A US multicenter study of hepatitis C treatment of liver transplant recipients with protease-inhibitor triple therapy

James R. Burton, Jacqueline G. O'Leary, Elizabeth C. Verna, Varun Saxena, Jennifer L. Dodge, Richard T. Stravitz, Joshua Levitsky, James F. Trotter, Gregory T. Everson, Robert S. Brown, Norah A. Terrault

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63 Scopus citations

Abstract

Background & Aims NS3/4A protease inhibitors, boceprevir or telaprevir, combined with peginterferon and ribavirin was the standard treatment for HCV genotype 1 and remains the only available direct antiviral drug based therapy in some countries. Efficacy and safety data in liver transplant recipients are limited. Methods This was a retrospective cohort study of 81 patients with genotype 1 HCV treated with boceprevir (10%) or telaprevir (90%) plus peginterferon and ribavirin at 6 US transplant centers (53% stage 3-4/4 fibrosis, 57% treatment experienced). The primary end point was undetectable HCV RNA 12 weeks after treatment completion (SVR12). Results The intent-to-treat SVR12 rate was 63% (51/81). Patients with an extended rapid virologic response, (undetectable HCV RNA at 4 and 12 weeks after starting boceprevir or telaprevir), had a higher rate of SVR12 than all other patients (85% vs. 15%, p <0.001). Adverse effects were common; 21% of patients experienced hemoglobin <8 g/dl and 57% required blood transfusions during the first 16 weeks. Twenty seven percent were hospitalized and 9% died; all were liver-related. Conclusions The addition of boceprevir or telaprevir to peginterferon and ribavirin yields SVR12 of 63% in liver transplant recipients with genotype 1 recurrent HCV, despite a high prevalence of advanced fibrosis and prior non-response to peginterferon and ribavirin. Rapid virologic response predicted a high likelihood of SVR. Despite a doubling of SVR rates, poor tolerability and high rates of adverse events were frequent and pose barriers to its widespread application.

Original languageEnglish (US)
Pages (from-to)508-514
Number of pages7
JournalJournal of Hepatology
Volume61
Issue number3
DOIs
StatePublished - Sep 2014

Keywords

  • Antiviral therapy
  • Boceprevir
  • Interferon
  • Ribavirin
  • Telaprevir

ASJC Scopus subject areas

  • Hepatology

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    Burton, J. R., O'Leary, J. G., Verna, E. C., Saxena, V., Dodge, J. L., Stravitz, R. T., Levitsky, J., Trotter, J. F., Everson, G. T., Brown, R. S., & Terrault, N. A. (2014). A US multicenter study of hepatitis C treatment of liver transplant recipients with protease-inhibitor triple therapy. Journal of Hepatology, 61(3), 508-514. https://doi.org/10.1016/j.jhep.2014.04.037