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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01667731
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Human Immunodeficiency Virus Drug: SOF Drug: RBV Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • GS-7977
  • PSI-7977
  • Sovaldi®

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:
  • GS-7977
  • PSI-7977
  • Sovaldi®

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:
  • GS-7977
  • PSI-7977
  • Sovaldi®

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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change From Baseline in HCV RNA at Week 1 [ Time Frame: Baseline; Week 1 ]
  3. Change From Baseline in HCV RNA at Week 2 [ Time Frame: Baseline; Week 2 ]
  4. Change From Baseline in HCV RNA at Week 4 [ Time Frame: Baseline; Week 4 ]
  5. Change From Baseline in HCV RNA at Week 6 [ Time Frame: Baseline; Week 6 ]
  6. Change From Baseline in HCV RNA at Week 8 [ Time Frame: Baseline; Week 8 ]
  7. 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

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667731


Locations
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United States, Alabama
Birmingham, Alabama, United States
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
United States, District of Columbia
Washington DC, District of Columbia, United States
United States, Florida
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Missouri
Kansas City, Missouri, United States
United States, New Jersey
Hillsborough, New Jersey, United States
United States, New Mexico
Santa Fe, New Mexico, United States
United States, New York
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Washington
Seattle, Washington, United States
Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Anuj Gaggar, MD, PhD Gilead Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01667731    
Other Study ID Numbers: GS-US-334-0123
First Posted: August 17, 2012    Key Record Dates
Results First Posted: November 21, 2014
Last Update Posted: November 21, 2014
Last Verified: November 2014
Keywords provided by Gilead Sciences:
Hepatitis C
Chronic
HCV
 HIV
Human Immunodeficiency Virus
Co-Infected
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Immunologic Deficiency Syndromes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Immune System Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Slow Virus Diseases
Genital Diseases
Urogenital Diseases
Sofosbuvir
Antiviral Agents
Anti-Infective Agents