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JAC Advance Access published online on October 24, 2008
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkn429
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© The Author 2008. 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

Original research

Hepatic safety of tipranavir plus ritonavir (TPV/r)-based antiretroviral combinations: effect of hepatitis virus co-infection and pre-existing fibrosis

Juan Macías1,2, Francisco Orihuela3, Antonio Rivero4, Pompeyo Viciana5, Manuel Márquez6, Joaquín Portilla7, María J. Ríos8, Leopoldo Muñoz9, Juan Pasquau10, Manuel A. Castaño3, Laila Abdel-Kader1,11, Juan A. Pineda1,* for the Hepatip Study Group

1 Unidad de Enfermedades Infecciosas, Hospital Universitario de Valme, Seville, Spain 2 Servicio de Medicina Interna, Hospital Universitario de Valme, Seville, Spain 3 Unidad de Enfermedades Infecciosas, Hospital Universitario Carlos de Haya, Malaga, Spain 4 Unidad de Enfermedades Infecciosas, Hospital Universitario de Reina Sofía, Córdoba, Spain 5 Servicio de Enfermedades Infecciosas, Hospital Universitario de Virgen del Rocío, Seville, Spain 6 Unidad de Enfermedades Infecciosas, Hospital Universitario Virgen de la Victoria, Malaga, Spain 7 Unidad de Enfermedades Infecciosas, Hospital General Universitario de Alicante, Alicante, Spain 8 Unidad de Enfermedades Infecciosas, Hospital Universitario de Virgen Macarena, Seville, Spain 9 Unidad de Enfermedades Infecciosas, Hospital Universitario San Cecilio, Granada, Spain 10 Unidad de Enfermedades Infecciosas, Hospital Universitario Virgen de las Nieves, Granada, Spain 11 Servicio de Farmacia, Hospital Universitario de Valme, Seville, Spain

Received 13 May 2008; returned 15 July 2008; revised 11 September 2008; accepted 18 September 2008

* Corresponding author. Tel: +34-955015864; Fax: +34-955015787; E-mail: japineda{at}telefonica.net

Objectives: The aim of this study was to evaluate the incidence and risk factors of severe liver events among HIV-infected patients treated with drug combinations including tipranavir boosted with ritonavir (TPV/r).

Methods: One hundred and fifty patients were selected because they started a regimen that included TPV/r (500/200 mg twice a day) and had clinical visits at least every 3 months. Patients who discontinued TPV/r before their first visit were included.

Results: Twelve (8%) individuals developed grade ≥3 transaminase elevation (G ≥ 3TE). Nine (6%) patients discontinued TPV/r due to liver events. Six (8.6%) of 70 hepatitis C virus (HCV) co-infected patients and 6 (7.5%) of 80 subjects without HCV co-infection developed G ≥ 3TE (P = 1). Liver fibrosis was evaluable in 48 (63%) of 76 individuals with hepatitis B virus and/or HCV infection. Four (13%) of 30 subjects with moderate-to-severe fibrosis and none of 18 with mild fibrosis showed G ≥ 3TE (P = 0.3). None of nine patients with cirrhosis showed G ≥ 3TE.

Conclusions: Liver tolerability of TPV/r was generally good in a cohort of patients with a high proportion of HCV co-infection, including subjects with advanced fibrosis. The presence of HCV co-infection was not associated with an increased risk of severe transaminase elevations.

Key Words: hepatotoxicity , HBV , HCV , liver fibrosis


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