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Liver toxicity associated with antiretroviral therapy including efavirenz or ritonavir-boosted protease inhibitors in a cohort of HIV/hepatitis C virus co-infected patients

2011; Oxford University Press; Volume: 66; Issue: 11 Linguagem: Inglês

10.1093/jac/dkr357

1460-2091

Karin Neukam, J Mira, Josefa Ruiz‐Morales, A. Rivero, Antonio Collado, Almudena Torres-Cornejo, Dolores Merino, Ignacio de los Santos, Juan Macı́as, Mercedes González‐Serrano, Ángela Camacho, Ginés David Parra-García, Juan A. Pineda, António Rivero‐Juarez, Inés Pérez‐Camacho, Julián Torre‐Cisneros, A. Aliaga-Jimenez, Luís F. López‐Cortés, Rosario Palacios-Muñoz, J. Santos-Gonzalez, Manuel Márquez, Enrique Nuño-Álvarez, Antonio Fernández,

HIV Research and Treatment

To compare the frequency of grade 3 or 4 transaminase elevations (TEs) in HIV/hepatitis C virus (HCV) co-infected patients who started a three-antiretroviral drug regimen including efavirenz or a ritonavir-boosted protease inhibitor (PI/r) and the influence of pre-existing significant hepatic fibrosis or cirrhosis. All pre-treated or treatment-naive HIV/HCV co-infected patients who started an antiretroviral regimen including two nucleos(t)ide reverse transcriptase inhibitors along with efavirenz or a PI/r in seven Spanish centres from January 2007 to December 2009 were included in this prospective study. Of 262 patients included in this study, 76 (29%) individuals began antiretroviral therapy (ART) including efavirenz and 186 (71%) a PI/r-based combination. The median (interquartile) follow-up was 14.0 (6.2–23.7) months. A total of 20 (7.6%) patients presented grade 3–4 TEs. Four (1.5%) subjects discontinued ART due to this adverse event. Grade 3–4 TEs were observed in 5 (6.6%) subjects receiving efavirenz and 15 (8.1%) treated with PI/r (P = 0.681). Three (6.5%) patients in the efavirenz group with significant fibrosis developed grade 3–4 TEs versus 2 (8.7%) without pre-existing significant fibrosis (P = 0.743). In the PI/r group, the corresponding figures were 10 (8.8%) and 5 (9.3%), respectively (P = 0.931). The frequency of grade 3–4 TEs associated with efavirenz-based ART combinations under clinical practice conditions is low and similar to that found in patients receiving PI/r currently used in HIV/HCV co-infected patients. The baseline fibrosis stage does not have an impact on the development of TEs caused by these antiretroviral drugs in this population.