Washington: US health advisers on Thursday urged regulators to approve Truvada, made by Gilead Sciences, as the first preventive pill against HIV/AIDS instead of just a treatment for infected people.
The favourable vote came after clinical trials showed Truvada could lower the risk of HIV in gay men by 44 to 73 per cent, and was hailed by some AIDS advocates as a potent new tool against HIV.
However, many concerns were raised during a marathon 11-hour panel meeting in which about three dozen health care providers warned that the pill could boost risky behaviours and possibly lead to a drug-resistant strain of HIV.
A final decision by the FDA is expected by June 15. Mitchell Warren, executive director of HIV prevention group AVAC, said after the vote that pre-exposure prophylaxis (PrEP), or the method of taking a drug ahead of potential exposure to HIV, “while not a panacea, will be an essential additional part to the world’s success in ending AIDS.”“For the millions of men and women who remain at risk for HIV worldwide, each new HIV prevention option offers additional hope,” he added.
The drug, made by the California-based Gilead Sciences, is currently available as a treatment for people with HIV in combination with other anti-retroviral drugs, and received FDA approval in 2004.
But critics noted that the pill is costly — up to $14,000 per year — and could offer a false sense of protection, leading to a spike in unsafe sex and a new surge in AIDS cases.