[TuPe1.1C29] The relative role of HCV-coinfection, adherence to antiretrovirals and plasma drug levels on the incidence of ALT elevation during HAART

3rd International AIDS Society Conference on HIV Pathogenesis and Treatment

Rio de Janeiro - July 24 - 27, 2005

THE RELATIVE ROLE OF HCV-COINFECTION, ADHERENCE TO ANTIRETROVIRALS AND PLASMA DRUG LEVELS ON THE INCIDENCE OF ALT ELEVATION DURING HAART

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuPe1.1C29

Ammassari A.¹, Cozzi-lepri A.², Trotta M.P.³, Bonora S.⁴, Marconi P.³, Repetto D.⁵, Nasta P.⁶, Di Perri G.⁴, d'Arminio Monforte A.⁵, Antinori A.³
¹Università Cattolica S. Cuore, Rome, Italy, ²Royal Free and University College Medical School, London, United Kingdom, ³INMI L. Spallanzani, Rome, Italy, ⁴Università degli Studi di Torino, Torino, Italy, ⁵Ospedale L. Sacco - Università degli Studi di Milano, Milano, Italy, ⁶Università degli Studi di Brescia, Brescia, Italy

INTRODUCTION: The aim of this analysis was to determine incidence of ALT elevations following initiation of a HAART regimen, and to define the role of chronic viral hepatitis, self-reported adherence (SR-Adh) and alcohol use, plasma drug levels and use of specific antiretroviral drugs in its development.

METHODS: Prospective cohort study. SR-Adh was calculated as number of pills taken divided by those prescribed over the last 3 days. Plasma levels of antiretrovirals were concurrently assessed. A pharmacokinetic score (PKS) was derived for NNRTIs and PIs: undetectability/sub-optimal (score=0) or optimal/expected (score=1) ranges of concentration. NRTI backbone was given a joint score adjusted for drug half-lives. The relative rate (RR) of developing ALT elevation (increase >2.6-times the upper limit of the normal range or >100 UI above baseline levels) was calculated using a multivariable Poisson regression model.

RESULTS: 251 patients included: 34.7% HIV/HCV co-infected. Thirty-one cases of ALT elevation (4.4 per 100 pys, 95% CI: 3.0-6.2) were observed, with an incidence (per 100 pys) of 3.8 (95% CI: 2.3-6.1) in patients with 100% SR-Adh, and of 7.1 (2.6-15.4) in those reporting <100% SR-Adh. NNRTI-treated patients with PKS=1 had an incidence of ALT elevation of 3.9 (1.4-8.5) compared with 4.5 in those with PKS=0 (2.9-6.7); in PI-treated persons the incidence was 3.2 (0.7-9.2) and 4.6 (3.1-6.6) for PKS=1 and PKS=0, respectively. Finally, incidence of ALT elevation was 3.3 (1.7-6.0) for NRTI-PKS=1, and 5.3 (3.3-8.2) for NRTI-PKS=0. At multivariable analysis only subjects HCV-Ab-pos (RR=2.71 vs. HCV-neg; 95% CI:1.05-7.00, p=0.04), and those with longer exposure to ART (RR=1.44 per year longer; 95% CI:1.08-1.97, p=0.01) were independently at higher risk of ALT elevation.

CONCLUSIONS: HCV co-infection and longer duration of ART, rather than use of specific drugs, seem to be associated with an increased risk of ALT elevation. These associations could not be explained by differences in adherence behaviour or antiretroviral levels.

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050724
Clinical | TuPe1.1C29 | Adriana Ammassari
Hepatitis viruses

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