Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-12-31

Brief Summary

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This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.

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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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SOF+PEG+RBV

Participants will receive SOF+PEG+RBV for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

PEG

Intervention Type DRUG

Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection

RBV

Intervention Type DRUG

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Interventions

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SOF

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

Intervention Type DRUG

PEG

Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection

Intervention Type DRUG

RBV

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Intervention Type DRUG

Other Intervention Names

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Sovaldi® GS-7977 PSI-7977

Eligibility Criteria

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Inclusion Criteria

* Infection with genotype 2 or 3 HCV infection
* Cirrhosis determination
* Individual is treatment-experienced
* Screening laboratory values within defined thresholds
* Individual has 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 a direct-acting antiviral drug targeting the HCV NS5B 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 interfere with treatment, assessment, or compliance with the study protocol
* Excessive alcohol ingestion or significant drug abuse

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No