Friday, May 11, 2012
PI Applauds Positive FDA PrEP Decision: Urges Immediate Implementation Steps
San Francisco, CA — Project Inform cheered the decision Thursday by an advisory committee to the U.S. Food and Drug Administration (FDA) that the agency should approve tenofovir disoproxil fumarate/emtricitabine (TDF/FTC or Truvada) to prevent HIV acquisition in HIV-negative men who have sex with men and in HIV-negative heterosexual men and women in serodiscordant relationships with HIV-positive sex partners. This new use for the HIV medication, called pre-exposure prophylaxis (PrEP), is urgently needed to reverse the tide of the AIDS epidemic, and Project Inform is calling for immediate planning to determine how best to further test and implement the intervention.
“Though the FDA doesn’t have to go along with the committee’s decision, it usually does,” explains David Evans, Director of Research Advocacy for Project Inform. “This means that after more than a decade of research we are tantalizingly close to having the first new effective HIV prevention tool in 30 years. We must deploy it as quickly, but safely, as possible.”
“PrEP won’t be for everyone and alone it cannot end the HIV epidemic,” cautions Project Inform’s Executive Director, Dana Van Gorder. But the science proves that in those who take it every day, in conjunction with other prevention methods, it could seriously disrupt the epidemic within sexual networks where individuals are most vulnerable to infection. We are delighted the FDA panel recognized need for PrEP and its great promise.”
At the FDA hearing, TDF/FTC’s maker, Gilead Sciences, laid out a host of demonstration and implementation projects they intend to fund to help further define how best to use PrEP in the real world. These studies are expected to include more than 30,000 HIV-negative, straight, gay, bisexual and transgender men and women. During the hearing, the committee also debated the best way to monitor key health parameters to ensure safe use. In order to translate these into reality on the ground, Project Inform is recommending the following actions:
- We urge haste in getting the demonstration projects off the ground. While the pivotal studies submitted for FDA approval prove that PrEP can work, and suggested the best way to use it, there remain critical gaps in knowledge that must be addressed to help us use it most effectively and safely. Moreover, key populations, such as young black men who have sex with men (MSM), were not included in sufficient numbers in these early studies and we must understand how PrEP works in that community, which has the highest rate of new infections in the country.
- Project Inform also asks that key stakeholders, including governmental agencies, health care providers, sexual health service providers, HIV prevention providers and community members continue with earlier efforts to define roadblocks to PrEP implementation and methods for overcoming those roadblocks. Guidance from the Public Health Service and the US Centers for Disease Control and Prevention (CDC) must also move quickly to offer guidance to health care providers on how best to safely prescribe PrEP.
- Lastly, public and private providers of the medication, including Gilead, must come together and make determinations on how to offer and pay for PrEP for those at highest risk of HIV infection. Project Inform hopes that Gilead makes good on a promise made at the advisory committee hearing to institute a patient assistance program to offer the drug for free to those without health insurance.
“We have reached a monumental milestone in the HIV epidemic,” Evans said. “We must not squander this amazing opportunity. Between aggressive testing, care retention and treatment efforts for those infected with HIV and PrEP for those who are HIV negative, I can see for the first time in my life the beginning of the end of the epidemic,” Evans continued. “To paraphrase the great playwright Tony Kushner, â€˜let the great work begin.’”