The announcement of the approval of oral pre-exposure prophylaxis (PrEP) for HIV prevention by South Africa's Medicines Control Council is a major step forward for the national and global responses to AIDS, and should spur other countries and global health organizations to quickly follow suit.
South Africa's approval of the fixed-dose combination of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, or trade name Truvada) as PrEP is the capstone on a transformational year for PrEP. The French Ministry of Health granted provisional approval of TDF/FTC as PrEP in November; the World Health Organization recommended PrEP as an additional prevention option for all people at substantial risk of HIV infection worldwide in September; and the PEPFAR Scientific Advisory Board recommended swift integration of PrEP into comprehensive HIV prevention programs in PEPFAR countries. This October recommendation came with a particular focus on young women at high risk as well as gay men and other men who have sex with men, and recommended steps to overcome regulatory barriers in countries where PrEP is not yet approved.
Daily oral PrEP is finally beginning to take its place as a core element of global HIV prevention.
But PrEP rollout is still happening far too slowly for millions of women and men at risk for HIV. Other countries need to follow South Africa's lead and find ways to deliver this life-saving option today.
Young women, especially, are in desperate need of new prevention options they can control. While regulatory approval in South Africa should help accelerate access to oral PrEP, additional work is needed to ensure that millions of women, and men, from across the globe are able to benefit from a breakthrough that was developed expressly for them.
To elevate this from rhetoric to on-the-ground access and impact, a coordinated, global push to secure additional regulatory approvals, mobilize funding, raise awareness, generate demand and establish systems to get PrEP into the hands of all people most likely to benefit is needed. South Africa's experience may offer a model for other nations, but there is no reason to wait. PEPFAR, the Global Fund and other key stakeholders (including Gilead Sciences and the generic manufacturers of TDF/FTC) should be working with countries to break down barriers to PrEP access within the next year.
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