AEGiS-Glasgow [PL10.3] HAART-associated hepatotoxicity in HIV/HCV co-infected patients: the role of liver histologic damage and drug levels

Seventh International Congress on Drug Therapy in HIV Infection

Glasgow, UK - 14-17 November 2004

[PL10.3] HAART-associated hepatotoxicity in HIV/HCV co-infected patients: the role of liver histologic damage and drug levels

Int Cong Drug Therapy HIV 2004 Nov 14-18;7:Abstract No. PL10.3

Lidia Aranzabal , Jose L. Casado , Javier Moya , Ana Marin , Carmen Quereda , Ana Moreno , Santiago Moreno
Infectious Diseases, Ramon y Cajal Hospital, Madrid, Spain

HCV infection is a known risk factor for hepatotoxicity in HIV-infected patients. The aim of this study was to asses the influence of liver histologic stage in the rate of HAART-related liver toxicity.

Prospective cohort study of 107 HIV/HCV co-infected patients who underwent liver biopsy between October'00 and September'03. Fibrosis was staged using a scoring of 0 (no fibrosis) to 4 (cirrhosis). Hepatotoxicity was defined as an increase in AST/ALT levels up to five times the upper limit of normal, or 3.5 fold increase if baseline levels were abnormal. Plasma trough levels of nevirapine were measured by HPLC in 30 patients

Hepatotoxicity was seen in 27 cases (25%; 5.1/100 person-years on therapy). The rate was greater for patients with fibrosis 3-4 than for fibrosis 1-2 (7.6 vs 3/100 person-years; 38 vs 15% respectively, RR 2.75; 95%CI, 1.08-6.97; p=0.03). During the study, 86 patients received NNRTIs, and 12 (16%) had liver toxicity. Fibrosis 1-2 was associated with lower toxicity (3/100 person-years for nevirapine; 3.3/100 person-years for efavirenz; 3.4/100 person-years not receiving NNRTIs). However, there was a greater incidence of hepatotoxicity in patients with fibrosis 3-4 receiving NNRTIs (11.7/100 person-years for nevirapine; 8.6/100 person- years for efavirenz; 4/100 person-years for non-NNRTI based therapies). Plasma trough levels of nevirapine were higher according to histologic damage (5593 ng/ml in fibrosis 1 vs 9167 ng/ml in fibrosis 4), but there was no association between drug levels and hepatotoxicity

HAART-associated hepatotoxicity is correlated with HCV related histologic damage. There was no difference in hepatotoxicity between different antiretroviral therapies for patients with mild fibrosis

SESSION 10: HEPATITIS CO-INFECTIONS AND ADVERSE EVENTS II

2004-11-14
PL10.3

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