Multicenter experience using simeprevir and sofosbuvir with or without ribavirin to treat hepatitis C genotype 1 after liver transplant

Surakit Pungpapong, Bashar Aqel, Michael Leise, K. Tuesday Werner, Jennifer L. Murphy, Tanisha M. Henry, Kristen Ryland, Amy E. Chervenak, Kymberly D. Watt, Hugo E Vargas, Andrew P. Keaveny

Research output: Contribution to journalArticle

131 Scopus citations

Abstract

Treatment with an all-oral interferon-free antiviral regimen using simeprevir and sofosbuvir with or without ribavirin (RBV) for 12 weeks resulted in high sustained virologic response (SVR) rates along with minimal adverse events in non-liver transplant (LT) patients with hepatitis C virus (HCV) genotype 1 infection. This is the first multicenter report on the efficacy, safety, and tolerability of this regimen in LT recipients. A total of 123 patients (76% male, 74% white, 60% genotype 1a, 30% METAVIR F3-F4, 4% decompensation, 11% cholestatic recurrence, 7% had kidney transplant, and 82% previously failed pegylated interferon/RBV-based regimens) received treatment and were followed for a median of 30 weeks (range 12-53 weeks). The median time from LT to treatment was 32 months (range 2-317 months). Tacrolimus was the primary immunosuppression in 91% of patients. Minimal immunosuppression dose adjustments were required. An SVR 12 weeks after treatment completion (SVR12) was achieved in 90% of patients (95% confidence interval 84%-96%). In patients with genotype 1a infection, the SVR12 rate was significantly lower in those with METAVIR F3-F4 (71%) compared to those with F0-F2 (91%). Half of the patients achieved undetected HCV RNA at treatment week 4, and their SVR12 rate was significantly higher (96%) compared to those with detectable HCV RNA (83%). Treatment was very well tolerated with mild degrees of adverse events, except for one death possibly due to drug-induced lung injury. In the 25 patients who received RBV, 72% developed anemia requiring intervention. Conclusion: An all-oral interferon-free antiviral regimen using simeprevir and sofosbuvir with or without RBV for 12 weeks was very well tolerated and resulted in excellent SVR12 rates in LT recipients with HCV genotype 1 infection.

Original languageEnglish (US)
Pages (from-to)1880-1886
Number of pages7
JournalHepatology
Volume61
Issue number6
DOIs
StatePublished - Jun 1 2015

    Fingerprint

ASJC Scopus subject areas

  • Hepatology

Cite this

Pungpapong, S., Aqel, B., Leise, M., Werner, K. T., Murphy, J. L., Henry, T. M., Ryland, K., Chervenak, A. E., Watt, K. D., Vargas, H. E., & Keaveny, A. P. (2015). Multicenter experience using simeprevir and sofosbuvir with or without ribavirin to treat hepatitis C genotype 1 after liver transplant. Hepatology, 61(6), 1880-1886. https://doi.org/10.1002/hep.27770