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Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation.

Publication ,  Journal Article
Charlton, M; Gane, E; Manns, MP; Brown, RS; Curry, MP; Kwo, PY; Fontana, RJ; Gilroy, R; Teperman, L; Muir, AJ; McHutchison, JG; Symonds, WT ...
Published in: Gastroenterology
January 2015

BACKGROUND & AIMS: Interferon alfa-based regimens used to treat recurrent hepatitis C virus (HCV) infection after liver transplantation are poorly tolerated, associated with generally modest efficacy, and can interact with immunosuppressive agents. We evaluated the efficacy and safety of an interferon-free regimen of the nucleotide polymerase inhibitor sofosbuvir combined with ribavirin for 24 weeks in treating post-transplantation HCV infection. METHODS: In a prospective, multicenter, open-label pilot study, we enrolled patients with compensated recurrent HCV infection of any genotype after a primary or secondary liver transplantation. All patients received 24 weeks of sofosbuvir 400 mg daily and ribavirin starting at 400 mg daily, which was adjusted according to creatinine clearance and hemoglobin values. The primary end point was sustained virologic response 12 weeks after treatment. RESULTS: Of the 40 patients enrolled and treated, 78% were male, 85% were white, 83% had HCV genotype 1, 40% had cirrhosis (based on biopsy), and 88% had been previously treated with interferon. Sustained virologic response 12 weeks after treatment was achieved by 28 of 40 patients (70%; 90% confidence interval: 56%-82%). Relapse accounted for all cases of virologic failure. No patients had detectable viral resistance during or after treatment. The most common adverse events were fatigue (30%), diarrhea (28%), and headache (25%). In addition, 20% of the subjects experienced anemia. Two patients discontinued study treatment because of adverse events, which were considered unrelated to study treatment. No deaths, graft losses, or episodes of rejection occurred. No interactions with any concomitant immunosuppressive agents were reported. CONCLUSIONS: Sofosbuvir and ribavirin combination therapy for 24 weeks is an effective and well-tolerated interferon-free treatment for post-transplantation HCV infection. EudraCT, Number: 2012-002417-19; ClinicalTrials.gov, Number: NCT01687270.

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Published In

Gastroenterology

DOI

EISSN

1528-0012

Publication Date

January 2015

Volume

148

Issue

1

Start / End Page

108 / 117

Location

United States

Related Subject Headings

  • Viral Load
  • Uridine Monophosphate
  • United States
  • Treatment Outcome
  • Time Factors
  • Spain
  • Sofosbuvir
  • Ribavirin
  • Recurrence
  • RNA, Viral
 

Citation

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Chicago
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MLA
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Charlton, M., Gane, E., Manns, M. P., Brown, R. S., Curry, M. P., Kwo, P. Y., … Terrault, N. A. (2015). Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology, 148(1), 108–117. https://doi.org/10.1053/j.gastro.2014.10.001
Charlton, Michael, Edward Gane, Michael P. Manns, Robert S. Brown, Michael P. Curry, Paul Y. Kwo, Robert J. Fontana, et al. “Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation.Gastroenterology 148, no. 1 (January 2015): 108–17. https://doi.org/10.1053/j.gastro.2014.10.001.
Charlton M, Gane E, Manns MP, Brown RS, Curry MP, Kwo PY, et al. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology. 2015 Jan;148(1):108–17.
Charlton, Michael, et al. “Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation.Gastroenterology, vol. 148, no. 1, Jan. 2015, pp. 108–17. Pubmed, doi:10.1053/j.gastro.2014.10.001.
Charlton M, Gane E, Manns MP, Brown RS, Curry MP, Kwo PY, Fontana RJ, Gilroy R, Teperman L, Muir AJ, McHutchison JG, Symonds WT, Brainard D, Kirby B, Dvory-Sobol H, Denning J, Arterburn S, Samuel D, Forns X, Terrault NA. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology. 2015 Jan;148(1):108–117.
Journal cover image

Published In

Gastroenterology

DOI

EISSN

1528-0012

Publication Date

January 2015

Volume

148

Issue

1

Start / End Page

108 / 117

Location

United States

Related Subject Headings

  • Viral Load
  • Uridine Monophosphate
  • United States
  • Treatment Outcome
  • Time Factors
  • Spain
  • Sofosbuvir
  • Ribavirin
  • Recurrence
  • RNA, Viral