Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

Gilead Sciences328 enrolled

Overview

This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

328

Conditions

Chronic Hepatitis C

Interventions

SofosbuvirDRUG

Sofosbuvir 400 mg tablet administered orally once daily

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)

PEGDRUG

Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Infection with HCV genotype 1, 4, 5, or 6 * Cirrhosis determination * Subject met the following classifications: * Treatment-naive * Screening laboratory values within defined thresholds * Not treated with any investigational drug or device within 30 days of screening * 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

Locations (56)

Outcomes

Primary Outcomes

Percentage of Participants Achieving Sustained Virologic Response (SVR)12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.

Time frame: Posttreatment Week 12

Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug

The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.

Time frame: Baseline to Week 12

Secondary Outcomes

Percentage of Participants Achieving SVR4

SVR4 was defined as HCV RNA \< LLOQ 4 weeks after cessation of therapy

Time frame: Posttreatment Week 4

Percentage of Participants Achieving SVR24

SVR24 was defined as HCV RNA \< LLOQ 24 weeks after cessation of therapy

Time frame: Posttreatment Week 24

Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.

Time frame: Baseline to Week 12

Percentage of Participants With Viral Relapse

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

Data from ClinicalTrials.gov

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University of Alabama Birmingham

Birmingham, Alabama, United States

SCTI Research Foundation

Coronado, California, United States

Kaiser Permanente

Los Angeles, California, United States

Peter J. Ruane, MD, Inc.

Los Angeles, California, United States

Anthony Mills MD, Inc.

Los Angeles, California, United States

University of California San Diego

San Diego, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

Kaiser Permanente

San Diego, California, United States

Quest Clinical Research

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

...and 46 more locations