Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection
- Registration Number
- NCT02021643
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 687
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- HCV treatment-naive (HCV genotype 1, 2, 3 or 6), defined as no prior exposure to any interferon (IFN), RBV, or other approved or experimental HCV-specific direct-acting antiviral agent, or HCV treatment-experienced (HCV genotype 1, 2, 3, or 6 only) with medical records that include sufficient detail of prior treatment with IFN to allow for categorization of prior response as either IFN Intolerant, non-responder, or experiences viral breakthrough or relapse
- HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy
Key
- Current or prior history of any clinically-significant illness (other than HCV)
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non-HCV etiology
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sofosbuvir+RBV 12 weeks RBV Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks. Sofosbuvir+RBV+PEG 12 weeks PEG Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks. Sofosbuvir+RBV 16 weeks Sofosbuvir Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks. Sofosbuvir+RBV+PEG 12 weeks Sofosbuvir Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks. Sofosbuvir+RBV 12 weeks Sofosbuvir Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks. Sofosbuvir+RBV+PEG 12 weeks RBV Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks. Sofosbuvir+RBV 16 weeks RBV Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks. Sofosbuvir+RBV 24 Weeks Sofosbuvir Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks. Sofosbuvir+RBV 24 Weeks RBV Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event Up to 24 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants With On-Treatment Virologic Failure Up to 24 weeks Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment.
Percentage of Participants With Viral Relapse Up to Posttreatment Week 24 Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Change From Baseline in HCV RNA (log10 IU/mL) Up to 24 weeks