This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Placebo to match SOF was administered orally once daily.
Percentage of Participants Achieving SVR12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Time frame: Posttreatment Week 12
Adverse Events Leading to Permanent Discontinuation of Study Drug
Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.
Time frame: Baseline to Week 16
Percentage of Participants Achieving SVR4
SVR4 was defined as HCV RNA \< LLOQ 4 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Time frame: Posttreatment Week 4
Percentage of Participants Achieving SVR24
SVR24 was defined as HCV RNA \< LLOQ 24 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Time frame: Posttreatment Week 24
Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
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Placebo to match RBV was administered orally twice daily.
SCTI Research Foundation
Coronado, California, United States
Kaiser Permanente
Los Angeles, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Anthony Mills MD, Inc.
Los Angeles, California, United States
UCSD Antiviral Research Center
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Kaiser Permanente
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
South Denver Gastroenterology, PC
Englewood, Colorado, United States
...and 57 more locations
Time frame: Up to 16 weeks
Percentage of Participants With Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Time frame: End of treatment to posttreatment Week 24