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

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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

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Ribavirin
Hepatitis C
Genotype
Transplants
Liver
Hepacivirus
Interferons
Immunosuppression
Antiviral Agents
Therapeutics
Infection
RNA
Lung Injury
Tacrolimus
Sofosbuvir
Simeprevir
Anemia
Confidence Intervals
Kidney
Safety

ASJC Scopus subject areas

  • Hepatology

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Multicenter experience using simeprevir and sofosbuvir with or without ribavirin to treat hepatitis C genotype 1 after liver transplant. / Pungpapong, Surakit; Aqel, Bashar; Leise, Michael; Werner, K. Tuesday; Murphy, Jennifer L.; Henry, Tanisha M.; Ryland, Kristen; Chervenak, Amy E.; Watt, Kymberly D.; Vargas, Hugo E; Keaveny, Andrew P.

In: Hepatology, Vol. 61, No. 6, 01.06.2015, p. 1880-1886.

Research output: Contribution to journalArticle

Pungpapong, S, Aqel, B, Leise, M, Werner, KT, Murphy, JL, Henry, TM, Ryland, K, Chervenak, AE, Watt, KD, Vargas, HE & Keaveny, AP 2015, 'Multicenter experience using simeprevir and sofosbuvir with or without ribavirin to treat hepatitis C genotype 1 after liver transplant', Hepatology, vol. 61, no. 6, pp. 1880-1886. https://doi.org/10.1002/hep.27770
Pungpapong, Surakit ; Aqel, Bashar ; Leise, Michael ; Werner, K. Tuesday ; Murphy, Jennifer L. ; Henry, Tanisha M. ; Ryland, Kristen ; Chervenak, Amy E. ; Watt, Kymberly D. ; Vargas, Hugo E ; Keaveny, Andrew P. / Multicenter experience using simeprevir and sofosbuvir with or without ribavirin to treat hepatitis C genotype 1 after liver transplant. In: Hepatology. 2015 ; Vol. 61, No. 6. pp. 1880-1886.
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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.",
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AU - Aqel, Bashar

AU - Leise, Michael

AU - Werner, K. Tuesday

AU - Murphy, Jennifer L.

AU - Henry, Tanisha M.

AU - Ryland, Kristen

AU - Chervenak, Amy E.

AU - Watt, Kymberly D.

AU - Vargas, Hugo E

AU - Keaveny, Andrew P.

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