Introduction: There is no data on response guided therapy in liver transplant recipients with HCV genotype I recurrence.

Aim: This is a Clinical Protocol developed to assess the safety and efficacy of triple antiviral therapy with interferon, ribavirin, and Telaprevir (TVR) in liver transplant recipients with recurrent hepatitis C on immunosuppressant therapy with Tacrolimus

Methods: 18 liver transplant patients with genotype 1 HCV infection and histological changes of recurrent HCV were started on combination therapy with pegylated interferon, Ribavirin and TVR for 12 weeks followed by Interferon/ Ribavirin for 12 or 36 weeks (RGT). At the start of therapy, the TAC dose was reduced to approximately to 25- 35 fold lower than baseline and maintained at levels between 4-8ng/ml with weekly dosing of 0.5 to 1mg/week. After completing Telaprevir, Tacrolimus was gradually re-introduced and titrated based on levels. Tacrolimus levels, CBC, Chemistry, HCV RNA and clinic evaluation of patients were performed rigorously during the treatment duration. Patients who were naÏve or previous relapsers without cirrhosis in allograft were given total 24 weeks of Rx after starting TVR if they achieved eRVR

Results: 10 males and 8 females who ranged from 6months to 8yrs after liver transplantation were treated with this protocol. 11/18 were genotype 1a and 13/18 were previous non responders to Pegylated Interferon/Ribavirin. Duration of therapy was guided by virologic response per Telaprevir label and adverse effects. 8 patients completed 24 weeks of therapy and stopped Rx based on eRVR, prior history and histology. 6/8 had ETR. Of these 4 patients have achieved SVR24. Of the remaining, 2 patients relapsed, one broke through at wk 24 and one patient has no early relapse after ETR. 2/10 patients in the 48 week group had ETR so far. SVR data on patients completing 48 weeks of therapy is awaited.

Conclusion: Our initial experience reveals a 50% (and possibly 62.5%) SVR after 24 weeks of RGT in post liver transplant patients with genotype I HCV recurrence treated with Telaprevir based triple therapy. Further controlled studies will be needed to assess the role for RGT in liver transplant recipients receiving TVR based therapy.

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