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Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

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ClinicalTrials.gov Identifier: NCT01687270
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.

Condition or disease Intervention/treatment Phase
Recurrent Chronic Hepatitis C Virus Post Liver Transplant Drug: Sofosbuvir Drug: RBV Phase 2

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant
Study Start Date : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SOF+RBV
Participants will receive sofosbuvir+RBV for 24 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: RBV
Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.
Other Name: Ribasphere®



Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 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. Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) [ Time Frame: Posttreatment Weeks 4, 24, and 48 ]
    SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24 [ Time Frame: Weeks 12 and 24 ]
  3. HCV RNA and Change From Baseline at Weeks 2, 4, and 8 [ Time Frame: Baseline; Weeks 2, 4, and 8 ]
  4. Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]

    Virologic failure was defined as on-treatment virologic failure or virologic relapse.

    • On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment
    • Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)



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

Inclusion Criteria:

  • Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to baseline/Day 1 visit
  • Liver transplant ≥ 6 months and ≤ 12 years prior to screening
  • Naive to all nucleotide/nucleoside treatments for chronic HCV infection

Exclusion Criteria:

  • Multiorgan transplant that includes heart or lung recipient
  • Subjects with de novo or recurrent Hepatocellular Carcinoma(HCC) post transplant
  • Current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose of corticosteroid)
  • Infection with hepatitis B virus (HBV) or HIV at screening
  • Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis

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): NCT01687270


Locations
United States, California
San Francisco, California, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, New York
New York, New York, United States, 10016
New York, New York, United States, 10032
France
Villejuif, France
Germany
Hannover, Lower Saxony, Germany
New Zealand
Grafton, Auckland, New Zealand
Spain
Barcelona, Spain
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Jill M. Denning, MA Gilead Sciences

Publications of Results:
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01687270     History of Changes
Other Study ID Numbers: GS-US-334-0126
2012-002417-19 ( EudraCT Number )
First Posted: September 18, 2012    Key Record Dates
Results First Posted: December 19, 2014
Last Update Posted: December 19, 2014
Last Verified: December 2014

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