GALAXY

GALAXY study: SMV + SOF ± RBV in recurrent genotype 1 HCV infection post liver transplantation

O’Leary JG. Transplant International 2017; 30:196-208

Anti-HCV
Simeprevir
Sofosbuvir
Ribavirin
Genotype
1
Cirrhosis
No
Special population
Liver transplantation

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Design

  • SMV: 150 mg QD
  • SOF: 400 mg QD
  • RBV : 1000 or 1200 mg/day (BID dosing) according to body weight (< or = 75 kg)

Objective

  • SVR12 by ITT

Baseline characteristics and disposition

SVR12


* 1 relapse (W4 post-treatment) : 53-y, white male, 7.7 years since liver transplant, genotype 1a no 80K, F2, baseline HCV RNA : 4,130,000 IU/ml ; no emerging NS3 or NS5B mutations at failure

Adverse events, %


* 1 transplant rejection (W12 post-treatment) ; tacrolimus level decreased from 13.8 m g/l (baseline) to 3.2 m g/l (rejection)

Summary

  • Treatment with SMV + SOF with or without RBV, for 12 weeks, or with SMV + SOF, for 24 weeks, was efficacious in liver transplant recipients with recurrent HCV genotype 1 infection
    • Overall SVR12 of 91.3%
    • 1 relapse occurred after 12 weeks of SMV + SOF + RBV
  • Treatment was generally well tolerated
  • 1 transplant rejection was observed, in the context of decreased tacrolimus plasma levels
  • In conclusion, 12 weeks of SMV + SOF is an effective combination for liver transplant recipients without cirrhosis presenting recurrence of HCV genotype 1 infection