FOR IMMEDIATE RELEASE
Contact: Chris Viveiros
FDA SHOULD APPROVE EMTRICITABINE-TENOFOVIR DISOPROXIL FUMARATE FOR USE IN HIV PREVENTION, FENWAY HEALTH SAYS
Fenway Health submits public comment on biomedical prevention technology to be reviewed by U.S. Food and Drug Administration by May 10, 2012
Fenway Health has called on the FDA to support a pending supplemental new drug application for emtricitabine/tenofovir disoproxil fumarate 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.
Fenway Health submitted written comment to the FDA April 26, 2012, for consideration at a public hearing May 10.
“We are hopeful that the full dossier of submitted PrEP research, based on multiple clinical trials with a number of different populations vulnerable to HIV, can lead to a responsible regulatory and marketing plan that allows for safe use in the populations who may benefit the most from this innovative development,” read the written comment submitted by Fenway Health. ”If the FDA approves the additional indication of the use of tenofovir-emtricitabine for PrEP, health programs and individuals will have improved choices to address one of the Administration’s domestic health priorities, and save lives.”
Fenway Health’s comment summarized the clinical trials that have shown efficacy with men and women, including gay and bisexual men. It then said, “Some have raised concerns about PrEP related to potential side effects, risk compensation (the idea that people will stop using condoms if PrEP becomes available), and drug resistance. However, reviews of five major clinical trials involving about 6,000 participants by the Forum for Collaborative HIV Research found no greater risk of side effects, no risk compensation, and no clinically significant development of drug resistance in participants.”
The comment concluded by saying, “We therefore urge the FDA to approve the application of Gilead Sciences Inc.’s supplemental new drug application for emtricitabine/tenofovir disoproxil fumarate for reducing the risk of acquiring HIV by means of pre-exposure prophylaxis (PrEP) offered as part of a comprehensive prevention package including risk reduction counseling.”
“We believe that if the FDA looks closely at the science, it will see the merit of allowing PrEP to be added to our tool kit to prevent HIV infections,” said Kenneth Mayer, M.D., Medical Research Director and Co-Chair of The Fenway Institute at Fenway Health and a leading researcher in the field of biomedical HIV prevention. “We must deploy new tools to prevent new infections, which are affecting 50,000 Americans each year and more than 2 million people worldwide, most in Africa,” Mayer continued. “PrEP combined with sustained behavioral interventions and medical care to maintain adherence could help us finally begin to turn the tide with this virus.”
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.
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.