GlaxoSmithKline this morning revealed it has secured “traditional” approval from the US Food and Drug Administration for its controversial triple combination anti-HIV medication Trizivir (abacavir, lamivudine and zidovudine). However, the positive decision was marred by another attack from the AIDS Healthcare Foundation, which claims the UK giant is continuing to unsafely promote Trizir to treatment-naïve patients.
The FDA grants traditional approval for a medication based on data from clinical trials of 48 weeks or more. Accelerated approval, which requires fewer weeks of data for drugs that will meet unmet medical needs, was granted to Trizivir in 2000, based on analysis of 24-week data.
Approximately 40,000 patients in the USA take Trizivir, a twice-daily pill that comes with no food or water restrictions. However, its use has not been without concerns. The AHF has previously petitioned the drug regulatory agency, calling for it pull Trizivir from the US market after a US-Government sponsored study showed that the product was inferior to other available anti-HIV therapies in HIV-positive patients who had never before received any antiretroviral treatment [[12/08/03b]], [[20/08/03b]].
In its statement, GSK says: “The use of Trizivir in therapy-naive adults may preserve the use of other classes of antiretroviral agents for the future.” Said AIDS Healthcare Foundation President Michael Weinstein: “For GSK to promote Trizivir to treatment-naïve patients, despite the drug’s proven lack of efficacy in a published NIH study is grossly irresponsible.”
GSK has previously told PharmaTimes News Online that despite Trizivir not proving as efficacious as the other groups in the US government trial, 74% of patients taking its drug alone had undetectable levels of virus. He pointed out that AIDS treatment is all about finding the right cocktail of therapies, and this action by AHF would only serve to limit treatment options.