First AIDS-Prevention Drug Backed
A US advisory panel has urged regulators to approve Truvada by Gilead Sciences as the first pill for prevention of human immunodeficiency virus (HIV).
The Antiviral Drugs Advisory Committee, which advises the US Food and Drug Administration, voted 19-3 in favor of prescribing the drug to HIV-negative gay men and 19-2 with one abstention in favor for uninfected people who are involved with HIV-positive partners.
When it came to the question of whether it should be approved for others at risk for acquiring HIV through sexual activity, the panel voted 12 in favour and eight against with two abstaining.
The FDA does not have to abide by the recommendations of its advisory panel, though it usually does.
The vote came after a marathon 11-hour meeting of the FDA panel and a lengthy public comment session in which many health care providers voiced concerns about the drug and its potential to encourage risky behaviour.
Truvada is already approved as a treatment for people with HIV and is taken along with existing anti-retroviral drugs.