U.S.Approves Anti - HIV Drug

WASHINGTON: The U.S. Food and Drug Administration this week gave its first every nod for an anti-HIV drug, Truvada, to pharmaceutical firm Gilead Sciences. However, the move was greeted with skepticism 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 in take 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.

According to some public health advocates, these studies show that Truvada could be a preventive measure fro high – risk individuals such as those with HIV – positive partners – only when combined with sexual health counseling 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 counseling”. 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 the AHF, argued that healthy individuals should be required to show proof of a negative HIV test before getting Truvada as a preventive medicine. “If it” s that important, why isn’t it a requirement?’’ he was quoted as saying.

One of Mr. Weinstein 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 might spread these strains 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 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 mile – stone 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.       

Thank You

THE HINDU JULY18,2012