European Agency: Safety Studies of HIV Drugs Must Continue

Ongoing studies into the long-term cardiovascular safety of HIV therapies should continue until at least 2005, even though early results appear reassuring, according to the European Medicines Evaluation Agency. Following the first observations of lipodystrophy in 1998, an EMEA committee asked all companies marketing protease inhibitors to collectively find out the prevalence and incidence of long-term cardiovascular complications.

Companies making both protease inhibitors and other antiretroviral products agreed jointly to support studies under an oversight committee representing companies, academia, patient organizations, and European and US drug regulatory agencies.

In a statement on EMEA's Web site, the committee for proprietary medicinal products said results so far obtained from two studies "clearly demonstrate that the benefit/risk balance of antiretroviral treatment remains strongly positive." "The long-term cardiovascular effect of combination antiretroviral therapy in HIV-infected patients has not been conclusively demonstrated and therefore concerns about the risk of cardiovascular disease should not lead to the withholding of combination antiretroviral therapy."

The committee said that extending the studies until at least January 2005 was necessary to obtain a definite answer. It regards this as part of the ongoing commitment from marketing-authorization holders. An EMEA spokesperson said the agency did not have a formal document saying the companies had agreed to continue funding the studies. However, the oversight committee has welcomed the call to continue the studies, which should encourage the companies to do so.

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