Publication of data from three trials of pre-exposure prophylaxis (PrEP) for HIV – including the pivotal Partners PrEP trial – Wednesday in the New England Journal of Medicine provides strong evidence that HIV-negative men and women who consistently take a daily antiretroviral (ARV) pill (either TDF/FTC, brand name Truvada, or TDF, brand name Viread) can significantly reduce their risk of HIV infection.
The New England Journal of Medicine articles provide an in-depth review of safety, efficacy, adherence, and risk behaviors in three trials whose primary results have been previously presented at scientific conferences and to the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Gilead Sciences’ application for a prevention indication for TDF/FTC for HIV-negative adults. Data from the three studies—including the FEM-PrEP study, which was stopped early for futility—underscore the need for adherence to the prescribed regimen of a once-daily pill to achieve protection from HIV infection.
“The evidence published today is clear: If you perceive yourself to be at risk, if you take your pill daily, and if you receive the drug as part of a comprehensive package of HIV prevention interventions and testing, oral PrEP can dramatically reduce your chances of becoming infected,” said Mitchell Warren, AVAC executive director.
“Daily oral PrEP is not a silver bullet or a stand-alone prevention solution. There are many strategies that work, including treatment for HIV-positive people, that will need to be brought to scale if we are to have the needed impact on new infections.”
“However, there will be men and women around the world for whom daily oral PrEP using TDF/FTC can be a life-saving prevention tool. Choice matters. For the millions of men and women who remain at risk for HIV worldwide, each new HIV prevention option offers additional hope that we will achieve the end of the epidemic.”
“Much of the momentum to roll out PrEP has focused on gay men in the United States, and PrEP will be an important option for many gay men. But, as these studies suggest, PrEP is also a viable and important option for heterosexual men and women in Africa and other parts of the world. We must ensure global access to this lifesaving intervention,” Warren added.
An action agenda for global PrEP implementation
AVAC is calling for immediate actions to ensure that PrEP can be made available to people at risk of HIV quickly, safely and through programs that maximize safety, use of comprehensive HIV prevention and impact on HIV infections.
AVAC’s recommendations include:
- Regulatory approval: The U.S. FDA is considering approval of the drug TDF/FTC (marketed as Truvada) for daily PrEP among adults of risk of HIV infection. The FDA should approve Truvada for prevention. Regulatory agencies in other countries should quickly move to evaluate the evidence from these three trials among heterosexuals and the iPrEx trial among gay and bisexual men and transgender women and fast track regulatory decisions.
- Public health guidance: The U.S. Centers for Disease Control and Prevention, the World Health Organization and other public health agencies should issue guidance on the appropriate use of daily TDF/FTC as PrEP in different populations and settings as soon as possible. Guidance is needed by providers and people at risk, and to help governments and funders set priorities for PrEP implementation.
- Demonstration projects: Real-world studies are urgently needed to answer important questions about how best to implement PrEP, including who can benefit most; how to provide PrEP safely and efficiently; how to integrate PrEP with other essential prevention methods such as condoms; and how to ensure high levels of adherence, which research has shown to be essential for PrEP to work. Currently, only a limited number of demonstration projects are planned or underway.
- Funding: As robust demonstration projects get underway, donors and governments should be quantifying resource needs for daily oral PrEP to be introduced as a sustained public health initiative for key populations. Funding for PrEP should not detract from other essential HIV prevention and treatment efforts. However, funders and governments should start now to quantify and identify resources for public health programming to bring daily oral PrEP using TDF/FTC to those who need it most.
- Additional research: Studies are currently underway to test PrEP in additional populations, including injecting drug users and to evaluate new drugs and less frequent PrEP dosing schedules. Trial sponsors, manufactures and regulatory agencies should stand ready to act on new data and further expand options for preventing HIV infection.
“PrEP, together with other prevention strategies that we have now and those still to be developed, could help to significantly reduce the global burden of HIV infections and could be a life-saving intervention for some men and women,” Warren added. “Multiple clinical trials have clearly shown that PrEP is safe and effective when used as prescribed. But clinical trials are not the “real world”—they are well-controlled environments designed to give clear data. We all must now act on the scientific evidence and translate it into real-world reductions in HIV infections. We simply cannot afford to dismiss any new options in the quest to end AIDS.”
Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.