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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sofosbuvir+RBV 12 weeks

Participants will receive sofosbuvir+RBV for 12 weeks.

Group Type EXPERIMENTAL

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400 mg tablet administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Interventions

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Sofosbuvir

Sofosbuvir 400 mg tablet administered orally once daily

Intervention Type DRUG

RBV

Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Intervention Type DRUG

Other Intervention Names

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GS-7977 PSI-7977 Sovaldi® Copegus®

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No