 12: unquantifiable HCV RNA | Week 16: unquantifiable HCV RNA | Week 20: unquantifiable HCV RNA | Week 24: unquantifiable HCV RNA |
---|
Arm B: LDV/SOF | 0 | 0 | 3 | 3 | 2 | 3 | 3 | 3 |
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Percentage of Participants With Protocol-specified Renal Events
The study protocol defined renal events as (1) ≥Grade 2 creatinine clearance (CRCL) after study entry, or (2) new urinalysis proteinuria and/or glucosuria, defined as ≥1+ or an increase ≥1+ from baseline. The percentage of participants who experienced any renal event, and the percentages of participants who experienced each component of the outcome are provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple events. Each participant is counted at most once within category, and in the overall summary line. (NCT02605304)
Timeframe: From study entry to study completion (Week 36 in Arm A, Week 48 in Arm B)
Intervention | percentage of participants (Number) |
---|
| Overall (any renal event) | CRCL ≥ Grade 2 | Proteinuria | Glucosuria |
---|
Arm A: LDV/SOF + RBV | 25.0 | 25.0 | 25.0 | 0 |
,Arm B: LDV/SOF | 33.3 | 33.3 | 0 | 0 |
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CD4+ T-cell (CD4) Count Change From Baseline
Change in CD4 count was calculated as value at the post entry visit minus the value at study entry. (NCT02605304)
Timeframe: Entry and at 12 (and 24 in Arm B) weeks after study entry
Intervention | cells/mm^3 (Median) |
---|
| Week 12: CD4 change |
---|
Arm A: LDV/SOF + RBV | -102 |
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Percentage of Participants With Sustained Virologic Response at 4 Weeks After Treatment Discontinuation (SVR4)
SVR4 was defined as HCV RNA below the LLOQ of the assay (either TD or TND) at 4 weeks after treatment discontinuation. The sample within the visit window, closest to the targeted time was used. If there was no HCV RNA sample within visit window, then the participant was considered not to have achieved SVR4, unless there were preceding and subsequent HCV RNA measurements that were both NCT02605304)
Timeframe: At 4 weeks after treatment discontinuation (i.e., at 16 weeks after study entry in Arm A and at 28 weeks after study entry in Arm B).
Intervention | percentage of participants (Number) |
---|
Arm A: LDV/SOF + RBV | 100.0 |
Arm B: LDV/SOF | 100.0 |
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Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)
SVR12 was defined as HCV RNA below the LLOQ of the assay (either target detected [TD] or target not detected [TND]) at 12 weeks after treatment discontinuation. The sample within the visit window, closest to the targeted time was used. If there was no HCV RNA sample within visit window, then the participant was considered not to have achieved SVR12, unless there were preceding and subsequent HCV RNA measurements that were both NCT02605304)
Timeframe: At 12 weeks after treatment discontinuation (i.e., at 24 weeks after study entry in Arm A and at 36 weeks after study entry in Arm B).
Intervention | percentage of participants (Number) |
---|
Arm A: LDV/SOF + RBV | 100.0 |
Arm B: LDV/SOF | 100.0 |
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CD4+ T-cell (CD4) Count Change From Baseline
Change in CD4 count was calculated as value at the post entry visit minus the value at study entry. (NCT02605304)
Timeframe: Entry and at 12 (and 24 in Arm B) weeks after study entry
Intervention | cells/mm^3 (Median) |
---|
| Week 12: CD4 change | Week 24: CD4 change |
---|
Arm B: LDV/SOF | 365 | 138 |
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Number of Participants With HIV-1 RNA >50 Copies/mL
HIV-1 RNA testing was performed at a central laboratory using Abbott RealTime HIV-1 assay (Abbott Laboratories, Lake Bluff, IL, USA). (NCT02605304)
Timeframe: Entry (Week 0); at 4, 12 (and 24 in Arm B) weeks after study entry, and at 4 weeks after treatment discontinuation
Intervention | Participants (Count of Participants) |
---|
| Week 0: HIV-1 RNA >50 copies/mL | Week 4: HIV-1 RNA >50 copies/mL | Week 12: HIV-1 RNA >50 copies/mL | Post treatment Week 4: HIV-1 RNA >50 copies/mL |
---|
Arm A: LDV/SOF + RBV | 0 | 0 | 0 | 0 |
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Percentage of Participants With Grade 3 or Higher Adverse Event (AE), Serious AE (SAE), or AE Reported as the Reason for Permanent Discontinuation of Study Treatment
Percentage of participants who experienced an AE (diagnosis, sign/symptom or laboratory abnormality) of ≥Grade 3, SAE according to International Conference on Harmonisation (ICH) criteria, or AE reported as the reason for permanent study treatment discontinuation, during study treatment and up to 30 days after study treatment. Events that were ongoing at the same grade from prior to study treatment initiation were excluded. AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (V2.0) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. The percentage of participants who experienced any event (overall), and the percentage of participants who experienced each component of the outcome are provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple events. Each participant is counted at most once within category, and in the overall summary line. (NCT02605304)
Timeframe: From study treatment initiation to 30 days after study treatment discontinuation. Duration of treatment was 12 weeks in Arm A and 24 weeks in Arm B.
Intervention | percentage of participants (Number) |
---|
| Overall (any event) | Diagnosis ≥ Grade 3 | Laboratory event ≥ Grade 3 | Sign/symptom ≥ Grade 3 | SAE | AE that led to treatment discontinuation |
---|
Arm A: LDV/SOF + RBV | 50.0 | 0 | 50.0 | 0 | 0 | 0 |
,Arm B: LDV/SOF | 0 | 0 | 0 | 0 | 0 | 0 |
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Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)
SVR24 was defined as HCV RNA below the LLOQ of the assay (either TD or TND) at 24 weeks after treatment discontinuation. The sample from a visit greater than 20 weeks after treatment discontinuation which was closest to the targeted week (24 weeks post treatment), not followed by any HCV RNA result ≥LLOQ, was used. If there was no HCV RNA sample within this window, then the participant was considered not to have achieved SVR24. HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). Wilson (score) method was used for confidence intervals. (NCT02605304)
Timeframe: At 24 weeks after treatment discontinuation (i.e., at 36 weeks after study entry in Arm A and at 48 weeks after study entry in Arm B).
Intervention | percentage of participants (Number) |
---|
Arm A: LDV/SOF + RBV | 100.0 |
Arm B: LDV/SOF | 100.0 |
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Change From Baseline in HCV RNA (Primary Study)
(NCT02607735)
Timeframe: Baseline; Weeks 1, 2, 4, 8 and 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
Placebo (Primary Study) | 0.02 | 0.02 | -0.01 | 0.05 | 0.03 |
,SOF/VEL/VOX (Primary Study) | -4.20 | -4.81 | -5.07 | -5.11 | -5.10 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02607735)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX (Primary Study) | 96.2 |
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Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
(NCT02607735)
Timeframe: Weeks 1, 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
Placebo (Primary Study) | 0 | 0 | 0 | 0 | 0 |
,SOF/VEL/VOX (Primary Study) | 15.6 | 56.7 | 92.7 | 100.0 | 99.6 |
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Change From Baseline in HCV RNA (Deferred Treatment Substudy)
(NCT02607735)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL/VOX (Deferred Treatment Substudy) | -4.30 | -4.93 | -5.16 | -5.20 | -5.20 |
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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)
(NCT02607735)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX (Primary Study) | 0.4 |
Placebo (Primary Study) | 2.0 |
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Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively. (NCT02607735)
Timeframe: Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR12 | SVR24 |
---|
SOF/VEL/VOX (Deferred Treatment Substudy) | 98.6 | 97.3 | 97.3 |
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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02607735)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX (Primary Study) | 96.2 |
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment, respectively. (NCT02607735)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX (Primary Study) | 97.7 |
Placebo (Primary Study) | 0 |
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Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)
"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA LLOQ while on treatment), or~Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit." (NCT02607735)
Timeframe: Up to Posttreatment Week 24 (Deferred Treatment Substudy)
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX (Deferred Treatment Substudy) | 2.7 |
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Percentage of Participants With Virologic Failure (Primary Study)
"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA LLOQ while on treatment), or~Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit." (NCT02607735)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX (Primary Study) | 2.7 |
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Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
(NCT02607735)
Timeframe: Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL/VOX (Deferred Treatment Substudy) | 14.3 | 62.6 | 93.2 | 100.0 | 100.0 |
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Change From Baseline in HCV RNA
(NCT02607800)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL 12 Weeks | -4.24 | -4.77 | -4.99 | -5.03 | -5.03 |
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Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
(NCT02607800)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX 8 Weeks | 0 |
SOF/VEL 12 Weeks | 0.5 |
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Percentage of Participants With HCV RNA < LLOQ On Treatment
(NCT02607800)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 |
---|
SOF/VEL/VOX 8 Weeks | 24.8 | 65.9 | 92.4 | 99.2 |
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Percentage of Participants With HCV RNA < LLOQ On Treatment
(NCT02607800)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL 12 Weeks | 22.7 | 61.3 | 92.0 | 99.8 | 99.8 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02607800)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR 24 |
---|
SOF/VEL 12 Weeks | 98.9 | 98.0 |
,SOF/VEL/VOX 8 Weeks | 96.4 | 95.0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT02607800)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX 8 Weeks | 4.2 |
SOF/VEL 12 Weeks | 0.7 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02607800)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX 8 Weeks | 95.2 |
SOF/VEL 12 Weeks | 98.2 |
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Change From Baseline in HCV RNA
(NCT02607800)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 |
---|
SOF/VEL/VOX 8 Weeks | -4.23 | -4.75 | -4.95 | -4.99 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as :~Breakthrough (confirmed HCV RNA ≥ LLOQ [15 IU/mL] after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or~Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)" (NCT02613871)
Timeframe: First dose date up to Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF FDC | 0 |
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HCV RNA Change From Baseline While on Treatment
(NCT02613871)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
LDV/SOF FDC | -4.14 | -4.63 | -4.73 | -4.73 | -4.73 |
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Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
LLOQ = 15 IU/mL (NCT02613871)
Timeframe: Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Intervention | percentage of participants (Number) |
---|
| Posttreatment Week 24 | Posttreatment Week 36 | Posttreatment Week 48 | Posttreatment Week 60 | Posttreatment Week 72 | Posttreatment Week 84 | Posttreatment Week 96 | Posttreatment Week 108 |
---|
LDV/SOF FDC | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
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Plasma HBV DNA Change From Baseline While on Treatment
(NCT02613871)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
LDV/SOF FDC | -0.06 | 0.08 | 0.37 | 0.51 | 0.24 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment
LLOQ = 15 IU/mL (NCT02613871)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
LDV/SOF FDC | 33.3 | 82.0 | 100.0 | 100.0 | 100.0 |
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Serum LOXL-2 Level Change From Baseline While on Treatment
(NCT02613871)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | pg/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
LDV/SOF FDC | -2 | -6 | -15 | -22 | -27 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02613871)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
| Genotype 1 | Genotype 2 | Total |
---|
LDV/SOF FDC | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug
(NCT02613871)
Timeframe: First dose date up to 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF FDC | 0.0 |
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Percentage of Participants That Required HBV Therapy During the Study
(NCT02613871)
Timeframe: First dose date up to Posttreatment Week 108
Intervention | percentage of participants (Number) |
---|
LDV/SOF FDC | 7.2 |
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Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
(NCT02613871)
Timeframe: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Intervention | log10 IU/mL (Mean) |
---|
| Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 24 | Change at Posttreatment Week 36 | Change at Posttreatment Week 48 | Change at Posttreatment Week 60 | Change at Posttreatment Week 72 | Change at Posttreatment Week 84 | Change at Posttreatment Week 96 | Change at Posttreatment Week 108 |
---|
LDV/SOF FDC | 0.49 | 0.66 | 0.56 | 0.67 | 0.68 | 0.70 | 0.55 | 0.50 | 0.41 | 0.38 |
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Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study
(NCT02613871)
Timeframe: First dose date up to Posttreatment Week 108
Intervention | percentage of participants (Number) |
---|
LDV/SOF FDC | 0.0 |
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Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36
(NCT02613871)
Timeframe: Posttreatment Weeks 4, 12, and 36
Intervention | pg/mL (Mean) |
---|
| Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 36 |
---|
LDV/SOF FDC | -30 | -32 | -41 |
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment. (NCT02613871)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF FDC | 100.0 |
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HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
(NCT02613871)
Timeframe: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Intervention | log10 IU/mL (Mean) |
---|
| Change at Posttreatment Week 4 | Change at Posttreatment Week 12 | Change at Posttreatment Week 24 | Change at Posttreatment Week 36 | Change at Posttreatment Week 48 | Change at Posttreatment Week 60 | Change at Posttreatment Week 72 | Change at Posttreatment Week 84 | Change at Posttreatment Week 96 | Change at Posttreatment Week 108 |
---|
LDV/SOF FDC | -0.16 | -0.01 | -0.02 | -0.07 | -0.10 | -0.16 | -0.20 | -0.25 | -0.32 | -0.37 |
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HBsAg Level Change From Baseline While on Treatment
(NCT02613871)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
LDV/SOF FDC | -0.14 | -0.18 | -0.25 | -0.41 | -0.47 |
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Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108
"FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:~Presence of cirrhosis = FibroScan result of > 12.5 kPa~Absence of cirrhosis = FibroScan result of ≤ 12.5 kPa" (NCT02613871)
Timeframe: Posttreatment Weeks 12, 60, and 108
Intervention | kPa (Mean) |
---|
| Posttreatment Week 12 | Posttreatment Week 60 | Posttreatment Week 108 |
---|
LDV/SOF FDC | 8.0 | 7.2 | 7.1 |
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Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Intention-to-treat (ITT) Population
To evaluate the proportion of participants with HCV RNA below the level of quantification at 12 weeks post treatment following SOF/VEL for 6 weeks as compared with 12 weeks in people with recent HCV infection- among intention-to-treat (ITT) population The ITT population included all randomized participants, with loss to follow-up deemed treatment failure. (NCT02625909)
Timeframe: 12 weeks post treatment
Intervention | Participants (Count of Participants) |
---|
Drug: SOF/VEL for 6 Weeks | 76 |
Drug: SOF/VEL for 12 Weeks | 86 |
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Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Modified Intention-to-treat (ITT) Population
To evaluate the proportion of participants with HCV RNA below the level of quantification at 12 weeks post treatment following SOF/VEL for 6 weeks as compared with 12 weeks in people with recent HCV infection- among modified intention-to-treat (ITT) population The modified ITT population included participants in the ITT population, but excluded those with non-virological reasons for treatment failure (including death and loss to follow-up) and reinfection. (NCT02625909)
Timeframe: 12 Weeks Post End of Treatment
Intervention | Participants (Count of Participants) |
---|
Drug: SOF/VEL for 6 Weeks | 76 |
Drug: SOF/VEL for 12 Weeks | 86 |
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Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Per Protocol (PP) Population
To evaluate the proportion of participants with HCV RNA below the level of quantification at 12 weeks post treatment following SOF/VEL for 6 weeks as compared with 12 weeks in people with recent HCV infection- among Per Protocol (PP) population The per protocol population included participants who received >90% of scheduled treatment for >90% of the scheduled treatment period with follow-up virologic data at SVR12 (excluding reinfection and retreatments) (NCT02625909)
Timeframe: 12 weeks post treatment
Intervention | Participants (Count of Participants) |
---|
Drug: SOF/VEL for 6 Weeks | 69 |
Drug: SOF/VEL for 12 Weeks | 77 |
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Number of Participants With Undetectable HCV RNA at End of Treatment (ETR) of SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Intention-to-treat (ITT) Population
To evaluate the proportion of participants with HCV RNA below the level of quantification at end of treatment of SOF/VEL for 6 Weeks as compared With 12 Weeks in People With Recent HCV Infection The ITT population included all randomized participants, with loss to follow-up deemed treatment failure. (NCT02625909)
Timeframe: End of treatment - week 6 of the shortened treatment duration arm, and week 12 of the standard treatment duration arm
Intervention | Participants (Count of Participants) |
---|
Drug: SOF/VEL for 6 Weeks | 85 |
Drug: SOF/VEL for 12 Weeks | 87 |
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Number of Participants With Virologic Failure
Number of participants who had a nonresponse to treatment or a relapse of disease under study. (NCT02631772)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
| Nonresponse | Relapse |
---|
Late Cohort, Arm 1 | 0 | 1 |
,Late Cohort, Arm 2 | 1 | 2 |
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Treatment Efficacy
Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen (NCT02631772)
Timeframe: 12 Weeks
Intervention | % of participants (Number) |
---|
Late Cohort, Arm 1 | 88 |
Late Cohort, Arm 2 | 75 |
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Hemoglobin Levels
Change in hemoglobin levels over the course of the study (NCT02631772)
Timeframe: Week 4, Week 8, Week 12, Week 16
Intervention | g/dL (Mean) |
---|
| Hemoglobin levels at Week 4 | Hemoglobin levels at Week 8 | Hemoglobin levels at Week 12 | Hemoglobin levels at Week 16 |
---|
Late Cohort, Arm 1 | 13.1 | 13.3 | 13.7 | 13.6 |
,Late Cohort, Arm 2 | 12.9 | 11.2 | 12.0 | 13.1 |
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Percentage of Participants With HCV RNA < LLOQ On Treatment
(NCT02639247)
Timeframe: Weeks 1, 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL 12 Weeks | 17.2 | 56.3 | 90.7 | 98.7 | 99.3 |
,SOF/VEL/VOX 12 Weeks | 15.9 | 62.6 | 88.5 | 100.0 | 98.9 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02639247)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participcants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF/VEL 12 Weeks | 91.4 | 90.1 |
,SOF/VEL/VOX 12 Weeks | 98.4 | 97.8 |
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Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
(NCT02639247)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX 12 Weeks | 0 |
SOF/VEL 12 Weeks | 0.7 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02639247)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX 12 Weeks | 97.8 |
SOF/VEL 12 Weeks | 90.1 |
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Percentage of Participants With Virologic Failure
"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02639247)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX 12 Weeks | 0.5 |
SOF/VEL 12 Weeks | 9.9 |
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Change From Baseline in HCV RNA
(NCT02639247)
Timeframe: Weeks 1, 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
SOF/VEL 12 Weeks | -4.17 | -4.78 | -5.06 | -5.08 | -5.09 |
,SOF/VEL/VOX 12 Weeks | -4.29 | -4.93 | -5.13 | -5.17 | -5.17 |
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Percentage of Participants With HCV RNA < LLOQ On Treatment
(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL 12 Weeks | 10.1 | 50.9 | 85.2 | 99.1 | 100.0 |
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02639338)
Timeframe: Posttreatment Weeks 4 and 24
Intervention | percentage of participants (Number) |
---|
| SVR4 | SVR24 |
---|
SOF/VEL 12 Weeks | 97.2 | 96.3 |
,SOF/VEL/VOX 8 Weeks | 97.3 | 96.4 |
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Change From Baseline in HCV RNA
(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 |
---|
SOF/VEL/VOX 8 Weeks | -4.06 | -4.60 | -4.84 | -4.90 |
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Change From Baseline in HCV RNA
(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12
Intervention | log10 IU/mL (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL 12 Weeks | -4.09 | -4.73 | -5.00 | -5.09 | -5.14 |
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Percentage of Participants With HCV RNA < LLOQ On Treatment
(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 8 |
---|
SOF/VEL/VOX 8 Weeks | 17.3 | 56.4 | 87.3 | 97.3 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT02639338)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX 8 Weeks | 1.8 |
SOF/VEL 12 Weeks | 1.8 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02639338)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX 8 Weeks | 96.4 |
SOF/VEL 12 Weeks | 96.3 |
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Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
(NCT02639338)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL/VOX 8 Weeks | 0 |
SOF/VEL 12 Weeks | 0.9 |
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Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. (NCT02640157)
Timeframe: Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment
Intervention | percentage of participants (Number) |
---|
Arm A | 0.4 |
Arm B | 0 |
Arm C | 0.6 |
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Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. (NCT02640157)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug
Intervention | percentage of participants (Number) |
---|
Arm A | 1.4 |
Arm B | 0.9 |
Arm C | 3.3 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02640157)
Timeframe: 12 weeks after the last actual dose of study drug
Intervention | percentage of participants (Number) |
---|
Arm A | 95.3 |
Arm B | 96.5 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A
SVR12 was defined as plasma HCV RNA level NCT02640157)
Timeframe: 12 weeks after the last actual dose of study drug
Intervention | percentage of participants (Number) |
---|
Arm A | 95.3 |
Arm C | 94.9 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B
SVR12 was defined as plasma HCV RNA level NCT02640157)
Timeframe: 12 weeks after the last actual dose of study drug
Intervention | percentage of participants (Number) |
---|
Arm A | 95.3 |
Arm B | 96.5 |
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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02671500)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 96.5 |
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Change From Baseline in HCV RNA
(NCT02671500)
Timeframe: Baseline and up to Week 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 10 | Change at Week 12 |
---|
SOF/VEL | -4.38 | -4.89 | -5.02 | -5.03 | -5.03 | -5.03 | -5.03 |
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Percentage of Participants With HCV RNA < LLOQ On Treatment
(NCT02671500)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12
Intervention | Percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 |
---|
SOF/VEL | 27.7 | 73.8 | 95.5 | 99.7 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02671500)
Timeframe: Posttreatment Week 4
Intervention | Percentage of participants (Number) |
---|
SOF/VEL | 97.1 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02671500)
Timeframe: Up to 12 weeks
Intervention | Percentage of participants (Number) |
---|
SOF/VEL | 0 |
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Percentage of Participants With Overall Virologic Failure
Virologic failure was defined as: (1) On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT02671500)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 3.2 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02671500)
Timeframe: Posttreatment Week 12
Intervention | Percentage of participants (Number) |
---|
SOF/VEL (Overall) | 96.5 |
SOF/VEL (China - Region 1) | 96.2 |
SOF/VEL (Southeast Asia - Region 2) | 97.3 |
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Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 weeks after start of the F/TAF-based regimen were analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02707601)
Timeframe: 24 weeks after start of HIV treatment
Intervention | percentage of participants (Number) |
---|
E/C/F/TAF + LDV/SOF | 1.4 |
F/R/TAF + LDV/SOF | 1.4 |
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Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment. (NCT02707601)
Timeframe: HCV Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
E/C/F/TAF + LDV/SOF | 98.6 |
F/R/TAF + LDV/SOF | 98.6 |
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Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment
(NCT02707601)
Timeframe: Up to 32 weeks plus 30 days
Intervention | percentage of participants (Number) |
---|
E/C/F/TAF + LDV/SOF (Co-administration: Week 8 to Week 20) | 62.5 |
F/R/TAF + LDV/SOF (Co-administration: Week 8 to Week 20) | 69.4 |
E/C/F/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV Week 12) | 83.8 |
F/R/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV to Week 12) | 79.7 |
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Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)
Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment. (NCT02707601)
Timeframe: HCV Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
E/C/F/TAF + LDV/SOF | 98.6 |
F/R/TAF + LDV/SOF | 95.8 |
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Change From Baseline in HCV RNA at Week 8
(NCT02722837)
Timeframe: Baseline (Day 1); Week 8
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -4.93 |
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Change From Baseline in HCV RNA at Week 12
(NCT02722837)
Timeframe: Baseline (Day 1); Week 12
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -4.93 |
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Change From Baseline in HCV RNA at Week 1
(NCT02722837)
Timeframe: Baseline (Day 1); Week 1
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -4.17 |
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Change From Baseline in HCV RNA at Week 2
(NCT02722837)
Timeframe: Baseline (Day 1); Week 2
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -4.70 |
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Change From Baseline in HCV RNA at Week 4
(NCT02722837)
Timeframe: Baseline (Day 1); Week 4
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -4.90 |
[back to top]
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
(NCT02722837)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02722837)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 99.2 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02722837)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 100.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12
(NCT02722837)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 100.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2
(NCT02722837)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 64.7 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4
(NCT02722837)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 96.6 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8
(NCT02722837)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 100.0 |
[back to top]
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02722837)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 99.2 |
[back to top]
Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or~Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)" (NCT02722837)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 0.8 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1
(NCT02722837)
Timeframe: Week 1
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 21.0 |
[back to top]
Percentage of Participants With With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method. (NCT02723084)
Timeframe: Treatment Weeks 1, 2, 4, 8 (end of treatment for arm A), and 12 (end of treatment for arm B) or premature discontinuation from treatment
Intervention | percentage of participants (Number) |
---|
Arm A | 0 |
Arm B | 0 |
[back to top]
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Non-inferiority of Arm A to Arm B
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02723084)
Timeframe: 12 weeks after the last actual dose of study drug
Intervention | percentage of participants (Number) |
---|
Arm A | 97.8 |
Arm B | 93.5 |
[back to top]
Percentage of Participants With Post-Treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. 95% CI was calculated using the Wilson score method. (NCT02723084)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug
Intervention | percentage of participants (Number) |
---|
Arm A | 0 |
Arm B | 4.4 |
[back to top]
Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02723084)
Timeframe: 12 weeks after the last actual dose of study drug
Intervention | percentage of participants (Number) |
---|
Arm A | 97.8 |
[back to top]
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02728206)
Timeframe: Posttreatment Week 4
Intervention | Percentage of participants (Number) |
---|
SOF/VEL | 88.9 |
[back to top]
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02728206)
Timeframe: Posttreatment Week 12
Intervention | Percentage of participants (Number) |
---|
SOF/VEL | 77.8 |
[back to top]
Percentage of Participants With Overall Virologic Failure
Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA ≥ 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA ≥ 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA < 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. (NCT02728206)
Timeframe: Up to Posttreatment Week 12
Intervention | Percentage of participants (Number) |
---|
SOF/VEL | 0 |
[back to top]
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02728206)
Timeframe: Up to Week 4
Intervention | Percentage of participants (Number) |
---|
SOF/VEL | 11.1 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ On Treatment
(NCT02728206)
Timeframe: Days 3, 5, 7, 14, 21, and 28
Intervention | Percentage of participants (Number) |
---|
| Day 3 | Day 5 | Day 7 | Day 14 | Day 21 | Day 28 |
---|
SOF/VEL | 0 | 0 | 0 | 33.3 | 85.7 | 85.7 |
[back to top]
Change From Baseline in HCV RNA at Week 10
(NCT02738333)
Timeframe: Baseline; Week 10
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF (Cohort 1) | -4.92 |
SOF+RBV (Cohort 1) | -4.93 |
LDV/SOF (Cohort 2) | -4.76 |
[back to top]
Change From Baseline in HCV RNA at Week 1
(NCT02738333)
Timeframe: Baseline; Week 1
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF (Cohort 1) | -4.18 |
SOF+RBV (Cohort 1) | -4.34 |
LDV/SOF (Cohort 2) | -4.24 |
[back to top]
Change From Baseline in HCV RNA at Week 12
(NCT02738333)
Timeframe: Baseline; Week 12
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF (Cohort 1) | -4.92 |
SOF+RBV (Cohort 1) | -4.92 |
LDV/SOF (Cohort 2) | -4.76 |
[back to top]
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02738333)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 97.2 |
SOF+RBV (Cohort 1) | 98.1 |
LDV/SOF (Cohort 2) | 96.0 |
[back to top]
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02738333)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 96.2 |
SOF+RBV (Cohort 1) | 95.4 |
LDV/SOF (Cohort 2) | 96.0 |
[back to top]
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02738333)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 96.2 |
SOF+RBV (Cohort 1) | 95.4 |
LDV/SOF (Cohort 2) | 96.0 |
[back to top]
Percentage of Participants With Overall Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02738333)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 2.8 |
SOF+RBV (Cohort 1) | 3.7 |
LDV/SOF (Cohort 2) | 4.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 8
(NCT02738333)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 100.0 |
SOF+RBV (Cohort 1) | 100.0 |
LDV/SOF (Cohort 2) | 100.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 6
(NCT02738333)
Timeframe: Week 6
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 99.0 |
SOF+RBV (Cohort 1) | 99.1 |
LDV/SOF (Cohort 2) | 100.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 5
(NCT02738333)
Timeframe: Week 5
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 98.1 |
SOF+RBV (Cohort 1) | 99.1 |
LDV/SOF (Cohort 2) | 100.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 4
(NCT02738333)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 98.1 |
SOF+RBV (Cohort 1) | 96.3 |
LDV/SOF (Cohort 2) | 100.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 3
(NCT02738333)
Timeframe: Week 3
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 90.6 |
SOF+RBV (Cohort 1) | 90.7 |
LDV/SOF (Cohort 2) | 96.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 2
(NCT02738333)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 73.6 |
SOF+RBV (Cohort 1) | 76.6 |
LDV/SOF (Cohort 2) | 76.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 12
(NCT02738333)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 100.0 |
SOF+RBV (Cohort 1) | 100.0 |
LDV/SOF (Cohort 2) | 100.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 10
(NCT02738333)
Timeframe: Week 10
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 100.0 |
SOF+RBV (Cohort 1) | 100.0 |
LDV/SOF (Cohort 2) | 100.0 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 1
(NCT02738333)
Timeframe: Week 1
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 24.5 |
SOF+RBV (Cohort 1) | 31.5 |
LDV/SOF (Cohort 2) | 32.0 |
[back to top]
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02738333)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
LDV/SOF (Cohort 1) | 0.9 |
SOF+RBV (Cohort 1) | 1.9 |
LDV/SOF (Cohort 2) | 0 |
[back to top]
Change From Baseline in HCV RNA at Week 8
(NCT02738333)
Timeframe: Baseline; Week 8
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF (Cohort 1) | -4.92 |
SOF+RBV (Cohort 1) | -4.93 |
LDV/SOF (Cohort 2) | -4.76 |
[back to top]
Change From Baseline in HCV RNA at Week 6
(NCT02738333)
Timeframe: Baseline; Week 6
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF (Cohort 1) | -4.91 |
SOF+RBV (Cohort 1) | -4.92 |
LDV/SOF (Cohort 2) | -4.76 |
[back to top]
Change From Baseline in HCV RNA at Week 5
(NCT02738333)
Timeframe: Baseline; Week 5
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF (Cohort 1) | -4.91 |
SOF+RBV (Cohort 1) | -4.92 |
LDV/SOF (Cohort 2) | -4.76 |
[back to top]
Change From Baseline in HCV RNA at Week 4
(NCT02738333)
Timeframe: Baseline; Week 4
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF (Cohort 1) | -4.89 |
SOF+RBV (Cohort 1) | -4.91 |
LDV/SOF (Cohort 2) | -4.76 |
[back to top]
Change From Baseline in HCV RNA at Week 3
(NCT02738333)
Timeframe: Baseline; Week 3
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF (Cohort 1) | -4.87 |
SOF+RBV (Cohort 1) | -4.89 |
LDV/SOF (Cohort 2) | -4.75 |
[back to top]
Change From Baseline in HCV RNA at Week 2
(NCT02738333)
Timeframe: Baseline; Week 2
Intervention | log10 IU/mL (Mean) |
---|
LDV/SOF (Cohort 1) | -4.76 |
SOF+RBV (Cohort 1) | -4.81 |
LDV/SOF (Cohort 2) | -4.64 |
[back to top]
Number of Participants Who Achieve End of Treatment Virologic Response (ETR) at Completion of Therapy.
Per protocol analysis. End of Treatment Virologic Response as measure by an undetectable HCV RNA level completion of therapy. (NCT02745535)
Timeframe: Week 12
Intervention | Participants (Count of Participants) |
---|
SOF/VEL/VOX | 71 |
[back to top]
Number of Participants Who Achieve Sustained Virologic Response (SVR) 12 Weeks After Completion of Therapy (SVR12)
Intention to treat (ITT) analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 12 weeks after completion of therapy. (NCT02745535)
Timeframe: Post-treatment week 12
Intervention | Participants (Count of Participants) |
---|
SOF/VEL/VOX | 70 |
[back to top]
Number of Participants Who Achieve Sustained Virologic Response (SVR) 24 Weeks After Completion of Therapy.
Per protocol analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 24 weeks after completion of therapy. (NCT02745535)
Timeframe: Post-treatment week 24
Intervention | Participants (Count of Participants) |
---|
SOF/VEL/VOX | 70 |
[back to top]
Number of Participants Who Achieve Sustained Virologic Response (SVR) 4 Weeks After Completion of Therapy.
Per protocol analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 4 weeks after completion of therapy. (NCT02745535)
Timeframe: Post-treatment week 4
Intervention | Participants (Count of Participants) |
---|
SOF/VEL/VOX | 70 |
[back to top]
Number of Participants With Grade 3 and 4 Adverse Events
Number of participants with grade 3 and 4 adverse events during treatment with and/or within 30 of completion of SOF/VEL/VOX in HCV infected (NCT02745535)
Timeframe: up to 16 weeks
Intervention | Participants (Count of Participants) |
---|
SOF/VEL/VOX | 12 |
[back to top]
Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR
Number of alcoholics with HCV type 1 genotype who had advanced fibrosis F3/F4 who achieve SVR (NCT02759861)
Timeframe: 12 weeks after the end of Harvoni therapy
Intervention | Participants (Count of Participants) |
---|
F3/F4 | 8 |
[back to top]
The Number of Subjects Who Achieve Negative RNA in Alcoholics
Sustained viral response in treatment -naive heavy alcohol drinking patients. (NCT02759861)
Timeframe: 12 weeks after the end of Harvoni therapy
Intervention | Participants (Count of Participants) |
---|
Harvoni x 8 or 12 Weeks | 14 |
[back to top]
HCV RNA at Week 2
(NCT02781558)
Timeframe: Week 2
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | 1.52 |
SOF/VEL + RBV | 1.47 |
[back to top]
HCV RNA at Week 12
(NCT02781558)
Timeframe: Week 12
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | 1.15 |
SOF/VEL + RBV | 1.15 |
[back to top]
Change From Baseline in HCV RNA at Week 8
(NCT02781558)
Timeframe: Baseline; Week 8
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -5.04 |
SOF/VEL + RBV | -5.13 |
[back to top]
Change From Baseline in HCV RNA at Week 4
(NCT02781558)
Timeframe: Baseline; Week 4
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -4.96 |
SOF/VEL + RBV | -5.09 |
[back to top]
Change From Baseline in HCV RNA at Week 2
(NCT02781558)
Timeframe: Baseline; Week 2
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -4.67 |
SOF/VEL + RBV | -4.80 |
[back to top]
Change From Baseline in HCV RNA at Week 12
(NCT02781558)
Timeframe: Baseline; Week 12
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -5.04 |
SOF/VEL + RBV | -5.13 |
[back to top]
Percentage of Participants With Virologic Failure
"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement" (NCT02781558)
Timeframe: Up to Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 5.9 |
SOF/VEL + RBV | 1.9 |
[back to top]
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02781558)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 91.1 |
SOF/VEL + RBV | 96.1 |
[back to top]
HCV RNA at Week 4
(NCT02781558)
Timeframe: Week 4
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | 1.22 |
SOF/VEL + RBV | 1.19 |
[back to top]
Percentage of Participants Who Have HCV RNA < LLOQ at Week 8
(NCT02781558)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 99.0 |
SOF/VEL + RBV | 100.0 |
[back to top]
Percentage of Participants Who Have HCV RNA < LLOQ at Week 4
(NCT02781558)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 85.0 |
SOF/VEL + RBV | 90.3 |
[back to top]
Percentage of Participants Who Have HCV RNA < LLOQ at Week 2
(NCT02781558)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 51.0 |
SOF/VEL + RBV | 44.7 |
[back to top]
Percentage of Participants Who Have HCV RNA < LLOQ at Week 12
(NCT02781558)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 99.0 |
SOF/VEL + RBV | 100.0 |
[back to top]
Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)
SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment. (NCT02781558)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 93.1 |
SOF/VEL + RBV | 97.1 |
[back to top]
HCV RNA at Week 8
(NCT02781558)
Timeframe: Week 8
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | 1.15 |
SOF/VEL + RBV | 1.15 |
[back to top]
Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event
(NCT02781558)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 1.0 |
SOF/VEL + RBV | 1.9 |
[back to top]
Change From Baseline in HCV RNA at Week 4
(NCT02781571)
Timeframe: Baseline; Week 4
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -5.13 |
[back to top]
Change From Baseline in HCV RNA at Week 2
(NCT02781571)
Timeframe: Baseline; Week 2
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -4.75 |
[back to top]
Change From Baseline in HCV RNA at Week 12
(NCT02781571)
Timeframe: Baseline; Week 12
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -5.22 |
[back to top]
Percentage of Participants With Virologic Failure
"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 12 weeks of treatment)~Virologic relapse:~HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement" (NCT02781571)
Timeframe: Up to Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 2.5 |
[back to top]
Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02781571)
Timeframe: Posttreatment Week 4
Intervention | Percentage of participants (Number) |
---|
SOF/VEL | 97.5 |
[back to top]
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02781571)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 96.2 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 8
(NCT02781571)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 98.7 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 4
(NCT02781571)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 85.9 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 2
(NCT02781571)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 40.5 |
[back to top]
Percentage of Participants With HCV RNA < LLOQ at Week 12
(NCT02781571)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 100.0 |
[back to top]
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
(NCT02781571)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 1.3 |
[back to top]
HCV RNA at Week 8
(NCT02781571)
Timeframe: Week 8
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | 1.15 |
[back to top]
HCV RNA at Week 4
(NCT02781571)
Timeframe: Week 4
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | 1.23 |
[back to top]
HCV RNA at Week 2
(NCT02781571)
Timeframe: Week 2
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | 1.59 |
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HCV RNA at Week 12
(NCT02781571)
Timeframe: Week 12
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | 1.15 |
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Change From Baseline in HCV RNA at Week 8
(NCT02781571)
Timeframe: Baseline; Week 8
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL | -5.20 |
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Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Mutations in the HCV Population From the Deceased Donors
"Number of participants with NS5A resistance mutations in the HCV population from the deceased donors.~Number of donors with NS5A resistance mutations" (NCT02781649)
Timeframe: Baseline
Intervention | Participants (Count of Participants) |
---|
Donor Genotype 1a no Resistance or 1b | 0 |
Donor Genotype 1a With Resistance | 0 |
Donor Genotype 2 or 3 | 0 |
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Viral Response
This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 12 (NCT02781649)
Timeframe: 12 weeks after completing treatment
Intervention | Participants (Count of Participants) |
---|
Donor Genotype 1a no Resistance or 1b | 7 |
Donor Genotype 1a With Resistance | 0 |
Donor Genotype 2 or 3 | 3 |
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Kidney Function at 12 Months
Serum creatinine mg/dL at 12 months following transplantation (NCT02781649)
Timeframe: 12 months following transplantation
Intervention | mg/dL (Median) |
---|
Donor Genotype 1a no Resistance or 1b | 1.0 |
Donor Genotype 2 or 3 | 1.3 |
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Kidney Function at 6 Months
Serum creatinine mg/dL at 6 months following transplantation (NCT02781649)
Timeframe: 6 months following transplantation
Intervention | mg/dL (Median) |
---|
Donor Genotype 1a no Resistance or 1b | 1.12 |
Donor Genotype 2 or 3 | 0.9 |
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Antibody Development
Number of kidney transplant recipients who become reactive for HCV antibody (NCT02781649)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
Donor Genotype 1a no Resistance or 1b | 3 |
Donor Genotype 1a With Resistance | 0 |
Donor Genotype 2 or 3 | 2 |
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HCV SVR Durability -No Cirrhosis
Number/Percentage of patients with persistence of viral cure, SVR (SVR = Sustained Virologic Response)- defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. (NCT02786537)
Timeframe: 24 weeks post-end of treatment up to 153 weeks
Intervention | Participants (Count of Participants) |
---|
EBR/GZR | 255 |
EBR/GZR With Ribavirin | 17 |
SOF/LDV | 146 |
SOF/LDV With RBV | 2 |
PrOD | 14 |
PrOD With RBV | 36 |
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HCV SVR Durability-Patients With Cirrhosis
Percentage of Cirrhotic patients with persistence of viral cure, SVR, (SVR= Sustained Virologic Response) defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. (NCT02786537)
Timeframe: Up to 132 weeks post HCV treatment
Intervention | Participants (Count of Participants) |
---|
EBR/GZR | 43 |
EBR/GZR With RBV | 7 |
SOF/LDV | 35 |
SOF/LDV With RBV | 7 |
PrOD | 6 |
PrOD With RBV | 7 |
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Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF
"Participants completed the Patient Reported Outcomes surveys (PROs) 'PROMIS Nausea/Vomiting -4 Short Form' at baseline and during treatment. Raw scores are converted to standardized T-scores with a range of 45.0-80.1. Higher scores indicate worse nausea/vomiting.~Results presented as mean difference from baseline to average of on Treatment Scores (highest/worst) score during treatment.~A negative (-) PROMIS change score is suggestive of symptom improvement or lack of drug side effect. Estimates of mean change were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes." (NCT02786537)
Timeframe: Baseline and Average On-Treatment Score
Intervention | units on a scale (Mean) |
---|
EBR/GZR With RBV | -0.3 |
EBR/GZR | -0.6 |
SOF/LDV With RBV | -1.6 |
SOF/LDV | -0.4 |
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Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF
The number of participants with adverse events that led to early treatment discontinuation (defined as duration less than originally prescribed treatment regimen) (NCT02786537)
Timeframe: Treatment start date through treatment completion (up to 24 weeks)
Intervention | Participants (Count of Participants) |
---|
EBR/GZR Regimen | 12 |
SOF/LDV Regimen | 4 |
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Mean Change in Nausea/Vomiting PRO Score -Phase 1
"Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.~The estimates of mean change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes. The model expressed mean score as a function of DAA regimen, cirrhosis status, HCV genotype, sex, age, race, and previous treatment status." (NCT02786537)
Timeframe: Baseline to On-Treatment
Intervention | units on a scale (Mean) |
---|
EBR/GZR With RBV | 1.3 |
EBR/GZR | -1.4 |
SOF/LDV With RBV | -3.9 |
SOF/LDV | -0.7 |
PrOD With RBV | 2.5 |
PrOD | 0.7 |
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Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2
Number of participants who achieved SVR (sustained virologic response), defined as undetectable HCV RNA 12 weeks post-treatment with RASs (Resistant Associated Substitutions) after treatment with EBR/GZR or SOF/LDV regimen (NCT02786537)
Timeframe: 12 weeks post HCV treatment
Intervention | Participants (Count of Participants) |
---|
| With NS5a RAS | Without NS5a RAS |
---|
EBR/GZR Regimen | 47 | 485 |
,SOF/LDV Regimen | 42 | 286 |
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Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation
Change in HCV-associated symptoms was calculated as the mean differences of mean scores from multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS)-- Fatigue, nausea, belly pain, sleep disturbance, and diarrhea) and functional status (well-being) when comparing baseline to early post-treatment and late post treatment surveys. Mean change scores were calculated by comparing baseline to early post-treatment (1 yr) and late post-treatment (approximately 3 years) surveys. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.Negative numbers suggest better symptoms (improvement in HCV-associated symptoms). PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35.HCV-PRO positive estimates suggest baseline functional well-being improvement. (NCT02786537)
Timeframe: 1 year post treatment discontinuation (Early post-tx)
Intervention | units on a scale (Mean) |
---|
| Nausea | Belly Pain | Diarrhea | Fatigue | Sleep Disturbance | Cognitive Impairment | HCV-PRO |
---|
EBR/GZR Regimen | 0.00 | -0.82 | -1.12 | -2.08 | 0.65 | -0.54 | 8.02 |
,SOF/LDV Regimen | -4.99 | -6.47 | -5.77 | -7.59 | -1.72 | -4.48 | 9.90 |
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Change in Functional Status (HCV-PRO) Within Treatment
"HCV-PRO score, a validated PROMIS survey used to evaluate overall functioning and well-being in HCV patients, was utilized to compare long-term 'within treatment' changes of functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive estimate (Post treatment to baseline) suggests baseline functional well-being improvement.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Treatment start date up to 2 years post-treatment
Intervention | score on a scale (Mean) |
---|
| 9 months post treatment | 20 months post treatment |
---|
EBR/GZR Regimen | 8.02 | 9.87 |
,SOF/LDV Regimen | 9.90 | 11.54 |
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Treatment Non-Adherence Probability Estimates
"The Voils Medication Adherence Survey (VMAS) was used to evaluate medication adherence during HCV treatment. Participants responded to three questions about the extent of adherence during the past seven days of treatment (during early and late on-treatment occasions). Participants responded using a five-point ordinal scale of missed dosing from 1 (none of the time) to 5 (all of the time). On each occasion participants were coded as being Non-adherent if any response was > 1, otherwise they were coded as Adherent. Probability estimates of percentage of patients reporting non-adherence were calculated per HCV treatment (Direct Acting Antiviral-DAA) regimen: 1)EBR/GZV (elbasvir/grazoprevir, 2)SOF/LDV (sofosbuvir/ledipasvir), 3)PrOD" (NCT02786537)
Timeframe: 12-16 weeks of HCV treatment
Intervention | percentage of patients (Number) |
---|
EBR/GZR | 23 |
SOF/LDV | 19 |
PrOD | 26 |
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Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV
"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation at discretion of provider).~mITT with imputation (missing=failure). Total number of subjects reflects participants from EBR/GZR with or without RBV and SOF/LDV with or without RBV randomized during Phase 1 and Phase 2." (NCT02786537)
Timeframe: 12 weeks post-treatment
Intervention | Participants (Count of Participants) |
---|
EBR/GZR With RBV | 40 |
EBR/GZR | 516 |
SOF/LDV With RBV | 14 |
SOF/LDV | 335 |
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Post-treatment Progression/Regression of Liver Disease-Fib-4
Mean change (delta) in FIB-4, an indirect non-invasive measure of liver fibrosis, calculated as baseline median -long term follow up median, following SVR after any of the study treatment regimens. Change in FIB-4 where negative values indicate improvement in liver fibrosis score and positive values indicate worsening of fibrosis score. There is no upper or lower limit for change. FIB-4 = age (years) * AST(IU/L)/Platelets (10^3/L) * ALT^.5(IU/L). In general, Score of 0-1.29 is low risk for advanced fibrosis, 1.30-1.67: intermediate risk for advanced liver fibrosis, >2.67: high risk for advanced fibrosis. (NCT02786537)
Timeframe: Baseline to up to 3 years post treatment discontinuation
Intervention | score on a scale (Median) |
---|
EBR/GZR, SOF/LDV or PrOD Based HCV Treatment | -1.36 |
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Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)
"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~Number of subjects reflects participants who started EBR/GZR or SOF/LDV- based treatment (with or without RBV) during Phase 1 and 2." (NCT02786537)
Timeframe: 12-24 weeks post HCV treatment
Intervention | Participants (Count of Participants) |
---|
EBR/GZR With RBV | 40 |
EBR/GZR | 516 |
SOF/LDV With RBV | 14 |
SOF/LDV | 335 |
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Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation
"SVR (Sustained Virologic Response) 12 will be defined as patients who have undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~mITT with imputation (missing=failure). Total number of subjects reflects participants from Phase 1 only." (NCT02786537)
Timeframe: 12 weeks post-treatment
Intervention | Participants (Count of Participants) |
---|
EBR/GZR With RBV | 9 |
EBR/GZR | 108 |
SOF/LDV With RBV | 6 |
SOF/LDV | 88 |
PrOD With RBV | 77 |
PrOD | 42 |
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Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)
"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~Number of subjects reflects participants randomized during Phase 1 only." (NCT02786537)
Timeframe: 12 -24 weeks post-treatment
Intervention | Participants (Count of Participants) |
---|
EBR/GZR With RBV | 9 |
EBR/GZR | 108 |
SOF/LDV With RBV | 6 |
SOF/LDV | 88 |
PrOD With RBV | 77 |
PrOD (Phase 1 Only) | 42 |
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Mean Change in Headache-PRO Scores -Phase 1
Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement in symptom. (NCT02786537)
Timeframe: Baseline to On-Treatment
Intervention | units on a scale (Mean) |
---|
EBR/GZR With Ribavirin (RBV) | 0.0 |
EBR/GZR Regimen | -0.8 |
SOF/LDV With RBV | -0.7 |
SOF/LDV | -0.5 |
PrOD With RBV Regimen | -0.2 |
PrOD | -2.2 |
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Mean Change in Headache-EBR/GZR and SOF/LDV
Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD (NCT02786537)
Timeframe: Baseline to On-Treatment
Intervention | units on a scale (Mean) |
---|
EBR/GZR With RBV | -0.8 |
EBR/GZR | -0.7 |
SOF/LDV With RBV | 0.4 |
SOF/LDV | -0.8 |
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Mean Change in HCV-PRO (Functional Well-being) EBR/GZR vs. SOF/LDV Score-Phase 2
"HCV-PRO, a survey designed to assess functional status of patients with HCV and measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered. End of Treatment -Baseline were used to calculate CHANGE in outcome. Number of subjects reflects participants from both Phase 1 and 2." (NCT02786537)
Timeframe: End of Treatment - Baseline
Intervention | score on a scale (Mean) |
---|
EBR/GZR With RBV | 3.2 |
EBR/GZR | 6.1 |
SOF/LDV With RBV | 6.3 |
SOF/LDV | 6.8 |
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Mean Change in HCV- PRO- Phase 1
"HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'overall functioning and well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Baseline to End of Treatment
Intervention | units on a scale (Mean) |
---|
EBR/GZR With RBV | -0.9 |
EBR/GZR | 5.6 |
SOF/LDV With RBV | 2.5 |
SOF/LDV | 6.9 |
PrOD With RBV | 3.2 |
PrOD | 9.9 |
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Mean Change in Fatigue PRO Score -Phase 1
Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline to On-treatment
Intervention | units on a scale (Mean) |
---|
EBR/GZR With RBV | 1.5 |
EBR/GZR | -1.2 |
SOF/LDV With RBV | -7.2 |
SOF/LDV | -2.0 |
PrOD With RBV | -1.9 |
PrOD | -3.0 |
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Mean Change in Fatigue PRO -EBR/GZR vs SOF/LDV
Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline and Average On-Treatment Score
Intervention | score on a scale (Mean) |
---|
EBR/GZR With RBV | -1.0 |
EBR/GZR | -2.1 |
SOF/LDV With RBV | -3.7 |
SOF/LDV | -2.2 |
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16 Wk EBR/GZR With RBV Efficacy on Patients With HCV RASs
"Efficacy of Hepatitis C Virus (HCV) Treatment with Zepatier (Elbasvir/Grazobevir) with Ribavirin (RBV) for 16 weeks when used in Genotype 1a patients with Baseline RASs (NS5a Resistance Associated Substitutions or RAPs -Resistance Associated Polymorphisms).~Efficacy defined as HCV RNA undetectable 12 weeks post treatment. Table excludes Genotype 1b patients." (NCT02786537)
Timeframe: 12 weeks post treatment
Intervention | Participants (Count of Participants) |
---|
EBR/GZR With RBV-16 Weeks | 34 |
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Percentage of Participants With HCV RNA < LLOQ at Week 12
(NCT02822794)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 100.0 |
SOF/VEL+RBV 24 Weeks | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 16
(NCT02822794)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 24 Weeks | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 2
(NCT02822794)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 64.3 |
SOF/VEL+RBV 24 Weeks | 70.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 20
(NCT02822794)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 24 Weeks | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 24
(NCT02822794)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 24 Weeks | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 3
(NCT02822794)
Timeframe: Week 3
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 91.1 |
SOF/VEL+RBV 24 Weeks | 90.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 4
(NCT02822794)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 98.2 |
SOF/VEL+RBV 24 Weeks | 98.3 |
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Percentage of Participants With HCV RNA < LLOQ at Week 5
(NCT02822794)
Timeframe: Week 5
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 98.2 |
SOF/VEL+RBV 24 Weeks | 98.3 |
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Percentage of Participants With HCV RNA < LLOQ at Week 6
(NCT02822794)
Timeframe: Week 6
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 100.0 |
SOF/VEL+RBV 24 Weeks | 98.3 |
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Percentage of Participants With HCV RNA < LLOQ at Week 8
(NCT02822794)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 100.0 |
SOF/VEL+RBV 24 Weeks | 100.0 |
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Percentage of Participants With Overall Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02822794)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 15.8 |
SOF/VEL+RBV 24 Weeks | 3.3 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02822794)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks (GT1) | 85.1 |
SOF/VEL+RBV 12 Weeks (GT2) | 70.0 |
SOF/VEL+RBV 24 Weeks (GT1) | 97.9 |
SOF/VEL+RBV 24 Weeks (GT2) | 91.7 |
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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02822794)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 82.5 |
SOF/VEL+RBV 24 Weeks | 96.7 |
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02822794)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 86.0 |
SOF/VEL+RBV 24 Weeks | 98.3 |
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Change From Baseline in HCV RNA at Week 1
(NCT02822794)
Timeframe: Baseline; Week 1
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 12 Weeks | -4.40 |
SOF/VEL+RBV 24 Weeks | -4.36 |
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Change From Baseline in HCV RNA at Week 10
(NCT02822794)
Timeframe: Baseline; Week 10
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 12 Weeks | -5.13 |
SOF/VEL+RBV 24 Weeks | -5.06 |
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Change From Baseline in HCV RNA at Week 12
(NCT02822794)
Timeframe: Baseline; Week 12
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 12 Weeks | -5.13 |
SOF/VEL+RBV 24 Weeks | -5.06 |
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Change From Baseline in HCV RNA at Week 16
(NCT02822794)
Timeframe: Baseline; Week 16
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 24 Weeks | -5.06 |
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Change From Baseline in HCV RNA at Week 2
(NCT02822794)
Timeframe: Baseline; Week 2
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 12 Weeks | -4.91 |
SOF/VEL+RBV 24 Weeks | -4.89 |
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Change From Baseline in HCV RNA at Week 20
(NCT02822794)
Timeframe: Baseline; Week 20
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 24 Weeks | -5.06 |
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Change From Baseline in HCV RNA at Week 24
(NCT02822794)
Timeframe: Baseline; Week 24
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 24 Weeks | -5.06 |
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Change From Baseline in HCV RNA at Week 3
(NCT02822794)
Timeframe: Baseline; Week 3
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 12 Weeks | -5.07 |
SOF/VEL+RBV 24 Weeks | -5.02 |
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Change From Baseline in HCV RNA at Week 4
(NCT02822794)
Timeframe: Baseline; Week 4
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 12 Weeks | -5.12 |
SOF/VEL+RBV 24 Weeks | -5.04 |
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Change From Baseline in HCV RNA at Week 5
(NCT02822794)
Timeframe: Baseline; Week 5
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 12 Weeks | -5.13 |
SOF/VEL+RBV 24 Weeks | -5.05 |
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Change From Baseline in HCV RNA at Week 6
(NCT02822794)
Timeframe: Baseline; Week 6
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 12 Weeks | -5.13 |
SOF/VEL+RBV 24 Weeks | -5.05 |
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Change From Baseline in HCV RNA at Week 8
(NCT02822794)
Timeframe: Baseline; Week 8
Intervention | log10 IU/mL (Mean) |
---|
SOF/VEL+RBV 12 Weeks | -5.13 |
SOF/VEL+RBV 24 Weeks | -5.06 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT02822794)
Timeframe: Up to 24 weeks
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 1.8 |
SOF/VEL+RBV 24 Weeks | 3.3 |
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Percentage of Participants With HCV RNA < LLOQ at Week 1
(NCT02822794)
Timeframe: Week 1
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 21.1 |
SOF/VEL+RBV 24 Weeks | 25.0 |
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Percentage of Participants With HCV RNA < LLOQ at Week 10
(NCT02822794)
Timeframe: Week 10
Intervention | percentage of participants (Number) |
---|
SOF/VEL+RBV 12 Weeks | 100.0 |
SOF/VEL+RBV 24 Weeks | 100.0 |
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Response in Patients With Mixed Cryoglobulinemia (MC)
Response to medication in patients with MC categorized as either complete response (100% response) vs partial response (50% response). (NCT02825212)
Timeframe: up to 24 weeks after treatment
Intervention | Participants (Count of Participants) |
---|
| Partial Response | Complete Response | No Response |
---|
Pts With Hep C Virus Infection-Related Cryoglobulinemia | 9 | 0 | 1 |
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Sustained Virologic Response (SVR)
Number of participants who attain SVR, ie, cleared HCV (NCT02825212)
Timeframe: 2-4 weeks and 24 weeks after treatment
Intervention | Participants (Count of Participants) |
---|
| 2-4 weeks after treatment | 24 weeks after treatment |
---|
Pts With Hep C Virus Infection-Related Cryoglobulinemia | 10 | 10 |
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Number of Subjects With Sustained Virologic Response (SVR) 4
The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 4 weeks after completing treatment. (NCT02858180)
Timeframe: 4 weeks after completing treatment
Intervention | Participants (Count of Participants) |
---|
Heart Failure Cohort | 8 |
Lung Disease Cohort | 3 |
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Number of Subjects With Sustained Virologic Response (SVR) 12
The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 12 weeks after completing therapy. (NCT02858180)
Timeframe: 12 weeks after completing treatment
Intervention | Participants (Count of Participants) |
---|
Heart Failure Cohort | 10 |
Lung Disease Cohort | 3 |
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Number of Subjects Who Completed 24 Weeks of Therapy
The primary safety endpoint is the number of subjects who complete a full course of therapy. (NCT02858180)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
Heart Failure Cohort | 0 |
Lung Disease Cohort | 1 |
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Discontinuation for Adverse Events and Serious Adverse Events
Assessment for discontinuation due to adverse events and serious adverse events, as addressed by adverse events and laboratory tests. Final study visit is 12 weeks after treatment. (NCT02858180)
Timeframe: 12 weeks after completing treatment
Intervention | Participants (Count of Participants) |
---|
Heart Failure Cohort | 0 |
Lung Disease Cohort | 0 |
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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
(NCT02868242)
Timeframe: First dose date up to Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 0 |
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Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02868242)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02868242)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 100.0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT02868242)
Timeframe: Baseline to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 50 IU/mL) at 12 weeks after stopping study treatment. (NCT02868242)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF | 100.0 |
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HCV RNA Change From Baseline/Day 1
(NCT02868242)
Timeframe: Baseline; Weeks 1, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 1 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
LDV/SOF | -3.34 | -3.62 | -3.36 | -3.62 |
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Percentage of Participants With HCV RNA < LLOQ While on Treatment
(NCT02868242)
Timeframe: Weeks 1, 4, 8, and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 4 | Week 8 | Week 12 |
---|
LDV/SOF | 89.5 | 100.0 | 94.7 | 100.0 |
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Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
"The HCV RNA levels (viral burden) from each infected hepatocytes were measured using Quantitative Real-Time Polymerase Chain Reaction (PCR) from each participants at pre-treatment and post-treatment.~The level of HCV RNA (viral burden) decline were reported from intracellular hepatocytes and compared to those treated with Sofosbuvir/Velpatasvir (SOF/VEL) vs Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) and between HCV mono infection and HIV/HCV co infection groups." (NCT02938013)
Timeframe: Pre-treatment, after first week
Intervention | International unit (IU) per hepatocyte (Median) |
---|
| Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Pre treat | Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Post treat | Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)Pre treat | Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)Post treat | Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)Pre treat | Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)Post treat | Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)Pre treat | Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)Post treat | Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)Pre treat | Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)Post treat |
---|
Group A | 8.61 | 20.91 | 19.74 | 0 | 10.35 | 14.76 | 29.25 | 9.15 | 15.3 | 14.55 |
,Group B | 7.57 | 2.83 | 11.04 | 12.93 | 27.18 | 9.25 | 3.45 | 0 | 2.36 | 2.27 |
,Group C | 32.7 | 37.8 | 18.36 | 8.16 | 30 | 15.72 | 14.25 | 0 | 5.49 | 4.09 |
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Reduction Over the First Week in Plasma HCV RNA
"During one week after treatment with direct-acting antivirals, the decline from the baseline plasma HCV RNA levels observed for each individual participant using HCV Quantitative real time PCR.~The level of HCV RNA decline compared to those treated with Sofosbuvir/Velpatasvir (SOF/VEL) vs Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) and between HCV mono infection and HIV/HCV co infection groups." (NCT02938013)
Timeframe: Pre-treatment, up to 1 week
Intervention | IU/ml (Median) |
---|
| Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) | Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C) | Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C) | Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C) | Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C) |
---|
Group A | 631 | 217.75 | 1029.75 | 6617.5 | 2506.5 |
,Group B | 2240 | 884.75 | 1348500 | 551.5 | 627.5 |
,Group C | 14817.5 | 635.5 | 5327.5 | 65075 | 12992.5 |
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Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
"Estimate the total number of HCV-infected Hepatocytes (virus burden) for each participant between pre-treatment liver biopsy and post treatment liver biopsy samples using HCV Quantitative real time PCR.~Comparison of total number of HCV-infected Hepatocytes (virus burden) were reported between HCV mono infection and co infection groups." (NCT02938013)
Timeframe: Pre-treatment, Day 7
Intervention | Hepatocytes (Number) |
---|
| Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C)pre trea | Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C)pos trea | Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)pre trea | Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)pos trea | Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)pretreat | Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)postreat | Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)pre trea | Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)pos trea | Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)pretre | Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)postre |
---|
Group A | 45 | 2 | 53 | 0 | 18 | 2 | 109 | 3 | 126 | 18 |
,Group B | 16 | 5 | 11 | 1 | 212 | 9 | 24 | 1 | 4 | 1 |
,Group C | 290 | 7 | 33 | 3 | 216 | 24 | 13 | 0 | 74 | 12 |
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Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
"Total number of hepatocytes that express interferon-stimulated genes (ISGs) were estimated using Quantitative real time PCR for each participant on pre-treatment and post treatment liver biopsy samples.~Comparison of total number of hepatocytes that express interferon-stimulated genes (ISGs) were reported between HCV mono infection and co infection groups." (NCT02938013)
Timeframe: Pre-treatment, up to 1 week
Intervention | ISG positive hepatocytes (Number) |
---|
| Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Pre Treatment | Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Post Treatment | Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C) Pre Treatment | Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C) Post Treatment | Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C) Pre Treatment | Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C) Post Treatment | Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C) Pre Treatment | Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C) Post Treatment | Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C) Pre Treatment | Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C) Post Treatment |
---|
Group A | 14 | 8 | 57 | 62 | 78 | 83 | 71 | 71 | 79 | 72 |
,Group B | 71 | 68 | 36 | 24 | 66 | 46 | 49 | 27 | 67 | 66 |
,Group C | 41 | 68 | 39 | 40 | 55 | 57 | 36 | 63 | 34 | 42 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug. (NCT02939989)
Timeframe: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
Intervention | percentage of participants (Number) |
---|
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks | 100 |
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks | 96.4 |
Total | 97.0 |
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Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed. (NCT02939989)
Timeframe: From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).
Intervention | percentage of participants (Number) |
---|
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks | 0 |
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks | 3.6 |
Total | 3.0 |
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Percentage of Participants With On-treatment Virologic Failure
"On-treatment virologic failure was defined as meeting one of the following:~confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the treatment period; or~confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or~HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment." (NCT02939989)
Timeframe: 12 or 16 weeks depending on the treatment regimen
Intervention | percentage of participants (Number) |
---|
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks | 0 |
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks | 0 |
Total | 0 |
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Percentage of Participants With HCV RNA < LLOQ While on Study Treatment
(NCT02994056)
Timeframe: Weeks 2, 4, 8, and 12
Intervention | Percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL+ RBV (GT-1) | 38.9 | 100.0 | 100.0 | 100.0 |
,SOF/VEL+ RBV (GT-2) | 0 | 75.0 | 100.0 | 100.0 |
,SOF/VEL+ RBV (GT-3) | 71.4 | 100.0 | 100.0 | 100.0 |
,SOF/VEL+ RBV (Total) | 43.8 | 96.6 | 100.0 | 100.0 |
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Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
"MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. No change was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; Decrease was assigned for differences that were less than or equal to -2; and Increase was assigned for values that were greater than or equal to 2." (NCT02994056)
Timeframe: Baseline to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| Decrease (Improvement) | No Change | Increase (Worsening) |
---|
SOF/VEL+ RBV | 52.6 | 21.1 | 26.3 |
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Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event
(NCT02994056)
Timeframe: First dose date up to Week 12
Intervention | percentage of participants (Number) |
---|
| Discontinuation of SOF/VEL | Discontinuation of RBV |
---|
SOF/VEL+ RBV | 6.3 | 21.9 |
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Absolute HCV RNA Level Through Week 12
(NCT02994056)
Timeframe: Baseline; Weeks 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL+ RBV (GT-1) | 5.46 | 1.47 | 1.15 | 1.15 | 1.15 |
,SOF/VEL+ RBV (GT-2) | 6.01 | 1.63 | 1.15 | 1.15 | 1.15 |
,SOF/VEL+ RBV (GT-3) | 4.84 | 1.43 | 1.15 | 1.15 | 1.15 |
,SOF/VEL+ RBV (Total) | 5.17 | 1.46 | 1.15 | 1.15 | 1.15 |
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Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment. (NCT02994056)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL+ RBV (Total) | 87.5 |
SOF/VEL+ RBV (GT-1) | 88.9 |
SOF/VEL+ RBV (GT-2) | 80.0 |
SOF/VEL+ RBV (GT-3) | 85.7 |
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Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02994056)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL+ RBV (Total) | 75.0 |
SOF/VEL+ RBV (GT-1) | 72.2 |
SOF/VEL+ RBV (GT-2) | 80.0 |
SOF/VEL+ RBV (GT-3) | 71.4 |
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Number of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT02994056)
Timeframe: Baseline up to Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
SOF/VEL+ RBV (GT-1) | 0 |
SOF/VEL+ RBV (GT-2) | 0 |
SOF/VEL+ RBV (GT-3) | 1 |
SOF/VEL+ RBV (Total) | 1 |
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Change From Baseline in HCV RNA
(NCT02994056)
Timeframe: Baseline; Weeks 2, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
SOF/VEL+ RBV (GT-1) | -4.06 | -4.39 | -4.39 | -4.39 |
,SOF/VEL+ RBV (GT-2) | -4.50 | -4.88 | -4.72 | -4.72 |
,SOF/VEL+ RBV (GT-3) | -3.41 | -3.70 | -3.70 | -3.70 |
,SOF/VEL+ RBV (Total) | -3.72 | -3.99 | -4.00 | -4.00 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02994056)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL+ RBV (Total) | 78.1 |
SOF/VEL+ RBV (GT-1) | 72.2 |
SOF/VEL+ RBV (GT-2) | 80.0 |
SOF/VEL+ RBV (GT-3) | 85.7 |
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Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class
CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24. (NCT02994056)
Timeframe: Baseline to Posttreatment Week 24
Intervention | Percentage of participants (Number) |
---|
| Improved CPT Class | Worsened CPT Class | No Change CPT Class |
---|
SOF/VEL+ RBV | 42.1 | 0 | 57.9 |
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Treatment Phase: Percentage of Participants With Virologic Failure
Virologic failure was defined as: On-treatment virologic failure - Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT03022981)
Timeframe: Up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old | 1.0 |
6 to < 12 Years Old | 1.4 |
3 to < 6 Years Old | 0.0 |
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Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. (NCT03022981)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old | 96.1 |
6 to < 12 Years Old | 94.5 |
3 to < 6 Years Old | 82.9 |
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Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR 24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. (NCT03022981)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old | 95.1 |
6 to < 12 Years Old | 93.2 |
3 to < 6 Years Old | 82.9 |
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Treatment Phase: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT03022981)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old | 95.1 |
6 to < 12 Years Old | 93.2 |
3 to < 6 Years Old | 82.9 |
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Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or Any AEs leading to premature discontinuation of study drug. (NCT03022981)
Timeframe: From first dose through last dose of the study drug (Up to 12 weeks) plus 30 days
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old | 0.0 |
6 to < 12 Years Old | 2.7 |
3 to < 6 Years Old | 2.4 |
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Treatment Phase: Growth and Development as Measured by Parental Height
Mid-parental height was calculated as the average of the biological father's and mother's heights. For boys, the sex-adjusted mid-parental height was calculated by adding 2.5 inches or 6.5 cm to the mean of the parents' heights. For girls, 2.5 inches or 6.5 cm was subtracted from the mean of the parents' heights. (NCT03022981)
Timeframe: Day 1
Intervention | cm (Median) |
---|
12 to < 18 Years Old | 170.5 |
6 to < 12 Years Old | 170.0 |
3 to < 6 Years Old | 168.7 |
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PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT03022981)
Timeframe: First dose date up to Day 7
Intervention | percentage of participants (Number) |
---|
12 to < 18 Years Old | 0.0 |
6 to < 12 Years Old | 0.0 |
3 to < 6 Years Old | 0.0 |
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PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). (NCT03022981)
Timeframe: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose
Intervention | hours*nanograms per milliliter (h*ng/mL) (Mean) |
---|
12 to < 18 Years Old | 4479.3 |
6 to < 12 Years Old | 3697.5 |
3 to < 6 Years Old | 4450.3 |
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PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). (NCT03022981)
Timeframe: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose
Intervention | h*ng/mL (Mean) |
---|
12 to < 18 Years Old | 3020.1 |
6 to < 12 Years Old | 1764.5 |
Cohort 3 (3 to < 6 Years Old) | 3306.2 |
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Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment
Percentage of participants with HCV RNA < LLOQ while on treatment by analysis visit. (NCT03022981)
Timeframe: Weeks 1, 4, 8, and 12
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 4 | Week 8 | Week 12 |
---|
12 to < 18 Years Old | 44.1 | 96.1 | 100.0 | 100.0 |
,3 to < 6 Years Old | 36.8 | 91.4 | 100.0 | 100.0 |
,6 to < 12 Years Old | 39.7 | 94.4 | 98.6 | 98.6 |
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Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline
A SOF/VEL FDC swallowability assessment was performed using placebo tablets at baseline. (NCT03022981)
Timeframe: Baseline
Intervention | Participants (Count of Participants) |
---|
| SOF/VEL 400/100mg Placebo Tablet, Able to Swallow | SOF/VEL 400/100mg Placebo, Not Able to Swallow | SOF/VEL 200/50mg Placebo, Able to Swallow | SOF/VEL 200/50mg Placebo, Not Able to Swallow |
---|
12 to < 18 Years Old | 92 | 10 | 10 | 0 |
,6 to < 12 Years Old | 1 | 0 | 72 | 1 |
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Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey
To evaluate the effect of treatment with SOF/VEL on general and disease-specific health-related QoL, the PedsQL™ Pediatric QoL Inventory V4.0 Short Form (SF15) was completed at Day 1, end of treatment, early termination (if applicable), and posttreatment Weeks 12 and 24. The SF15 questionnaire represented 4 domains: physical, emotional, social, and school functioning, with the emotional, social, and school functioning domains representing the psychosocial health summary. Neuropsychiatric assessment was conducted using the PedsQL™ Pediatric QoL Inventory V4.0 SF15 psychosocial domain-related scores. Items were calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better QoL. (NCT03022981)
Timeframe: Baseline; Week 12, End of Treatment (EOT), Posttreatment/Follow-up (FU) Week-12 (FU-12), and FU Week-24 (FU-24)
Intervention | score on a scale (Mean) |
---|
| Parents Reports, Total Score at Baseline | Parents Reports, Total Score at Week 12 | Parents Reports, Total Score at EOT | Parents Reports, Total Score at Follow Up-12 | Parents Reports, Total Score at Follow Up-24 | Participants Reports, Total Score at Baseline | Participants Reports, Total Score at Week 12 | Participants Reports, Total Score at EOT | Participants Reports, Total Score at Follow Up-12 | Participants Reports, Total Score at Follow Up-24 |
---|
12 to < 18 Years Old | 80.0 | 82.4 | 82.4 | 81.7 | 80.8 | 79.9 | 80.9 | 80.9 | 82.5 | 81.4 |
,3 to < 6 Years Old | 86.5 | 87.3 | 87.0 | 87.7 | 88.3 | 82.2 | 83.3 | 83.3 | 80.5 | 82.1 |
,6 to < 12 Years Old | 79.7 | 82.8 | 82.2 | 81.5 | 79.7 | 77.9 | 80.0 | 79.7 | 81.1 | 81.7 |
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Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment
Drug-resistant substitutions were analyzed as part of the Virology Study. Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline deep sequencing of the HCV nonstructural protein (NS)5A and NS5B genes was performed for all participants at the first time point after virologic failure if the plasma or serum sample was available. Pretreatment full-length NS5A deep sequencing data were obtained at a 15% assay cutoff for the Resistance Analysis Population which covered all NS5A and NS5B nucleoside inhibitor (NI) resistance-associated variants (RAVs). (NCT03022981)
Timeframe: First dose date up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
| Pretreatment NS5A NI RAVs | Pretreatment NS5B NI RAVs |
---|
12 to < 18 Years Old | 16.3 | 5.1 |
,3 to < 6 Years Old | 18.1 | 3.0 |
,6 to < 12 Years Old | 10.2 | 0.0 |
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Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12
Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability. (NCT03022981)
Timeframe: Week 12
Intervention | Participants (Count of Participants) |
---|
| Taste, Participants Who Did Not Taste Study Drug | Taste, Participants Who Marked > 60 to 100 | Taste, Participants Who Marked 40 to 60 | Taste, Participants Who Marked 0 to < 40 | Easy to Take, Participants Who Marked > 60 to 100 | Easy to Take, Participants Who Marked 40 to 60 | Easy to Take, Participants Who Marked 0 to < 40 | Feel About Taking Pills, Who Marked > 60 to 100 | Feel About Taking Pills, Who Marked 40 to 60 | Feel About Taking Pills, Who Marked 0 to < 40 |
---|
12 to < 18 Years Old | 49 | 24 | 10 | 7 | 83 | 3 | 3 | 82 | 3 | 3 |
,12 to <18 Years Old | 2 | 5 | 1 | 3 | 9 | 0 | 2 | 8 | 1 | 2 |
,3 to < 6 Years Old | 8 | 4 | 4 | 7 | 20 | 1 | 2 | NA | NA | NA |
,3 to <6 Years Old | 2 | 1 | 3 | 2 | 6 | 1 | 1 | NA | NA | NA |
,6 to < 12 Years Old | 33 | 14 | 12 | 11 | 65 | 5 | 0 | 60 | 7 | 3 |
,6 to <12 Years Old | 0 | 0 | 1 | 0 | 1 | 0 | 0 | NA | NA | NA |
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Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1
Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability. (NCT03022981)
Timeframe: Day 1
Intervention | Participants (Count of Participants) |
---|
| Taste, Participants Who Did Not Taste Study Drug | Taste, Participants Who Marked > 60 to 100 | Taste, Participants Who Marked 40 to 60 | Taste, Participants Who Marked 0 to < 40 | Easy to Take, Participants Who Marked > 60 to 100 | Easy to Take, Participants Who Marked 40 to 60 | Easy to Take, Participants Who Marked 0 to < 40 |
---|
12 to < 18 Years Old | 61 | 16 | 11 | 3 | 82 | 5 | 2 |
,12 to <18 Years Old | 5 | 3 | 1 | 2 | 9 | 1 | 1 |
,3 to < 6 Years Old | 8 | 6 | 4 | 9 | 13 | 4 | 10 |
,3 to <6 Years Old | 5 | 3 | 1 | 3 | 4 | 2 | 6 |
,6 to < 12 Years Old | 42 | 11 | 6 | 12 | 60 | 3 | 8 |
,6 to <12 Years Old | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
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Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline
Tanner Pubertal Staging was assessed for pubic hair growth and genitalia development (males) and for pubic hair growth and breast development (females) in stages 1 to 5. Tanner stages were used to evaluate the onset and progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to the medial surface of the thighs); Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts); Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes and penis, 3: Enlargement of penis, 4: Penis size enlargement, 5: Genitalia adult in size and shape). (NCT03022981)
Timeframe: Baseline; EOT, FU-12 and FU-24
Intervention | Participants (Count of Participants) |
---|
| Pubic Hair (Male): Baseline, Stage 1 | Pubic Hair (Male): Baseline, Stage 2 | Pubic Hair (Male): Baseline, Stage 3 | Pubic Hair (Male): Baseline, Stage 4 | Pubic Hair (Male): Baseline, Stage 5 | Pubic Hair (Male): EOT, Stage 1 | Pubic Hair (Male): EOT, Stage 2 | Pubic Hair (Male): EOT, Stage 3 | Pubic Hair (Male): EOT, Stage 4 | Pubic Hair (Male): EOT, Stage 5 | Pubic Hair (Male): FU-12, Stage 1 | Pubic Hair (Male): FU-12, Stage 2 | Pubic Hair (Male): FU-12, Stage 3 | Pubic Hair (Male): FU-12, Stage 4 | Pubic Hair (Male): FU-12, Stage 5 | Pubic Hair (Male): FU-24, Stage 1 | Pubic Hair (Male): FU-24, Stage 2 | Pubic Hair (Male): FU-24, Stage 3 | Pubic Hair (Male): FU-24, Stage 4 | Pubic Hair (Male): FU-24, Stage 5 | Genitalia (Male): Baseline, Stage 1 | Genitalia (Male): Baseline, Stage 2 | Genitalia (Male): Baseline, Stage 3 | Genitalia (Male): Baseline, Stage 4 | Genitalia (Male): Baseline, Stage 5 | Genitalia (Male): EOT, Stage 1 | Genitalia (Male): EOT, Stage 2 | Genitalia (Male): EOT, Stage 3 | Genitalia (Male): EOT, Stage 4 | Genitalia (Male): EOT, Stage 5 | Genitalia (Male): FU-12, Stage 1 | Genitalia (Male): FU-12, Stage 2 | Genitalia (Male): FU-12, Stage 3 | Genitalia (Male): FU-12, Stage 4 | Genitalia (Male): FU-12, Stage 5 | Genitalia (Male): FU-24, Stage 1 | Genitalia (Male): FU-24, Stage 2 | Genitalia (Male): FU-24, Stage 3 | Genitalia (Male): FU-24, Stage 4 | Genitalia (Male): FU-24, Stage 5 | Pubic Hair (Female): Baseline, Stage 1 | Pubic Hair (Female): Baseline, Stage 2 | Pubic Hair (Female): Baseline, Stage 3 | Pubic Hair (Female): Baseline, Stage 4 | Pubic Hair (Female): Baseline, Stage 5 | Pubic Hair (Female): EOT, Stage 1 | Pubic Hair (Female): EOT, Stage 2 | Pubic Hair (Female): EOT, Stage 3 | Pubic Hair (Female): EOT, Stage 4 | Pubic Hair (Female): EOT, Stage 5 | Pubic Hair (Female): FU-12, Stage 1 | Pubic Hair (Female): FU-12, Stage 2 | Pubic Hair (Female): FU-12, Stage 3 | Pubic Hair (Female): FU-12, Stage 4 | Pubic Hair (Female): FU-12, Stage 5 | Pubic Hair (Female): FU-24, Stage 1 | Pubic Hair (Female): FU-24, Stage 2 | Pubic Hair (Female): FU-24, Stage 3 | Pubic Hair (Female): FU-24, Stage 4 | Pubic Hair (Female): FU-24, Stage 5 | Breasts (Female): Baseline, Stage 1 | Breasts (Female): Baseline, Stage 2 | Breasts (Female): Baseline, Stage 3 | Breasts (Female): Baseline, Stage 4 | Breasts (Female): Baseline, Stage 5 | Breasts (Female): EOT, Stage 1 | Breasts (Female): EOT, Stage 2 | Breasts (Female): EOT, Stage 3 | Breasts (Female): EOT, Stage 4 | Breasts (Female): EOT, Stage 5 | Breasts (Female): FU-12, Stage 1 | Breasts (Female): FU-12, Stage 2 | Breasts (Female): FU-12, Stage 3 | Breasts (Female): FU-12, Stage 4 | Breasts (Female): FU-12, Stage 5 | Breasts (Female): FU-24, Stage 1 | Breasts (Female): FU-24, Stage 2 | Breasts (Female): FU-24, Stage 3 | Breasts (Female): FU-24, Stage 4 | Breasts (Female): FU-24, Stage 5 |
---|
12 to < 18 Years Old | 4 | 3 | 10 | 14 | 19 | 2 | 4 | 7 | 13 | 24 | 1 | 5 | 6 | 10 | 25 | 1 | 4 | 2 | 13 | 25 | 4 | 3 | 8 | 16 | 19 | 2 | 3 | 7 | 15 | 23 | 1 | 4 | 7 | 11 | 24 | 1 | 2 | 4 | 13 | 25 | 2 | 3 | 9 | 16 | 22 | 2 | 2 | 6 | 10 | 30 | 2 | 1 | 8 | 8 | 32 | 2 | 0 | 8 | 9 | 31 | 1 | 5 | 6 | 17 | 23 | 1 | 2 | 6 | 14 | 27 | 1 | 2 | 5 | 15 | 28 | 1 | 0 | 6 | 13 | 30 |
,3 to < 6 Years Old | 17 | 0 | 0 | 0 | 0 | 13 | 0 | 0 | 0 | 0 | 14 | 0 | 0 | 0 | 0 | 14 | 0 | 0 | 0 | 0 | 17 | 0 | 0 | 0 | 0 | 13 | 0 | 0 | 0 | 0 | 14 | 0 | 0 | 0 | 0 | 14 | 0 | 0 | 0 | 0 | 24 | 0 | 0 | 0 | 0 | 21 | 0 | 0 | 0 | 0 | 21 | 0 | 0 | 0 | 0 | 20 | 1 | 0 | 0 | 0 | 24 | 0 | 0 | 0 | 0 | 21 | 0 | 0 | 0 | 0 | 21 | 0 | 0 | 0 | 0 | 20 | 1 | 0 | 0 | 0 |
,6 to < 12 Years Old | 31 | 2 | 1 | 0 | 0 | 28 | 3 | 1 | 0 | 0 | 26 | 3 | 1 | 0 | 0 | 29 | 2 | 1 | 0 | 0 | 31 | 2 | 1 | 0 | 0 | 28 | 3 | 1 | 0 | 0 | 26 | 3 | 1 | 0 | 0 | 27 | 4 | 1 | 0 | 0 | 31 | 5 | 2 | 0 | 0 | 29 | 5 | 2 | 1 | 0 | 24 | 7 | 3 | 1 | 0 | 24 | 6 | 1 | 4 | 0 | 29 | 6 | 3 | 0 | 0 | 25 | 9 | 2 | 1 | 0 | 20 | 11 | 2 | 2 | 0 | 20 | 10 | 3 | 2 | 0 |
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Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12
(NCT03022981)
Timeframe: Baseline; Weeks 1, 4, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Baseline | Change from Baseline at Week 1 | Change from Baseline at Week 4 | Change from Baseline at Week 8 | Change from Baseline at Week 12 |
---|
12 to < 18 Years Old | 6.06 | -4.46 | -4.89 | -4.91 | -4.91 |
,3 to < 6 Years Old | 5.86 | -4.06 | -4.49 | -4.56 | -4.56 |
,6 to < 12 Years Old | 5.87 | -4.28 | -4.64 | -4.69 | -4.70 |
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Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles
An age- and sex-specific percentile was derived for each weight, height, and BMI measurement according to the SAS program available on the CDC website using the year 2000 growth charts. (NCT03022981)
Timeframe: Baseline; Weeks 1, 4, 8, 12, FU-4, FU-12, and FU-24
Intervention | percentile (Median) |
---|
| Baseline | Change From Baseline at Week 1 | Change From Baseline at Week 4 | Change From Baseline at Week 8 | Change From Baseline at Week 12 | Change From Baseline at FU-4 | Change From Baseline at FU-12 | Change From Baseline at FU-24 |
---|
12 to < 18 Years Old | 67.2 | 0.0 | 0.0 | 0.0 | 0.2 | 0.1 | 0.0 | 0.1 |
,3 to < 6 Years Old | 64.6 | -0.5 | 0.3 | 0.2 | -1.7 | -0.8 | -0.8 | -1.3 |
,6 to < 12 Years Old | 45.9 | 0.1 | 0.2 | 0.1 | 0.5 | 0.0 | 0.5 | 1.4 |
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Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles
An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts. (NCT03022981)
Timeframe: Baseline; Weeks 1, 4, 8, 12, Follow-up (FU) Week 4 (FU-4), FU-12, and FU-24
Intervention | percentile (Median) |
---|
| Baseline | Change From Baseline at Week 1 | Change From Baseline at Week 4 | Change From Baseline at Week 8 | Change From Baseline at Week 12 | Change From Baseline at FU-4 | Change From Baseline at FU-12 | Change From Baseline at FU-24 |
---|
12 to < 18 Years Old | 44.5 | 0.0 | 0.0 | 0.0 | -0.1 | 0.0 | -0.2 | -0.6 |
,3 to < 6 Years Old | 39.3 | 0.5 | 1.4 | 0.3 | 0.2 | 1.2 | 0.6 | 0.3 |
,6 to < 12 Years Old | 41.9 | 0.1 | 0.2 | -0.1 | 0.2 | 0.2 | 0.1 | -0.2 |
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Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age
Bone age was determined based on x-ray of the left wrist, hand, and fingers. Baseline value is the last available value on or prior to first dose date of study drug. (NCT03022981)
Timeframe: Baseline; FU-24
Intervention | years (Median) |
---|
| Baseline | Change From Baseline at FU-24 |
---|
12 to < 18 Years Old | 15.5 | 0.6 |
,3 to < 6 Years Old | 4.8 | 0.5 |
,6 to < 12 Years Old | 7.8 | 1.0 |
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PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7
(NCT03022981)
Timeframe: Baseline; Day 7
Intervention | log10 international units per mL (IU/mL) (Mean) |
---|
| Baseline | Change from Baseline at Day 7 |
---|
12 to < 18 Years Old | 6.09 | -4.48 |
,3 to < 6 Years Old | 5.77 | -3.94 |
,6 to < 12 Years Old | 5.84 | -4.20 |
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PK Parameter: AUCtau of SOF
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036839)
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
Intervention | h*ng/mL (Mean) |
---|
LDV/SOF for 8 Weeks | 2435.4 |
LDV/SOF for 12 Weeks | 2296.6 |
LDV/SOF for 24 Weeks | 2838.2 |
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PK Parameter: Cmax of SOF
Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036839)
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
Intervention | ng/mL (Mean) |
---|
LDV/SOF for 8 Weeks | 1059.8 |
LDV/SOF for 12 Weeks | 1005.8 |
LDV/SOF for 24 Weeks | 1052.5 |
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HCV RNA
(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Intervention | log10 IU/mL (Mean) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 12 |
---|
LDV/SOF for 12 Weeks | 1.22 | 1.15 | 1.15 | 1.15 | 1.15 |
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HCV RNA
(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Intervention | log10 IU/mL (Mean) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
LDV/SOF for 24 Weeks | 1.18 | 1.15 | 1.15 | 1.15 | 1.15 | 1.15 | 1.15 | 1.15 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
"The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA < LLOQ detected plus the number of participants with HCV RNA < LLOQ target not detected (TND). LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method." (NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 |
---|
LDV/SOF for 8 Weeks | 84.4 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
"The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA < LLOQ detected plus the number of participants with HCV RNA < LLOQ target not detected (TND). LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method." (NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 12 |
---|
LDV/SOF for 12 Weeks | 90.3 | 100.0 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
"The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA < LLOQ detected plus the number of participants with HCV RNA < LLOQ target not detected (TND). LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method." (NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
LDV/SOF for 24 Weeks | 84.2 | 100.0 | 94.7 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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Change From Baseline in HCV RNA
(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 |
---|
LDV/SOF for 8 Weeks | -4.63 | -4.61 | -4.61 | -4.61 |
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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
(NCT03036839)
Timeframe: First dose date up to Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF for 8 Weeks | 0 |
LDV/SOF for 12 Weeks | 0 |
LDV/SOF for 24 Weeks | 0 |
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Change From Baseline in HCV RNA
(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 12 |
---|
LDV/SOF for 12 Weeks | -4.71 | -4.79 | -4.79 | -4.79 | -4.79 |
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Change From Baseline in HCV RNA
(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 |
---|
LDV/SOF for 24 Weeks | -4.67 | -4.71 | -4.81 | -4.81 | -4.79 | -4.79 | -4.79 | -4.75 |
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method. (NCT03036839)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
LDV/SOF for 8 Weeks | 97.8 |
LDV/SOF for 12 Weeks | 100.0 |
LDV/SOF for 24 Weeks | 84.2 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method. (NCT03036839)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
LDV/SOF for 8 Weeks | 93.3 |
LDV/SOF for 12 Weeks | 100.0 |
LDV/SOF for 24 Weeks | 84.2 |
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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method. (NCT03036839)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF for 8 Weeks | 93.3 |
LDV/SOF for 12 Weeks | 100.0 |
LDV/SOF for 24 Weeks | 84.2 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT03036839)
Timeframe: Baseline up to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
LDV/SOF for 8 Weeks | 0 |
LDV/SOF for 12 Weeks | 0 |
LDV/SOF for 24 Weeks | 0 |
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Pharmacokinetics (PK) Parameter: AUCtau of LDV
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036839)
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
Intervention | h*ng/mL (Mean) |
---|
LDV/SOF for 8 Weeks | 11923.9 |
LDV/SOF for 12 Weeks | 13632.7 |
LDV/SOF for 24 Weeks | 13542.5 |
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HCV RNA
(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Intervention | log10 IU/mL (Mean) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 |
---|
LDV/SOF for 8 Weeks | 1.17 | 1.15 | 1.15 | 1.15 |
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PK Parameter: Cmax of LDV
Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036839)
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
Intervention | ng/mL (Mean) |
---|
LDV/SOF for 8 Weeks | 544.2 |
LDV/SOF for 12 Weeks | 618.4 |
LDV/SOF for 24 Weeks | 607.0 |
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Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL. (NCT03036852)
Timeframe: First dose date up to Posttreatment Week 24
Intervention | Participants (Count of Participants) |
---|
SOF/VEL | 0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT03036852)
Timeframe: Baseline to Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL (Total) | 3.4 |
SOF/VEL (GT-1) | 4.0 |
SOF/VEL (GT-2) | 0 |
SOF/VEL (GT-3) | 6.3 |
SOF/VEL (GT-4) | 0 |
SOF/VEL (GT-6) | 0 |
SOF/VEL (Indeterminate) | 0 |
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Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment. (NCT03036852)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL (Total) | 96.6 |
SOF/VEL (GT-1) | 96.0 |
SOF/VEL (GT-2) | 100.0 |
SOF/VEL (GT-3) | 93.8 |
SOF/VEL (GT-4) | 100.0 |
SOF/VEL (GT-6) | 100.0 |
SOF/VEL (Indeterminate) | 100.0 |
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Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment. (NCT03036852)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL (Total) | 94.9 |
SOF/VEL (GT-1) | 92.0 |
SOF/VEL (GT-2) | 100.0 |
SOF/VEL (GT-3) | 93.8 |
SOF/VEL (GT-4) | 100.0 |
SOF/VEL (GT-6) | 100.0 |
SOF/VEL (Indeterminate) | 100.0 |
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment. (NCT03036852)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL (Total) | 94.9 |
SOF/VEL (GT-1) | 92.0 |
SOF/VEL (GT-2) | 100.0 |
SOF/VEL (GT-3) | 93.8 |
SOF/VEL (GT-4) | 100.0 |
SOF/VEL (GT-6) | 100.0 |
SOF/VEL (Indeterminate) | 100.0 |
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PK Parameter: Cmax of SOF
Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Intervention | ng/mL (Mean) |
---|
SOF/VEL | 1041.0 |
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PK Parameter: Cmax of VEL
Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Intervention | ng/mL (Mean) |
---|
SOF/VEL | 226.9 |
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PK Parameter: Ctau of VEL
Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Intervention | ng/mL (Mean) |
---|
SOF/VEL | 137.2 |
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Change From Baseline in HCV RNA
(NCT03036852)
Timeframe: Baseline; Weeks 2, 4, 6, 8, and 12
Intervention | log10 IU/mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 12 |
---|
SOF/VEL (GT-1) | -4.69 | -4.81 | -4.81 | -4.81 | -4.81 |
,SOF/VEL (GT-2) | -3.78 | -4.05 | -4.05 | -4.05 | -4.05 |
,SOF/VEL (GT-3) | -5.07 | -5.20 | -5.20 | -5.20 | -5.20 |
,SOF/VEL (GT-4) | -4.23 | -4.48 | -4.48 | -4.48 | -4.48 |
,SOF/VEL (GT-6) | -5.29 | -5.29 | -5.29 | -5.29 | -5.29 |
,SOF/VEL (Indeterminate) | -3.24 | -3.26 | -3.26 | -3.26 | -3.26 |
,SOF/VEL (Total) | -4.54 | -4.69 | -4.69 | -4.69 | -4.69 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
(NCT03036852)
Timeframe: Weeks 2, 4, 6, 8, and 12
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 12 |
---|
SOF/VEL (GT-1) | 76.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,SOF/VEL (GT-2) | 85.7 | 100.0 | 100.0 | 100.0 | 100.0 |
,SOF/VEL (GT-3) | 43.8 | 100.0 | 100.0 | 100.0 | 100.0 |
,SOF/VEL (GT-4) | 50.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,SOF/VEL (GT-6) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,SOF/VEL (Indeterminate) | 80.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,SOF/VEL (Total) | 67.8 | 100.0 | 100.0 | 100.0 | 100.0 |
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Pharmacokinetic (PK) Parameter: AUCtau of SOF
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Intervention | h*ng/mL (Mean) |
---|
SOF/VEL | 2381.9 |
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PK Parameter: AUCtau of VEL
AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Intervention | h*ng/mL (Mean) |
---|
SOF/VEL | 4279.4 |
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Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
(NCT03036852)
Timeframe: First dose date up to Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 0 |
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Number of Participants Achieving Sustained Virologic Response (SVR)
Number of participants with non-detectable Hepatitis C Virus (HCV) Ribonucleic acid (RNA) post-treatment as measured by SVR testing (NCT03057847)
Timeframe: End of treatment (12 weeks postpartum) up to 18 months
Intervention | Participants (Count of Participants) |
---|
SOF/VEL | 13 |
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Number of Missed Treatment Doses
Treatment adherence assessed by missed treatment doses (NCT03057847)
Timeframe: End of treatment (12 weeks postpartum)
Intervention | doses (Median) |
---|
SOF/VEL | 2 |
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Number of Participants Reporting Treatment Side Effects
Number of participants reporting treatment side effects using standardized list (NCT03057847)
Timeframe: End of treatment (12 weeks postpartum)
Intervention | Participants (Count of Participants) |
---|
SOF/VEL | 12 |
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Intravenous Drug Use Recidivism
Rate of intravenous drug use recidivism by participant self-report and Urine Drug Screening (NCT03057847)
Timeframe: 15 months post-treatment, up to 18 months
Intervention | Participants (Count of Participants) |
---|
SOF/VEL | 3 |
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Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment
Number of participants initiating HCV treatment (NCT03057847)
Timeframe: Delivery to 10 months postpartum
Intervention | Participants (Count of Participants) |
---|
SOF/VEL | 21 |
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HCV Reinfection
Count of participants 15 months post-treatment with Hepatitis C Virus reinfection as measured by related lab tests (NCT03057847)
Timeframe: 15 months post-treatment
Intervention | Participants (Count of Participants) |
---|
SOF/VEL | 0 |
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
(NCT03074331)
Timeframe: Up to Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 0 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT03074331)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 93.0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as the following:~On Treatment Virologic Failure: HCV RNA persistently ≥ LLOQ through 12 weeks of treatment (nonresponse), or~Relapse: HCV RNA ≥ LLOQ at Posttreatment Week 12 having achieved HCV RNA < LLOQ at end of treatment." (NCT03074331)
Timeframe: Up to Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL 12 Weeks | 2.3 |
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Number of Participants With Resolution of Active PCT by 7 Months After Start of Therapy
Resolution of active PCT, defined as normalization of plasma porphyrins (less than 0.9 mcg/dL) by 7 months after start of therapy (NCT03118674)
Timeframe: 7 months
Intervention | Participants (Count of Participants) |
---|
Harvoni | 9 |
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Number of Participants With Complete Biochemical Remission of PCT
Defined as a decrease of the sum of urinary uro- and hepta-carboxyl porphyrins to less than 100 mcg/g creatinine and a normal urine porphyrin HPLC pattern defined as the total of highly carboxylated porphyrins (uro- and heptacarboxyl-porphyrins) being less than that of coproporphyrins, and the absence of a plasma fluorescence peak by fluorescence scanning (NCT03118674)
Timeframe: 12 Months
Intervention | Participants (Count of Participants) |
---|
Harvoni | 5 |
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Number of Participants With Cure of CHC
Defined as no detectable HCV RNA at end of treatment and persisting for at least 12 weeks after end of treatment. (NCT03118674)
Timeframe: Up to 15 months
Intervention | Participants (Count of Participants) |
---|
Harvoni | 11 |
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Time to Resolution of Active PCT
Time to resolution of active PCT, defined as cessation of any new blisters or bullae and normalization of plasma porphyrins (NCT03118674)
Timeframe: through study completion, an average of 1 year
Intervention | days (Mean) |
---|
Harvoni | 240 |
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Adherence to Study Treatment
To assess adherence to velpatasvir/sofosbuvir therapy among participants administered treatment in the context of visits to an outpatient addiction clinic for buprenorphine/naloxone replacement therapy and mental health care. (NCT03235154)
Timeframe: This outcome measure will be assessed for each participant during a 12 week course of study treatment.
Intervention | % of prescribed doses taken (Mean) |
---|
Single Arm Intervention | 94 |
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Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment (SVR-12)
To assess the effectiveness of HCV treatment with velpatasvir/sofosbuvir administered by psychiatrist/licensed buprenorphine/naloxone providers during regularly scheduled visits to an outpatient addiction clinic for buprenorphine/naloxone replacement therapy and mental healthcare, as measured by percentage of patients achieving SVR-12 (defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of study treatment), (NCT03235154)
Timeframe: This outcome measure will be assessed for each participant 12 weeks after completion of a 12 week course of treatment
Intervention | Participants (Count of Participants) |
---|
Treatment Arm | 7 |
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Adherence as Assessed by the Total Percentage of Tablets Taken (Out of Those Dispensed) During the Treatment Period
Adherence of daily directly observed therapy group from daily logs Adherence measured by counting tablets returned after each 2 week treatment period (fortnightly pickup groups) Adherence of participants infected with genotype 3 and treated with Sovaldi measured using medication event monitoring system (MEMS®) cap. (NCT03236506)
Timeframe: 12 weeks for genotype 1 HCV, 8 weeks for genotype 3 HCV infection
Intervention | percentage of medication taken (Mean) |
---|
Daily Observed Therapy | 69 |
Fortnightly Pick-up | 96 |
Fortnightly Pick-up +Psych Intervention | 98 |
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Change of Serum Hepatitis B Surface Antigen (HBsAg as Measured in log10 IU/mL) Level as an Indicator of Antiviral Activity of Ledipasvir and/or Sofosbuvir in Subjects With Chronic Hepatitis B From Baseline to End of 12 Weeks Treatment.
Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir and/or sofosbuvir and their HBsAg will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change (decline) in HBsAg from baseline to end of the 12 week treatment will be compared. (NCT03312023)
Timeframe: 12 weeks
Intervention | Log10 IU/mL (Mean) |
---|
Group A (LDV/SOF for Low Replicative HBV) | 0.39 |
Group B (LDV/SOF for Viral Suppressed HBV) | 0.40 |
Group C (SOF for Low Replicative HBV) | 0.19 |
Group D (LDV for Low Replicative HBV) | -0.05 |
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Changes in Serum Hepatitis B Virus DNA Levels (HBV DNA as Measured in IU/mL) With Treatment of Ledipasvir and/or Sofosbuvir From Baseline to End of 12 Weeks of Treatment in Subjects With Chronic Hepatitis B Infection.
"Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir and/or sofosbuvir and their serum hepatitis B DNA levels (HBV DNA) will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change in HBV DNA levels from baseline to end of the 12 week treatment will be compared.~Note: Group B (virally suppressed HBV subjects) - all had HBV DNA below the limit of detection; Hence, mean change was 0." (NCT03312023)
Timeframe: 12 weeks
Intervention | Log10 IU/mL (Mean) |
---|
Group A (LDV/SOF for Low Replicative HBV) | 0.51 |
Group B (LDV/SOF for Virally Suppressed HBV) | 0 |
Group C (SOF for Low Replicative HBV) | 0.68 |
Group D (LDV for Low Replicative HBV) | 0.21 |
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Incidence of Adverse Events Leading to Permanent Discontinuation of Ledipasvir and/or Sofosbuvir Treatment in Subjects With Chronic Hepatitis B Infection.
Number of subjects who discontinued study drug due to adverse event (NCT03312023)
Timeframe: 12 Weeks
Intervention | Participants (Count of Participants) |
---|
Group A (LDV/SOF for Low Replicative HBV) | 0 |
Group B (LDV/SOF for Viral Suppressed HBV) | 0 |
Group C (SOF for Low Replicative HBV) | 0 |
Group D (LDV for Low Replicative HBV) | 0 |
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Medication Adherence
Adherence to medication regimen defined using a combination of the biometric data for Arms 1 and 2 and self-report and pill counts for Arm 3. Percentage reporting at least 90% adherence (NCT03480932)
Timeframe: 4 weeks for SOF+DAC+PEG and 12 weeks for SOF+DAC
Intervention | Participants (Count of Participants) |
---|
SOF+DAC+PEG | 35 |
SOF+DAC, DOT | 31 |
SOF+DAC, Standard | 10 |
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Serious Adverse Events
Number of participants with treatment-related serious adverse events by laboratory tests and physician examination (NCT03480932)
Timeframe: 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC
Intervention | Participants (Count of Participants) |
---|
SOF+DAC+PEG | 0 |
SOF+DAC, DOT | 0 |
SOF+DAC, Standard | 0 |
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SVR12
Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion (NCT03480932)
Timeframe: 12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC
Intervention | Participants (Count of Participants) |
---|
SOF+DAC+PEG | 26 |
SOF+DAC, DOT | 30 |
SOF+DAC, Standard | 17 |
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Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12
"HCV RNA levels were measured by using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test v2.0. This assay has a lower limit of quantitation (LLOQ) = 15 IU/mL.~The outcome includes both results where Target was Detected (TD) but below LLOQ and results were Target was Not Detected (TND)" (NCT03487848)
Timeframe: 12 weeks after last dose
Intervention | Percent of Participants (Number) |
---|
Daclatasvir (DCV) + Sofosbuvir (SOF) | 100 |
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Apparent Total Body Clearance (CLT/F) for Daclatasvir
(NCT03487848)
Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Intervention | mL/min (Geometric Mean) |
---|
Daclatasvir (DCV) + Sofosbuvir (SOF) | 86.69 |
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Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir
(NCT03487848)
Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Intervention | h*ng/mL (Geometric Mean) |
---|
Daclatasvir (DCV) + Sofosbuvir (SOF) | 11535.45 |
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Maximum Observed Plasma Concentration (Cmax) for Daclatasvir
(NCT03487848)
Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Intervention | ng/mL (Geometric Mean) |
---|
Daclatasvir (DCV) + Sofosbuvir (SOF) | 1215.32 |
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Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis
"Laboratory tests abnormalities were analyzed in the following categories:~Hematology (hemoglobin, platelets, international normalized ratio (INR), white blood cell count (WBC), lymphocytes (absolute), neutrophils + bands (absolute; ANC)).~Hepatobiliary enzymes (ALT, AST, alkaline phosphatase, total bilirubin, albumin).~Pancreatic enzymes (lipase, creatinine). Tests results were reported by worst toxicity grade (0 to 4) based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (2017).~Only laboratory abnormalities with a worst toxicity grade 3 or higher in any of the above-mentioned tests, experienced during the follow-up period, are reported here." (NCT03487848)
Timeframe: From day after last dose to end of follow-up period (up to approximately 96 weeks)
Intervention | Participants (Count of Participants) |
---|
Daclatasvir (DCV) + Sofosbuvir (SOF) | 2 |
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Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir
(NCT03487848)
Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Intervention | Hours (Median) |
---|
Daclatasvir (DCV) + Sofosbuvir (SOF) | 2.00 |
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Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis
"Laboratory tests abnormalities were analyzed in the following categories:~Hematology (hemoglobin, platelets, international normalized ratio (INR), white blood cell count (WBC), lymphocytes (absolute), neutrophils + bands (absolute; ANC)).~Hepatobiliary enzymes (ALT, AST, alkaline phosphatase, total bilirubin, albumin).~Pancreatic enzymes (lipase, creatinine). Tests results were reported by worst toxicity grade (0 to 4) based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (2017).~Only laboratory abnormalities with a worst toxicity grade 3 or higher in any of the above-mentioned tests, experienced during the on-treatment period, are reported here." (NCT03487848)
Timeframe: From the day after first dose to last dose (approximately 12 weeks)
Intervention | Participants (Count of Participants) |
---|
Daclatasvir (DCV) + Sofosbuvir (SOF) | 1 |
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Number of Participants Experiencing Adverse Events
This outcome describes the number of participants experiencing different types of any grade adverse events. (NCT03487848)
Timeframe: From first dose to last dose (12 weeks)
Intervention | Participants (Count of Participants) |
---|
| Adverse Events (AEs) | Serious Adverse Events (SAEs) | AEs leading to discontinuation |
---|
Daclatasvir (DCV) + Sofosbuvir (SOF) | 4 | 0 | 0 |
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Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir
(NCT03487848)
Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Intervention | ng/mL (Geometric Mean) |
---|
Daclatasvir (DCV) + Sofosbuvir (SOF) | 152.94 |
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Percentage of Participants Who Prematurely Discontinued HCV Study Medications
"Since there were no planned clinic visits during the 12 week study medication period, the last dose of study treatment was self-reported by participants, and recorded at the SVR evaluation visit at 24 weeks. Premature treatment discontinuation was defined when the self-reported final dose date was <11 weeks (<77 days) after the date of initial dose (accounting for any reported treatment holds). Participants discontinuing study follow up without information about completion of HCV study medications were counted as having prematurely discontinued medications.~A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method." (NCT03512210)
Timeframe: From at least 22 weeks and up to 76 weeks from treatment initiation
Intervention | percentage of participants (Number) |
---|
MINMON 24 Weeks With SOF/VEL 12 Weeks | 1.0 |
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Percentage of Participants With Sustained Virologic Response 12 (SVR12)
"SVR12 was defined as plasma HCV RNA less than the lower limit of quantification (LLOQ) from the earliest sample drawn at least 22 weeks following study treatment initiation (i.e. at a visit scheduled at least 10 weeks after scheduled end of study treatment). Participants without any HCV RNA result at least 22 weeks after treatment initiation will be considered as having HCV RNA greater than the LLOQ.~LLOQ was defined as <15 IU/mL for results tested at USA centralized testing laboratory Quest using the Roche COBAS® HCV Quantitative nucleic acid test for use on the COBAS® 6800/8800 assays for quantitation (and detection) of HCV, and <12 IU/mL for results tested at regional international labs using Abbott RealTime HCV assay for quantitation (and detection) of HCV.~A two-sided 95%, confidence interval was calculated for this percentage using the Wilson (score) method." (NCT03512210)
Timeframe: From at least 22 weeks and up to 76 weeks from treatment initiation
Intervention | percentage of participants (Number) |
---|
MINMON 24 Weeks With SOF/VEL 12 Weeks | 95.0 |
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Percentage of Participants With at Least One Unplanned Clinic Visit Prior to SVR12 Evaluation
"According to the study minimal monitoring intervention, there were no planned clinic visits prior to study week 24, when SVR12 was scheduled to be evaluated. An unplanned clinic visit was defined as an in-clinic visit occurring from treatment initiation to up to week 22.~A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method." (NCT03512210)
Timeframe: From treatment initiation to 22 weeks
Intervention | percentage of participants (Number) |
---|
MINMON 24 Weeks With SOF/VEL 12 Weeks | 3.8 |
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Percentage of Participants With an Occurrence of Serious Adverse Events According to International Council for Harmonization (ICH) Criteria
"Serious adverse events (SAEs) as defined by ICH guidelines.~A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method." (NCT03512210)
Timeframe: From treatment initiation to 28 weeks
Intervention | percentage of participants (Number) |
---|
MINMON 24 Weeks With SOF/VEL 12 Weeks | 3.5 |
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Percentage of Participants With an Occurrence of One or More Non-serious, Grade >= 3 Adverse Event (AE), or Treatment Limiting AE.
"AEs included all primary diagnoses, primary signs/symptoms, and primary laboratory abnormalities that either had severity grade ≥ 3 or led to a change in study medication. Serious Adverse Events (SAE) by International Council for Harmonization (ICH) criteria were excluded as they contributed to the primary safety outcome measure.~Severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1.~A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method." (NCT03512210)
Timeframe: From treatment initiation to 28 weeks
Intervention | percentage of participants (Number) |
---|
MINMON 24 Weeks With SOF/VEL 12 Weeks | 5.8 |
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Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)
"The primary outcome was sustained virologic response, defined as HCV RNA below the lower limit of quantification 12 weeks after treatment completion (SVR12). Secondary outcomes included the proportion of patients with SVR24 defined as HCV RNA < lower limit of quantification 24 weeks after the end of treatment; with viral relapse defined as HCV RNA 1 log increase in viral RNA after treatment week 1.~Safety was measured as the adverse events and serious adverse events attributed by the investigator to HCV infection or antiviral therapy; the proportion of recipients who prematurely discontinued antiviral therapy before the planned end of treatment; and patient and graft survival at 6 months post-transplant." (NCT03619837)
Timeframe: 12 weeks after end of treatment
Intervention | Participants (Count of Participants) |
---|
Treatment Arm | 23 |
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Survival Rate of Patients and Their Allografts 6 Months Post Transplant
Graft and patient survival at 24 weeks after transplant (NCT03619837)
Timeframe: 6 months from time of liver transplant
Intervention | Participants (Count of Participants) |
---|
Treatment Arm | 23 |
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Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment
1 of 23 patients prematurely discontinued antiviral therapy due to intercurrent graft-versus-host disease that progressed to multiorgan failure. (NCT03619837)
Timeframe: 12 weeks after start of treatment
Intervention | Participants (Count of Participants) |
---|
Treatment Arm | 1 |
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Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant
Estimated glomerular filtration rate (eGFR) at 6 and 12 months post-transplant was to test the safety of utilizing of HepC positive kidneys. (NCT03801707)
Timeframe: 6 and 12 months
Intervention | ml/min/1.73m^2 (Median) |
---|
| eGFR at 6 months | eGFR at 12 months |
---|
Intervention Group | 54 | 46 |
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Graft Survival at 6 and 12 Months
Graft survival at 6 and 12 months measuring safety of utilizing HepC positive kidneys. (NCT03801707)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
| 6 months graft survival | 12 months graft survival |
---|
Intervention Group | 30 | 30 |
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Patient's Survival at 6 and 12 Months
Patient's survival at 6 and 12 months measuring safety of utilizing of HepC positive kidneys. (NCT03801707)
Timeframe: 6 and 12 months
Intervention | Participants (Count of Participants) |
---|
| 6 months patient survival | 12 months patient survival |
---|
Intervention Group | 30 | 30 |
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Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment
Proportion of patients with undetectable hepatitis C virus (HCV) polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment was to test the efficacy of the treatment. (NCT03801707)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
Intervention Group | 28 |
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Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein
Change in high-sensitivity C-reactive protein (NCT03823911)
Timeframe: Baseline to 72 weeks after functional cure of HCV
Intervention | mg/L (Mean) |
---|
Hepatitis C Mono-Infected | 0.6 |
HIV and Hepatitis C Co-Infected | 0 |
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Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug
TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug. (NCT04112303)
Timeframe: First dose date up to Week 12.1
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 0 |
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Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)
SVR24 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment. (NCT04112303)
Timeframe: Posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 100.0 |
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Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)
SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment. (NCT04112303)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 100.0 |
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Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment. (NCT04112303)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 100.0 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IL/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment." (NCT04112303)
Timeframe: First dose date up to posttreatment Week 24
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 0 |
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Number of Participants With Alanine Aminotransferase (ALT) Normalization
Number of participants with ALT normalization, defined as ALT > upper limit of normal (ULN) (ULN = 43 U/L) at baseline and ALT ≤ ULN, at each visit was presented. (NCT04211909)
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12
Intervention | participants (Number) |
---|
| Baseline (ALT>ULN) | Week 2 (ALT≤ ULN) | Week 4 (ALT≤ ULN) | Week 8 (ALT≤ ULN) | Week 12 (ALT≤ ULN) |
---|
SOF/VEL | 21 | 21 | 21 | 19 | 17 |
,SOF/VEL/VOX | 16 | 13 | 13 | 13 | 13 |
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Change From Baseline in HCV RNA
(NCT04211909)
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12
Intervention | log10 IU/mL (Mean) |
---|
| Baseline | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
SOF/VEL | 5.95 | -4.78 | -4.81 | -4.79 | -4.79 |
,SOF/VEL/VOX | 6.48 | -5.19 | -5.33 | -5.33 | -5.33 |
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Percentage of Participants With Virologic Failure
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment )~Virologic relapse:~• Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT04211909)
Timeframe: Baseline up to Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 1.9 |
SOF/VEL/VOX | 0 |
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Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment
SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) 4 weeks after stopping study treatment. (NCT04211909)
Timeframe: Posttreatment Week 4
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 98.1 |
SOF/VEL/VOX | 100 |
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Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment
SVR12 was defined as HCV RNA < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment. (NCT04211909)
Timeframe: Posttreatment Week 12
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 98.1 |
SOF/VEL/VOX | 100 |
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Percentage of Participants With HCV RNA < LLOQ on Treatment
LLOQ was 15 IU/mL. (NCT04211909)
Timeframe: Week 2, Week 4, Week 8, Week 12
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 8 | Week 12 |
---|
SOF/VEL | 90.6 | 100.0 | 100.0 | 100.0 |
,SOF/VEL/VOX | 69.7 | 100.0 | 100.0 | 100.0 |
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Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
(NCT04211909)
Timeframe: First dose date up to 12 weeks plus 30 days
Intervention | percentage of participants (Number) |
---|
SOF/VEL | 1.9 |
SOF/VEL/VOX | 0 |
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