Hepatitis C, Chronic
Conditions
Keywords
Hepatitis C, Chronic, HCV
Brief summary
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).
Interventions
DRUGSofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
DRUGGS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
DRUGRBV
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)
Placebo to match sofosbuvir administered orally once daily
DRUGPlacebo to match GS-0938
Placebo to match GS-0938 administered orally once daily
Sponsors
Quintiles, Inc.
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic HCV-infection * Naive to all HCV antiviral treatment * Otherwise healthy patients
Exclusion criteria
* Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab * History of any other clinically significant chronic liver disease * Medical history which the investigator considers the patient unsuitable for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12) | Post-treatment Week 12 | SVR12 was defined as HCV RNA \< LLOQ 12 weeks after the last dose of all study drugs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HCV RNA | Baseline to Week 12 | — |
| Percentage of Participants With HCV RNA < LLOQ during treatment | Baseline to Week 12 | — |
| Percentage of Participants Who Experienced Adverse Events | Baseline to Week 24 plus 30 days | Adverse events (AEs) were summarized across the participant population. A participant was counted once if they had a qualifying event. |
| Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24) | Post-treatment Weeks 4 and 24 | SVR4 and SVR24 was defined as HCV RNA \< LLOQ 4 and 24 weeks after the last dose of all study drugs, respectively. |
| Percentage of Participants Who Developed Resistance to Sofosbuvir | Baseline to Week 24 | — |
| Percentage of Participants With ALT Normalization | Baseline to post-treatment Week 4 | ALT normalization was defined as ALT \> ULN at baseline and ALT ≤ ULN at a subsequent visit. |
Countries
Puerto Rico, United States
Outcome results
None listed