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CLINICAL TRIAL
JOURNAL ARTICLE
Telaprevir with peginterferon/ribavirin for retreatment of null responders with advanced fibrosis post-orthotopic liver transplant.
Clinical Transplantation 2014 June
INTRODUCTION: Aggressive recurrence of hepatitis C remains problematic post-orthotopic liver transplant (OLT). There are limited data on treatment of HCV infection with telaprevir/boceprevir therapy with peginterferon/ribavirin (PR) post-OLT.
AIM: To review our experience with telaprevir addition to peginterferon/ribavirin in treatment of aggressive hepatitis C in null responders to PR post-OLT.
METHODS: Adult patients with recurrent HCV infection post-OLT with null response to peginterferon/ribavirin for 12 wk (<2 log reduction) received four-wk lead-in PEG-IFN alfa-2b (1.0 μg/kg/wk) plus RBV (600-1000 mg/d) followed by addition of telaprevir 750 q8. All patients were converted to cyclosporine from tacrolimus (TAC).
RESULTS: Seven patients (3 M, 4 F), mean age 56 yr, were treated. Three were <1 yr post-OLT, six had cirrhosis and one bridging fibrosis. Three of seven achieved sustained virologic response. All patients required RBV dose reduction, 6/7 required erythropoietin, 5/7 required filgrastim, and 2/7 required eltrombopag for platelets <20 000 μL. There were no supratherapeutic/subtherapeutic CYA levels encountered, no episodes of renal insufficiency.
CONCLUSIONS: Conversion to CYA followed by four-wk peginterferon/ribavirin lead-in with addition of telaprevir can lead to significant clearance rates at week 24 in null responders with advanced fibrosis although high rates of anemia/RBV dose reduction, growth factor, and transfusion requirements were noted.
AIM: To review our experience with telaprevir addition to peginterferon/ribavirin in treatment of aggressive hepatitis C in null responders to PR post-OLT.
METHODS: Adult patients with recurrent HCV infection post-OLT with null response to peginterferon/ribavirin for 12 wk (<2 log reduction) received four-wk lead-in PEG-IFN alfa-2b (1.0 μg/kg/wk) plus RBV (600-1000 mg/d) followed by addition of telaprevir 750 q8. All patients were converted to cyclosporine from tacrolimus (TAC).
RESULTS: Seven patients (3 M, 4 F), mean age 56 yr, were treated. Three were <1 yr post-OLT, six had cirrhosis and one bridging fibrosis. Three of seven achieved sustained virologic response. All patients required RBV dose reduction, 6/7 required erythropoietin, 5/7 required filgrastim, and 2/7 required eltrombopag for platelets <20 000 μL. There were no supratherapeutic/subtherapeutic CYA levels encountered, no episodes of renal insufficiency.
CONCLUSIONS: Conversion to CYA followed by four-wk peginterferon/ribavirin lead-in with addition of telaprevir can lead to significant clearance rates at week 24 in null responders with advanced fibrosis although high rates of anemia/RBV dose reduction, growth factor, and transfusion requirements were noted.
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