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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

Tracking Information
First Submitted Date  ICMJE April 29, 2014
First Posted Date  ICMJE May 1, 2014
Results First Submitted Date  ICMJE June 21, 2016
Results First Posted Date  ICMJE August 3, 2016
Last Update Posted Date August 3, 2016
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • 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.
  • Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
  • Incidence of adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Baseline to Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • 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.
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • Proportion of participants with sustained virologic response (SVR) at 4 weeks after discontinuation of therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.
  • Proportion of participants experiencing viral breakthrough [ Time Frame: Baseline to Week 12 ]
    Viral breakthrough is 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
  • Proportion of participants experiencing viral relapse [ Time Frame: Week 12 to Posttreatment Week 12 ]
    Viral relapse is defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus Infection
Intervention  ICMJE
  • 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)
Study Arms  ICMJE Experimental: Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+RBV for 12 weeks.
Interventions:
  • Drug: Sofosbuvir
  • Drug: RBV
Publications * Ho SB, Monto A, Peyton A, Kaplan DE, Byrne S, Moon S, Copans A, Rossaro L, Roy A, Le H, Dvory-Sobol H, Zhu Y, Brainard DM, Guyer W, Shaikh O, Fuchs M, Morgan TR; VALOR study team. Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities. Clin Gastroenterol Hepatol. 2017 Feb;15(2):282-288. doi: 10.1016/j.cgh.2016.05.024. Epub 2016 May 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2015)
66
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2014)
100
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02128542
Other Study ID Numbers  ICMJE GS-US-334-1379
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lorenzo Rossaro, MD Gilead Sciences
PRS Account Gilead Sciences
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP