AIDS foundation attacks GSK
In reaction to the FDA's traditional approval of Trizivir, GlaxoSmithKline's (GSK) fixed-dose AIDS drug, the AIDS Healthcare Foundation (AHF) has decried GSK's continued promotion of its all-in-one AIDS treatment, despite the drug's demonstrated failure in a 2003 National Institute of Health (NIH) trial.
In reaction to the FDA's traditional approval of Trizivir, GlaxoSmithKline's (GSK) fixed-dose AIDS drug, the AIDS Healthcare Foundation (AHF) has decried GSK's continued promotion of its all-in-one AIDS treatment, despite the drug's demonstrated failure in a 2003 National Institute of Health (NIH) trial.
The study, published in the New England Journal of Medicine, 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. At the time, NIH researchers said they would not go on prescribing Trizivir alone as part of the trial.
'For GSK to promote Trizivir for the treatment of naive patients, despite the drug's proven lack of efficacy, is grossly irresponsible,' said Michael Weinstein, AHF president. 'We will persist in our efforts to inform people of the dangers of this drug and continue to be proactive in our efforts to protect the health of people living with HIV.'
The AHF has undertaken a campaign appealing to the FDA and to individual states to have Trizivir placed on prior authorization status before it is made available through programs like the AIDS Drug Assistance Program (ADAP), which provides HIV/AIDS treatment to no-income, low-income and underinsured patients.
In mid-March, 2003 the NIH suspended part of a two-year government sponsored AIDS clinical trials group study (ACTG 5095) comparing AZT+3TC+abacavir (the components of Trizivir) to other regimens (Trizivir+Sustiva and Trizivir+Combivir) when it quickly found that the Trizivir combination alone did not protect patients as effectively as some of the other combinations of medicines. The Trizivir-only arm of the study was stopped after a large percentage of patients experienced virologic failure, their viral load increasing to a dangerous level much sooner than that of the patients in the other two arms of the study. At the time, Trizivir was the fifth most prescribed HIV medication in the US.
In its press statement announcing the FDA approval, GSK said: 'the use of Trizivir in therapy-naive adults may preserve the use of other classes of antiretroviral agents for the future.'