Next Thursday, May 10, the US FDA’s Antiviral Drugs Advisory Committee will meet to review and consider Gilead Science, Inc.’s application for a prevention indication for the anti-HIV treatment drug Truvada (TDF/FTC). This is a critical moment in biomedical HIV prevention. This update links to a recent statement from US civil society groups on the importance of PrEP and a revamped PrEP Watch website that we’ve created with partners as a home for updates on the FDA review process and links to comments from a range of advocates. This update also includes details on how to watch or attend next week’s deliberations and information on an advocates’ follow-up teleconference planned for the week of May 14.
If you are in the DC area next week we encourage you to attend the meeting—details including the exact timing and location can be found here. If you are unable to attend in person, you can follow the proceedings via live webcast. Further information on the webcast, including the web address for the webcast, will be made available at least two days in advance of the meeting on the FDA website: 2012 Meeting Materials, Antiviral Drugs Advisory Committee.
This past December, Gilead submitted a dossier to the FDA requesting a prevention indication for all HIV-negative adults for its combination antiretroviral treatment drug TDF/FTC. If this supplemental new drug application is approved, TDF/FTC will be the first antiretroviral approved for use to prevent [or reduce the risk of] sexually acquired HIV-negative people.
A key part of the review process is the deliberations of and recommendation from the FDA’s Antiviral Drugs Advisory Committee, which is made up of member experts in the field and a consumer representative. On May 10, the committee will review the data on TDF/FTC as PrEP. In addition the committee will review written comments and hear in-person testimony from the public. (AVAC director Mitchell Warren is among the individuals selected by lottery to present oral comments. Visit PrEP Watch for copies of his remarks on behalf of AVAC on May 10.)
At the end of the meeting the committee will vote on a number of questions regarding Gilead’s application. The FDA will consider the recommendations in making its decision whether to approve the application (committee recommendations are not binding). A final decision from the FDA is expected by June 15. [For more information on this process check out AVAC's Advocate's Primer for Public Participation.]
The PrEP Watch website (www.prepwatch.org) is now host to background materials on the FDA review process for TDF/FTC as PrEP along with comments and supportive statements that have been submitted from a range of groups, including a recent letter from a number of civil society organizations from across the US. If you or someone you know is looking to learn more about the process or read some of the supportive statements that have been submitted, please be sure to check out PrEP Watch!
During the week of May 14, AVAC will host a global advocates’ teleconference to discuss the proceedings from the May 10 FDA Advisory Committee meeting and consider next steps. Look for timing and call-in details in an Advocates’ Network posting next week and on the AVAC website.
If you have any questions please be in touch, and we look forward to discussing next steps with many of you on the advocates teleconference!