Today the US Food and Drug Administration (FDA) announced the approval of the antiretroviral drug TDF/FTC (brand name Truvada) for use as pre-exposure prophylaxis (PrEP) among sexually active adult men and women in the US. This announcement marks the first-ever FDA approval of a drug to reduce the risk of HIV infection in adults.
This approval paves the way for daily oral PrEP using TDF/FTC to be introduced as HIV prevention in the US. AVAC and other advocates have been actively discussing and tracking progress in defining the funding mechanisms and pilot projects needed to move ahead with implementation without delay. More information on this coalition of groups and our work available at www.prepwatch.org.
The FDA decision also has global implications. It is a signal that daily oral TDF/FTC for PrEP should be closely considered by regulatory and public health authorities in every country where this strategy could have an impact. The World Health Organization (WHO) is expected to release “rapid guidance” on PrEP in the immediate future providing more direction and a basis for developing country decision making.
Daily oral PrEP using TDF/FTC is a powerful HIV prevention strategy. It is also demanding to use (protection depends on consistent pill use) and will never replace male and female condoms or other prevention tools. Moreover, TDF/FTC is an essential drug for AIDS treatment, and the access agendas for TDF/FTC as part of ART is of paramount importance.
As advocates, we recognize these challenges and welcome the opportunity to address them head-on in the US, which the FDA approval has helped to provide, and around the world.
Read AVAC’s statement which includes recommendations for next steps.
Visit www.prepwatch.org for continuing coverage and for statements from a range of groups on the recent decision.
Next week's International AIDS Conference will be an important opportunity to discuss this news and implications. We invite you to join AVAC and partners at a Sunday (1:30pm) satellite session, "PrEP for HIV Prevention: Maximizing Success." For information on other PrEP- and HIV prevention research related events, check out the conference road map at www.avac.org/event/aids-vaccine-2012.
This is also a conversation that will continue well after the conference—and to that end, AVAC will be hosting calls for both US and international advocates to discuss and map out next steps in light of the recent decision. Look for details in an upcoming Advocates’ Network update!
We look forward to working with all of you on making TDF/FTC as PrEP a reality for those who need it—and please be in touch with comments or questions.