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BROWSE SLIDES

Design

Treatment regimens

• SOF 400 mg : 1 pill qd
• RBV : 400mg/day escalating to 1000 or 1200 mg/day (bid dosing) according to body weight (< or ≥ 75 kg), dose adapted on hemoglobin level

Objectives

• Primary endpoint : SVR₁₂ (HCV RNA < 12 IU/ml) by intention to treat, with 2-sided 95% CI, no formal statistical criteria

Baseline characteristics and outcome

SVR₁₂ according to subgroups

• Rate lower if
  • Male
  • Cirrhosis
  • Non-CC IL28B genotypes
  • HCV Genotype 1b

Resistance assessment

• NS5B sequencing : no baseline S282T variant
• At relapse, 1 patient with emergence of V321A

Pharmacokinetic assessment

• Increase in metabolite GS-331007 (< 2 fold) and SOF AUCtau in the post-transplant period

Safety

• No deaths, graft losses or rejection
• Grade 3 adverse events in 6 patients
• Serious adverse events : 10 in 6 patients, all unrelated to study drugs
• Adverse events leading to discontinuation : 1 pneumonia,1 hepatocarcinoma

Summary

• In this open-label, uncontrolled, non randomised study, 24 weeks of SOF + RBV without interferon led to SVR₁₂ in 70% of patients (28 of 40) with recurrence of HCV infection after liver transplantation
• This study confirms the absence of impact of SOF + RBV on co-administered immunosuppressive agents
  • No net directional changes in trough levels of cyclosporine or tacrolimus were observed during the study