FOR IMMEDIATE RELEASE
Contact: Chris Viveiros
FENWAY HEALTH COMMENDS FDA PANEL AS IT RECOMMENDS APPROVAL OF FTC-TDF AS PRE-EXPOSURE PROPHYLAXIS FOR HIV PREVENTION
Today the U.S. Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee recommended that an antiretroviral medication be indicated for use in preventing HIV, in what is known as pre-exposure prophylaxis (PrEP). The advisory committee’s recommendations will now be considered by the FDA, which is expected to issue a final decision on the matter by June 15, 2012. The FDA usually accepts the advice of its advisory panels.
The FDA committee voted 19-3 to recommend indicating emtricitabine/tenofovir disoproxil fumarate (FTC-TDF) as PrEP for HIV-uninfected men who have sex with men (MSM), 19-2 with 1 abstention to recommend indicating FTC-TDF as PrEP for uninfected partners (male or female) in serodiscordant couples, and 12-8 with 2 abstentions to recommend indicating PrEP for other adults at risk for HIV through sexual activity.
The FDA committee’s recommendation came after a review of a supplemental new drug application for FTC-TDF to reduce the risk of acquiring HIV in men and women by pre-exposure prophylaxis (PrEP), offered as part of a comprehensive HIV-prevention package including risk reduction counseling. The FDA’s Antiviral Drugs Advisory Committee recommended approving FTC-TDF for PrEP with MSM, serodiscordant couples, and others at risk of HIV through sexual activity. The FDA heard testimony from Gilead Sciences, the manufacturer of FTC-TDF, as well as researchers and advocates.
"Today is an exiciting day for HIV prevention. Although FTC-TDF for PrEP is not a panacea, this approach can prevent many new infections and could dramatically impact HIV transmission worldwide,” said Kenneth H. Mayer, MD, Medical Research Director and Co-Chair of The Fenway Institute at Fenway Health. “We at Fenway Health are gratified to have been involved with this field of research for several decades and are delighted to have helped to demonstrate the utility of this approach for prevention."
PrEP has shown efficacy with men who have sex with men (MSM) and heterosexual women and men. Biomedical prevention interventions such as PrEP have great potential, especially if coupled with traditional prevention approaches such as condom use, expanded testing, and linkage to treatment and care. Modeling demonstrates the most effective deployment of PrEP will be in combination with scaled-up HIV treatment of people who are known to be HIV-positive, as this was shown to reduce infections.
Recent press coverage has emphasized the cost of FTC-TDF. Last year four Centers for Disease Control and Prevention researchers, in an article in JAIDS, estimated the medications would cost $8,030 per person per year.  While the cost of PrEP in the U.S. would be substantial, private insurers and state Medicaid departments are open to providing coverage. Today Gilead also indicated it would offer a patient assistance program for uninsured individuals seeking to use FTC-TDF for PrEP. Low-cost generic medications could enable access in low-income countries. The prioritization of highly vulnerable populations could increase the cost-effectiveness of PrEP. Providing PrEP is also much less expensive than treating someone for HIV over the course of a lifetime. Recent modeling of PrEP implementation coupled with scaled-up treatment (focusing on the general adult population in Botswana, and serodiscordant couples in South Africa) predicts that PrEP could significantly reduce HIV incidence. It would also save on health care costs and lost economic productivity.
The Fenway Institute participated in both a CDC-funded PrEP safety study and the iPrEX efficacy study that evaluated the use of tenofovir-emtricitabine for antiretroviral chemoprophylaxis for men who have sex with men (MSM) and transgender women. It is currently involved with a number of PrEP research studies.
Pre-exposure chemoprophylaxis—taking antiretroviral medications to prevent HIV transmission—could be a “game changer” for HIV prevention, according to an analysis released by The Fenway Institute in February. The Fenway review of PrEP implementation issues, titled Pre-exposure prophyalxis for HIV prevention: Moving toward implementation, summarizes the state of PrEP and microbicides research as of early 2012, looks at willingness to use PrEP among various populations, addresses concerns about PrEP that could present obstacles to implementation, offers strategies for effective implementation, and examines policy issues related to cost and how to make PrEP accessible to those most vulnerable to HIV. Based on a review of published research and interviews with policy makers, funders and other stakeholders, it examines regulatory developments and planning underway both within the U.S. and globally.
A PDF of the PrEP brief is available online at fenwayhealth.org/prepimplementation.
For more than forty years, Fenway Health has been working to make life healthier for the people in our neighborhood, the LGBT community, people living with HIV/AIDS and the broader population. The Fenway Institute at Fenway Health is an interdisciplinary center for research, training, education and policy development focusing on national and international health issues. Fenway’s Sidney Borum Jr. Health Center cares for youth and young adults ages 12 to 29 who may not feel comfortable going anywhere else, including those who are LGBT or just figuring things out; homeless or living on the streets; struggling with substance use or abuse; sex workers; or living with HIV/AIDS.
 Koppenhaver R, Sorensen S, Farnham P, Sansom S. The cost-effectiveness of pre-exposure prophylaxis in men who have sex with men in the United States: An epidemic model. JAIDS. 2011, October 1. 58;2:e51-e52.