Less than a month after South Africa’s national regulatory authority, the Medicines Control Council, approved tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, or trade name Truvada) for PrEP, Kenya took the same step. The country’s Pharmacy and Poisons Board (PPB)—the regulatory body that considers new drugs—also approved TDF/FTC for PrEP for adults at high risk of sexually acquiring HIV-1 infection.
Notably, the PPB made this decision within 30 days of receiving a submission from Gilead, the drug’s manufacturer. This swift approval sets a strong precedent for other countries and should spur other countries and global health organizations to quickly follow suit.
Both countries' approvals of TDF/FTC 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 the leadership of Kenya and South Africa 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 these two countries 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 and Kenya's experiences 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.
For more information:
- Map: Regulatory Status of TDF/FTC for PrEP
- Release from South African Medicines Control Council
- South African PrEP Advocates Applaud the Approval of Truvada for PrEP and Call for Accelerated Action from South African Government to follow the WHO PrEP Guidelines
- The Desmond Tutu HIV Foundation Hails Approval of PrEP to Combat HIV Infections in South Africa
- Give Us ARVs So We Don’t Get HIV, commentary in the South African Mail & Guardian