Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic HCV Infection

Treatments: Drug: RBV; Drug: Sofosbuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02074514

GS-US-334-0116

Details and patient eligibility

About

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HCV RNA ≥10^4 IU/mL at screening
• Confirmed chronic HCV genotype 1 or 3 infection
• HCV treatment naive
• Approximately 30% of individuals may have compensated cirrhosis at screening

Exclusion criteria

• Any other chronic liver disease
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Current or prior history of clinical hepatic de-compensation
• Contraindication to RBV therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
• Chronic use of systemically administered immunosuppressive agents
• History of solid organ transplantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Sofosbuvir+RBV 16 weeks

Experimental group

Description:

Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.

Treatment:

Drug: Sofosbuvir

Drug: RBV

Sofosbuvir+RBV 24 weeks

Experimental group

Description:

Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.

Treatment:

Drug: Sofosbuvir

Drug: RBV