Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

November 14, 2014 updated by: Gilead Sciences

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Coronado, California, United States
      • Los Angeles, California, United States
      • Lutherville, California, United States
      • Oakland, California, United States
      • Sacramento, California, United States
      • San Francisco, California, United States
      • Torrance, California, United States
    • District of Columbia
      • Washington DC, District of Columbia, United States
    • Florida
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Tampa, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Missouri
      • Kansas City, Missouri, United States
    • New Jersey
      • Hillsborough, New Jersey, United States
    • New Mexico
      • Santa Fe, New Mexico, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Durham, North Carolina, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection
  • HCV RNA > 1 x 10^4 IU/mL at screening
  • Infection with HCV genotype 1, 2 or 3 as determined at screening
  • HIV-1 infection confirmed with positive ELISA or Western blot at screening
  • Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV.
  • Confirmation of chronic HCV infection
  • Ability to determine presence/absence of cirrhosis.

  • HIV antiretroviral therapy (ARV) criteria of one of the following:

    • ARV untreated with a CD4 T-cell count > 500 cells/mm^3
    • On a stable, protocol-approved, ARV for > 8 weeks prior to screening with a CD4 T-cell count > 200 cells/mm^3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the screening visit
  • Approved HIV antiretroviral medications based on drug interaction studies
  • Not been treated with any investigational drug or device within 30 days of the screening visit
  • Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV
  • Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV
  • Must be of generally good health as determined by the investigator.
  • Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)

Exclusion Criteria:

  • Non-genotype 1/2/3 or mixed genotype at screening
  • Genotype 1 with prior treatment for HCV
  • Poor control with ARV regimen
  • Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
  • Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
  • A new AIDS-defining condition diagnosed within 30 days prior to screening
  • Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to baseline
  • Infection with hepatitis B virus (HBV)
  • Contraindication to RBV therapy
  • Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day)
  • History of solid organ transplantation or malignancy diagnosed or treated within 5 years
  • Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SOF+RBV 12 Weeks (GT 2/3, TN)
Treatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
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)
EXPERIMENTAL: SOF+RBV 24 Weeks (GT 2/3, TE)
Treatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
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)
EXPERIMENTAL: SOF+RBV 24 Weeks (GT 1, TN)
Treatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+RBV for 24 weeks.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time Frame: Up to 24 weeks
The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HCV RNA at Week 2
Time Frame: Baseline; Week 2
Baseline; Week 2
Change From Baseline in HCV RNA at Week 4
Time Frame: Baseline; Week 4
Baseline; Week 4
Change From Baseline in HCV RNA at Week 8
Time Frame: Baseline; Week 8
Baseline; Week 8
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Posttreatment Weeks 4 and 24
Change From Baseline in HCV RNA at Week 1
Time Frame: Baseline; Week 1
Baseline; Week 1
Change From Baseline in HCV RNA at Week 6
Time Frame: Baseline; Week 6
Baseline; Week 6
Percentage of Participants Experiencing On-treatment Virologic Failure
Time Frame: Up to 24 weeks

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
Up to 24 weeks
Percentage of Participants Experiencing Viral Relapse
Time Frame: Up to Posttreatment Week 24
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Up to Posttreatment Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

August 9, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (ESTIMATE)

August 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-0123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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