Cape Town -The approval of a highly potent antiretroviral drug as a prophylaxis in South Africa has been widely welcomed by HIV scientists and treatment advocates, with some describing it as an “important step forward”.
The Medicines Control Council (MCC) confirmed this week that it had approved the drug at a meeting last month.
The Treatment Action Campaign (TAC) has cautioned that the approval of a mixed dose combination drug, Truvada, should not be seen as a licence to reckless sexual behaviour.
TAC spokesperson Marcus Low said: “Our advice to people is to continue using condoms to protect themselves and their sexual partners. We also encourage men to undergo medical circumcision since this helps reduce the risk of contracting HIV. (Truvada) should be seen as an additional layer of protection in addition to these other methods.”
Truvada, which is a combination of tenofovir and emtracitabine, is already used in combination with another ARV as a treatment for HIV‚ but has not been licensed legally for prevention.
Truvada, which prevents HIV by up to 100 percent if taken daily, was approved as a prevention drug by the US Food and Drug Administration in 2012.
In South Africa, Aspen applied to the council for the use of the drug as prevention at the end of 2013.
The use of Truvada has been criticised globally, amid concerns that it may promote unsafe sex and promiscuity.
MCc registrar Dr Joey Gouws said the drug, which was already widely used to treat HIV infections, was expected to benefit all HIV-negative adults who were at high risk of contracting the HIV infection. These would include, among others, sex workers, bisexual men, gay men and those in relationships where one partner was HIV-positive and another one not.
Gouws said now that the drug had been approved for prevention, people who felt at risk could simply approach their doctors and ask for prescription.
“But the drug won’t be dispensed willy-nilly. We hope that medical practitioners will be a guard against abuse of the drug.
“Prescription will depend on a number of factors, including the medical history of a patient and whether the patient is indeed at high risk of HIV infection.
“Everybody who is at high risk of infection will qualify for it as long as this is approved by a medical practitioner,” she said.
Pregnant women would, however, not be eligible for the drug as its safety in pregnancy had not been established.
Deputy director of the Desmond Tutu HIV Foundation, Professor Linda Gail Bekker, who has campaigned for the licensing of the drug, said: “Approval of PrEP (pre-exposure prophylaxis) brings a major tool the goal of ending Aids to the Republic.
“We are in the midst of a prevention revolution and have a great opportunity to really begin to reduce new infections in all populations, especially those who are young and particularly vulnerable to infection.
“It is critical to have this powerful intervention at our disposal,” she said.
Bekker said the next step was to support the Department of Health to figure out the best way to make PrEP available to those most at risk from HIV infection.
“Turning off the tap to new infections is a critical investment for the future of South Africa,” she said.
Ntando Yola, HIV prevention advocate from the foundation, described the approval of Truvda as a “an important step forward in the move to make oral PrEP available” in the country.
Low added that the first priority must be to provide all HIV-positive people with treatment.
Cape Argus