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A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

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ClinicalTrials.gov Identifier: NCT01783678
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Allocation: 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 Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
Study Start Date : January 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Genotype 2 treatment-naive
Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks.
 Drug: Sofosbuvir
Sofosbuvir 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: Genotype 2/3 treatment-experienced
Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.
 Drug: Sofosbuvir
Sofosbuvir 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: Genotype 1/3/4 treatment-naive
Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.
 Drug: Sofosbuvir
Sofosbuvir 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)


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) 12 weeks following the last dose of study drug.

  2. Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Up to 24 weeks ]
    The percentage of participants permanently 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 < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.

  2. HCV RNA Change From Baseline at Week 1 [ Time Frame: Baseline; Week 1 ]
  3. HCV RNA Change From Baseline at Week 2 [ Time Frame: Baseline; Week 2 ]
  4. HCV RNA Change From Baseline at Week 4 [ Time Frame: Baseline; Week 4 ]
  5. HCV RNA Change From Baseline at Week 6 [ Time Frame: Baseline; Week 6 ]
  6. HCV RNA Change From Baseline at Week 8 [ Time Frame: Baseline; Week 8 ]
  7. Percentage of Participants Experiencing Virologic Failure [ Time Frame: Baseline up to Posttreatment Week 24 ]

    On-treatment virologic failure was defined as either:

    • Virologic breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment).

    Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit."



Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection
  • HCV RNA > 10,000 IU/mL at screening

  • HCV treatment history:

    • Treatment-naive for HCV genotypes 1, 2, 3, or 4, or
    • Treatment-experienced for HCV genotypes 2 or 3

  • HIV antiretroviral (ARV) criteria:

    • On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for > 8 weeks prior to screening, or
    • ARV untreated for ≥ 8 weeks prior to screening, with a CD4 T-cell count > 500 cells/mm^3
  • Presence or absence of cirrhosis; a liver biopsy may be required
  • Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis
  • Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

Exclusion Criteria:

  • HCV genotype 1 or 4 with previous HCV treatment
  • Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing
  • A new AIDS-defining condition diagnosed within 30 days prior to screening
  • Prior use of any other inhibitor of the HCV NS5B polymerase
  • History of any other clinically significant chronic liver disease
  • Evidence of or history of decompensated liver disease
  • Chronic hepatitis B virus (HBV) infection
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of immunosuppressive agents or immunomodulatory agents
  • Clinically relevant drug or alcohol abuse within 12 months of screening
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator
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): NCT01783678


Locations
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Australia, New South Wales
Darlinghurst, New South Wales, Australia
Sydney, New South Wales, Australia
Australia, Victoria
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
France
Lyon, France
Nice, France
Paris, France
Germany
Berlin, Germany
Bonn, Germany
Duesseldorf, Germany
Frankfurt, Germany
Hamburg, Germany
Würzburg, Germany
Italy
Bergamo, Italy
Milano, Italy
Napoli, Italy
Rome, Italy
Torino, Italy
Spain
Barcelona, Spain
Madrid, Spain
Seville, Spain
United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Sussex, United Kingdom
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: NCT01783678    
Other Study ID Numbers: GS-US-334-0124
First Posted: February 5, 2013    Key Record Dates
Results First Posted: April 30, 2015
Last Update Posted: April 30, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
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
Hepatitis, Chronic
Immune System Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Slow Virus Diseases
Sofosbuvir
Antiviral Agents
Anti-Infective Agents