Truvada® approved by the FDA for the prevention of HIV
The latest milestone in the 30-year battle against HIV, is Monday’s approval of Truvada® by the American Food and Drug Administration (FDA) for the prevention of HIV transmission. Truvada® is the first anti-retroviral (ARV) drug to gain approval as a preventive measure for healthy HIV negative people who are at high risk of acquiring HIV through sexual activity, such as those who have HIV-infected partners.
Commencing in 2010, studies have shown that the drug could help prevent people from contracting HIV when used as a precautionary or preventive measure. A three-year study (the Global iPrEx study) found that daily doses reduced the risk of infection in healthy gay and bisexual men by 42% when accompanied by a comprehensive package of prevention interventions which included distribution of condoms and condom-compatible lubricant, and extensive counselling. Last year another study found that Truvada® reduced infection by 75% in heterosexual couples in which one partner was infected with HIV and the other was negative.
Using Truvada® for HIV prevention purposes represents a major breakthrough which significantly expands available HIV-preventive measures. Although welcoming this development, Health4Men, a project of the Anova Health Institute that facilitates free sexual healthcare to men who have sex with men (MSM), simultaneously issued a note of caution.
Executive director of the Anova Health Institute, Prof James McIntyre, warned that Truvada® merely augments but does not replace other available strategies for preventing HIV infection. “The strength of this development lies in the fact that it adds another layer of protection by turbo-charging existing strategies such as consistent condom use and reducing your number of sexual partners. Using Truvada® for prevention can never be a stand-alone; it is essential that it be used in conjunction with other prevention methods to form a reliable combination of strategies that reinforce each other.”
Glenn de Swardt of Health4Men noted that the approval of Truvada® does not imply that MSM could indulge in irresponsible sexual behaviour: “We’re waving a red flag reminding men that Truvada® does not in any way provide an excuse for barebacking (having unprotected sex). The basics haven’t changed; always use condoms and compatible lubricant for anal sex.”
Importantly, Truvada® is not yet registered for HIV prevention purposes in South Africa. However it can already be used with discretion by experienced physicians in selected situations if patients can afford paying for it themselves. Health4men has been actively involved in the development of guidelines for the safe use of Truvada® among MSM in South Africa. De Swardt explains: “Health4Men has already scripted Truvada® for prevention purposes at our Ivan Toms Centre for Men’s Health in Cape Town, a public service clinic run in partnership between Anova Health Institute and the Department of Health. The department has not yet included Truvada® for prevention in their health programs and it is therefore not freely available.”