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• W2978732007 abstract "Purpose: Limited data are available on using telaprevir (TVR)-based triple therapy to treat HCV recurrence post-liver transplantation (LTx). A study in healthy volunteers shows that TVR leads to major increase in tacrolimus (TAC) blood concentration. We report our preliminary experience on the effects of TVR on TAC pharmacokinetics (PK) and the safety of TVR-based therapy in the post-LTx setting. 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: Four patients (1F, 3M), mean age 56.3 years, mean time from LTx 3.25 years, and mean fibrosis stage of 2.5 were treated. Two were HCV treatment naïve and two were prior null-responders post-LTx. The mean duration of treatment was 10.75 weeks (range 8-16 weeks). 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 1353.46 ng.hr/mL (range 685.25-2040.05) compared to an expected AUC of 67 ng.hr/mL without TVR. The highest TAC level that we encountered in our study was 16.2 ng/mL (at 12-hour level after the initial dose). Clinically significant anemia (Hb <10 g/dL) developed in 2, requiring a decrease of the ribavirin dose to 400 mg daily and starting epoietin. No significant neurologic toxicity was encountered. The mean creatinine increased from 1.12 to 1.35 mg/dL. We did not encounter any infections or episodes of acute rejection. Conclusion: 1. TVR had a profound effect on TAC metabolism; 2. Dose reduction of TAC based on blood levels is associated with normal TAC blood levels; 3. TVR therapy for HCV recurrence post-OLT in patients on TAC-based immunosuppression appears feasible; 4. The effect on renal function requires additional study. Longer follow-up is needed to demonstrate efficacy in achieving control of HCV. Disclosure: Naim Alkhouri, MD - Speaker's Bureau and Advisory Board Member of Vertex (makers of telaprevir). Nizar N Zein - Speaker's Bureau and Advisory Board Member of Vertex (makers of telaprevir)." @default.
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• W2978732007 date "2012-10-01" @default.
• W2978732007 modified "2023-09-26" @default.
• W2978732007 title "Effect of Telaprevir on the Pharmacokinetics of Tacrolimus in the Treatment of Hepatitis C After Liver Transplantation Presidential Poster" @default.
• W2978732007 doi "https://doi.org/10.14309/00000434-201210001-00429" @default.
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