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Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis (VALOR-HCV)

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: NCT02128542
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans with compensated cirrhosis and genotype 2 HCV infection.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: Sofosbuvir Drug: RBV Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4, Multicenter, Open Label Study to Investigate the Efficacy and Safety of an All Oral Combination of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis VALOR-HCV: Veterans Affairs alL Oral Regimen of SOF+RBV in GT2 HCV
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+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 (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy [ 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. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.

  2. Percentage of Participants Experiencing Viral Breakthrough [ Time Frame: Up to Posttreatment Weak 12 ]

    Viral breakthrough was defined as either:

    • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment
    • HCV RNA ≥ LLOQ at the last available on-treatment measurement with no subsequent follow-up values

  3. Percentage of Participants Experiencing Viral Relapse [ Time Frame: Up to Posttreatment Week 12 ]
    Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment.

  4. Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment [ Time Frame: Pretreatment and Posttreatment Week 12 ]
    Deep sequencing of the HCV NS5B gene was attempted for all participants who had virologic failure at pretreatment and posttreatment time points if the level of HCV RNA in the plasma sample was ≥ 1000 IU/L.



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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.
  • Treatment-naive or treatment-experienced adult, U.S. Veteran
  • Chronic genotype 2 (GT2) HCV infection Classified as:

    • Eligible for treatment with interferon (IFN)-based therapy
    • Ineligible for IFN treatment
    • Intolerant to IFN.
  • Cirrhosis determination
  • Laboratory parameters within prespecified ranges at screening:
  • A negative serum pregnancy test is required for females of childbearing potential
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • Lactating females must agree to discontinue nursing before study drug is administered.
  • Males must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV, or 90 days after their last dose of study drug if not taking RBV.
  • Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
  • Must be of generally good health as determined by the Investigator.

Exclusion Criteria:

  • Current participation in an interventional clinical trial.
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
  • History of any other clinically significant chronic liver disease (e.g., hemochromatosis; Wilson's disease; α1-antitrypsin deficiency), except nonalcoholic steatohepatitis (NASH).
  • Decompensated liver
  • History of hemoglobinopathies
  • Contraindication or hypersensitivity to RBV
  • 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 participation for the full duration of the study, such that it is not in the best interest of the individual to participate.
  • Clinically significant ECG abnormality at screening.
  • History of solid organ transplantation.
  • Presence of hepatocellular carcinoma (HCC) Malignancy within 5 years prior to screening, with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer and prostate cancer in remission). Individuals under evaluation for possible malignancy are not eligible.
  • Prior treatment with an NS5B polymerase inhibitor.
  • Chronic use of systemic immunosuppressive agents or immunomodulatory agents (e.g., prednisone equivalent > 10 mg/day).
  • Concomitant disallowed as per the Sovaldi Packet Insert.
  • Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
  • History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
  • Use of any prohibited concomitant medications as described in the study protocol
  • Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
  • Male with pregnant female partner.
  • In the judgment of the investigator any clinically-relevant drug or alcohol abuse within 12 months of screening that may interfere with treatment, assessment or compliance with the protocol.

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): NCT02128542


Locations
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United States, California
Long Beach, California, United States, 90822
Los Angeles, California, United States, 90073
Palo Alto, California, United States, 94394
San Diego, California, United States, 92102
San Francisco, California, United States, 94121
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, Florida
Miami, Florida, United States, 33125
United States, Georgia
Decatur, Georgia, United States, 30033
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Missouri
Kansas City, Missouri, United States, 64128
United States, North Carolina
Durham, North Carolina, United States, 27705
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
Dallas, Texas, United States, 75216
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Lorenzo Rossaro, MD Gilead Sciences

Publications of Results:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02128542     History of Changes
Other Study ID Numbers: GS-US-334-1379
First Posted: May 1, 2014    Key Record Dates
Results First Posted: August 3, 2016
Last Update Posted: August 3, 2016
Last Verified: June 2016

Keywords provided by Gilead Sciences:
Veterans HCV

Additional relevant MeSH terms:
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Hepatitis C
Virus Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents