[TuPe1.1C14] Liver enzyme elevation after singe PI vs. boosted PI vs. NNRTI-based HAART in a cohort of 1038 HCV/HIV co-infected patients: results of the MASTER-EPOKA-a cohort

3rd International AIDS Society Conference on HIV Pathogenesis and Treatment

Rio de Janeiro - July 24 - 27, 2005

LIVER ENZYME ELEVATION AFTER SINGE PI VS. BOOSTED PI VS. NNRTI-BASED HAART IN A COHORT OF 1038 HCV/HIV CO-INFECTED PATIENTS: RESULTS OF THE MASTER-EPOKA-A COHORT

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuPe1.1C14

Torti C.¹, Lapadula G.¹, Casari S.¹, Puoti M.¹, Quiros-Roldan E.¹, Bella D.¹, Pastore G.², Ladisa N.², Minoli L.³, Sotgiu G.³, Mazzotta F.⁴, Lo Caputo S.⁴, Bonora S.⁵, Filice G.³, Carosi G.¹
¹University of Brescia, Brescia, Italy, ²University of Bari, Bari, Italy, ³University of Pavia, Pavia, Italy, ⁴S.M. Annunziata Hospital, Florence, Italy, ⁵University of Turin, Turin, Italy

INTRODUCTION: To estimate incidence and risk factors for AST/ALT elevations (hepatotoxicity) in a clinical representative cohort of HCV/HIV patients on different HAART (single-PI, multiple-PI, NNRTI-based).

METHODS: Data from a prospective cohort of HIV/HCV patients were analyzed. Patients starting a first new HAART from Jan 2001 to March 2004 have been selected and stratified into antiretroviral (ARV) naïve (N) and experienced (E). As-treated analysis was conducted with either time-to-grade >III or IV AST/ALT (WHO) as dependent variable. The following variables were tested at Cox regression models: gender, age, risk factor for HIV acquisition, CD4+ nadir, chronic HBV, baseline ALT, AST, previous LFTs elevation >grade III, baseline CD4+/mm³, incremental CD4+ (zenith minus baseline), baseline HIV RNA, use of IFN, use of NNRTI or PI in the treatment history, use and length of D4T/DDI exposure, 3TC in the current HAART, treatment group (single PI, multiple PI and NNRTI-based), and APRI-score.

RESULTS: 1,038 patients (155 N, 883 E). In N group, incidence of grade >III AST/ALT was 17.71% per patient-year (grade IV: 4.13). Only baseline AST (HR:1.118, 95%CI 1.011-1.235; p:0.029) and incremental CD4+ (HR:1.112, 95%CI 1.002-1.233; p:0.045) were associated with time-to-grade >III event. Incidence of grade >III AST/ALT in E group was 8.22% per patient-year (grade IV: 1.08). At multivariate analysis, baseline ALT (HR:1.137 per 10 IU/L, 95%CI 1.081-1.197; p<0.001), previous hepatotoxicity (HR: 3.051, 95%CI 1.654-5.627; p<0.001), and use of NNRTI (HR: 2.752, 95%CI 1.147-6.602; p:0.023) were associated with time-to-event.

CONCLUSIONS: Higher risk of hepatotoxicity and different pattern of risk factors appeared in N compared to E patients. Single or multiple PI-based regimens were not associated with risk of hepatotoxicity either in N or E groups. A cautious approach and strict monitoring should be applied in HIV/HCV E patients with a previous hepatotoxicity, higher baseline ALT and prescribed NNRTI-containing regimens, who have an high risk of liver toxicity.

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050724
Clinical | TuPe1.1C14 | Carlo Torti
Hepatitis viruses

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