This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response \[SVR\]) versus risk (safety and resistance).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
239
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12)
SVR12 was defined as HCV RNA \< LLOQ 12 weeks after the last dose of all study drugs.
Time frame: Post-treatment Week 12
Percentage of Participants Who Experienced Adverse Events
Adverse events (AEs) were summarized across the participant population. A participant was counted once if they had a qualifying event.
Time frame: Baseline to Week 24 plus 30 days
Change from baseline in HCV RNA
Time frame: Baseline to Week 12
Percentage of Participants With HCV RNA < LLOQ during treatment
Time frame: Baseline to Week 12
Percentage of Participants With ALT Normalization
ALT normalization was defined as ALT \> ULN at baseline and ALT ≤ ULN at a subsequent visit.
Time frame: Baseline to post-treatment Week 4
Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24)
SVR4 and SVR24 was defined as HCV RNA \< LLOQ 4 and 24 weeks after the last dose of all study drugs, respectively.
Time frame: Post-treatment Weeks 4 and 24
Percentage of Participants Who Developed Resistance to Sofosbuvir
Time frame: Baseline to Week 24
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Placebo to match sofosbuvir administered orally once daily
Placebo to match GS-0938 administered orally once daily
Alabama Liver & Digestive Specialists
Montgomery, Alabama, United States
Unnamed facility
Bakersfield, California, United States
Unnamed facility
Coronado, California, United States
Unnamed facility
La Mesa, California, United States
Unnamed facility
Los Angeles, California, United States
CLI
Los Angeles, California, United States
UCSD Antiviral Research Center
San Diego, California, United States
eStudy Site
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
...and 34 more locations