On January 25, Project Inform (PI), along with 25 other top HIV advocacy groups, sent a letter to the U.S. Food and Drug Administration (FDA) asking them to give a speedy review to Gilead Science’s application for the anti-HIV medication Truvada (tenofovir and emtricitabine) for pre-exposure prophylaxis (PrEP). PrEP involves having at-risk HIV-negative individuals take Truvada daily, in combination with practicing safe sex, to lower their risk of acquiring HIV.
When Gilead submitted its application for FDA review at the end of December, it asked the agency to give the application priority review status, meaning that the FDA would have to review the application and make a decision within six months. Now the FDA has three options: 1) it can dismiss the application entirely; 2) it can grant priority review; or 3) it can grant traditional review within a standard ten-month period.
With one prominent HIV service provider aggressively demanding that the FDA deny Gilead’s application outright, even as HIV-rates rapidly escalate in some communities, PI believes it is vital that the FDA not buckle under political pressure or ignore the urgency of the identifying new prevention methods, instead giving a speedy and fair look at the data on PrEP and making a decision based on facts.
A recent report by the Forum for Collaborative HIV Research on a meeting it held in August (to which PI contributed) lays out the kinds of safety issues that the FDA will be asked to consider when they review the data. It offers a balanced view of the types of safeguards that experts feel would be best put in place to ensure that PrEP is used properly and safely. The consensus at that meeting—filled with researchers, health care providers and community advocates—was that these types of safeguards would go a long way toward addressing concerns that have been raised about PrEP, including the potential for people to develop drug-resistant HIV, experience side effects or increase their HIV risk behaviors.Â
(http://hivforumannals.org/index.php/annals)
As a marketed HIV drug, Truvada is currently available to anyone who has a prescription for it, whether HIV-positive or negative. Without FDA approval, only those who can pay cash or whose private insurance covers Truvada can easily gain access to it. This not only ensures that those most at risk of HIV—especially young Black and Latino gay and bisexual men—will be unable to benefit from it, but that Truvada will be provided without the kinds of safeguards outlined in the Forum report.
Project Inform will continue to work diligently to bring this promising new prevention tool to those who need it most, including through community.