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

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: RBV; Drug: SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01896193

GS-US-334-0119

Details and patient eligibility

About

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed chronic genotype 1 or 3 HCV infection
• HCV treatment-naive
• Individuals will have cirrhosis status assessment; liver biopsy may be required.
• Screening laboratory values within predefined thresholds
• Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion criteria

• Pregnant or nursing female or male with pregnant female partner
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Contraindication to ribavirin therapy
• Excessive alcohol ingestion as defined by protocol
• History of solid organ transplantation
• Current or prior history of clinical hepatic decompensation
• History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 2 patient groups

SOF+RBV 16 Weeks

Experimental group

Description:

SOF+RBV for 16 weeks

Treatment:

Drug: RBV

Drug: SOF

SOF+RBV 24 Weeks

Experimental group

Description:

SOF+RBV for 24 weeks

Treatment:

Drug: RBV

Drug: SOF