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Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study.

Publication ,  Journal Article
O'Leary, JG; Fontana, RJ; Brown, K; Burton, JR; Firpi-Morell, R; Muir, A; O'Brien, C; Rabinovitz, M; Reddy, R; Ryan, R; Shprecher, A ...
Published in: Transpl Int
February 2017

This prospective, randomized, phase 2 study in subjects with recurrent hepatitis C virus (HCV) genotype 1 postorthotopic liver transplant evaluated once-daily simeprevir 150 mg + sofosbuvir 400 mg, with and without ribavirin 1000 mg. Primary endpoint was proportion of subjects with week 12 sustained virologic response (SVR12). Thirty-three subjects without cirrhosis were randomized 1:1:1 into three arms (stratified by genotype/subtype and Q80K): Arm 1, simeprevir + sofosbuvir + ribavirin, 12 weeks; Arm 2, simeprevir + sofosbuvir, 12 weeks; Arm 3, simeprevir + sofosbuvir, 24 weeks; 13 additional subjects (two with cirrhosis, 11 without cirrhosis) entered Arm 3. All 46 subjects received at least one dose of study drug; median age, 60 years; 73.9% male; 80.4% White; 71.7% genotype/subtype 1a [12 (36.4%) of these had Q80K]; median 4.5 years post-transplant. Among randomized subjects, SVR12 was achieved by 81.8% in Arm 1, 100% in Arm 2, and 93.9% in Arm 3; two subjects did not achieve SVR12: one viral relapse (follow-up week 4; Arm 1) and one missing follow-up week 12 data. In total, five subjects had a serious adverse event, considered unrelated to treatment per investigator. Simeprevir exposure was increased relative to the nontransplant setting, but not considered clinically relevant. Simeprevir + sofosbuvir treatment, with or without ribavirin, was efficacious and well tolerated (ClinicalTrials.gov Identifier: NCT02165189).

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Published In

Transpl Int

DOI

EISSN

1432-2277

Publication Date

February 2017

Volume

30

Issue

2

Start / End Page

196 / 208

Location

Switzerland

Related Subject Headings

  • Treatment Outcome
  • Surgery
  • Postoperative Complications
  • Patient Reported Outcome Measures
  • Middle Aged
  • Male
  • Liver Transplantation
  • Humans
  • Hepatitis C
  • Hepacivirus
 

Citation

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O’Leary, J. G., Fontana, R. J., Brown, K., Burton, J. R., Firpi-Morell, R., Muir, A., … Brown, R. S. (2017). Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study. Transpl Int, 30(2), 196–208. https://doi.org/10.1111/tri.12896
O’Leary, Jacqueline G., Robert J. Fontana, Kimberly Brown, James R. Burton, Roberto Firpi-Morell, Andrew Muir, Christopher O’Brien, et al. “Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study.Transpl Int 30, no. 2 (February 2017): 196–208. https://doi.org/10.1111/tri.12896.
O’Leary, Jacqueline G., et al. “Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study.Transpl Int, vol. 30, no. 2, Feb. 2017, pp. 196–208. Pubmed, doi:10.1111/tri.12896.
O’Leary JG, Fontana RJ, Brown K, Burton JR, Firpi-Morell R, Muir A, O’Brien C, Rabinovitz M, Reddy R, Ryan R, Shprecher A, Villadiego S, Prabhakar A, Brown RS. Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study. Transpl Int. 2017 Feb;30(2):196–208.
Journal cover image

Published In

Transpl Int

DOI

EISSN

1432-2277

Publication Date

February 2017

Volume

30

Issue

2

Start / End Page

196 / 208

Location

Switzerland

Related Subject Headings

  • Treatment Outcome
  • Surgery
  • Postoperative Complications
  • Patient Reported Outcome Measures
  • Middle Aged
  • Male
  • Liver Transplantation
  • Humans
  • Hepatitis C
  • Hepacivirus