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)
|ClinicalTrials.gov Identifier: NCT01542788|
Recruitment Status : Completed
First Posted : March 2, 2012
Results First Posted : February 17, 2014
Last Update Posted : May 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: SOF Drug: RBV Drug: Placebo to match SOF Drug: Placebo to match RBV||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||278 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||February 2013|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542788
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