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Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the phase III randomized, double-blind ECHO and THRIVE trials

par Nelson, Mark;Amaya, Gerardo;Clumeck, Nathan ;Arns da cunha, Clovis;Jayaweera, Dushyantha;Junod, Patrice;Li, Taisheng;Tebas, Pablo;Stevens, Marita;Buelens, Annemie;Vanveggel, Simon;Boven, Katia;Abusamra, Lorena;Cahn, Pedro;Laplume, Héctor;Cassetti, Isabel;Ceriotto, Mariana;Martins, M.D.;Krolewiecki, Alejandro;Amarilis Lugo, L.;Bolan, Robert;Bush, Larry Marc;Corales, Roberto Baun;Crane, Lawrence Richard;De Vente, J.;Fischl, Margaret A.;Gathe, Joseph;Greenberg, Richard;Henry, Kenneth;Jayaweera, D.;Kumar, Princy Suresh;Lalezari, Jacob;Leider, Jason;Lubelchek, Ronald Jay;Martorell, Claudia;Mounzer, Karam;Cohen, Calvin;Olivet, Hannah;Ortiz, Reinaldo;Rhame, Frank;Roberts, Afsoon;Ruane, Peter;Scribner, Anita;Segal-Maurer, Sorana;Short, William;Sloan, Louis;Wilkin, Timothy;Wohlfeiler, Michael;Yangco, Bienvenido
Référence Journal of antimicrobial chemotherapy, 67, 8, page (2020-2028), dks130
Publication Publié, 2012-08

Article révisé par les pairs

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Résumé :

Objectives: The efficacy and hepatic safety of the non-nucleoside reverse transcriptase inhibitors rilpivirine (TMC278) and efavirenz were compared in treatment-naive, HIV-infected adults with concurrent hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in the pooled week 48 analysis of the Phase III, double-blind, randomized ECHO (NCT00540449) and THRIVE (NCT00543725) trials. Methods: Patients received 25 mg of rilpivirine once daily or 600 mg of efavirenz once daily, plus two nucleoside/nucleotide reverse transcriptase inhibitors. At screening, patients had alanine aminotransferase/aspartate aminotransferase levels ≤5× the upper limit of normal. HBV and HCV status was determined at baseline by HBV surface antigen, HCV antibody and HCV RNA testing. Results: HBV/HCV coinfection status was known for 670 patients in the rilpivirine group and 665 in the efavirenz group. At baseline, 49 rilpivirine and 63 efavirenz patients [112/1335 (8.4%)] were coinfected with either HBV [55/1357 (4.1%)] or HCV [57/1333 (4.3%)]. The safety analysis included all available data, including beyond week 48. Eight patients seroconverted during the study (rilpivirine: five; efavirenz: three). A higher proportion of patients achieved viral load <50 copies/mL (intent to treat, time to loss of virological response) in the subgroup without HBV/HCV coinfection (rilpivirine: 85.0%; efavirenz: 82.6%) than in the coinfected subgroup (rilpivirine: 73.5%; efavirenz: 79.4%) (rilpivirine, P = 0.04 and efavirenz, P = 0.49, Fisher's exact test). The incidence of hepatic adverse events (AEs) was low in both groups in the overall population (rilpivirine: 5.5% versus efavirenz: 6.6%) and was higher in HBV/HCV-coinfected patients than in those not coinfected (26.7% versus 4.1%, respectively). Conclusions: Hepatic AEs were more common and response rates lower in HBV/HCV-coinfected patients treated with rilpivirine or efavirenz than in those who were not coinfected. © The Author 2012. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved.