Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon (POSITRON)
|Chronic Hepatitis C||Drug: SOF Drug: RBV Drug: Placebo to match SOF Drug: Placebo to match RBV||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon|
- Percentage of Participants Achieving SVR12 [ Time Frame: Post-treatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy
- Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug [ Time Frame: Baseline to Week 12 ]The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.
- Percentage of Participants Achieving SVR4 [ Time Frame: Post-treatment Week 4 ]SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
- Percentage of Participants Achieving SVR24 [ Time Frame: Post-treatment Week 24 ]SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
- Percentage of Participants Experiencing Viral Breakthrough [ Time Frame: Baseline to Week 12 ]Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values
- Percentage of Participants Experiencing Viral Relapse [ Time Frame: End of treatment to post-treatment Week 24 ]Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
|Study Start Date:||March 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Participants were randomized to receive SOF+RBV for 12 weeks.
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:Drug: RBV
Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Placebo Comparator: Placebo
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
Drug: Placebo to match SOF
Placebo to match SOF was administered orally once daily.Drug: Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.
Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.
Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542788
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