The U.S. Food and Drug Administration made history this week as it gave its first ever nod for an anti-HIV drug, Truvada, to pharmaceutical firm Gilead Sciences. Yet the move was greeted with scepticism in some quarters, particularly from AIDS Healthcare Foundation, the U.S.’ largest HIV/AIDS non-profit medical provider, which described the FDA decision as “reckless.”
Truvada is known chemically as a fixed-dose, daily intake combination of emtricitabine and tenofovir disoproxil fumarate. Since 2004 it has been marketed as a treatment for those already infected with HIV. However beginning in 2010, clinical studies demonstrated that the drug could prevent people from contracting the infection in the first place.
According to some public health advocates these studies show that Truvada could be a preventive measure for high-risk individuals such as those with HIV-positive partners — only when combined with sexual health counselling and the use of condoms.
In particular reports cited a three-year study showing that a daily intake of Truvada reduced the “risk of infection in healthy gay and bisexual men by 42 per cent when accompanied by condoms and counselling.”
In 2011 another study found that Truvada reduced infection by 75 per cent in heterosexual couples in which one partner was infected, according to reports.
However Michael Weinstein, co-founder and president of AHF, argued that healthy individuals should be required to show proof of a negative HIV test before getting Truvada as a prevention medicine. “If it’s that important, why isn’t it a requirement?’’ he was quoted as saying.
One of Mr. Weinstein’s biggest concerns is that close to 21 per cent of HIV-positive individuals in the U.S. were said to be unaware of their infection. If they did not get tested before taking Truvada as prevention, “there is a possibility that the HIV strains they have could become resistant to treatment — and that they might spread these strains unknowingly to their partners.”
Also the requirement that it be taken daily may be too onerous and skipped dosages could thus lead to further risk that drug-resistant HIV strains may emerge, the AHF has noted.
Yet announcing the FDA’s approval the agency’s Commissioner Margaret Hamburg said, “Today’s approval marks an important milestone in our fight against HIV... every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country.”
