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JAC Advance Access published online on May 23, 2006
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkl214
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© The Author 2006. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org
Received December 11, 2005
Revised April 2, 2006
Accepted May 4, 2006

Original article

Incidence of and risk factors for severe hepatotoxicity of nelfinavir-containing regimens among HIV-infected patients with chronic hepatitis C

José A. Mira 1, Juan Macías 2, José A. Girón-González 3, Dolores Merino 4, Mercedes González-Serrano 5, Manuel E. Jiménez-Mejías 6, Francisco J. Caballero-Granado 7, Julián Torre-Cisneros 8, Alberto Terrón 9, Mark I. Becker 10, Jesús Gómez-Mateos 2, Ana Arizcorreta-Yarza 3, Juan A. Pineda 2 *, and for the Grupo Andaluz Para el Estudio de las Enfermedades Infecciosas (GAEI)

1 Servicio de Medicina Interna, Hospital Universitario de Valme, Sevilla, Spain; Unidad de Enfermedades Infecciosas, Hospital Universitario de Valme, Sevilla, Spain
2 Unidad de Enfermedades Infecciosas, Hospital Universitario de Valme, Sevilla, Spain
3 Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario Puerta del Mar, Cádiz, Spain
4 Servicio de Medicina Interna, Hospital Juan Ramón Jiménez, Huelva, Spain
5 Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario Virgen de la Victoria, Málaga, Spain
6 Servicio de Enfermedades Infecciosas, Hospital Universitario Virgen del Rocío, Sevilla, Spain
7 Sección de Enfermedades Infecciosas, Hospital Punta de Europa, Algeciras, Cádiz, Spain
8 Sección de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Córdoba, Spain
9 Servicio de Medicina Interna, Hospital Universitario de Jerez, Cádiz, Spain
10 F. Hoffman-La Roche, San Diego, USA

* To whom correspondence should be addressed.
Juan A. Pineda, E-mail: japineda{at}nacom.es


  Abstract

Objectives: To determine the incidence of and risk factors for severe hepatotoxicity of nelfinavir-containing regimens among human immunodeficiency virus/hepatitis C virus (HIV/HCV)-coinfected patients with known stage of liver fibrosis.

Methods: All HIV/HCV-coinfected patients were monitored for a period of 12 months after starting nelfinavir-containing regimens and, with an available liver biopsy, were included in a retrospective study.

Results: A total of 82 patients were included in the study. Nine (10.9%) HIV/HCV-coinfected patients showed an episode of severe hepatotoxicity during the study period. Eight (9.8%) individuals showed grade 3 or 4 change in levels of serum alanine aminotransferase and one subject presented with an event of decompensated liver cirrhosis. Six (18.2%) of 33 patients with advanced liver fibrosis and three (6%) of 49 individuals without advanced liver fibrosis showed an episode of severe hepatotoxicity (P = 0.1). In the multivariate analysis, only nevirapine use during nelfinavir therapy [adjusted odds ratio (AOR) 8.9; 95% confidence interval (CI), 1.4-54.1; P = 0.01] was independently associated with risk of development of severe liver toxicity.

Conclusions: The incidence of severe hepatotoxicity of nelfinavir-containing regimens is low among HIV/HCV-coinfected patients with known stage of liver fibrosis. In addition, our findings show that concomitant nevirapine use is associated with an increased risk of severe hepatotoxicity in these subjects. Likewise, the proportion of severe liver toxicity tended to be higher in individuals with advanced liver fibrosis.

Keywords: protease inhibitors; nevirapine; liver fibrosis; liver toxicity.
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