FDA Committee Recommends TDF/FTC (Truvada) as PrEP: Summary and May 15 global call
May 11, 2012
Yesterday an Advisory Committee to the US Food and Drug Administration (FDA) recommended that the antiretroviral TDF/FTC (brand name Truvada) be licensed for use as an HIV prevention tool for HIV-negative people in the US. This development moves the field one step closer to a new prevention option for HIV-negative men and women.
This update contains a link to AVAC’s press release <http://mlist.orchidsuites.net/lists/lt.php?id=KkoCCwNUXQFWCR4FC1BSAEoGDlBQAFI%3D> on the committee’s recommendation, information about a May 15 advocates’ call to discuss what this means in the US and internationally, and a brief discussion of yesterday’s historic events.
Yesterday’s Advisory Committee recommendation is not binding. The FDA will take the recommendation into account as it makes its decision whether to approve TDF/FTC for prevention, a decision that is expected on or before June 15. If the FDA does follow the committee’s recommendation, PrEP using daily TDF/FTC will be the first new, non-surgical biomedical prevention tool against sexual transmission in nearly twenty years—voluntary medical male circumcision for HIV prevention was recommended by WHO/UNAIDS in 2007; the female condom was licensed by the US FDA in 1993. For gay men and other men who have sex with men, the wait for a new option has been even longer. This new strategy would not replace condoms but would instead be an additional element of combination prevention at a moment when rates of new infections among key populations, including women and young gay men of color, are climbing.
Join AVAC and its partners for an advocates’ teleconference on Tuesday, May 15 at 10am ET (check www.timeanddate.com <http://mlist.orchidsuites.net/lists/lt.php?id=KkoCCwNUXQFWCB4FC1BSAEoGDlBQAFI%3D> for the time in your area). The call will include a review of the committee recommendation and discussion of critical next steps, with a focus on the time between now and the FDA decision in June. It will explore the outcomes of the meeting in terms of the committee’s recommendations on labeling, patient education, follow-on research and demonstration projects. It will also discuss the implications of this recommendation, and a potential FDA approval, for other countries, particularly in sub-Saharan Africa.
Register here. <http://mlist.orchidsuites.net/lists/lt.php?id=KkoCCwNUXQFXAR4FC1BSAEoGDlBQAFI%3D>
The May 10 vote to recommend TDF/FTC for PrEP took place after nearly twelve hours of presentations and testimony, including statements urging the committee to recommend approval, which came from Mitchell Warren of AVAC, Chris Collins of amfAR, Douglas Brooks of the Justice Resource Institute, Erika Aaron of Drexel University and Lindsey Dawson of the AIDS Institute. Matthew Rose, of the National Lesbian and Gay Journalists Association and a member of AVAC’s PxROAR program, spoke especially eloquently about the lack of prevention options that meet the needs of his community of young black gay men, and urged the committee to follow the science and provide another needed choice.
Committee members asked a range of questions about the trial data including side effects, the evidence showing that people with higher levels of adherence had higher levels of protection, and other issues about how to ensure safe and effective use. They also focused attention on steps Gilead Sciences, Inc., the maker of TDF/FTC, said it would take to introduce the drug with a prevention indication. The committee commented on various patient and provider education steps presented by the company and developed a list of committee suggestions for implementation and post-marketing research. It will be critical for advocates to monitor and assist with implementation of follow-on items.
The docket for public comment [no. FDA-2012-N-0218] will remain open until Thursday, May 17 (click here <http://mlist.orchidsuites.net/lists/lt.php?id=KkoCCwNUXQFXAB4FC1BSAEoGDlBQAFI%3D> for contact details for submitting comments electronically or by mail). These written comments will also be available to the FDA as it deliberates. Advocates are strongly encouraged to submit their views before the May 17 deadline.
The webcast from the proceedings should be available in the next week on the FDA website <http://mlist.orchidsuites.net/lists/lt.php?id=KkoCCwNUXQFXAx4FC1BSAEoGDlBQAFI%3D> ; a full transcript of the proceedings will not be available until next month. AVAC will post these links on its website <http://mlist.orchidsuites.net/lists/lt.php?id=KkoCCwNUXQFXAh4FC1BSAEoGDlBQAFI%3D> and on www.prepwatch.org <http://mlist.orchidsuites.net/lists/lt.php?id=KkoCCwNUXQFXBR4FC1BSAEoGDlBQAFI%3D> , a central repository of information on the FDA review and civil society voices. Background information including basic fact sheets, a summary of the PrEP pipeline and other materials can be found at www.avac.org/prep <http://mlist.orchidsuites.net/lists/lt.php?id=KkoCCwNUXQFXBB4FC1BSAEoGDlBQAFI%3D> .
We welcome your questions, ideas and suggestions in this dynamic time and look forward to welcoming you on next week’s advocates’ call <http://mlist.orchidsuites.net/lists/lt.php?id=KkoCCwNUXQFXAR4FC1BSAEoGDlBQAFI%3D> !