January 7, 2013

Telaprevir Post Liver Transplant

Provided by NATAP

Telaprevir-based triple therapy in liver transplant patients with hepatitis C virus: A 12-week pilot study providing safety and efficacy data, this study was just published in Liver transplantation Dec 7 2012, full text below....."a remarkable number of patients (8/9) had an undetectable viral load at week 12.......triple therapy with TVR has promising antiviral efficacy in LT patients with respect to treatment weeks 4 and 12. The management of drug-drug interactions during TVR exposure is a therapeutic challenge, but they may be more controllable if CSA is used as the main immunosuppressive agent. Triple therapy has an acceptable safety profile, although the treatment is quite intense with respect to cost and time. Therefore, we recommend that this therapy be conducted only by expert transplant hepatologists with strict surveillance of the patients because of the potential development of severe side effects.......this pilot study provides evidence showing that TVR-based triple therapy is effective within the first 4 to 12 weeks in LT patients suffering from HCV genotype 1 recurrence, and it also provides evidence showing that drug-drug interactions between TVR and immunosuppressants can be handled appropriately through the close monitoring of trough levels and adequate dosage adjustments.....Because both TVR and immunosuppressants (eg, calcineurin inhibitors) are substrates of cytochrome P450 3A4 and this can result in significant drug-drug interactions, the dosages of the immunosuppressants had to be modified during concomitant medication......There is also evidence showing that drug-drug interactions between the PI TVR and immunosuppressants can be controlled if the dosing of the drugs is carefully adapted......the maintenance of stable trough levels of immunosuppressants during the TVR exposure time still remains a challenging problem, especially for TAC and SIR. Thus, the dose reduction factors for the immunosuppressants differed and ranged from 22-fold (for TAC) to 2.5-fold (for CSA)......we suggest CSA as the main immunosuppressive agent to be used in the context of future TVR-based triple therapies."

An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients, Verified October 2012 by Vertex Pharmaceuticals Incorporated http://clinicaltrials.gov/ct2/show/NCT0146750

EASL 2012: Use of Telaprevir Plus Peg Interferon/Ribavirin for Null Responders Post OLT With Advanced Fibrosis/Cholestatic Hepatitis C - (05/04/12)

Triple Therapy Using Telaprevir In The Treatment of Hepatitis C Recurrence After Liver Transplantation: An Early Single Center Experience. - (02/03/12)

A case report of successful peginterferon, ribavirin, and daclatasvir therapy for recurrent cholestatic hepatitis c following liver retransplantation - published in Hepatology July 2011 (08/20/12)

Telaprevir, boceprevir, cytochrome P450 and immunosuppressive agents - A potentially lethal cocktail (see article below editorial) - Editorial; http://www.natap.org/2011/HCV/071211_02.htm

Closing Summary by Jean-Michel Pawlotsky Part 3: New data on ...www.natap.org/2012/EASL/EASL_70.htm

Apr 22, 2012 - ... data on telaprevir & boceprevir, post-transplant telaprevir/boceprevir ... HEPATITIS C RECURRENCE AFTER LIVER TRANSPLANTATION

HCV1

HCV2

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