FDA-approved HIV prophylactic welcomedComment on this story
South African HIV clinicians have welcomed an announcement that the US Food and Drug Administration (FDA) has approved the use of an antiretroviral by sexually active HIV-negative men and women as a method 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 disproxil fumarate/emtricibatine (TDF/FTC), also known as Truvada, in HIV prevention.
TDF/FTC has been used to treat HIV infection since 2004, in combination with other antiretroviral drugs.
The announcement means the pill can be taken by uninfected men and women a day before and after exposure (know as pre-exposure prophylaxis or PrEP).
Dr Francesca Conradie, president of the Southern African HIV Clinicians Society, welcomed the announcement, but said there was no single answer to the prevention of HIV infection.
“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,” she said.
Conradie reiterated that they were not advocating the abandonment of safer sexual practices – the use of condoms for example.
The US drug regulatory authority also stressed that TDF/FTC should be used “in combination with safer sex practices to prevent sexually acquired HIV infection in adults at high risk”.
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.
“This is a watershed moment for both US and global HIV prevention efforts,” said Avac executive director Mitchell Warren.
“This is the first completely new biomedical HIV-prevention tool to receive FDA approval in 19 years. Importantly, PrEP is a user-controlled method that greatly reduces HIV risk and does not need to be used immediately before or during sex.”
Local scientists have had 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 the topic.
He believes that young African women are the most vulnerable and that PrEP provides the best HIV-prevention option for this group.
World-renowned HIV-prevention expert Professor Glenda Gray was more cautious.
“The frequent lack of availability of antiretroviral drugs suggests that existing antiretroviral treatment programmes are already overwhelmed.
“Until robust trial data is available to guide the complexity of practice here, we should not grasp at straws. Giving effective antiretroviral treatment to HIV-infected persons earlier and enhancing the use of proven strategies should be the current mainstays,” she wrote.