carbamates has been researched along with Co-infection in 67 studies
Excerpt | Relevance | Reference |
---|---|---|
"Ombitasvir/paritaprevir/ritonavir with dasabuvir (OBV/PTV/r + DSV) ± ribavirin (RBV) is approved for hepatitis C virus (HCV) genotype 1 (GT1) treatment in HIV-1 coinfected patients." | 9.24 | TURQUOISE-I Part 1b: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin for Hepatitis C Virus Infection in HIV-1 Coinfected Patients on Darunavir. ( Adeyemi, O; Bhatti, L; Hu, YB; Khatri, A; King, JR; Lalezari, J; Ruane, P; Saag, M; Shulman, NS; Trinh, R; Viani, RM; Wyles, D, 2017) |
" In a phase 2 study we aimed to assess the efficacy and safety of grazoprevir (MK-5172; HCV NS3/4A protease inhibitor) and two doses of elbasvir (MK-8742; HCV NS5A inhibitor) in patients with HCV mono-infection and HIV/HCV co-infection." | 9.20 | Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando ( Barr, E; Bourliere, M; DeJesus, E; Dutko, F; Gerstoft, J; Haber, B; Hezode, C; Howe, AY; Hwang, P; Kugelmas, M; Mallolas, J; Murillo, A; Nahass, R; Pol, S; Robertson, M; Serfaty, L; Shaughnessy, M; Shibolet, O; Sulkowski, M; Vierling, JM; Wahl, J; Weis, N; Zuckerman, E, 2015) |
" The C-EDGE CO-INFECTION study assessed the efficacy, safety, and tolerability of grazoprevir (MK-5172) plus elbasvir (MK-8742) in patients with HCV and HIV co-infection." | 9.20 | Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. ( Barr, E; Bloch, M; Gress, J; Katlama, C; Klopfer, S; Lalezari, J; Mallolas, J; Matthews, GV; Nelson, M; Nguyen, BY; Orkin, C; Platt, HL; Robertson, MN; Rockstroh, JK; Saag, MS; Shaughnessy, M; Sulkowski, M; Wahl, J; Zamor, PJ, 2015) |
"A systematic literature review of Phase III clinical trials identified 2 trials of SOF+R-PHOTON-1 (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) and PHOTON-2 (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) suitable for comparison with the trial of DCV+SOF in patients coinfected with HIV and HCV-ALLY-2 (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])." | 8.93 | Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison. ( Ackerman, P; Kalsekar, A; Kelley, C; Mu, F; Peeples, M; Signorovitch, J; Song, J; Swallow, E; Yuan, Y, 2016) |
"We report a case of hepatitis B virus reactivation in a Caucasian patient infected with hepatitis C virus during treatment with sofosbuvir and velpatasvir." | 7.91 | Hepatitis B virus reactivation sustained by a hepatitis B virus surface antigen immune-escape mutant isolate in a patient who was hepatitis B core antibody positive during treatment with sofosbuvir and velpatasvir for hepatitis C virus infection: a case r ( Andreoni, M; Aragri, M; Cerva, C; Ferrari, L; Foroghi Biland, L; Gentile, A; Malagnino, V; Salpini, R; Sarmati, L; Svicher, V; Teti, E, 2019) |
"Among 41 patients treated, 35 (85%) patients had genotype 1b HCV infection, 6 (15%) had co-infection with human immunodeficiency virus, 35 (85%) failed previous peginterferon and ribavirin therapy, 25 (61%) had compensated liver cirrhosis, and 3 (7%) had liver transplantation." | 7.85 | Real-life efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir in chronic hepatitis C patients in Hong Kong. ( But, DY; Chan, CK; Chan, HL; Chan, KH; Fung, J; Hui, YT; Lai, CL; Lai, MS; Lam, YS; Lao, WC; Li, C; Lui, GC; Seto, WK; Tsang, OT; Wong, GL; Wong, VW; Yuen, MF, 2017) |
"Safety and tolerability evaluation of adapted dose regimens containing fosamprenavir/ritonavir (FPV/r) in HIV-infected subjects with viral hepatitis co-infection." | 7.83 | Fosamprenavir/ritonavir in patients with viral hepatitis coinfection: an observational multicohort study. ( Cerini, C; Cozzi-Lepri, A; d'Arminio Monforte, A; Giralda, M; Nasta, P; Pimenta, JM; Salmon, D; Winnock, M, 2016) |
" However, evening atazanavir plus ritonavir and lopinavir/ritonavir regimens are not recommended in combination with the 3D regimen." | 6.82 | Evaluation of Drug-Drug Interactions Between Hepatitis C Antiviral Agents Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and HIV-1 Protease Inhibitors. ( Awni, W; Dutta, S; Khatri, A; Menon, R; Podsadecki, T; Trinh, R; Wang, H, 2016) |
"The SOF/VEL ± RBV is a safe and efficacious treatment option for GT3 HCV patients in a real-world setting." | 5.62 | Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort. ( Ang, TL; Fock, KM; Koh, J; Kumar, LS; Kumar, R; Kwek, A; Law, NM; Lee, ZC; Li, W; Tan, J; Tan, YB; Teo, EK; Thurairajah, PH; Wong, YJ, 2021) |
"DCV was dosed at week 4 and at week 8 of treatment, and RBV at week 8." | 5.43 | Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin. ( Andreis, S; Basso, M; Cattelan, AM; Cavinato, S; Dal Bello, F; Loregian, A; Messa, L; Nannetti, G; Palù, G; Parisi, SG; Scaggiante, R, 2016) |
" No discontinuations were attributed to treatment-related adverse events." | 5.43 | 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. ( Ackerman, P; Bhore, R; Luetkemeyer, AF; McDonald, C; Noviello, S; Ramgopal, M, 2016) |
"We conducted a nonrandomized clinical trial of 12 or 24 weeks of paritaprevir-ritonavir-ombitasvir plus dasabuvir (PrOD) with or without ribavirin in persons with HCV-1/HIV coinfection suppressed with antiretroviral therapy." | 5.34 | Hepatitis C Virus (HCV) Direct-Acting Antiviral Therapy in Persons With Human Immunodeficiency Virus-HCV Genotype 1 Coinfection Resulting in High Rate of Sustained Virologic Response and Variable in Normalization of Soluble Markers of Immune Activation. ( Alston-Smith, BL; Anthony, DD; Balagopal, A; Bhattacharya, D; Cohen, DE; Damjanovska, S; Kowal, CM; Shive, CL; Smeaton, LM; Sulkowski, MS; Wyles, DL, 2020) |
"Elbasvir/grazoprevir is a once-daily fixed-dose combination therapy for the treatment of chronic HCV infection, including HCV/HIV coinfection." | 5.30 | Assessment of drug interaction potential between the HCV direct-acting antiviral agents elbasvir/grazoprevir and the HIV integrase inhibitors raltegravir and dolutegravir. ( Butterton, JR; Caro, L; Fandozzi, C; Feng, HP; Fraser, I; Guo, Z; Huang, X; Iwamoto, M; Jumes, P; Ma, J; Mangin, E; Marshall, WL; Panebianco, D; Ross, LL; Talaty, J; Yeh, WW, 2019) |
"To evaluate the efficacy and safety of pegylated interferon-lambda-1a (Lambda)/ribavirin (RBV)/daclatasvir (DCV) for treatment of patients coinfected with chronic hepatitis C virus (HCV) and human immunodeficiency virus (HIV)." | 5.24 | Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients. ( Conway, B; Lazzarin, A; Luetkemeyer, A; Molina, JM; Nelson, M; Portsmouth, S; Romanova, S; Rubio, R; Srinivasan, S; Xu, D, 2017) |
"Ombitasvir/paritaprevir/ritonavir with dasabuvir (OBV/PTV/r + DSV) ± ribavirin (RBV) is approved for hepatitis C virus (HCV) genotype 1 (GT1) treatment in HIV-1 coinfected patients." | 5.24 | TURQUOISE-I Part 1b: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin for Hepatitis C Virus Infection in HIV-1 Coinfected Patients on Darunavir. ( Adeyemi, O; Bhatti, L; Hu, YB; Khatri, A; King, JR; Lalezari, J; Ruane, P; Saag, M; Shulman, NS; Trinh, R; Viani, RM; Wyles, D, 2017) |
" In a phase 2 study we aimed to assess the efficacy and safety of grazoprevir (MK-5172; HCV NS3/4A protease inhibitor) and two doses of elbasvir (MK-8742; HCV NS5A inhibitor) in patients with HCV mono-infection and HIV/HCV co-infection." | 5.20 | Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando ( Barr, E; Bourliere, M; DeJesus, E; Dutko, F; Gerstoft, J; Haber, B; Hezode, C; Howe, AY; Hwang, P; Kugelmas, M; Mallolas, J; Murillo, A; Nahass, R; Pol, S; Robertson, M; Serfaty, L; Shaughnessy, M; Shibolet, O; Sulkowski, M; Vierling, JM; Wahl, J; Weis, N; Zuckerman, E, 2015) |
" The C-EDGE CO-INFECTION study assessed the efficacy, safety, and tolerability of grazoprevir (MK-5172) plus elbasvir (MK-8742) in patients with HCV and HIV co-infection." | 5.20 | Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. ( Barr, E; Bloch, M; Gress, J; Katlama, C; Klopfer, S; Lalezari, J; Mallolas, J; Matthews, GV; Nelson, M; Nguyen, BY; Orkin, C; Platt, HL; Robertson, MN; Rockstroh, JK; Saag, MS; Shaughnessy, M; Sulkowski, M; Wahl, J; Zamor, PJ, 2015) |
"AbbVie's 3 direct-acting antiviral (3D) regimen containing ombitasvir, paritaprevir, ritonavir, and dasabuvir with and without ribavirin is approved for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection." | 4.95 | Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir: Drug Interactions With Antiretroviral Agents and Drugs forSubstance Abuse. ( King, JR; Menon, RM, 2017) |
"A systematic literature review of Phase III clinical trials identified 2 trials of SOF+R-PHOTON-1 (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) and PHOTON-2 (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) suitable for comparison with the trial of DCV+SOF in patients coinfected with HIV and HCV-ALLY-2 (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])." | 4.93 | Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison. ( Ackerman, P; Kalsekar, A; Kelley, C; Mu, F; Peeples, M; Signorovitch, J; Song, J; Swallow, E; Yuan, Y, 2016) |
"The current recommendation for treating hepatitis C virus (HCV) in HIV patients includes the combination of sofosbuvir (SOF) and daclatasvir (DCV)." | 4.02 | Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus. ( Dehghan Manshadi, SA; Kalantari, S; Karimi, J; Malekzadeh, R; Malekzadeh, Z; Mardani, M; Merat, D; Merat, S; Mirminachi, B; Mohraz, M; Nikbin, M; Norouzi, A; Poustchi, H; Rasoolinejad, M; Sali, S; Sedghi, R; Sharifi, AH; Somi, MH; Tabarsi, P; Tayeri, K, 2021) |
" Twelve weeks long treatment with sofsobuvir, daclatasvir, ribavirin, and tenofovir resulted in sustained virological response (SVR) and cleared HBV, HCV, and HEV in diabetic and asthmatic patient." | 3.96 | Successful treatment of HBV, HCV, & HEV, with 12-week long use of tenofovir, sofosbuvir, daclatasvir, and ribavirin: A case report. ( Wahid, B, 2020) |
"We report a case of hepatitis B virus reactivation in a Caucasian patient infected with hepatitis C virus during treatment with sofosbuvir and velpatasvir." | 3.91 | Hepatitis B virus reactivation sustained by a hepatitis B virus surface antigen immune-escape mutant isolate in a patient who was hepatitis B core antibody positive during treatment with sofosbuvir and velpatasvir for hepatitis C virus infection: a case r ( Andreoni, M; Aragri, M; Cerva, C; Ferrari, L; Foroghi Biland, L; Gentile, A; Malagnino, V; Salpini, R; Sarmati, L; Svicher, V; Teti, E, 2019) |
"Among 41 patients treated, 35 (85%) patients had genotype 1b HCV infection, 6 (15%) had co-infection with human immunodeficiency virus, 35 (85%) failed previous peginterferon and ribavirin therapy, 25 (61%) had compensated liver cirrhosis, and 3 (7%) had liver transplantation." | 3.85 | Real-life efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir in chronic hepatitis C patients in Hong Kong. ( But, DY; Chan, CK; Chan, HL; Chan, KH; Fung, J; Hui, YT; Lai, CL; Lai, MS; Lam, YS; Lao, WC; Li, C; Lui, GC; Seto, WK; Tsang, OT; Wong, GL; Wong, VW; Yuen, MF, 2017) |
"The combination of ombitasvir, dasabuvir, and paritaprevir/ritonavir (considered as the 3D regimen) has proven to be associated with high sustained virologic response and optimal tolerability in hepatitis C virus-infected patients." | 3.83 | Severe Hyperbilirubinemia in an HIV-HCV-Coinfected Patient Starting the 3D Regimen That Resolved After TDM-Guided Atazanavir Dose Reduction. ( Cattaneo, D; Clementi, E; Gervasoni, C; Milazzo, L; Riva, A, 2016) |
"Safety and tolerability evaluation of adapted dose regimens containing fosamprenavir/ritonavir (FPV/r) in HIV-infected subjects with viral hepatitis co-infection." | 3.83 | Fosamprenavir/ritonavir in patients with viral hepatitis coinfection: an observational multicohort study. ( Cerini, C; Cozzi-Lepri, A; d'Arminio Monforte, A; Giralda, M; Nasta, P; Pimenta, JM; Salmon, D; Winnock, M, 2016) |
" Most common adverse events (AEs) were fatigue, neutropenia, anemia, asthenia and headache." | 2.84 | Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. ( Ackerman, P; Berenguer, J; Cheinquer, H; Côté, P; Dieterich, D; Eley, T; Fessel, WJ; Gadano, A; Hernandez, D; Hughes, E; Lazzarin, A; Liu, Z; Matthews, G; McPhee, F; Mendez, P; Molina, JM; Moreno, C; Noviello, S; Pineda, JA; Pulido, F; Rivero, A; Rockstroh, J; Sulkowski, MS; Zakharova, N, 2017) |
" However, evening atazanavir plus ritonavir and lopinavir/ritonavir regimens are not recommended in combination with the 3D regimen." | 2.82 | Evaluation of Drug-Drug Interactions Between Hepatitis C Antiviral Agents Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and HIV-1 Protease Inhibitors. ( Awni, W; Dutta, S; Khatri, A; Menon, R; Podsadecki, T; Trinh, R; Wang, H, 2016) |
"The pharmacokinetic data support coadministration of daclatasvir with atazanavir/ritonavir, efavirenz and/or tenofovir." | 2.78 | Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir. ( Bertz, R; Bifano, M; Grasela, D; Hartstra, J; Hwang, C; Kandoussi, H; Oosterhuis, B; Sevinsky, H; Tiessen, R; Velinova-Donga, M, 2013) |
"6%) were the most effective combinations for HIV/HCV co-infected patients, with SVR rates of approximately 94% and above while severe adverse events were rare." | 2.66 | Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysis. ( Fan, XG; Ma, SJ; Xiong, YH; Zheng, YX, 2020) |
" The safety data available for LDV/SOF±RBV and OBV/PTV/r±DSV±RBV show that discontinuation due to adverse events was necessary in no more than 3% of patients and the frequency of serious adverse events was between 0 and 11%, in particular in real-world studies." | 2.55 | Hepatitis C: efficacy and safety in real life. ( Flisiak, R; Flisiak-Jackiewicz, M; Pogorzelska, J, 2017) |
"The SOF/VEL ± RBV is a safe and efficacious treatment option for GT3 HCV patients in a real-world setting." | 1.62 | Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort. ( Ang, TL; Fock, KM; Koh, J; Kumar, LS; Kumar, R; Kwek, A; Law, NM; Lee, ZC; Li, W; Tan, J; Tan, YB; Teo, EK; Thurairajah, PH; Wong, YJ, 2021) |
" Incidence rates of liver adverse events (LAE) were calculated; Poisson regression model was used to identify factors associated with LAE." | 1.56 | Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts. ( Bonora, S; Cingolani, A; d'Arminio Monforte, A; Lo Caputo, S; Marinaro, L; Mussini, C; Puoti, M; Rossotti, R; Saracino, A; Soria, A; Tavelli, A; Uberti-Foppa, C, 2020) |
"7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision." | 1.51 | Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice - Vie-KinD study. ( Ahumada, A; Aldamiz-Echevarría, T; Baliellas, C; Barril, G; Benlloch, S; Bonet, L; Carmona, I; Castaño, MA; Castro, Á; de Álvaro, C; de Los Santos, I; Delgado, M; Devesa-Medina, MJ; García-Buey, L; García-Samaniego, J; Gea-Rodríguez, F; González-Parra, E; Gutiérrez, ML; Jiménez-Pérez, M; Laguno, M; Londoño, MC; Losa, JE; Mallolas, J; Manzanares, A; Martín-Granizo, I; Montero-Alonso, M; Montes, ML; Morán-Sánchez, S; Morano, L; Muñoz-Gómez, R; Navascués, CA; Polo-Lorduy, B; Riveiro-Barciela, M; Rivero, A; Roget, M; Serra, MÁ, 2019) |
" Serious adverse events occurred in 3." | 1.48 | The safety and efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 1b infection. ( Barr, E; Cheng, W; George, J; Hwang, P; Kumada, H; Platt, H; Robertson, M; Serfaty, L; Sperl, J; Strasser, S; Talwani, R; Vierling, J; Wahl, J; Zeuzem, S, 2018) |
" No discontinuations were attributed to treatment-related adverse events." | 1.43 | 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. ( Ackerman, P; Bhore, R; Luetkemeyer, AF; McDonald, C; Noviello, S; Ramgopal, M, 2016) |
"DCV was dosed at week 4 and at week 8 of treatment, and RBV at week 8." | 1.43 | Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin. ( Andreis, S; Basso, M; Cattelan, AM; Cavinato, S; Dal Bello, F; Loregian, A; Messa, L; Nannetti, G; Palù, G; Parisi, SG; Scaggiante, R, 2016) |
"HRQoL/fatigue was evaluated at baseline (BL), midway, and 12 weeks after the end of treatment (FU)." | 1.43 | Interferon-free regimens improve health-related quality of life and fatigue in HIV/HCV-coinfected patients with advanced liver disease: A retrospective study. ( Aichelburg, MC; Bucsics, T; Chromy, D; Grabmeier-Pfistershammer, K; Mandorfer, M; Peck-Radosavljevic, M; Reiberger, T; Scheiner, B; Schwabl, P; Steiner, S; Trauner, M, 2016) |
" Raltegravir pharmacokinetic parameters remained unchanged whether administered on or off anti-HCV therapy." | 1.42 | Raltegravir Pharmacokinetics in Patients on Asunaprevir-Daclatasvir. ( Barrail-Tran, A; Cheret, A; Furlan, V; Molina, JM; Piroth, L; Rosa, I; Rosenthal, E; Taburet, AM; Vincent, C, 2015) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 56 (83.58) | 24.3611 |
2020's | 11 (16.42) | 2.80 |
Authors | Studies |
---|---|
Foroghi Biland, L | 1 |
Ferrari, L | 1 |
Malagnino, V | 1 |
Teti, E | 1 |
Cerva, C | 1 |
Gentile, A | 1 |
Aragri, M | 1 |
Salpini, R | 1 |
Svicher, V | 1 |
Andreoni, M | 1 |
Sarmati, L | 1 |
Londoño, MC | 1 |
Riveiro-Barciela, M | 1 |
Ahumada, A | 1 |
Muñoz-Gómez, R | 1 |
Roget, M | 1 |
Devesa-Medina, MJ | 1 |
Serra, MÁ | 1 |
Navascués, CA | 1 |
Baliellas, C | 1 |
Aldamiz-Echevarría, T | 1 |
Gutiérrez, ML | 1 |
Polo-Lorduy, B | 1 |
Carmona, I | 1 |
Benlloch, S | 1 |
Bonet, L | 1 |
García-Samaniego, J | 1 |
Jiménez-Pérez, M | 1 |
Morán-Sánchez, S | 1 |
Castro, Á | 1 |
Delgado, M | 1 |
Gea-Rodríguez, F | 1 |
Martín-Granizo, I | 1 |
Montes, ML | 1 |
Morano, L | 1 |
Castaño, MA | 1 |
de Los Santos, I | 1 |
Laguno, M | 1 |
Losa, JE | 1 |
Montero-Alonso, M | 1 |
Rivero, A | 2 |
de Álvaro, C | 1 |
Manzanares, A | 1 |
Mallolas, J | 3 |
Barril, G | 1 |
González-Parra, E | 1 |
García-Buey, L | 1 |
Cordie, A | 1 |
Elsharkawy, A | 1 |
Abdel Alem, S | 1 |
Meshaal, S | 1 |
El Akel, W | 1 |
Abdellatif, Z | 1 |
Kamal, W | 1 |
Al Askalany, M | 1 |
Kamel, S | 1 |
Abdel Aziz, H | 1 |
Kandeel, A | 1 |
Esmat, G | 1 |
Rossotti, R | 1 |
Tavelli, A | 1 |
Bonora, S | 1 |
Cingolani, A | 1 |
Lo Caputo, S | 1 |
Saracino, A | 1 |
Soria, A | 1 |
Marinaro, L | 1 |
Uberti-Foppa, C | 1 |
Mussini, C | 1 |
Puoti, M | 1 |
d'Arminio Monforte, A | 2 |
Patel, SV | 1 |
Jayaweera, DT | 1 |
Althoff, KN | 1 |
Eron, JJ | 1 |
Radtchenko, J | 1 |
Mills, A | 1 |
Moyle, G | 1 |
Santiago, S | 1 |
Sax, PE | 1 |
Gillman, J | 1 |
Mounzer, K | 1 |
Elion, RA | 1 |
Huhn, GD | 1 |
Balagopal, A | 2 |
Smeaton, LM | 2 |
Quinn, J | 1 |
Venuto, CS | 1 |
Morse, GD | 1 |
Vu, V | 1 |
Alston-Smith, B | 1 |
Cohen, DE | 2 |
Santana-Bagur, JL | 1 |
Anthony, DD | 2 |
Sulkowski, MS | 4 |
Wyles, DL | 2 |
Talal, AH | 1 |
Zheng, YX | 1 |
Ma, SJ | 1 |
Xiong, YH | 1 |
Fan, XG | 1 |
Damjanovska, S | 1 |
Shive, CL | 1 |
Kowal, CM | 1 |
Bhattacharya, D | 2 |
Alston-Smith, BL | 1 |
Wong, YJ | 1 |
Thurairajah, PH | 1 |
Kumar, R | 1 |
Tan, J | 1 |
Fock, KM | 1 |
Law, NM | 1 |
Li, W | 1 |
Kwek, A | 1 |
Tan, YB | 1 |
Koh, J | 1 |
Lee, ZC | 1 |
Kumar, LS | 1 |
Teo, EK | 1 |
Ang, TL | 1 |
Dehghan Manshadi, SA | 1 |
Merat, S | 1 |
Mohraz, M | 1 |
Rasoolinejad, M | 1 |
Sali, S | 1 |
Mardani, M | 1 |
Tabarsi, P | 1 |
Somi, MH | 1 |
Sedghi, R | 1 |
Tayeri, K | 1 |
Nikbin, M | 1 |
Karimi, J | 1 |
Sharifi, AH | 1 |
Kalantari, S | 1 |
Norouzi, A | 1 |
Merat, D | 1 |
Malekzadeh, Z | 1 |
Mirminachi, B | 1 |
Poustchi, H | 1 |
Malekzadeh, R | 1 |
Yunihastuti, E | 1 |
Amelia, F | 1 |
Hapsari, AI | 1 |
Wicaksana, B | 1 |
Natali, V | 1 |
Widhani, A | 1 |
Sulaiman, AS | 1 |
Karjadi, TH | 1 |
Wyles, D | 3 |
Saag, M | 1 |
Viani, RM | 1 |
Lalezari, J | 2 |
Adeyemi, O | 2 |
Bhatti, L | 1 |
Khatri, A | 2 |
King, JR | 2 |
Hu, YB | 1 |
Trinh, R | 2 |
Shulman, NS | 1 |
Ruane, P | 2 |
Taton, A | 1 |
Colson, P | 1 |
Dhiver, C | 2 |
Ruiz, JM | 1 |
Bregigeon, S | 1 |
Tomei, C | 1 |
Ressiot, E | 1 |
Menard, A | 1 |
Poizot-Martin, I | 1 |
Ravaux, I | 1 |
Lacarelle, B | 1 |
Solas, C | 1 |
Bräu, N | 1 |
Kottilil, S | 2 |
Daar, ES | 1 |
Workowski, K | 1 |
Luetkemeyer, A | 2 |
Kim, AY | 1 |
Doehle, B | 1 |
Huang, KC | 1 |
Mogalian, E | 1 |
Osinusi, A | 1 |
McNally, J | 1 |
Brainard, DM | 2 |
McHutchison, JG | 2 |
Naggie, S | 1 |
Sulkowski, M | 4 |
Younossi, ZM | 1 |
Stepanova, M | 1 |
Hunt, S | 1 |
Antón, MD | 1 |
Polanco, A | 1 |
Ferrando, I | 1 |
Latorre, P | 1 |
Pascual, A | 1 |
Moreno Osset, E | 1 |
Smolders, EJ | 2 |
Smit, C | 1 |
T M M de Kanter, C | 1 |
Dofferiiof, ASM | 1 |
Arends, JE | 1 |
Brinkman, K | 1 |
Rijnders, B | 1 |
van der Valk, M | 2 |
Reiss, P | 1 |
Burger, DM | 2 |
Uemura, H | 1 |
Tsukada, K | 1 |
Mizushima, D | 1 |
Aoki, T | 1 |
Watanabe, K | 1 |
Kinai, E | 1 |
Teruya, K | 1 |
Gatanaga, H | 1 |
Kikuchi, Y | 1 |
Sugiyama, M | 1 |
Mizokami, M | 1 |
Oka, S | 1 |
Tempestilli, M | 2 |
Fabbri, G | 2 |
Mastrorosa, I | 1 |
Timelli, L | 1 |
Notari, S | 2 |
Bellagamba, R | 1 |
Libertone, R | 2 |
Lupi, F | 1 |
Zaccarelli, M | 1 |
Antinori, A | 2 |
Agrati, C | 2 |
Ammassari, A | 2 |
Yoshimura, Y | 1 |
Miyata, N | 1 |
Komatsu, H | 1 |
Tachikawa, N | 1 |
Zeuzem, S | 2 |
Serfaty, L | 2 |
Vierling, J | 1 |
Cheng, W | 1 |
George, J | 1 |
Sperl, J | 1 |
Strasser, S | 1 |
Kumada, H | 1 |
Hwang, P | 2 |
Robertson, M | 2 |
Wahl, J | 3 |
Barr, E | 3 |
Talwani, R | 1 |
Platt, H | 1 |
Bischoff, J | 1 |
Rockstroh, JK | 3 |
Feng, HP | 1 |
Guo, Z | 1 |
Ross, LL | 1 |
Fraser, I | 1 |
Panebianco, D | 1 |
Jumes, P | 1 |
Fandozzi, C | 1 |
Caro, L | 1 |
Talaty, J | 1 |
Ma, J | 1 |
Mangin, E | 1 |
Huang, X | 1 |
Marshall, WL | 1 |
Butterton, JR | 1 |
Iwamoto, M | 1 |
Yeh, WW | 1 |
Begovac, J | 1 |
Krznarić, J | 1 |
Bogdanić, N | 1 |
Močibob, L | 1 |
Zekan, Š | 1 |
Wu, J | 1 |
Huang, P | 1 |
Fan, H | 1 |
Tian, T | 1 |
Xia, X | 1 |
Fu, Z | 1 |
Wang, Y | 1 |
Ye, X | 1 |
Yue, M | 1 |
Zhang, Y | 1 |
Maughan, A | 1 |
Sadigh, K | 1 |
Angulo-Diaz, V | 1 |
Mandimika, C | 1 |
Villanueva, M | 1 |
Lim, JK | 1 |
Ogbuagu, O | 1 |
Wahid, B | 2 |
Xiao, H | 1 |
Chen, J | 1 |
Wang, J | 1 |
Li, J | 1 |
Yang, F | 1 |
Lu, H | 1 |
Bifano, M | 1 |
Hwang, C | 1 |
Oosterhuis, B | 1 |
Hartstra, J | 1 |
Grasela, D | 1 |
Tiessen, R | 1 |
Velinova-Donga, M | 1 |
Kandoussi, H | 1 |
Sevinsky, H | 1 |
Bertz, R | 1 |
Martel-Laferrière, V | 1 |
Dieterich, DT | 1 |
Hezode, C | 1 |
Gerstoft, J | 1 |
Vierling, JM | 1 |
Pol, S | 1 |
Kugelmas, M | 1 |
Murillo, A | 1 |
Weis, N | 1 |
Nahass, R | 1 |
Shibolet, O | 1 |
Bourliere, M | 1 |
DeJesus, E | 1 |
Zuckerman, E | 1 |
Dutko, F | 1 |
Shaughnessy, M | 2 |
Howe, AY | 1 |
Haber, B | 1 |
Hayward, P | 1 |
Piroth, L | 2 |
Paniez, H | 1 |
Taburet, AM | 2 |
Vincent, C | 2 |
Rosenthal, E | 3 |
Lacombe, K | 2 |
Billaud, E | 2 |
Rey, D | 1 |
Zucman, D | 1 |
Bailly, F | 1 |
Bronowicki, JP | 1 |
Simony, M | 1 |
Diallo, A | 1 |
Izopet, J | 1 |
Aboulker, JP | 1 |
Meyer, L | 1 |
Molina, JM | 4 |
Mariño, Z | 1 |
Lens, S | 1 |
Gambato, M | 1 |
Forns, X | 1 |
Nelson, M | 2 |
Katlama, C | 1 |
Bloch, M | 1 |
Matthews, GV | 1 |
Saag, MS | 1 |
Zamor, PJ | 1 |
Orkin, C | 1 |
Gress, J | 1 |
Klopfer, S | 1 |
Nguyen, BY | 1 |
Platt, HL | 1 |
Robertson, MN | 1 |
Barrail-Tran, A | 1 |
Furlan, V | 1 |
Rosa, I | 1 |
Cheret, A | 1 |
Sollima, S | 2 |
Milazzo, L | 3 |
Torre, A | 1 |
Calvi, E | 1 |
Regalia, E | 1 |
Antinori, S | 1 |
Cheng, EY | 1 |
Saab, S | 1 |
Holt, CD | 1 |
Busuttil, RW | 1 |
Dutta, S | 1 |
Wang, H | 1 |
Podsadecki, T | 1 |
Awni, W | 1 |
Menon, R | 1 |
Mandorfer, M | 2 |
Schwabl, P | 2 |
Steiner, S | 2 |
Scheiner, B | 2 |
Chromy, D | 2 |
Bucsics, T | 2 |
Stättermayer, AF | 1 |
Aichelburg, MC | 2 |
Grabmeier-Pfistershammer, K | 2 |
Trauner, M | 2 |
Reiberger, T | 2 |
Peck-Radosavljevic, M | 3 |
Swallow, E | 1 |
Song, J | 1 |
Yuan, Y | 1 |
Kalsekar, A | 1 |
Kelley, C | 1 |
Peeples, M | 1 |
Mu, F | 1 |
Ackerman, P | 3 |
Signorovitch, J | 1 |
Cattaneo, D | 2 |
Riva, A | 1 |
Clementi, E | 1 |
Gervasoni, C | 2 |
Alric, L | 1 |
Bonnet, D | 1 |
Ackens, R | 1 |
Posthouwer, D | 1 |
Luetkemeyer, AF | 1 |
McDonald, C | 1 |
Ramgopal, M | 1 |
Noviello, S | 2 |
Bhore, R | 1 |
Campos-Varela, I | 1 |
Moreno, A | 1 |
Morbey, A | 1 |
Guaraldi, G | 1 |
Hasson, H | 1 |
Bhamidimarri, KR | 1 |
Castells, L | 1 |
Grewal, P | 1 |
Baños, I | 1 |
Bellot, P | 1 |
Terrault, NA | 1 |
Nasta, P | 1 |
Salmon, D | 1 |
Pimenta, JM | 1 |
Cerini, C | 1 |
Giralda, M | 1 |
Winnock, M | 1 |
Cozzi-Lepri, A | 1 |
D'Avolio, A | 2 |
Micheli, V | 1 |
Kanter, CT | 1 |
Grintjes, K | 1 |
Di Perri, G | 1 |
van Crevel, R | 1 |
Drenth, JP | 1 |
Schìtz, A | 1 |
Moser, S | 1 |
Marchart, K | 1 |
Haltmayer, H | 1 |
Gschwantler, M | 1 |
Hayashi, K | 1 |
Ishigami, M | 1 |
Ishizu, Y | 1 |
Kuzuya, T | 1 |
Honda, T | 1 |
Nishimura, D | 1 |
Goto, H | 1 |
Hirooka, Y | 1 |
Parisi, SG | 1 |
Loregian, A | 1 |
Andreis, S | 1 |
Nannetti, G | 1 |
Cavinato, S | 1 |
Basso, M | 1 |
Scaggiante, R | 1 |
Dal Bello, F | 1 |
Messa, L | 1 |
Cattelan, AM | 1 |
Palù, G | 1 |
Hirashima, N | 1 |
Iwase, H | 1 |
Shimada, M | 1 |
Ryuge, N | 1 |
Imamura, J | 1 |
Ikeda, H | 1 |
Tanaka, Y | 1 |
Matsumoto, N | 1 |
Okuse, C | 1 |
Itoh, F | 1 |
Yokomaku, Y | 1 |
Watanabe, T | 1 |
Ingiliz, P | 1 |
Petersen, J | 1 |
Welzel, TM | 1 |
Zhao, Y | 2 |
Jimenez-Exposito, MJ | 1 |
Chan, HL | 1 |
Tsang, OT | 1 |
Hui, YT | 1 |
Fung, J | 1 |
Lui, GC | 1 |
Lai, CL | 1 |
Wong, GL | 1 |
Chan, KH | 1 |
But, DY | 1 |
Lai, MS | 1 |
Lao, WC | 1 |
Chan, CK | 1 |
Lam, YS | 1 |
Seto, WK | 1 |
Li, C | 1 |
Yuen, MF | 1 |
Wong, VW | 1 |
Flisiak, R | 1 |
Pogorzelska, J | 1 |
Flisiak-Jackiewicz, M | 1 |
Belperio, PS | 1 |
Shahoumian, TA | 1 |
Loomis, TP | 1 |
Goetz, MB | 1 |
Mole, LA | 1 |
Backus, LI | 1 |
Fessel, WJ | 1 |
Lazzarin, A | 2 |
Berenguer, J | 1 |
Zakharova, N | 1 |
Cheinquer, H | 1 |
Côté, P | 1 |
Dieterich, D | 1 |
Gadano, A | 1 |
Matthews, G | 1 |
Moreno, C | 1 |
Pineda, JA | 1 |
Pulido, F | 1 |
Rockstroh, J | 1 |
Hernandez, D | 1 |
McPhee, F | 1 |
Eley, T | 1 |
Liu, Z | 1 |
Mendez, P | 1 |
Hughes, E | 1 |
Menon, RM | 1 |
Fontaine, H | 1 |
Metivier, S | 1 |
Antonini, T | 1 |
Valantin, MA | 1 |
Miailhes, P | 1 |
Harent, S | 1 |
Batisse, D | 1 |
Pageaux, GP | 1 |
Chas, J | 1 |
Aumaitre, H | 1 |
Dominguez, S | 1 |
Allegre, T | 1 |
Lafeuillade, A | 1 |
De Truchis, P | 1 |
Perre, P | 1 |
Leroy, V | 1 |
De Ledinghen, V | 1 |
Sogni, P | 1 |
Dabis, F | 1 |
Filipovics, A | 1 |
Fedchuk, L | 1 |
Akremi, R | 1 |
Bennai, Y | 1 |
Salmon Ceron, D | 1 |
Rubio, R | 1 |
Romanova, S | 1 |
Conway, B | 1 |
Xu, D | 1 |
Srinivasan, S | 1 |
Portsmouth, S | 1 |
Vavassori, A | 1 |
Lanza, P | 1 |
Izzo, I | 1 |
Casari, S | 1 |
Odolini, S | 1 |
Zaltron, S | 1 |
Festa, E | 1 |
Castelli, F | 1 |
Plaza, Z | 1 |
Soriano, V | 1 |
Vispo, E | 1 |
del Mar Gonzalez, M | 1 |
Barreiro, P | 1 |
Seclén, E | 1 |
Poveda, E | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Interferon-Free Therapy for Chronic Hepatitis C Virus Genotype 1 Infection in Participants With HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy (C_ASCENT)[NCT02194998] | Phase 2 | 46 participants (Actual) | Interventional | 2015-09-16 | Terminated (stopped due to The study closed to accrual before the planned accrual goal was attained due to the availability of newer directly-acting antiviral (DAA) treatments for HCV.) | ||
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 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 | ||
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 | ||
Open-Labeled Trial Of Direct-Acting Antiviral Treatment Of Hepatitis C-Negative Patients Who Receive Kidney Transplants From Hepatitis C-Positive Donors[NCT02743897] | Phase 1/Phase 2 | 62 participants (Actual) | Interventional | 2016-05-01 | Completed | ||
A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection[NCT01717326] | Phase 2 | 573 participants (Actual) | Interventional | 2013-02-07 | Completed | ||
Open-Labeled Trial Of Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors[NCT03146741] | Phase 1/Phase 2 | 20 participants (Actual) | Interventional | 2017-05-16 | Completed | ||
Pilot Study to Assess the Efficacy and Tolerance to a QUadruple Therapy With Asunaprevir , Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a, in HIV-HCV Genotype 1 or 4 Coinfected Patients Previously Null Responders to a Standard Pegylated Interfer[NCT01725542] | Phase 2 | 75 participants (Actual) | Interventional | 2012-12-31 | Completed | ||
Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4: Efficacy and Tolerability of Grazoprevir 100mg/Elbasvir 50mg During 8 Weeks[NCT02886624] | Phase 2 | 30 participants (Actual) | Interventional | 2017-05-31 | Completed | ||
Efficacy and Tolerability of Grazoprevir and Elbasvir in Peginterferon Alfa Plus Ribavirin Experienced Patients With Chronic Genotype 1 HCV and HIV Co-infection: a Non-randomised, Open-label Clinical Trial[NCT03098121] | Phase 4 | 40 participants (Actual) | Interventional | 2017-10-20 | Completed | ||
A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen Grazoprevir (GZR) and Elbasvir (EBR) in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV[NCT02105662] | Phase 3 | 218 participants (Actual) | Interventional | 2014-06-03 | 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 | ||
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 | ||||
A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)[NCT01471574] | Phase 3 | 549 participants (Actual) | Interventional | 2011-12-31 | Completed | ||
Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With H[NCT01866930] | Phase 3 | 453 participants (Actual) | Interventional | 2013-07-11 | Terminated (stopped due to Sponsor decision not based on any new unexpected safety findings or efficacy observations.) | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
HIV-1 VF was defined as two consecutive HIV-1 RNA results ≥ 200 copies/mL. (NCT02194998)
Timeframe: From treatment initiation to 4 weeks after last dose of HCV study treatment. HIV-1 RNA was measured at weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28. The durations for HCV study treatment for Cohorts A/C and Cohorts B/D were 24 and 12 weeks, respectively.
Intervention | Participants (Count of Participants) |
---|---|
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 1 |
HCV VF was defined as follows: confirmed increase from nadir in HCV RNA (defined as two consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point; failure to achieve HCV RNA
Timeframe: From treatment initiation to either 24 weeks (for Cohort A and C) or 12 weeks (for Cohort B and D). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
Intervention | Participants (Count of Participants) |
---|---|
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 1 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 1 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
Participants who had diagnoses leading to premature HCV study treatment or HIV-1 ARV discontinuation post treatment initiation. (NCT02194998)
Timeframe: From treatment initiation to end of study follow-up at 48 weeks.The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively. The duration for ARV treatment for all cohorts was 48 weeks.
Intervention | Participants (Count of Participants) |
---|---|
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 1 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
"Participants with an observed laboratory abnormalities grade 3 or higher post treatment initiation.~If entry (pre-treatment) lab result was grade 3, then a grade 4 result was required to meet this outcome.~Severity grading was based on DAIDS AE Grading Table, Version 1.0." (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
Intervention | Participants (Count of Participants) |
---|---|
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 5 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 3 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 3 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
Participants who experienced at least one observed SAEs as defined by ICH after initiating HCV study treatment through 30 days post date of last dose of HCV study treatment. (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
Intervention | Participants (Count of Participants) |
---|---|
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 1 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 1 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 2 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
"Participants with signs/symptoms of grade 3 or higher post treatment initiation.~Participants with grade 3 sign/symptom prior to treatment initiation must have had one grade higher than pre-treatment to meet this outcome.~Severity grading was based on DAIDS AE Grading Table, Version 1.0." (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
Intervention | Participants (Count of Participants) |
---|---|
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 2 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 3 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
Participants with one or more genotype mutations in protease conferring major resistance to any HIV-1 Protease Inhibitors (PI) antiretroviral drug, from a plasma sample drawn following confirmed HIV-1 VF outcome. (NCT02194998)
Timeframe: At confirmation of HIV-1 virologic failure.
Intervention | Participants (Count of Participants) |
---|---|
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
"SVR12 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 12 weeks post HCV treatment discontinuation.~A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method.~For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 12 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 12 post treatment discontinuation was instead used to define the primary outcome." (NCT02194998)
Timeframe: At 12 weeks after last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
Intervention | percentage of participants (Number) |
---|---|
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 95.2 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 60 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 100 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 100 |
"SVR24 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 24 weeks post treatment discontinuation.~A two-sided 90% confidence interval was calculated for the percentage of SVR24 response using method of Clopper-Pearson.~For those whose HCV early responses prior to SVR24 evaluation met the guidelines for HCV VF, their SVR24 outcome was defined as non-response. Those missing a HCV RNA result from the week 24 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 24 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 24 post treatment discontinuation was instead used to define the primary outcome." (NCT02194998)
Timeframe: At 24 weeks after the date of last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
Intervention | percentage of participants (Number) |
---|---|
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 90.5 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 60 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 93.3 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 100 |
Absolute change from baseline in IP-10 (Interferon gamma-induced protein 10) concentration in plasma, calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
Intervention | pg/mL (Median) | |
---|---|---|
Change from baseline to EOT | Change from baseline to 12 weeks post EOT | |
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | -244.4 | -127 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | -22.2 | -29.1 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | -116 | -83.1 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | -61.1 | -114.9 |
Absolute change from baseline in sCD14 levels in plasma calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
Intervention | ng/mL (Median) | |
---|---|---|
Change from baseline to EOT | Change from baseline to 12 weeks post EOT | |
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 307.6 | 145.2 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | -1,063.2 | -894.2 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | -380.3 | -22.6 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 318.2 | -987.0 |
Levels of IP-10 (Interferon gamma-induced protein 10) concentration in plasma. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
Intervention | pg/mL (Median) | ||
---|---|---|---|
IP-10 at baseline | IP-10 at EOT | IP-10 at 12 weeks post EOT | |
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 379 | 100.9 | 94.6 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 120.2 | 60.4 | 85.5 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 225.5 | 76.6 | 82.5 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 196.4 | 182.6 | 159.5 |
Levels of sCD14. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
Intervention | ng/mL (Median) | ||
---|---|---|---|
sCD14 at Baseline | sCD14 at EOT | sCD14 at 12 weeks post EOT | |
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 1,832.0 | 2,126.5 | 1,977.3 |
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 2,226.8 | 1,132.8 | 1,367.4 |
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 3,157.0 | 2,421.1 | 3,424.5 |
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 3,092.0 | 2,801.3 | 2,608.3 |
(NCT02480712)
Timeframe: Up to 12 weeks
Intervention | percentage of participants (Number) |
---|---|
SOF/VEL 12 Weeks | 1.9 |
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 |
"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 |
(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 |
(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 |
(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 |
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 |
(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 |
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
Timeframe: 24 weeks after end of all therapy (Study Week 36)
Intervention | percentage of participants (Number) |
---|---|
Grazoprevir + Elbasvir | 98.4 |
SOF + PR | 89.7 |
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
Timeframe: 4 weeks after end of all therapy (Study Week 16)
Intervention | percentage of participants (Number) |
---|---|
Grazoprevir + Elbasvir | 99.2 |
SOF + PR | 92.1 |
"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 |
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 |
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 (
Timeframe: 12 weeks after end of all therapy (Study Week 24)
Intervention | percentage of participants (Number) |
---|---|
Grazoprevir + Elbasvir | 99.2 |
SOF + PR | 90.5 |
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 |
Subjects with post-treatment sustained virologic response (SVR) = Number of subjects with negative HCV RNA 12 weeks after completing therapy / number of subjects treated post-kidney transplantation (NCT02743897)
Timeframe: Baseline to 24 weeks
Intervention | Participants (Count of Participants) |
---|---|
Direct-acting Antiviral Treatment for HCV | 62 |
Number of subjects with major adverse events attributable to HCV therapy in post-kidney transplant (NCT02743897)
Timeframe: Baseline to 52 weeks
Intervention | Participants (Count of Participants) |
---|---|
Direct-acting Antiviral Treatment for HCV | 1 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA. (NCT01717326)
Timeframe: From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)
Intervention | days (Mean) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 21.7 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 19.2 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 23.4 |
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 27.9 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 30.7 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 32.0 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 37.0 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 33.2 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 33.1 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 33.7 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 31.9 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 37.4 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 37.4 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 42.7 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 27.6 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 29.0 |
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 23.7 |
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 34.5 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 30.1 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 19.8 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 93.3 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 100.0 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 100.0 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.9 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 92.9 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 47.4 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 75.0 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 91.3 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 92.0 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 91.7 |
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 86.2 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 73.3 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 77.4 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 60.0 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 79.3 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 78.1 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 67.7 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 77.4 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 66.7 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 57.6 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 62.5 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 89.7 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 76.7 |
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 76.7 |
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 61.3 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 70.0 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 85.0 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 90.0 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 100.0 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 90.3 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 96.9 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 97.0 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 93.8 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 96.8 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 65.0 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 83.3 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 12 weeks after end of therapy (up to 30 weeks)
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 95.8 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 82.8 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 96.8 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 90.0 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 96.6 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 93.5 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 90.9 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.9 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 96.6 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 92.9 |
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 93.1 |
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 93.5 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 47.4 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 61.1 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 24 weeks after end of therapy (up to 42 weeks)
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 95.8 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 78.6 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 96.8 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 90.0 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 96.6 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 93.1 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 90.9 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.9 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 96.6 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 88.9 |
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 93.1 |
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 93.5 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 47.4 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 58.8 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 4 weeks after end of therapy (up to 22 weeks)
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 95.8 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 93.3 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 96.8 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 96.7 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 96.6 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.8 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 93.9 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.9 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 96.6 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 93.1 |
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 93.1 |
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 96.8 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 50.0 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 61.1 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 93.3 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 96.6 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 100.0 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 93.8 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.9 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 93.1 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 92.9 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 47.7 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 65.0 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 2
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 52.2 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 44.0 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 41.7 |
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 44.8 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 20.0 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 16.1 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 6.7 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 10.3 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 25.0 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 16.1 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 12.9 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 6.1 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 6.1 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 6.3 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 37.9 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 40.0 |
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 46.7 |
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 12.9 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 40.0 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 70.0 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 73.9 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 91.7 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 75.0 |
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 73.3 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 83.3 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 77.4 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 60.0 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 79.3 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 71.9 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 71.0 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 83.3 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 68.8 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 69.7 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 53.1 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 75.9 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 78.6 |
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 86.7 |
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 74.2 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 50.0 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 77.8 |
An AE was defined as any unfavorable 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. (NCT01717326)
Timeframe: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 0.0 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 0.0 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 0.0 |
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 0.0 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 0.0 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 0.0 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 0.0 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 0.0 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 6.3 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 0.0 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 3.1 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 0.0 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 0.0 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 0.0 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 0.0 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 0.0 |
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 0.0 |
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 0.0 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 0.0 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 4.8 |
An AE was defined as any unfavorable 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. (NCT01717326)
Timeframe: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)
Intervention | percentage of participants (Number) |
---|---|
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 88.0 |
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 85.7 |
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 91.7 |
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 90.0 |
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 72.7 |
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 87.1 |
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 77.4 |
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 65.5 |
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 87.5 |
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 83.9 |
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 81.3 |
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 78.8 |
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 97.0 |
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 81.3 |
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 65.5 |
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 53.3 |
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 73.3 |
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 54.8 |
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 85.0 |
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 90.5 |
The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR; negative HCV RNA after completing Zepatier therapy) / (number of subjects treated with Zepatier post-heart transplantation) (NCT03146741)
Timeframe: Baseline to 24 weeks
Intervention | Participants (Count of Participants) |
---|---|
Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) | 9 |
(NCT03146741)
Timeframe: Baseline to 52 weeks
Intervention | Severe adverse event (Number) |
---|---|
Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) | 0 |
CD4+ T cell count at 12 weeks post treatment (in HIV-positive co-infected patients) (NCT02886624)
Timeframe: 12 weeks
Intervention | cells/mm^3 (Median) |
---|---|
Grazoprevir/Elbasvir | 655 |
Number of participants with undetectable HIV RNA at 12 weeks post treatment (in HIV-positive co-infected patients) (NCT02886624)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|---|
Grazoprevir/Elbasvir | 27 |
Undetectable plasma HCV RNA (<12 IU/mL) 12 weeks post-treatment. (NCT02886624)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|---|
Grazoprevir/Elbasvir | 28 |
Number of patients missing study drug within the last four days during treatment (NCT02886624)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) |
---|---|
Grazoprevir/Elbasvir | 2 |
Number of patients harboring HCV (NS5A and NS3/4) resistance mutations 12 weeks post treatment (NCT02886624)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|---|
Grazoprevir/Elbasvir | 1 |
Number of patients with positive HCV RNA 48-weeks post treatment. (NCT02886624)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) | |
---|---|---|
With phylogentically different strain | With phylogentically similar strain | |
Grazoprevir/Elbasvir | 2 | 1 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy. (NCT02105662)
Timeframe: 12 weeks after end of all therapy (Study Week 24)
Intervention | percentage of participants (Number) |
---|---|
Grazoprevir+Elbasvir | 96.3 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy. (NCT02105662)
Timeframe: 24 weeks after end of all therapy (Study Week 36)
Intervention | percentage of participants (Number) |
---|---|
Grazoprevir+Elbasvir | 93.1 |
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. An AE can 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02105662)
Timeframe: Treatment Period (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|---|
Grazoprevir+Elbasvir | 0.0 |
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. An AE can 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02105662)
Timeframe: Treatment Period plus first 14 follow-up days (up to 14 weeks)
Intervention | percentage of participants (Number) |
---|---|
Grazoprevir+Elbasvir | 73.9 |
SVR12 was defined as HCV RNA
Timeframe: At follow-up Week 12
Intervention | Percentage of participants (Number) |
---|---|
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 96.4 |
SVR12 was defined as HCV RNA
Timeframe: At follow-up Week 12
Intervention | Percentage of participants (Number) |
---|---|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 97.7 |
SVR12 was defined as HCV RNA
Timeframe: At follow-up Week 12
Intervention | Percentage of participants (Number) |
---|---|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 75.6 |
SVR12 was defined as HCV RNA levels
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 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT02032888)
Timeframe: AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)
Intervention | Participants (Number) | ||||||
---|---|---|---|---|---|---|---|
AEs | SAEs | AEs requiring dose interruption or discontinuation | Treatment-related AEs | Treatment-related Grade 3 to 4 AEs | Grade 3 to 4 AEs | Death | |
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 37 | 3 | 0 | 17 | 0 | 4 | 0 |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 75 | 1 | 0 | 39 | 0 | 3 | 0 |
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 29 | 0 | 0 | 13 | 1 | 2 | 0 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT02032888)
Timeframe: AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.
Intervention | Participants (Number) | ||||
---|---|---|---|---|---|
AEs | SAEs | AEs Grade 3 to 4 | SAEs Grade 3 to 4 | Death | |
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 5 | 0 | 0 | 0 | 0 |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 11 | 3 | 3 | 2 | 1 |
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 5 | 1 | 1 | 1 | 1 |
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 |
Participants with HCV RNA levels
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 |
Participants with hepatitis C virus CV) levels to be
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 |
SVR is defined as hepatitis C virus RNA
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 |
SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, 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. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, 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. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Follow-up Week 12
Intervention | Percentage of participants (Number) |
---|---|
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | 75 |
HAART Therapy: Daclatasvir, 60 mg | 71.8 |
HAART: Daclatasvir, 30 mg + 60 mg | 71.7 |
HAART Therapy: Daclatasvir 30 or 60 or 90 mg | 73.3 |
Non-HAART Therapy: Daclatasvir, 60 mg | 87.5 |
Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing 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-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: From Day 1 to 7 days post last dose of study treatment (up to Week 48)
Intervention | Participants (Number) | |||
---|---|---|---|---|
Deaths | SAEs | Grade 3 to 4 AEs | AEs leading to discontinuation | |
HAART Therapy: Daclatasvir 30 or 60 or 90 mg | 2 | 24 | 93 | 17 |
HAART Therapy: Daclatasvir, 30 mg + 60 mg | 0 | 6 | 35 | 6 |
HAART Therapy: Daclatasvir, 60 mg | 1 | 6 | 12 | 4 |
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | 0 | 12 | 46 | 7 |
Non-HAART Therapy: Daclatasvir, 60 mg | 0 | 0 | 4 | 1 |
Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Intervention | Percentage of participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | Weeks 4 and 12 | End of treatment | Follow-up Week 12 | Follow-up Week 24 | |
HAART Therapy: Daclatasvir 30 or 60 or 90 mg | 39.7 | 71.5 | 82.7 | 84.1 | 84.1 | 85.2 | 78.7 | 84.8 | 73.3 | 70.4 |
Non-HAART Therapy: Daclatasvir, 60 mg | 41.7 | 91.7 | 95.8 | 87.5 | 95.8 | 91.7 | 91.7 | 95.8 | 87.5 | 83.3 |
Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Intervention | Percentage of participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | Weeks 4 and 12 | End of treatment | Follow-up Week 12 | Follow-up Week 24 | |
HAART Therapy: Daclatasvir 30 or 60 or 90 mg | 9 | 33.9 | 64.3 | 74.4 | 78 | 81.2 | 61.4 | 84.8 | 73.3 | 70.4 |
Non-HAART Therapy: Daclatasvir, 60 mg | 16.7 | 50 | 91.7 | 87.5 | 95.8 | 91.7 | 87.5 | 95.8 | 87.5 | 83.3 |
Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined. (NCT01471574)
Timeframe: End of treatment (up to Week 48)
Intervention | Percentage of participants (Number) | |
---|---|---|
HIV RNA <40 copies/mL | HIV RNA ≥400 copies/mL | |
HAART Therapy: Daclatasvir 30 or 60 or 90 mg | 90.6 | 0.4 |
HAART Therapy: Daclatasvir, 30mg + 60 mg | 93.4 | 0.0 |
HAART Therapy: Daclatasvir, 60 mg | 89.7 | 2.6 |
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | 88.6 | 0.0 |
Percentages calculated as number of responders/number who received treatment. (NCT01471574)
Timeframe: Follow-up Week 12
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
CC Genotype (n=36, 14, 39, 89, 6) | CT Genotype (n=72, 22, 50,144, 15) | TT Genotype (n=22, 3, 12, 37, 2) | Not reported (n=2, 0, 5, 7, 1) | |
HAART Therapy: Daclatasvir 30, 60 or 90 mg | 87.6 | 67.4 | 62.2 | 71.4 |
HAART Therapy: Daclatasvir, 30 mg + 60 mg | 79.5 | 70.0 | 58.3 | 60.0 |
HAART Therapy: Daclatasvir, 60 mg | 92.9 | 63.6 | 33.3 | 0.0 |
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | 94.4 | 66.7 | 68.2 | 100.0 |
Non-HAART Therapy: Daclatasvir, 60 mg | 100.0 | 93.3 | 50.0 | 0.0 |
All treated participants were monitored for change in Absolute CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48
Intervention | Cells/uL (Mean) |
---|---|
Cohort A: HCV GT-2 or GT-3 | -42.4 |
Cohort B: HCV GT-1 or GT-4 | -104.9 |
All treated participants were monitored for change in Platelet Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants (units of measurement = x10^9 cells/L). (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48
Intervention | 10^9 cells/L (Mean) |
---|---|
Cohort A: HCV GT-2 or GT-3 | 32.7 |
Cohort B: HCV GT-1 or GT-4 | 33.3 |
All treated participants were monitored for change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48
Intervention | Cells/µL (Mean) |
---|---|
Cohort A: HCV GT-2 or GT-3 | -0.38 |
Cohort B: HCV GT-1 or GT-4 | -0.50 |
All treated participants were monitored for percent change in CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48
Intervention | Percent change (Mean) |
---|---|
Cohort A: HCV GT-2 or GT-3 | -4.0 |
Cohort B: HCV GT-1 or GT-4 | -13.4 |
All treated participants were monitored for percent change in Platelet Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48
Intervention | Percent change (Mean) |
---|---|
Cohort A: HCV GT-2 or GT-3 | 16.9 |
Cohort B: HCV GT-1 or GT-4 | 20.1 |
All treated participants were monitored for percent change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48
Intervention | Percent change (Mean) |
---|---|
Cohort A: HCV GT-2 or GT-3 | -15.33 |
Cohort B: HCV GT-1 or GT-4 | -22.95 |
SVR12 was defined as HCV RNA less than lower limit of quantification (< LLOQ) (25 IU/mL; target detected or not detected) at follow-up week 12. (NCT01866930)
Timeframe: Follow-up week 12
Intervention | Participants (Count of Participants) |
---|---|
Cohort A: HCV GT-2 or GT-3 | 88 |
Cohort B: HCV GT-1 or GT-4 | 149 |
All treated participants were monitored for treatment emergent cytopenic abnormalities (anemia as defined by hemoglobin (Hb) < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000/mm3) during the treatment period (Weeks 1, 2, 4, 6, 8, 12, 20, and 24, and at Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits). (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48
Intervention | Participants (Count of Participants) |
---|---|
Cohort A: HCV GT-2 or GT-3 | 4 |
Cohort B: HCV GT-1 or GT-4 | 15 |
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=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. Treatment-related=having certain, probable, possible, or missing relationship to study drug. (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48
Intervention | Participants (Count of Participants) | |||
---|---|---|---|---|
Deaths | SAEs | Lambda Dose Reduction | Discontinuation due to AEs | |
Cohort A: HCV GT-2 or GT-3 | 0 | 6 | 4 | 4 |
Cohort B: HCV GT-1 or GT-4 | 3 | 12 | 19 | 13 |
All treated participants were monitored for IFN-associated Flu-like and Musculoskeletal symptoms. Flu-like symptoms were defined as pyrexia, chills, or pain. Musculoskeletal symptoms were defined as arthralgia, myalgia, or back pain. Subjects were monitored throughout the treatment period during the treatment period (After day 1 up to week 24, or After day 1 up to week 48 for subjects requiring those visits). (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48
Intervention | Participants (Count of Participants) | |
---|---|---|
Musculoskeletal symptoms | Flu-like symptoms | |
Cohort A: HCV GT-2 or GT-3 | 6 | 6 |
Cohort B: HCV GT-1 or GT-4 | 21 | 19 |
RVR is defined as HCV RNA < LLOQ target not detected at Week 4 and eRVR defined as HCV RNA < LLOQ target not detected at Weeks 4 and 12 (NCT01866930)
Timeframe: Treatment weeks 4 and 12
Intervention | Participants (Count of Participants) | |
---|---|---|
RVR | eRVR | |
Cohort A: HCV GT-2 or GT-3 | 82 | 80 |
Cohort B: HCV GT-1 or GT-4 | 149 | 138 |
Grade 3/4 treatment-emergent lab abnormalities that occurred in >=5% of subjects in either cohort are reported. The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AST = Aspartate aminotransferase, ALT = Alanine aminotransferase. (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48
Intervention | Participants (Count of Participants) | ||
---|---|---|---|
Total Bilirubin | AST | ALT | |
Cohort A: HCV GT-2 or GT-3 | 26 | 10 | 2 |
Cohort B: HCV GT-1 or GT-4 | 63 | 13 | 10 |
8 reviews available for carbamates and Co-infection
Article | Year |
---|---|
Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysis.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; C | 2020 |
Are there any challenges left in hepatitis C virus therapy of HIV-infected patients?
Topics: Antiretroviral Therapy, Highly Active; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Dr | 2020 |
Treating HCV in HIV 2013: on the cusp of change.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Coinfection; Drug Interactions; Drug Therapy, C | 2014 |
Advances in hepatitis C therapies.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatit | 2015 |
Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison.
Topics: Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Coinfection; Drug Therapy, Combin | 2016 |
Grazoprevir + elbasvir for the treatment of hepatitis C virus infection.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug Combinations; Dr | 2016 |
Hepatitis C: efficacy and safety in real life.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatit | 2017 |
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir: Drug Interactions With Antiretroviral Agents and Drugs forSubstance Abuse.
Topics: 2-Naphthylamine; Anilides; Anti-Retroviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Inte | 2017 |
14 trials available for carbamates and Co-infection
45 other studies available for carbamates and Co-infection
Article | Year |
---|---|
Hepatitis B virus reactivation sustained by a hepatitis B virus surface antigen immune-escape mutant isolate in a patient who was hepatitis B core antibody positive during treatment with sofosbuvir and velpatasvir for hepatitis C virus infection: a case r
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepatitis B; Hepatit | 2019 |
Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice - Vie-KinD study.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Ther | 2019 |
Sustained virologic response and changes in liver fibrosis parameters following 12-wk administration of generic sofosbuvir and daclatasvir in HIV/HCV-coinfected patients with HCV genotype 4 infection.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatit | 2020 |
Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepatitis C, Chronic; | 2020 |
Real-world efficacy of direct acting antiviral therapies in patients with HIV/HCV.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Drug Therapy, Combination; F | 2020 |
Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort.
Topics: Adult; Carbamates; Coinfection; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis | 2021 |
Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepatitis C, Chronic | 2021 |
Impact of sofosbuvir and daclastavir on health-related quality of life in patients co-infected with hepatitis C and human immunodeficiency virus.
Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepatitis C, Ch | 2021 |
Daclatasvir plasma concentration assessment in HIV-HCV-coinfected real-life patients.
Topics: Antiviral Agents; Carbamates; Coinfection; Genotype; Hepacivirus; Hepatitis C; Hepatitis C, Chronic; | 2017 |
Hepatitis B reactivation in a patient with chronic hepatitis C treated with direct-acting antivirals.
Topics: Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Therapy, Combination; Guani | 2018 |
Brief Report: High Need to Switch cART or Comedication With the Initiation of DAAs in Elderly HIV/HCV-Coinfected Patients.
Topics: Adult; Aged; Aged, 80 and over; Amides; Anti-Retroviral Agents; Antiviral Agents; Benzofurans; Carba | 2017 |
Plasma trough concentrations of antiretrovirals in HIV-infected persons treated with direct-acting antiviral agents for hepatitis C in the real world.
Topics: 2-Naphthylamine; Anilides; Anti-Retroviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Inte | 2018 |
Remarkable plasma HIV RNA decrease by ombitasvir/paritaprevir/ritonavir in an HIV-HCV coinfection case.
Topics: Adult; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Hepacivirus; Hepatitis C, | 2018 |
UPLC-MS/MS method for the simultaneous quantification of sofosbuvir, sofosbuvir metabolite (GS-331007) and daclatasvir in plasma of HIV/HCV co-infected patients.
Topics: Antiviral Agents; Carbamates; Chromatography, High Pressure Liquid; Coinfection; Hepatitis C; HIV In | 2018 |
The safety and efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 1b infection.
Topics: Adolescent; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, Phase I | 2018 |
The Proof Is in the Patient: Hepatitis C Virus Microelimination in the Swiss Human Immunodeficiency Virus Cohort Study.
Topics: Amides; Benzofurans; Carbamates; Cohort Studies; Coinfection; Cyclopropanes; Hepacivirus; HIV; HIV I | 2019 |
Successful treatment of genotype 3 hepatitis C infection in a noncirrhotic HIV infected patient on chronic dialysis with the combination of sofosbuvir and velpatasvir: A case report.
Topics: Antiviral Agents; Carbamates; Coinfection; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or More R | 2018 |
Effectiveness of ombitasvir/paritaprevir/ritonavir, dasabuvir for HCV in HIV/HCV coinfected subjects: a comprehensive analysis.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Clinical Trials as Topic; Coinfectio | 2019 |
Contemporary HCV pangenotypic DAA treatment protocols are exclusionary to real world HIV-HCV co-infected patients.
Topics: Adult; Aged; Aminoisobutyric Acids; Anti-Retroviral Agents; Antiviral Agents; Benzimidazoles; Carbam | 2019 |
Successful treatment of HBV, HCV, & HEV, with 12-week long use of tenofovir, sofosbuvir, daclatasvir, and ribavirin: A case report.
Topics: Aged; Antiviral Agents; Asthma; Carbamates; Coinfection; Diabetes Complications; Drug Administration | 2020 |
Hepatotoxicity and virological breakthrough of HCV following treatment with sofosbuvir, daclatasvir, and ribavirin in patients previously treated for tuberculosis.
Topics: Aged; Antitubercular Agents; Antiviral Agents; Carbamates; Chemical and Drug Induced Liver Injury; C | 2019 |
Antiviral therapy for HCV in hemophilia A patients with HIV-1 co-infection.
Topics: Adult; Antiviral Agents; Carbamates; CD4 Lymphocyte Count; Coinfection; Drug Therapy, Combination; H | 2019 |
HIV-hepatitis C co-infection.
Topics: Antiviral Agents; Carbamates; Coinfection; Hepatitis C; HIV Infections; Humans; Imidazoles; Pyrrolid | 2015 |
Raltegravir Pharmacokinetics in Patients on Asunaprevir-Daclatasvir.
Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepacivirus; He | 2015 |
Paritaprevir/ritonavir, ombitasvir, and dasabuvir for treatment of recurrent hepatitis C virus infection in the human immunodeficiency virus coinfected liver transplant recipient.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Therapy, C | 2016 |
Paritaprevir/ritonavir/ombitasvir and dasabuvir for the treatment of chronic hepatitis C virus infection.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Clinical Trials, Phase II as Topic; Clinica | 2015 |
Interferon-free treatment with sofosbuvir/daclatasvir achieves sustained virologic response in 100% of HIV/hepatitis C virus-coinfected patients with advanced liver disease.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepatitis C, Chronic; | 2016 |
Severe Hyperbilirubinemia in an HIV-HCV-Coinfected Patient Starting the 3D Regimen That Resolved After TDM-Guided Atazanavir Dose Reduction.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Atazanavir Sulfate; Carbamates; Coinfection; Cyclopropa | 2016 |
Treatment of chronic hepatitis C with direct acting antiviral agents in patients with haemophilia, end-stage liver disease and coinfected with HIV.
Topics: Adult; Antiviral Agents; Carbamates; CD4 Lymphocyte Count; Coinfection; Drug Interactions; Hemophili | 2016 |
12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepacivir | 2016 |
Treatment of severe recurrent hepatitis C after liver transplantation in HIV infected patients using sofosbuvir-based therapy.
Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; End Stage Liver Disease | 2016 |
Fosamprenavir/ritonavir in patients with viral hepatitis coinfection: an observational multicohort study.
Topics: Adult; Antiretroviral Therapy, Highly Active; Carbamates; Cause of Death; CD4 Lymphocyte Count; Coin | 2016 |
Darunavir-based Antiretroviral Therapy may Affect the Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in HCV/HIV-1 Coinfected Patients.
Topics: 2-Naphthylamine; Anilides; Carbamates; Coinfection; Cyclopropanes; Darunavir; Hepatitis C; HIV Infec | 2016 |
Sixty milligram daclatasvir is the right dose for hepatitis C virus treatment in combination with etravirine and darunavir/ritonavir.
Topics: Anti-HIV Agents; Antiviral Agents; Area Under Curve; Carbamates; Coinfection; Darunavir; Diuretics; | 2016 |
Direct Observed Therapy of Chronic Hepatitis C With Interferon-Free All-Oral Regimens at a Low-Threshold Drug Treatment Facility-a New Concept for Treatment of Patients With Borderline Compliance Receiving Opioid Substitution Therapy.
Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Directly Observed Therapy; Drug Th | 2016 |
A case of acute hepatitis B in a chronic hepatitis C patient after daclatasvir and asunaprevir combination therapy: hepatitis B virus reactivation or acute self-limited hepatitis?
Topics: Acute Disease; Aged, 80 and over; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combinati | 2016 |
Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Resistance, Viral; Drug Therapy, Combination; Female | 2016 |
Interferon-free regimens improve health-related quality of life and fatigue in HIV/HCV-coinfected patients with advanced liver disease: A retrospective study.
Topics: Antiviral Agents; Austria; Benzimidazoles; Carbamates; Coinfection; Fatigue; Female; Fluorenes; Hepa | 2016 |
Successful treatment of three patients with human immunodeficiency virus and hepatitis C virus genotype 1b co-infection by daclatasvir plus asunaprevir.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepaciv | 2017 |
Daclatasvir plus sofosbuvir, with or without ribavirin, in real-world patients with HIV-HCV coinfection and advanced liver disease.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Genotype; | 2017 |
Real-life efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir in chronic hepatitis C patients in Hong Kong.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Administra | 2017 |
Effectiveness of All-Oral Antiviral Regimens in 996 Human Immunodeficiency Virus/Hepatitis C Virus Genotype 1-Coinfected Patients Treated in Routine Practice.
Topics: Administration, Oral; Aged; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies; | 2017 |
Real-World Efficacy of Daclatasvir and Sofosbuvir, With and Without Ribavirin, in HIV/HCV Coinfected Patients With Advanced Liver Disease in a French Early Access Cohort.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug-Related Side Effects and Adverse Reacti | 2017 |
[Biliary and kidney lithiasis during treatment with daclatasvir/sofosbuvir/ribavirin and atazanavir/ritonavir + abacavir/lamivudine in an HIV/HCV genotype 4-infected patient: a case report.]
Topics: Adult; Anti-HIV Agents; Antiviral Agents; Atazanavir Sulfate; Biliary Tract Diseases; Carbamates; Co | 2017 |
Prevalence of natural polymorphisms at the HCV NS5A gene associated with resistance to daclatasvir, an NS5A inhibitor.
Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Resistance, Viral; Female; Genotype; Hepacivi | 2012 |