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news.The FDA has granted traditional approval status to GlaxoSmithKline's HIV combination treatment Trizivir. However, this has prompted condemnation from the AIDS Healthcare Foundation, which has spoken out against the drug's continued promotion following a trial failure.
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Trizivir (abacavir sulfate, lamivudine, and zidovudine) is a fixed-dose-combination tablet containing the three nucleoside reverse transcriptase inhibitors Epivir (lamivudine, 3TC), Retrovir (zidovudine, ZDV) and Ziagen (abacavir sulfate, ABC).
The drug is now indicated for the treatment of HIV infection, in combination with other antiretroviral agents or alone, and comes in the form of a single tablet to be taken twice a day.
In reaction to the approval announcement, the AIDS Healthcare Foundation (AHF) has decried GSK’s continued promotion of the all-in-one AIDS treatment despite the drug’s failure in a 2003 trial. This National Institute of Health (NIH) study demonstrated that the all-in-one regimen failed to effectively combat the virus in HIV-positive patients who had never before received any antiretroviral treatment.
AHF thus believes that Trizivir is not appropriate in most cases for treatment naive HIV patients.
“It’s disturbing that GSK would continue to aggressively market an AIDS drug that puts patients at risk,” said AHF 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.”