Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Sofosbuvir; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01910636

GS-US-334-0118

Details and patient eligibility

About

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Enrollment: 153 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic genotype 2 HCV-infection
• Male or female, age ≥ 20 years
• Body weight ≥ 40 kg
• HCV RNA ≥ 10,000 IU/mL at screening

Exclusion criteria

• Current or prior history of 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 1 patient group

Sofosbuvir+RBV 12 weeks

Experimental group

Description:

Participants will receive sofosbuvir+RBV for 12 weeks.

Treatment:

Drug: Sofosbuvir

Drug: RBV