9th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 19-21 July 2007, Sydney, Australia

ANTIRETROVIRAL TREATMENT RELATED ADVERSE EVENTS (AES) IN THE TREAT ASIA HIV OBSERVATION DATABASE (TAHOD)

Antiviral Therapy 2007; 12(Suppl. 2):L45 (abstract no. P-45)

J Zhou¹, PL Lim² and S Pujari³ on behalf of The TREAT Asia HIV Observational Database
¹National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, Australia; ²Tan Tock Seng Hospital, Singapore; ³Institute of Infectious diseases, Pune, India

BACKGROUND: In this paper we assess the feasibility of collecting extended AE data in TAHOD, a multicentre prospective cohort of patients with HIV in the Asia- Pacific region.

METHODS: AEs were collected previously as reasons for antiretroviral treatment change/stop during prospective follow-up. Since September 2005, specific clinical AEs (grade 3 and 4) according to ACTG criteria, and additional laboratory tests, have been incorporated into the data specification.

RESULTS: A total of 2,150 patients have been on antiretroviral treatment since March 2003, when reasons for treatment change/stop were recorded. The majority of treated patients (60%) started with three or more drugs containing at least one NNRTI (nevirapine or efavirenz), at least one NRTI (lamivudine [55%], stavudine [35%] or zidovudine [19%]). Up to September 2006, there were 1,367 patients with 2,121 episodes of treatment change/stop, of which 36% were reported to be due to AEs, with lipodystrophy (25% of all AEs), rash (15%), anaemia (10%), peripheral neuropathy (7%), and abnormal laboratory tests (6%) the most common. Since September 2005, grade 3 or 4 clinical AEs were reported in 9% of patients (284 AEs among 219 patients). The most common were lipoatrophy (39%), rash (17%), fat accumulation (11%) and peripheral neuropathy (7%). Grade 4 AEs (11 cases) or death (3 cases) were relatively rare. Laboratory testing varied considerably across the sites. Anaemia (26% of abnormal tests) was the most common AE identified from laboratory tests, followed by low HDL (16%), hypertriglycerideamia (14%), increased SGPT (11%), hypercholesterolaemia (10%), and hyperbilirubinaemia (8%).

CONCLUSIONS: The pattern of clinical and laboratory AE collected prospectively appeared to be relatively stable and follow a similar pattern to that reported in western countries. Our approach to collecting limited numbers of grade 3 or 4 AEs seems to be a feasible method in Asian HIV patients with diverse ethnic, social and economic backgrounds.

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2007-07-24
P-45

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