3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

LOW RISK OF HEPATOTOXICITY IN PATIENTS CURRENTLY STARTING HAART: THE HEPATOX STUDY

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuPe2.3C25

Aranzabal L.¹, Casado J.¹, Domingo P.², Lacruz J.³, Gutierrez F.⁴, Fontanet A.², Lopez-Aldeguer J.³, Arrizabalaga J.⁵, Portu J.⁶, Ena J.⁷, Górgolas M.⁸, Goyenechea A.⁸, Moreno S.^1
1Ramon y Cajal Hospital, Madrid, Spain, ²San Pau Hospital, Barcelona, Spain, ³La Fe Hospital, Valencia, Spain, ⁴Hospital de Eltx, Alicante, Spain, ⁵Aranzazu Hospital, Donostia, Spain, ⁶Txagorritxu Hospital, Vitoria, Spain, ⁷Hospital de Villajoyosa, Alicante, Spain, ⁸Fundación Jimenez Diaz, Madrid, Spain

INTRODUCTION: The current incidence of hepatotoxicity in patients starting HAART is unknown, due to the introduction of new antiretroviral regimens

METHODS: Prospective and multicenter study in 8 hospitals in Spain. A total of 256 HIV naïve patients starting HAART according to current guidelines during 2004 were included. Hepatotoxicity was defined as an increase in AST/ALT level over 5 times the upper limit of normal (ULN), or >3.5-fold increase if baseline enzyme levels were abnormal, with no other known precipitating cause.

RESULTS: Mean age was 40 years, 79% were male, 27% were former IDUs, and 30% were co-infected by HCV. At baseline, median CD4+ count was 176 cells/mm³ (10-459) and HIV RNA level was 107,996 copies/ml (4587-1,027,979). The most frequent regimens included r/lopinavir (39%), efavirenz (43%), or abacavir (31%) as third drug. A four-drug regimen was used in 11%. Overall, there were 10 episodes of hepatotoxicity (4%) in a median time of 100 days (21-169). All the events were asymptomatic, and no therapy was changed. There was no association between liver toxicity and age, sex, risk practice, CD4+ count at baseline or increase, or HIV RNA level. Only HCV coinfection was associated with hepatotoxicity, with 89% of episodes (RR 3.3, 95% CI 2.5-4.4; p<0.01). However, baseline liver enzyme levels did not predict hepatotoxicity. Overall, there was no significant association between liver toxicity and a specific drug or regimen (r/lopinavir 6%, efavirenz 2%, nevirapine 7%, abacavir 4%, or use of 4 drugs 3%), but the risk was higher for HCV-positive patients (r/lopinavir 18%, efavirenz 7%, abacavir 14%, or use of 4 drugs 17%).

CONCLUSIONS: Current use of antiretroviral regimens is associated to a lower rate of liver toxicity than previously described. HCV coinfection continues to be the main risk factor for hepatotoxicity in our population.

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Clinical | TuPe2.3C25 | Lidia Aranzabal
Cardiovascular risk and other toxicities

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