A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection
Overview
- Phase
- Phase 3
- Intervention
- Sofosbuvir
- Conditions
- Chronic HCV Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 687
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Sofosbuvir+RBV+PEG 12 weeks
Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
Intervention: Sofosbuvir
Sofosbuvir+RBV+PEG 12 weeks
Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
Intervention: RBV
Sofosbuvir+RBV+PEG 12 weeks
Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
Intervention: PEG
Sofosbuvir+RBV 12 weeks
Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.
Intervention: Sofosbuvir
Sofosbuvir+RBV 12 weeks
Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.
Intervention: RBV
Sofosbuvir+RBV 16 weeks
Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.
Intervention: Sofosbuvir
Sofosbuvir+RBV 16 weeks
Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.
Intervention: RBV
Sofosbuvir+RBV 24 Weeks
Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
Intervention: Sofosbuvir
Sofosbuvir+RBV 24 Weeks
Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
Intervention: RBV
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: 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
Time Frame: Up to 24 weeks
Secondary Outcomes
- Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Change From Baseline in HCV RNA (log10 IU/mL)(Up to 24 weeks)
- Percentage of Participants With On-Treatment Virologic Failure(Up to 24 weeks)
- Percentage of Participants With Viral Relapse(Up to Posttreatment Week 24)