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JAC Advance Access published online on February 14, 2008
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkn045
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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

Liver toxicity of antiretroviral combinations including atazanavir/ritonavir in patients co-infected with HIV and hepatitis viruses: impact of pre-existing liver fibrosis

J. A. Pineda1,*, J. Santos2, A. Rivero3, L. Abdel-Kader1,4, R. Palacios2, A. Camacho3, F. Lozano1, J. Macías on behalf of the Liverey Study Investigator Team1,{dagger}

1 Unidad de Enfermedades Infecciosas, Hospital Universitario de Valme, Seville, Spain 2 Unidad de Enfermedades; Infecciosas, Hospital Universitario Virgen de la Victoria, Malaga, Spain 3 Sección de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Cordoba, Spain 4 Servicio de Farmacia, Hospital Universitario de Valme, Seville, Spain

Received 5 November 2007; returned 15 January 2008; revised 13 December 2007; accepted 18 January 2008

* Corresponding author. Tel: +34-955015684; Fax: +34-955015787; E-mail: japineda{at}telefonica.net

Objectives: To appraise the rate of grade 3–4 transaminase elevations (TEs) and grade 4 total bilirubin elevation (TBE) in patients co-infected with human immunodeficiency virus (HIV) and hepatitis C or hepatitis B virus (HCV or HBV, respectively) who receive atazanavir/ritonavir. Moreover, the relationship between these events and the degree of prior liver fibrosis was evaluated.

Methods: A cohort of 189 HIV-infected patients, 175 co-infected with HCV, 4 with HBV and 10 with both, receiving atazanavir/ritonavir, was analysed. Baseline liver fibrosis was assessed in 113 (60%) patients. Twenty-four patients had cirrhosis, whereas such a diagnosis was ruled out in 58 patients.

Results: Twelve (6%) and 28 (15%) patients developed grade 3–4 TEs and grade 4 TBE, respectively. Eight (10%) of 84 patients with fibrosis ≥F2 versus 1 of 29 (3%) with F0-F1 (P = 0.51) developed grade 3–4 TEs. The frequencies of grade 3–4 TEs in patients with and without cirrhosis were 8% and 5% (P = 0.63), respectively. Grade 4 TBE was more common among patients with cirrhosis (35% versus 13%, P = 0.05) in the univariate analysis. In the multivariate study, the only predictor of grade 3–4 TEs was baseline CD4 cell count <300 cells/mm3 [adjusted OR (AOR) (95% CI) = 8.77 (1.07–71.42), P = 0.04]. The factors independently associated with grade 4 TBE were baseline total bilirubin >1 mg/dL [AOR (95% CI) = 3.2 (1.21–8.45), P = 0.01] and age >40 years [AOR (95% CI) = 2.98 (1.19–7.47), P = 0.02].

Conclusions: Prior significant liver fibrosis or cirrhosis do not increase substantially the risk of severe TE associated with atazanavir/ritonavir in patients co-infected with HIV and hepatitis viruses.

Key Words: liver disease , cirrhosis , hepatitis C , hepatitis B , antiviral therapy

{dagger} Members are listed in the Acknowledgements section.


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