Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Placebo to match RBV; Drug: RBV; Drug: SOF; Drug: Placebo to match SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01604850

GS-US-334-0108

Details and patient eligibility

About

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infection with HCV genotype 2 or 3
• Had cirrhosis determination
• Prior treatment failure
• Screening laboratory values within defined thresholds
• Subject had not been treated with any investigational drug or device within 30 days of the screening visit
• Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion criteria

• Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
• Pregnant or nursing female or male with pregnant female partner
• Current or prior history of clinical hepatic decompensation
• History of clinically significant illness or any other major medical disorder that may have interfered with subject treatment, assessment or compliance with the protocol
• Excessive alcohol ingestion or significant drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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202 participants in 2 patient groups

SOF+RBV+placebo

Experimental group

Description:

Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.

Treatment:

Drug: Placebo to match SOF

Drug: SOF

Drug: Placebo to match RBV

Drug: RBV

SOF+RBV

Experimental group

Description:

Participants were randomized to receive SOF+RBV for 16 weeks.

Treatment:

Drug: SOF

Drug: RBV