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

DESIGN AND OUTCOMES OF AN ANTIRETROVIRAL PHARMACOVIGILANCE PROGRAMME IN SOUTH AFRICA

Antiviral Therapy 2007; 12(Suppl. 2):L7 (abstract no. O-05)

U Mehta^1,2, DN Durrheim³, K Cohen1, M Osler3, T Kredo¹, A Boulle³ and G Maartens^1
1Division of Clinical Pharmacology, University of Cape Town, South Africa; ²Hunter New England Population Health, Australia; ³School of Public Health, University of Cape Town, South Africa

BACKGROUND: Access to antiretroviral (ARV) therapy is expanding on a large scale in Africa. The safety profile of these agents in routine public health programmes needs to be established. We report on the initial findings of a pharmacovigilance reporting system for antiretrovirals (ARVs).

METHODS: A passive stimulated reporting system of serious suspected adverse drug reactions (ADRs) was introduced at HIV/AIDS treatment facilities in the Western Cape province of South Africa using a specifically designed ADR form, which included simple case definitions of target events and a monthly zero reporting form. The system aimed to identify signals of new (ADRs) and potential risk factors contributing to serious ADRs. The performance of this system is reviewed 2 years after its initiation.

RESULTS: During the 24-month study period (15 March 2005 to 15 March 2007), 611 reports were received where the contribution of drug therapy could not be excluded, 18 (3%) in paediatric patients and 585 (96%) in adults (>16 years). Two signals of possible new ADRs associated with efavirenz: haemolytic anaemia and cerebellar ataxia. One report of a congenital anomaly and two reports of spontaneous abortions in the first trimester were reported with efavirenz exposure. Lactic acidosis or symptomatic hyperlactataemia (LASH) were the most frequently reported events (n=298, 49%) with all but three in patients taking stavudine-based regimens. LASH ADRs tended to be reported more frequently in women compared to non-LASH ADRs (238/293 [81%] versus 209/292 [72%]; P=0.031), and in patients with a higher body mass (≤60 kg: 53/153 [35%]; 61–75 kg: 132/241 [55%]; >75kg: 82/132 [62%]; P<0.001). Cases of LASH were also reported in patients on the stavudine 30 mg twice daily dose. The median time to detection of LASH ADRS was 336 days (IQR 267–436.5). Peripheral neuropathy was more commonly reported in older patients (median of 39 years [IQR 33–45] versus 35 years [IQR 30–41]; P<0.001) and lipodystrophic changes were more commonly reported in women (63/447 [14%] versus 4/134 [3%]; P=0.001).

CONCLUSION: This passive stimulated ADR reporting system has been useful in detecting signals, and guiding clinical care and drug policy in the province and nationally.

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2007-07-24
O-05

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