uracil and Chronic Hepatitis C

uracil has been researched along with Chronic Hepatitis C in 144 studies

2,4-dihydroxypyrimidine: a urinary biomarker for bipolar disorder

Research

Studies (144)

Authors

Clinical Trials (39)

Trial Overview

Trial Outcomes

Number of Participants Who Experienced HIV-1 Virologic Failure (VF)

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.

Number of Participants Who Prematurely Discontinued HCV Study Treatment for Any Reason Other Than HCV Virologic Failure (VF)

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 NCT02194998)
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.

Number of Participants With an Occurrence of Diagnoses Leading to Premature HCV Study Treatment or HIV-1 Antiretroviral (ARV) Discontinuation.

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.

Number of Participants With an Occurrence of Laboratory Abnormality Grade 3 or Higher.

"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.

Number of Participants With an Occurrence of Serious Adverse Events (SAEs) as Defined by International Conference on Harmonisation (ICH) Criteria

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.

Number of Participants With an Occurrence of Signs/Symptoms Grade 3 or Higher

"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.

Number of Participants With Selected HIV-1 Resistance Mutations Among Participants Who Experience HIV-1 Virologic Failure (VF)

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.

Percentage of Participants With Sustained Virologic Response at 12 Weeks After HCV Treatment Discontinuation (SVR12)

"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.

Percentage of Participants With Sustained Virologic Response at 24 Weeks After HCV Treatment Discontinuation (SVR24)

"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.

Change in IP-10 Concentration.

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.

Change in Soluble CD14 (sCD14)

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.

Levels of IP-10 Concentration.

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.

Levels of Soluble CD14 (sCD14)

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.

Part 1: Concentration of Drug in Blood Plasma Against Time [Area Under the Curve (AUC)] of Dasabuvir (DSV)

AUC is a measure of how long and how much drug is present in the body after dosing. The amount of dasabuvir present was measured up to 12 hours after dosing. For two subjects in the 15-29 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. For one subject in the 30-44 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. (NCT02486406)
Timeframe: At Week 2

Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV)

AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ombitasvir present was measured up to 24 hours after dosing. (NCT02486406)
Timeframe: At Week 2

Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV)

AUC is a measure of how long and how much drug is present in the body after dosing. The amount of paritaprevir present was measured up to 24 hours after dosing. (NCT02486406)
Timeframe: At Week 2

Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ritonavir (RTV)

AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ritonavir present was measured up to 24 hours after dosing. (NCT02486406)
Timeframe: At Week 2

Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV)

Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2

Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV)

Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2

Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV)

Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2

Part 1: Maximum Plasma Concentration (Cmax) of Ritonavir (RTV)

Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2

Parts 1 & 2: Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Actual Dose of Study Drug (SVR24), Summarized by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations

SVR24 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 24 weeks after the last actual dose of study drug. (NCT02486406)
Timeframe: 24 weeks after last dose of study drug (Week 36 or 48 depending on treatment duration)

Parts 1 and 2: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization During Treatment by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations

Alanine aminotransferase (ALT) normalization during treatment is defined as ALT ≤ the upper limit of normal (ULN) at the final treatment visit for participants with ALT > ULN at baseline. (NCT02486406)
Timeframe: 12 or 24 weeks after starting study drug, depending on treatment duration

Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12)

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. (NCT02486406)
Timeframe: 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)

Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12) Summarized by Formulation, Age and Weight Group, and Across All Subjects on the Adult Formulations

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. (NCT02486406)
Timeframe: 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)

Part 1: Lowest Plasma Concentration (Ctrough) of Dasabuvir (DSV)

Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8

Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV)

Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8

Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV)

Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8

Part 1: Lowest Plasma Concentration (Ctrough) of Ritonavir (RTV)

Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8

16 Wk EBR/GZR With RBV Efficacy on Patients With HCV RASs

"Efficacy of Hepatitis C Virus (HCV) Treatment with Zepatier (Elbasvir/Grazobevir) with Ribavirin (RBV) for 16 weeks when used in Genotype 1a patients with Baseline RASs (NS5a Resistance Associated Substitutions or RAPs -Resistance Associated Polymorphisms).~Efficacy defined as HCV RNA undetectable 12 weeks post treatment. Table excludes Genotype 1b patients." (NCT02786537)
Timeframe: 12 weeks post treatment

HCV SVR Durability -No Cirrhosis

Number/Percentage of patients with persistence of viral cure, SVR (SVR = Sustained Virologic Response)- defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. (NCT02786537)
Timeframe: 24 weeks post-end of treatment up to 153 weeks

HCV SVR Durability-Patients With Cirrhosis

Percentage of Cirrhotic patients with persistence of viral cure, SVR, (SVR= Sustained Virologic Response) defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. (NCT02786537)
Timeframe: Up to 132 weeks post HCV treatment

Mean Change in Fatigue PRO -EBR/GZR vs SOF/LDV

Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline and Average On-Treatment Score

Mean Change in Fatigue PRO Score -Phase 1

Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline to On-treatment

Mean Change in HCV- PRO- Phase 1

"HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'overall functioning and well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Baseline to End of Treatment

Mean Change in HCV-PRO (Functional Well-being) EBR/GZR vs. SOF/LDV Score-Phase 2

"HCV-PRO, a survey designed to assess functional status of patients with HCV and measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered. End of Treatment -Baseline were used to calculate CHANGE in outcome. Number of subjects reflects participants from both Phase 1 and 2." (NCT02786537)
Timeframe: End of Treatment - Baseline

Mean Change in Headache-EBR/GZR and SOF/LDV

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD (NCT02786537)
Timeframe: Baseline to On-Treatment

Mean Change in Headache-PRO Scores -Phase 1

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement in symptom. (NCT02786537)
Timeframe: Baseline to On-Treatment

Mean Change in Nausea/Vomiting PRO Score -Phase 1

"Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.~The estimates of mean change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes. The model expressed mean score as a function of DAA regimen, cirrhosis status, HCV genotype, sex, age, race, and previous treatment status." (NCT02786537)
Timeframe: Baseline to On-Treatment

Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF

"Participants completed the Patient Reported Outcomes surveys (PROs) 'PROMIS Nausea/Vomiting -4 Short Form' at baseline and during treatment. Raw scores are converted to standardized T-scores with a range of 45.0-80.1. Higher scores indicate worse nausea/vomiting.~Results presented as mean difference from baseline to average of on Treatment Scores (highest/worst) score during treatment.~A negative (-) PROMIS change score is suggestive of symptom improvement or lack of drug side effect. Estimates of mean change were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes." (NCT02786537)
Timeframe: Baseline and Average On-Treatment Score

Median Change in Fatigue -Phase 1

Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline to End of Treatment

Median Change in Fatigue-Phase 2

Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline-On Treatment (up to 16 weeks)

Median Change in HCV-PRO (Overall Well Being) -Phase 1

"HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'Overall Functioning and Well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Baseline to End of Treatment

Median Change in Headache -Phase 1

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD (NCT02786537)
Timeframe: 12 weeks (Baseline and Average On-treatment Score)

Median Change in Headache-Phase 2

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of median change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD (NCT02786537)
Timeframe: Baseline -on Treatment (12-16 weeks)

Median Change in Nausea PRO Score -Phase 1

"Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.~The estimates of change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes." (NCT02786537)
Timeframe: Baseline to end of treatment

Median Change in Nausea PROMIS Score-EBR/GZR SOF/LDV

"Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for change represent improvement.~The estimates of change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes." (NCT02786537)
Timeframe: Baseline- On Treatment (up to 16 weeks)

Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF

The number of participants with adverse events that led to early treatment discontinuation (defined as duration less than originally prescribed treatment regimen) (NCT02786537)
Timeframe: Treatment start date through treatment completion (up to 24 weeks)

Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)

"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~Number of subjects reflects participants randomized during Phase 1 only." (NCT02786537)
Timeframe: 12 -24 weeks post-treatment

Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation

"SVR (Sustained Virologic Response) 12 will be defined as patients who have undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~mITT with imputation (missing=failure). Total number of subjects reflects participants from Phase 1 only." (NCT02786537)
Timeframe: 12 weeks post-treatment

Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)

"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~Number of subjects reflects participants who started EBR/GZR or SOF/LDV- based treatment (with or without RBV) during Phase 1 and 2." (NCT02786537)
Timeframe: 12-24 weeks post HCV treatment

Post-treatment Progression/Regression of Liver Disease-Fib-4

Mean change (delta) in FIB-4, an indirect non-invasive measure of liver fibrosis, calculated as baseline median -long term follow up median, following SVR after any of the study treatment regimens. Change in FIB-4 where negative values indicate improvement in liver fibrosis score and positive values indicate worsening of fibrosis score. There is no upper or lower limit for change. FIB-4 = age (years) * AST(IU/L)/Platelets (10^3/L) * ALT^.5(IU/L). In general, Score of 0-1.29 is low risk for advanced fibrosis, 1.30-1.67: intermediate risk for advanced liver fibrosis, >2.67: high risk for advanced fibrosis. (NCT02786537)
Timeframe: Baseline to up to 3 years post treatment discontinuation

Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV

"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation at discretion of provider).~mITT with imputation (missing=failure). Total number of subjects reflects participants from EBR/GZR with or without RBV and SOF/LDV with or without RBV randomized during Phase 1 and Phase 2." (NCT02786537)
Timeframe: 12 weeks post-treatment

Treatment Non-Adherence Probability Estimates

"The Voils Medication Adherence Survey (VMAS) was used to evaluate medication adherence during HCV treatment. Participants responded to three questions about the extent of adherence during the past seven days of treatment (during early and late on-treatment occasions). Participants responded using a five-point ordinal scale of missed dosing from 1 (none of the time) to 5 (all of the time). On each occasion participants were coded as being Non-adherent if any response was > 1, otherwise they were coded as Adherent. Probability estimates of percentage of patients reporting non-adherence were calculated per HCV treatment (Direct Acting Antiviral-DAA) regimen: 1)EBR/GZV (elbasvir/grazoprevir, 2)SOF/LDV (sofosbuvir/ledipasvir), 3)PrOD" (NCT02786537)
Timeframe: 12-16 weeks of HCV treatment

Change in Functional Status (HCV-PRO) Within Treatment

"HCV-PRO score, a validated PROMIS survey used to evaluate overall functioning and well-being in HCV patients, was utilized to compare long-term 'within treatment' changes of functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive estimate (Post treatment to baseline) suggests baseline functional well-being improvement.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Treatment start date up to 2 years post-treatment

Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation

Change in HCV-associated symptoms was calculated as the mean differences of mean scores from multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS)-- Fatigue, nausea, belly pain, sleep disturbance, and diarrhea) and functional status (well-being) when comparing baseline to early post-treatment and late post treatment surveys. Mean change scores were calculated by comparing baseline to early post-treatment (1 yr) and late post-treatment (approximately 3 years) surveys. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.Negative numbers suggest better symptoms (improvement in HCV-associated symptoms). PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35.HCV-PRO positive estimates suggest baseline functional well-being improvement. (NCT02786537)
Timeframe: 1 year post treatment discontinuation (Early post-tx)

Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2

Number of participants who achieved SVR (sustained virologic response), defined as undetectable HCV RNA 12 weeks post-treatment with RASs (Resistant Associated Substitutions) after treatment with EBR/GZR or SOF/LDV regimen (NCT02786537)
Timeframe: 12 weeks post HCV treatment

Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment

"HCV-specific Functional Well-Being was measured using the disease-specific HCV-PRO. The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life.~The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T5 HCV-PRO mean score.~Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~HCV-PRO mean change scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful." (NCT02601820)
Timeframe: Baseline to 1 year post-treatment

Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment

"HCV-specific Functional Well-Being was measured using the disease-specific HCV-PRO.~The means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T4 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~HCV-PRO Mean Change Scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful." (NCT02601820)
Timeframe: Baseline to 3-months post-treatment

Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment

"Change in Overall Symptom Burden from Baseline to 1 year post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T5 TMSAS mean score.~Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful" (NCT02601820)
Timeframe: Baseline to 1 year post-treatment

Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment

"Change in Overall Symptom Burden from Baseline to 3-months post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS).~The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T4 TMSAS mean score.~Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~TMSAS Mean Change Scores could range from +/- 4.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful." (NCT02601820)
Timeframe: Baseline to 3-months post-treatment

Cumulative Out of Pocket Costs During HCV Treatment

"Cumulative out of pocket (OOP) costs incurred by patients during HCV treatment was measured by a survey recording 5 direct and 5 indirect costs of treatment. OOP costs were collected early on-treatment (T2), late on-treatment (T3), and early post-treatment (T4) in case patients paid bills after treatment ended.~The Mean is the average dollar ($$) amount for Total OOP Cost of HCV Treatment for the cohort, calculated by summing the OOP costs for each patient reported at T2+T3+T4." (NCT02601820)
Timeframe: Up to 24 weeks of HCV Treatment

Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment

"Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T4 mean. Lower change scores (-) indicate symptom improved~PROMIS Fatigue mean change score range = +/- 53.9~PROMIS Sleep Disturbance mean change score range = +/- 47.1~PROMIS Nausea mean change score range = +/- 44.0~PROMIS Diarrhea mean change score range = +/- 42.8~PROMIS Anger mean change score range = +/- 50.5.~PROMIS Anxiety mean change score range = +/- 41.4~PROMIS Depression mean change score range = +/- 43.1~PROMIS Cognitive Concern mean change score range = +/- 39.5~PROMIS Pain mean change score range = +/- 36.4~PROMIS Belly Pain mean change score range = +/- 50.2~Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically minimally important change (MIC). The 5% MIC = +/- 2.5 points.~Change scores were calculated for two subgroups: Patients who did and did not achieve SVR" (NCT02601820)
Timeframe: Baseline to 3-months post-treatment

Change in HCV-PRO Mean Scores From Baseline to On-Treatment

"HCV-specific Functional Well-Being was measured using the disease-specific HCV-PRO. The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life.~The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T2 HCV-PRO mean score or Baseline HCV-PRO mean score minus T3 HCV-PRO mean score.~HCV-PRO mean change scores range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful." (NCT02601820)
Timeframe: Baseline to up to 24 weeks of HCV Treatment

Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment

"Change in Overall Symptom Burden was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score.~Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful." (NCT02601820)
Timeframe: Baseline to up to 24 weeks of HCV Treatment

Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment

"Change in Treatment-Related Symptoms was measured using multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) and the Headache Impact Test (HIT-6). Mean CHANGE Scores were calculated as baseline mean score minus T2 mean score or baseline mean score minus T3 mean score. Lower change scores (-) indicate symptoms improved.~PROMIS Fatigue-7 mean change score range = +/- 53.9~PROMIS Sleep Disturbance-8a mean change score range = +/- 47.1~PROMIS Nausea/Vomiting-4 mean change score range = +/- 44.0~PROMIS Diarrhea-6 mean change score range = +/- 42.8~PROMIS Anger-5 mean change score range = +/- 50.5.~PROMIS Anxiety-4 mean change score range = +/- 41.4~HIT-6 mean change score range = +/- 42~To aid in interpretation of clinical significance, a 5% change from baseline is considered a minimally important change (MIC). The 5% MIC change in a PROMIS or HIT-6 score is +/- 2.5 points." (NCT02601820)
Timeframe: Baseline to up to 24 weeks of HCV Treatment

Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment

"Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T5 mean. Lower change scores (-) indicate symptom improved~PROMIS Fatigue mean change score range = +/- 53.9~PROMIS Sleep Disturbance mean change score range = +/- 47.1~PROMIS Nausea mean change score range = +/- 44.0~PROMIS Diarrhea mean change score range = +/- 42.8~PROMIS Anger mean change score range = +/- 50.5.~PROMIS Anxiety mean change score range = +/- 41.4~PROMIS Depression mean change score range = +/- 43.1~PROMIS Cognitive Concern mean change score range = +/- 39.5~PROMIS Pain mean change score range = +/- 36.4~PROMIS Belly Pain mean change score range = +/- 50.2~Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically minimally important change (MIC). The 5% MIC = +/- 2.5 points.~Change scores were calculated for two subgroups: Patients who did and did not achieve SVR" (NCT02601820)
Timeframe: Baseline to 1 year post-treatment

Percentage of Participants With Nonadherence During HCV Treatment

Medication adherence was measured using the Voils' Medication Adherence Survey (VMAS). The VMAS consists of 3 items that evaluated the extent of adherence using a 5-point Likert scale from 1=None of the time to 5=All of the time. The 3 items assess how often participants missed doses, skip doses, or do not take doses over the past 7 days and are averaged into a single score. A dichotomous variable was created to categorize patients as 100% (adherent) or <100% (nonadherent) during HCV treatment at early treatment (T2) and late treatment (T3). (NCT02601820)
Timeframe: Up to 24 weeks of HCV Treatment

Percentage of Female Participants Responding With SVR12

SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Female Participants Responding With SVR12: mITT-GT Population

SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants Who Achieve SVR12: mITT-GT Population

SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12

SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: Baseline and 12 weeks after the last actual dose of study drug

Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population

SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: Baseline and 12 weeks after the last actual dose of study drug

Percentage of Participants With On-Treatment Virologic Failure During Treatment Period

On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: Up to 8 weeks while on treatment

Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population

On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method. (NCT02582632)
Timeframe: Up to 8 weeks while on treatment

Percentage of Participants With Post-Treatment Relapse12

Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: Up to 12 weeks after last dose of study drug

Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population

Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: Up to 12 weeks after last dose of study drug

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. (NCT02517528)
Timeframe: 12 weeks after last dose of study drug

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)

SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China. (NCT02517528)
Timeframe: 24 weeks after last dose of study drug

Percentage of Participants With On Treatment Virologic Failure

On treatment virologic failure is defined as confirmed HCV RNA greater than or equal to the LLOQ at any point during treatment after HCV RNA less than LLOQ, confirmed increase from the lowest value post-baseline in HCV RNA (two consecutive HCV RNA measurements greater than 1 log10 IU/mL above the lowest value post-baseline) at any time point during treatment, or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks (greater than or equal to 36 days) of treatment. 95% CI is calculated using Wilson's score method. (NCT02517528)
Timeframe: Within 12 weeks after first dose of study drug

Percentage of Participants With Virologic Relapse

Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method. (NCT02517528)
Timeframe: Within 12 weeks after the last dose of study drug

Percentage of Participants With Virologic Relapse by Post-Treatment Week 24

Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 24 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method. (NCT02517528)
Timeframe: Within 24 weeks after the last dose of study drug

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during active treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during active treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of active treatment. (NCT02517515)
Timeframe: up to 12 weeks

Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02517515)
Timeframe: From the end of treatment through 12 weeks after the last dose of active study drug

Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02517515)
Timeframe: From the end of treatment through 24 weeks after the last dose of active study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02517515)
Timeframe: 12 weeks after the last actual dose of active study drug

Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)

SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02517515)
Timeframe: 24 weeks after the last actual dose of active study drug

Adherence: Percentage of Planned Duration of RBV Taken by Participant

(NCT02798315)
Timeframe: Up to 48 weeks

Change From Baseline in the PAM-13 Questionnaire

"The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Based on responses to the 13-item measure, the score is calculated by adding up the raw scores (range of the sum: 13 - 52) and mapping up the value onto a scale of 0-100 indicating strength of agreement with the 13 items. A higher score indicates that the patient is likely to participate more actively in health care processes and takes more responsibility for his or her health." (NCT02798315)
Timeframe: Up to 48 weeks

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug (NCT02798315)
Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug

Percentage of Participants With Breakthrough.

Breakthrough defined as at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment. (NCT02798315)
Timeframe: Up to EoT, maximum of 24 weeks

Percentage of Participants With Relapse at EoT

Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL. (NCT02798315)
Timeframe: Up to EoT, maximum of 24 weeks

Percentage of Participants With Virological Response at End of Treatment (EoT)

Virological response defined as HCV RNA level less than 50 IU/mL. (NCT02798315)
Timeframe: Up to EoT, maximum of 24 weeks

Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA

Percentage of the DAA dose taken in relation to the target dose of DAA (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose. (NCT02798315)
Timeframe: Up to 48 weeks

Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV

Percentage of the RBV dose taken in relation to the target dose of RBV (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose. (NCT02798315)
Timeframe: Up to 48 weeks

Patient Support Program (PSP) Questionnaire: Utilization of PSP Components

Percentage of participants using each component of the PSP, including personal support, educational and information material (printed, online) and additional digital and mobile resources (web-portal, app, and reminders). (NCT02798315)
Timeframe: Up to EoT, maximum of 24 weeks

Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse

On-treatment virologic failure defined as breakthrough (at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). Relapse (defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment). (NCT02798315)
Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug

Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria

Premature study drug discontinuation category is defined as participants who prematurely discontinued study drug and who experienced no on-treatment virologic failure. The final SVR non-response category was defined as missing SVR12 data and/or none of the above criteria. (NCT02798315)
Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug

Change From Baseline in Patient Activation Measure 13 (PAM-13)

"PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation." (NCT02618928)
Timeframe: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)

Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)

(NCT02618928)
Timeframe: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure. (NCT02618928)
Timeframe: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)

Percentage of Participants Achieving Virological Response at End of Treatment

Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. (NCT02618928)
Timeframe: End of treatment (week 8, 12, or 24 depending on the treatment regimen)

Percentage of Participants With Breakthrough

Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. (NCT02618928)
Timeframe: 8, 12, or 24 weeks (depending on the treatment regimen)

Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)

RVR 4 was defined as participants with HCV RNA < 50 IU/mL at week 4. (NCT02618928)
Timeframe: Week 4

Percentage of Participants With Relapse

Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. (NCT02618928)
Timeframe: End of treatment (week 8, 12, or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.

Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment

"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The Core Population with sufficient follow-up data regarding SVR12 included all core population participants who~had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE REGIMEN~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure." (NCT02618928)
Timeframe: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)

Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)

"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.~The Core population with sufficient follow-up data regarding SVR24 included all core population participants who~had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure." (NCT02618928)
Timeframe: 24 weeks after the last dose of study drug (week 32, 36, or 48 depending on the treatment regimen)

Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days

(NCT02618928)
Timeframe: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.

Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)

The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication. (NCT02618928)
Timeframe: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)

Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score

"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score

"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status with a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable)." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in Fatigue Impact Scale Total Score

"The Fatigue Impact Scale (FIS) questionnaire was used to assess the impact of fatigue on the quality of life of patients.~The FIS consists of 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a total score from of 0 to 160, where a lower score = less fatigue impact" (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism

"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism

"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Presenteeism indicates the percentage of impairment while working due to health problems." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment

"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)

"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Number of Participants in Each Non-response Category 12 Weeks Post-treatment

"SVR12 non-response was categorized according to the following:~On-treatment virologic failure (breakthrough [at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥ 50 IU/mL]);~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Death~Premature treatment discontinuation with no on-treatment virologic failure;~Insufficient virological response reported or HCV RNA ≥ 50 IU/mL post-EOT and none of the above criteria~Missing SVR12 data and/or none of the above criteria." (NCT02618928)
Timeframe: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)

Number of Participants Who Received Concomitant Medications

Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose. (NCT02618928)
Timeframe: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen

Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies

(NCT02618928)
Timeframe: From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of study drug. (NCT02582658)
Timeframe: 12 Weeks after the last dose of study drug

Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)

SVR12 is defined as HCV RNA levels < 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU). (NCT02582658)
Timeframe: 12 weeks after last dose of study drug

Percentage of Participants With On-treatment Virologic Failure (Breakthrough)

The percentage of participants with on-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment]). (NCT02582658)
Timeframe: Up to approximately 24 weeks

Percentage of Participants With Post-treatment Relapse

The percentage of participants with relapse (defined as HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL) (NCT02582658)
Timeframe: Up to 12 weeks after last dose of study drug

Percentage of Participants With Virological Response at End of Treatment (EoTR)

The percentage of participants with virological response (HCV RNA <50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin [RBV]). (NCT02582658)
Timeframe: Up to 24 weeks of treatment

Percentage of Planned Duration of Ribavirin (RBV) Taken

Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ [initially prescribed dose x planned duration]). (NCT02582658)
Timeframe: Up to 24 weeks of treatment

Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire

The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem (NCT02582658)
Timeframe: Day 0 to post treatment week 12

Patient Support Program (PSP) Utilization and Satisfaction Assessment

The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP. (NCT02582658)
Timeframe: Up to 24 weeks of treatment

Percentage of Participants Deviating From the Target ABBVIE Regimen Duration

Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days. (NCT02582658)
Timeframe: Up to 24 weeks of treatment

Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken

Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% to <=105%, >80% to <=95%, >50% to <=80%, <=50%. (NCT02582658)
Timeframe: Up to 24 weeks of treatment

Percentage of Participants With Adherence to Planned RBV Target Dose Taken

Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% - <=105%, >80% - <=95%, >50% - <=80%, <=50%. (NCT02582658)
Timeframe: Up to 24 weeks of treatment

Percentage of Participants With Co-morbidities and/or Co-infections

Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0). (NCT02582658)
Timeframe: Day 0

Percentage of Participants With Concomitant Medications

Percentage of participants taking at least 1 concomitant medication (NCT02582658)
Timeframe: Day 0 to end of treatment (up to 24 weeks)

Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire

The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement. (NCT02582658)
Timeframe: Day 0 and post treatment week 12

Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire

"The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management." (NCT02582658)
Timeframe: Day 0 and End of Treatment (EoT)

EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health). (NCT02851069)
Timeframe: 12 weeks post EoT (up to 24 weeks)

EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health). (NCT02851069)
Timeframe: 24 weeks post EoT (up to 24 weeks)

EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. (NCT02851069)
Timeframe: 12 weeks post EoT (up to 24 weeks)

EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. (NCT02851069)
Timeframe: 24 weeks post EoT (up to 24 weeks)

EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. (NCT02851069)
Timeframe: End of Treatment (up to 24 weeks)

EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health). (NCT02851069)
Timeframe: EoT (up to 24 weeks)

Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment

SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN [paritaprevir/ritonavir - ombitasvir ± dasabuvir] or ribavirin [RBV]). (NCT02851069)
Timeframe: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)

Percentage of Participants Meeting On-treatment Virologic Failure

On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL). (NCT02851069)
Timeframe: Up to EoT, maximum of 24 weeks

Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)

RVR4 was defined as HCV RNA < 50 IU/mL at Week 4. (NCT02851069)
Timeframe: Week 4

Percentage of Participants With Relapse

Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated. (NCT02851069)
Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug

Percentage of Participants With Relapse at EoT

Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window. (NCT02851069)
Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug

Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT

SVR24 was defined as HCV RNA < 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24. (NCT02851069)
Timeframe: 24 weeks after EoT (up to 24 weeks)

Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. (NCT02851069)
Timeframe: Up to EoT, maximum of 24 weeks

Percentage of Participants With Virologic Response at End of Treatment (EoT)

Virologic response is defined as HCV RNA level <50 IU/mL. (NCT02851069)
Timeframe: Up to EoT, maximum of 24 weeks

Number of Participants Meeting Premature Study Drug Discontinuation

Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough [at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]). (NCT02851069)
Timeframe: Up to EoT, maximum of 24 weeks

Number of Participants With Co-morbidities at Baseline (Day 0)

Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus [HIV] or hepatitis B virus [HBV], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other). (NCT02851069)
Timeframe: Baseline (Day 0)

Number of Participants With Concomitant Medications

"This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.~Abbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux." (NCT02851069)
Timeframe: Day 0 to EoT, maximum 24 weeks

Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria

"For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:~On-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]);~Relapse (defined as HCV RNA <50 IU/mL at actual EoT followed by HCV RNA ≥50 IU/mL post-treatment for participants who completed treatment [not more than 7 days shortened]);~Premature study drug discontinuation with no on-treatment virologic failure;~Missing SVR12 data and/or none of the above criteria (including participants with missing SVR12 data).~Abbreviations: EoT=end of treatment." (NCT02851069)
Timeframe: During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria

Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants Meeting Relapse Criteria

Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria

The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug

Percentage of Participants With Relapse

Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02803138)
Timeframe: Up to 48 weeks after the last actual dose of study drug

Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment

"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02803138)
Timeframe: 12 weeks (at least 70 days) after the last actual dose of study drug

Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02803138)
Timeframe: Up to 24 weeks

Percentage of Participants With Virologic Response at End of Treatment (EoT)

Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02803138)
Timeframe: Up to 24 weeks

Change From Baseline in Patient Activation Measure 13 (PAM-13)

"PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation" (NCT02807402)
Timeframe: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)

Number of Participants Who Received Concomitant Medications

Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose. (NCT02807402)
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. (NCT02807402)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Percentage of Participants Achieving Virological Response at End of Treatment

Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. (NCT02807402)
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen)

Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment

"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The core population with sufficient follow-up data regarding SVR12 included all core population participants who~had evaluable HCV RNA data ≥ 70 days after the last actual dose of paritaprevir/ritonavir, ombitasvir and dasabuvir~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of paritaprevir/ritonavir, ombitasvir with dasabuvir due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure." (NCT02807402)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Percentage of Participants With Breakthrough

Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. (NCT02807402)
Timeframe: 12 or 24 weeks (depending on the treatment regimen)

Percentage of Participants With Relapse

Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. (NCT02807402)
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.

Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days

(NCT02807402)
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.

Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)

The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication. (NCT02807402)
Timeframe: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)

Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score

"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score

"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. with a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable)." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism

"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism

"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Presenteeism indicates the percentage of impairment while working due to health problems." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment

"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)

"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies

(NCT02807402)
Timeframe: From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The over all median (minimum, maximum) duration of treatment was 84 (28, 175) days.

Number of Participants With Comorbidities

(NCT02807402)
Timeframe: Baseline

Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment

"SVR12 non-response was categorized according to the following:~On-treatment virologic failure (breakthrough [at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥ 50 IU/mL]);~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Death;~Premature treatment discontinuation with no on-treatment virological failure;~Missing SVR12 data and/or none of the above criteria." (NCT02807402)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Change From Baseline to EoT in PAM-13 Questionnaire

The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Scores range from 0 to 100. Higher scores indicate a higher level of knowledge, skill and confidence. (NCT02615145)
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks)

Percentage of Participants Taking ≥ 1 Co-Medication

(NCT02615145)
Timeframe: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)

Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection

(NCT02615145)
Timeframe: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)

Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)

RVR4 is defined as participants with HCV RNA < 50 IU/mL at Week 4. (NCT02615145)
Timeframe: Week 4

Percentage of Participants With Sustained Virologic Response (SVR12)

SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN. (NCT02615145)
Timeframe: 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)

Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)

SVR24 is defined as HCV RNA < 50 IU/mL 24 Weeks After EoT. (NCT02615145)
Timeframe: 24 Weeks After EoT (treatment period was 12 or 24 weeks)

Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)

SVR48 is defined as participants with HCV RNA < 50 IU/mL 48 weeks after EoT. (NCT02615145)
Timeframe: 48 Weeks After EoT (treatment period was 12 or 24 weeks)

Percentage of Participants With Virological Response at End of Treatment (EoTR)

Virological response is defined as HCV RNA < 50 IU/mL. End of Treatment (EoT) is defined as the last intake of ABBVIE REGIMEN or RBV. (NCT02615145)
Timeframe: EoT, (treatment period was 12 weeks or 24 weeks)

Change From Baseline in FACIT-F Scale Over Time

The FACIT-F Scale is a 13-item questionnaire that assesses self-reported fatigue during the past 7 days and its impact upon daily activities and function. Scores range from 0 - 100, with higher scores indicating a lesser degree of fatigue. (NCT02615145)
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT

Change From Baseline in PRISM Over Time

"PRISM is a visual quantitative method to assess the perceived burden of suffering due to illness. The distance between the center of the self (yellow disk) and the illness disk (red disk) is called self-illness separation (SIS) and is measured in cm (range is 0 - 27). The smaller the distance, the higher the burden of suffering." (NCT02615145)
Timeframe: Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)

Change From Baseline Over Time in WPAI: Total Activity Impairment

"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment indicates the percentage of general (non-work) activity impairment due to health problems." (NCT02615145)
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT

Change From Baseline Over Time in WPAI: Total Work Productivity Impairment

"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment indicates the percentage of overall work impairment due to health problems." (NCT02615145)
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT

Mean Duration of of ABBVIE REGIMEN and RBV Taken

Documented by participant interview and/or participant diary. (NCT02615145)
Timeframe: Up to Week 12 or Week 24

Mean Duration of of ABBVIE REGIMEN and RBV Taken

Documented by participant interview and/or participant diary. (NCT02615145)
Timeframe: Up to Week 12 or Week 24

Number of Participants With On-Treatment Virological Failure or Relapse

"The number of participants meeting the following SVR12 non-response categories:~On-treatment virological failure (breakthrough) defined >= 1 documented HCV RNA < 50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value >= 50 IU/mL)~Relapse defined as HCV RNA < 50 IU/mL at EoT followed by HCV RNA >= 50 IU/mL post-treatment in participants who completed treatment (<= 7 days shortened)." (NCT02615145)
Timeframe: Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies

An adverse event (AE) is defined as any untoward medical occurrence. If an AE meets any of the following criteria, it is considered serious: results in death, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in significant disability/incapacity, or is an important medical event. TEAEs are defined as any reported event that begins or worsens in severity after initiation of study drug through 30 days post-study drug dosing. (NCT02615145)
Timeframe: up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)

Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken