Back HIV/AIDS HIV/AIDS Topics HIV Prevention South Africa Approves Tenofovir/Emtricitabine for HIV Pre-exposure Prevention

South Africa Approves Tenofovir/Emtricitabine for HIV Pre-exposure Prevention

alt

The Medicines Control Council of South Africa has become only the third country to approve tenofovir plus emtricitabine (marketed in the U.S. as Truvada) for HIV pre-exposure prophylaxis (PrEP), and the only high-prevalence middle- or low-income country to do so, according to an announcement last week. The approval will cover a generic coformulation.

The U.S. Food and Drug Administration approved once-daily Truvada for PrEP in July 2012. Last month France became the second country -- and the first with a national health system -- to do so. France approved both a daily regimen for all people at risk for HIV infection and an intermittent or "on demand" regimen -- as used in the IPERGAY study -- for gay men who have frequent condomless sex.

Aspen, which already produces generic tenofovir/emtricitabine for HIV treatment, requested a supplemental approval for HIV prevention in 2013. The AIDS Healthcare Foundation, which has opposed PrEP is the U.S., also did so in South Africa. It is not yet clear whether or for whom government health coverage will pay for PrEP.

South Africa has one of the worst local HIV/AIDS epidemics, with a high incidence rate among both men and women. PrEP has been shown to be highly effective in studies of gay men, but efficacy has been lower in trials os women, in part due to lower in adherence and also because the drugs do not reach as high a level or last as long in vaginal as in rectal tissue.

Below is an edited excerpt from a Medicines Control Council press release announcing the approval.

Medicines Control Council approves fixed-dose combination of tenofovir disoproxyl fumarate and emtricitabine for pre-exposure prophylaxis of HIV

From: Registrar of Medicines, Medicines Control Council

Date: 3 December 2015

At its 75th meeting on 27-28 November 2015, the Medicines Control Council (MCC) approved the use of the fixed-dose combination of tenofovir disoproxyl fumarate and emtricitabine to include pre-exposure prophylaxis of HIV (also referred to as PrEP).

As the use of the fixed-dose combination of tenofovir disoproxyl fumarate and emtricibine represents a departure from the usual use of these antiretrovirals for the treatment of HIV infection, the MCC has also requested the applicants to implement a risk management plan, which requires applicants to provide prescribers with a detailed information pack, to gather data on adverse effects, and to report these to the MCC at 6-monthly intervals.

The Medicines Control Council (MCC) is responsible for regulating all medicines and medical devices in South Africa by ensuring that they meet standards of efficacy, safety and quality. The MCC operates in terms of the Medicines and Related Substances Act (Act 101 of 1965), the Regulations issued in terms of that Act, and associated guidelines.

12/9/15

Source

Registrar of Medicines, Medicines Control Council approves fixed-dose combination of tenofovir disoproxyl fumarate and emtricitabine for pre-exposure prophylaxis of HIV. Press release. December 3, 2015.