DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

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