Abstract

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Is abacavir (ABC)-containing combination antiretroviral therapy (CART) associated with myocardial infarction (MI)? No association identified in pooled summary of 54 clinical trials

Presented by Jaime Hernandez, United States.

A. Cutrell¹, J. Hernandez¹, J. Yeo², C. Brothers¹, W. Burkle¹, W. Spreen¹

¹GlaxoSmithKline Research & Development, HIV Medicine Development Center, Research Triangle Park, United States, ²GlaxoSmithKline Research & Development, HIV Medicine Development Center, Greenford, United Kingdom

Background: The DAD Study Group reported an unexpected increased risk of MI associated with abacavir therapy in their observational cohort of more than 33,000 HIV infected individuals. Because of this we analyzed our HIV data repository including 54 GSK-sponsored clinical trials with ³24 weeks of CART with and without abacavir.
Methods: Data were assessed from 14683 HIV-infected subjects who received abacavir-containing CART (n=9639; 7845 person years) or non-abacavir-containing CART (n=5044; 4653 person years). Adverse events reported as coronary artery disorders NEC and ischemic coronary artery disorders were used to select the events of interest, myocardial ischemia or infarction. Incidence rates per 1000 person/years were calculated and Poisson regression models used to calculate relative rates and p values using SAS.
Results: Baseline demographic and HIV disease characteristics, including lipids and glucose values, were similar. Incidences of coronary/myocardial events were low, comparable between the two groups, and no higher risk for these events was identified with abacavir (Table).

	Abacavir CART (95% CI)	Non-abacavir CART (95% CI)	Relative Rate and p value
Frequency of Coronary Artery Disorders	0.249% (95% CI 0.160-0.370)	0.416% (95% CI 0.258-0.636)
Rate/1000 patient-years Coronary Artery Disorders	3.447	5.817	0.593 (95% CI 0.348-1.010; P =0.055)
Frequency of MI	0.114% (95% CI 0.057-0.204)	0.139% (95% CI 0.056-0.286)
Rate/1000 patient-years MI	2.039	2.363	0.863 (95% CI 0.40-1.86; P =0.706)

The findings of DAD were unexpected. We carefully reviewed our preclinical and clinical data and were unable to identify a potential biologic mechanism to explain these results. In response to the DAD finding, GSK also analyzed relevant spontaneous reports from the GSK and FDA databases, and again did not confirm a signal of increased risk of myocardial ischemic events with abacavir.
Conclusions: No higher risk of MI associated with ABC-containing CART was identified in this review. As with all medications, physicians and patients must weigh the risks of HIV disease against the risks and benefits of the antiretroviral agents available.

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