Looking at tipranavir and ICH
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Looking at tipranavir and ICH "We would need to treat 455–5000 HIV-infected patients with tipranavir for 1 year to see a single excess [intracranial haemorrhage] event," according to the Veterans Aging Cohort Study Project Team. In light of the US FDA’s black box warning for tipranavir concerning intracranial haemorrhage (ICH),* the research team evaluated whether the rates of ICH reported among HIV-positive patients exposed to tipranavir are higher than those for HIV-positive patients not exposed to the antiretroviral. The team also examined the rates of ICH among HIV-infected and noninfected patients. Patients were identified from the US Veterans Health Information System-derived ’virtual cohort’ and from the Californian Medicaid-derived HIV dataset. Between 1 October 1997 and 31 December 2003, 16 541 HIV-infected veterans presented for care and were matched to 34 305 noninfected controls, and 28 023 HIV-infected Medicaid patients presented for care. Over this period, 33 HIV-infected veterans, 33 controls and 373 HIV-infected Medicaid patients received incident care for ICH. The crude event rates for the respective groups were 0.4, 0.1 and 4 cases/1000 person-years. Multivariate analysis of risk factors for ICH showed that HIV infection was associated with an incidence rate ratio of 2.48 (95% CI; 1.53, 4.02). When multivariate models were limited to patients with HIV and were adjusted for HIV factors, the association of combination antiretroviral therapy with ICH was not significant. * see Reactions 1109 p4; 801013553 Justice AC, et al. Drug toxicity, HIV progression, or comorbidity of aging: does tipranavir use increase the risk of intracranial hemorrhage? Clinical Infectious 801102785 Diseases 47: 1226-1230, No. 9, 1 Nov 2008
0114-9954/10/1228-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 15 Nov 2008 No. 1228
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