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

NCT01808248 | Completed Phase 2 Results

• 1 other identifier: GS-US-334-0151
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C

Keywords

HCV genotype 2 (GT-2); HCV genotype 3 (GT-3); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; Treatment-Naïve; GS-7977; Ribavirin; RBV; Peginterferon Alfa 2a; PEG; Additional relevant MeSH terms:; Hepatitis; Hepatitis A; Hepatitis, Chronic; Hepatitis C; Hepatitis C, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Peginterferon alfa-2a; Interferon-alpha; Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 12 weeks

Secondary Outcomes (3)

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

  Posttreatment Weeks 4 and 24

• Percentage of Participants Experiencing On-treatment Virologic Failure

  Up to 12 weeks

• Percentage of Participants Experiencing Viral Relapse

  Up to Posttreatment Week 24

Study Arms (1)

SOF+PEG+RBV

EXPERIMENTAL

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

Drug: SOF; Drug: PEG; Drug: RBV

Interventions

SOF DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

Also known as: Sovaldi®, GS-7977, PSI-7977

SOF+PEG+RBV

PEG DRUG

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

SOF+PEG+RBV

RBV 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)

SOF+PEG+RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Related Links

• Medicine Plus
• Hepatitis
• Hepatitis A
• Hepatitis C
• Drug Information available for:
• Ribavirin
• PEGINTERFERON ALFA-2A
• U.S. FDA Resources

MeSH Terms

Conditions

Hepatitis C; Hepatitis; Hepatitis A; Hepatitis, Chronic; Hepatitis C, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections

Interventions

Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences, Inc.

ClinicalTrialDisclosures@gilead.com

Study Officials

• Rob Hyland

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 11, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 12, 2014
• Results First Posted: September 12, 2014

Record last verified: 2014-09

Locations

US (1)