Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic HCV Infection

Treatments: Drug: RBV; Drug: PEG; Drug: Sofosbuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02021643

GS-US-334-0115

Details and patient eligibility

About

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.

Enrollment: 687 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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687 participants in 4 patient groups

Sofosbuvir+RBV+PEG 12 weeks

Experimental group

Description:

Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.

Treatment:

Drug: Sofosbuvir

Drug: RBV

Drug: PEG

Sofosbuvir+RBV 12 weeks

Experimental group

Description:

Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.

Treatment:

Drug: Sofosbuvir

Drug: RBV

Sofosbuvir+RBV 16 weeks

Experimental group

Description:

Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.

Treatment:

Drug: Sofosbuvir

Drug: RBV

Sofosbuvir+RBV 24 Weeks

Experimental group

Description:

Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.

Treatment:

Drug: Sofosbuvir

Drug: RBV