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

Gilead Sciences47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

SOFDRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

PEGDRUG

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

RBVDRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Alamo Medical Research

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 15 IU/mL) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

The percentage of participants discontinuing any study drug due to an adverse event was summarized.

Time frame: Up to 12 weeks

Secondary Outcomes

Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

Time frame: Posttreatment Weeks 4 and 24

Percentage of Participants Experiencing On-treatment Virologic Failure

On-treatment virologic failure was defined as: 1. Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 2. Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment

Time frame: Up to 12 weeks

Percentage of Participants Experiencing Viral Relapse

Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.

Data from ClinicalTrials.gov

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