Su1070 Safety and Efficacy of Telaprevir-Based Triple Therapy to ...

and for 7 of 37 patients (19%) without EVR. Conclusions: Approximately 70% of treatmentnaïve patients with HCV G1 infection undergoing triple therapy with boceprevir in German real-life achieve an EVR which allow shortage of triple therapy to 24 weeks. Achieving EVR is associated with age ≤50 years and a better virologic response to PegIFN/RBV lead-in. A virologic response rate of 90% together with a low treatment discontinuation rate of only 6% at TW24 in patients with EVR demonstrates a high efficacy of boceprevir triple therapy in this important patient subgroup.

Su1070 Safety and Efficacy of Telaprevir-Based Triple Therapy to Treat HCV Recurrence Post-Liver Transplantation Tavankit Singh, Gurshawn Singh, John J. Fung, Nizar N. Zein, Bijan Eghtesad, Naim Alkhouri Purpose: Recurrence of Hepatitis C Virus (HCV) in liver transplanted (LTx) patients is the most frequent cause of death and graft failure in patients who are infected with HCV. The use of protease inhibitors post-LTx has been controversial due to concerns regarding safety and serious adverse effects, including tacrolimus (TAC) toxicity and anemia. We report our experience on the effects of TVR on TAC pharmacokinetics (PK) and the safety of TVRbased therapy to treat HCV recurrence post-LTx. Methods: Patients with HCV genotype 1 recurrence post-LTx on stable dose of TAC for at least 6 months prior to starting the antiviral regimen were included in this study. TVR-based triple therapy was started with TVR 750 mg TID, ribavirin 600 mg daily, and peg-interferon α2a 180 mcg weekly. On day 1 of treatment, TAC at half the pre-treatment daily dose was given and levels were checked at 12 and 24 hours and every other day thereafter for 2 weeks to assess TAC PK. No additional TAC was given until the level was around 4-6 ng/mL. Once the maintenance dose of TAC was established, levels were assessed weekly. Results: Twenty-six patients (3F, 23M), mean age 57.8 years, mean time from LTx 3.7 years, and mean fibrosis stage of 2.4 was treated. Twenty were HCV treatment naive. The mean duration of treatment was 32 weeks (range 9-48 weeks). Twenty-two patients completed 12 weeks of TVR while on TAC. Thus far, eight patients completed 48 weeks of therapy of which 1 has relapsed and 3 have achieved SVR24. Thirteen patients are still undergoing therapy. The pre-treatment TAC dose ranged from 1-3 mg twice daily. The TAC dose required to maintain therapeutic levels was found to be approximately ¼- ½ the pre-treatment daily dose at a frequency of once weekly. The mean area under the concentration time curve (AUC) for TAC while on TVR was 510.4 nghr/mL (range 254.8-944.15) compared to an expected AUC of 67 ng-hr/mL without TVR. The highest TAC level that we encountered in our study was 23.6 ng/ml. Clinically significant anemia (Hb