Health-e News Service
South African HIV clinicians have welcomed an announcement that the Food and Drug Administration (FDA) in the US has approved the use of an antiretroviral drug by sexually-active HIV-negative men and women as a way of reducing the risk of HIV infection in adults.
The debate around the use of ARVs as prevention surfaced several years ago with a number of studies showing it to be effective and safe. In what has been described as possibly a major turning point, the FDA announced this week that it had approved the use of tenofovir disoproxil fumarate/ emtricitabine (TDF/FTC), also known as Truvada, in HIV prevention. TDF/FTC has been used to treat HIV infection since 2004, along with other antiretroviral drugs.
The FDA announcement means the pill can be taken by uninfected men and women a day before and after exposure (known as pre- exposure prophylaxis or PrEP).
Dr Francesca Conradie, president of the Southern African HIV Clinicians Society, welcomed the announcement.
She said there was no one single answer to the prevention of HIV infection, no “one size fits all”.
“However, we would like to stress that the efficacy of Truvada is linked to adherence. The risks of taking this medication erratically are great. Like the use of condoms, consistent use to prevent infection is mandatory. Should infection occur because the person is not taking medication daily, there is a risk of the development of resistance. It is really an all or nothing regimen,” she said.
Conradie reiterated that they were not advocating the abandonment of safer sexual practices – the use of condoms for example. “But in cases where people are unable to negotiate safer sexual practices, this is an ideal intervention.”
The US drug regulatory authority stressed that TDF/FTC should be used “in combination with safer sex practices to prevent sexually acquired HIV infection in adults at high risk” and stressed that the drug was not a substitute for safer sex practices.
The FDA announcement comes two months after an independent scientific advisory committee overwhelmingly recommended the use of TDF/FTC for PrEP and a week after the New England Journal of Medicine published two studies showing that the drug reduced the risk of HIV infection among heterosexual men and women in Africa.
The approval now paves the way for the drug to be introduced as HIV prevention in the US.
Mitchell Warren, executive director of AVAC, an NGO, said: “This is the first completely new biomedical HIV prevention tool to receive FDA approval in 19 years.
“Daily oral PrEP using TDF/FTC is absolutely not a silver bullet. It provides partial protection and is not a replacement for other prevention strategies like the male and female condom. It will not be right for everyone. It requires adherence, a confirmed HIV-negative diagnosis and monitoring.
“If you perceive yourself to be at risk, if you take your pill daily, and if you receive the drug as part of a comprehensive package of HIV prevention interventions and testing, oral PrEP using TDF/FTC can dramatically reduce your chances of becoming infected.”
An expensive drug, access to affordable, sustainable supplies of TDF/FTC is essential.
Local scientists have given the news a mixed response.
Professor Salim Abdool Karim, Medical Research Council president and director of the Centre for the Aids Programme of Research in SA, supports the use of PrEP and has written extensively on it.
He believes that young African women are the most vulnerable and are most at risk, and that PrEP provides the best HIV-prevention option specifically for this group, who are often unable to negotiate condom use or mutual monogamy.
“Nevertheless, PrEP … prevents HIV infection, thereby reducing the need for treatment of Aids in the future and is cost-effective.”
World-renowned HIV prevention expert Professor Glenda Gray is more cautious though, saying: “Existing antiretroviral treatment programmes are already overwhelmed. Until robust concordant trial data are available to guide the complexity of practice here, we should not grasp at straws.”