Pharmacokinetic study of raltegravir in HIV-infected patients with end-stage liver disease: the LIVERAL-ANRS 148 study
| Autor: | Caroline Barau, Joséphine Braun, Corine Vincent, Stéphanie Haim-Boukobza, Jean-Michel Molina, Patrick Miailhes, Isabelle Fournier, Jean-Pierre Aboulker, Daniel Vittecoq, Jean-Charles Duclos-Vallée, Anne-Marie Taburet, Elina Teicher, E. Teicher, J-C. Duclos-Vallée, J-P. Aboulker, J. Braun, I. Fournier, C. Vincent, A. Arulananthan, V. Eliette, F. Euphrasie, B. Guillon, P. Ralaimazava, S. Haïm-Boukobza, A-M. Roque-Afonso, L. Bonhomme-Faivre, E. Rudant, A-M. Taburet, J.P. Aboulker, S. Couffin-Cadiergues, C. Delaugerre, F. Durand, D. Vittecoq, P. Flandre, R. Garraffo, J. Ghosn, A. Marraud, G. Pageaux, O. Derradji, C. Bolliot, F. Churaqui, T.M. Antonini, A. Coilly, P. Ichai, O. Ogier, M. Belnard, J-M. Molina, V. De Lastours, S. Gazaignes, D. Ponscarme, H. Sauvageon, P. Miailhes, J. Koffi, S. Radenne, C. Brochier |
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| Rok vydání: | 2014 |
| Předmět: |
Microbiology (medical)
Adult Male medicine.medical_specialty animal structures Drug-Related Side Effects and Adverse Reactions Anti-HIV Agents medicine.medical_treatment HIV Infections Liver transplantation Pharmacology Gastroenterology Mycophenolic acid End Stage Liver Disease Liver disease Plasma Tandem Mass Spectrometry Internal medicine Raltegravir Potassium medicine Humans business.industry Immunosuppression Middle Aged Raltegravir medicine.disease Pyrrolidinones Infectious Diseases Treatment Outcome Tolerability Reverse Transcriptase Inhibitors Female Liver function business Viral load medicine.drug Chromatography Liquid |
| Zdroj: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 59(8) |
| ISSN: | 1537-6591 |
| Popis: | BACKGROUND The end-stage LIVER disease and RALtegravir-Agence Nationale de Recherche sur le Sida et les hepatites (LIVERAL-ANRS) 148 study aimed to evaluate the safety, efficacy, and pharmacokinetic parameters of raltegravir (RAL) in human immunodeficiency virus (HIV)-infected patients with end-stage liver disease (ESLD) (substudy 1) and to assess the lack of pharmacokinetic interaction between RAL and the immunosuppressive regimen introduced after liver transplant (substudy 2). METHODS All patients received 400 mg RAL twice daily plus 2 nucleoside reverse transcriptase inhibitors. Liver function and immunovirological parameters were monitored throughout the study. Serial blood samples were drawn to explore RAL pharmacokinetics. Plasma concentrations of protein unbound, total RAL, and RAL glucuronide were determined by liquid chromatography-tandem mass spectrometry. RESULTS Ten patients with ESLD were analyzed in substudy 1. Despite an increased RAL exposure, RAL was well tolerated in all patients and no patient had to stop RAL therapy because of adverse events. Four patients were analyzed in substudy 2. No pharmacokinetic interaction was observed between cyclosporine, mycophenolic acid, and RAL. RAL tolerability was excellent; there were no episodes of acute rejection or opportunistic infection. HIV-RNA levels remained controlled and CD4 cell counts remained stable in all patients throughout the study. CONCLUSIONS The results of the substudy 1 support RAL administration to patients with ESLD. Substudy 2 assesses the safety, tolerability, and efficacy of RAL therapy in HIV-infected patients after liver transplant. RAL might be recommended as a suitable antiretroviral therapy in HIV-infected patients undergoing liver transplant. |
| Databáze: | OpenAIRE |
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