Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.
Recurrent Chronic Hepatitis C Virus
Post Liver Transplant
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|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant|
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
- Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
- Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) [ Time Frame: Posttreatment Weeks 4, 24, and 48 ] [ Designated as safety issue: No ]SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.
- Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
- HCV RNA and Change From Baseline at Weeks 2, 4, and 8 [ Time Frame: Baseline; Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
- Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]
Virologic failure was defined as on-treatment virologic failure or virologic relapse.
- On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment
- Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)
|Study Start Date:||November 2012|
|Study Completion Date:||August 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Participants will receive sofosbuvir+RBV for 24 weeks.
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:Drug: RBV
Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.
Other Name: Ribasphere®
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687270
|United States, California|
|San Francisco, California, United States|
|United States, Indiana|
|Indianapolis, Indiana, United States|
|United States, Kansas|
|Kansas City, Kansas, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|United States, Michigan|
|Ann Arbor, Michigan, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States|
|United States, New York|
|New York, New York, United States, 10032|
|New York, New York, United States, 10016|
|Hannover, Lower Saxony, Germany|
|Grafton, Auckland, New Zealand|
|Study Director:||Jill M. Denning, MA||Gilead Sciences|