Choice in HIV Prevention Options: Let FDA Look at the PrEP Data

Support the call for FDA to examine the study results on
Pre-Exposure Prophylaxis (PrEP)
rather than playing into speculation and fear.

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March 16, 2011

We, the undersigned, are individuals, nonprofit organizations and coalitions who support development of new safe and effective HIV prevention and treatment options in the United States and globally.  We strongly disagree with the contents of the paid advertisement placed by the AIDS Healthcare Foundation (“AHF”) in US newspapers, and its related letter writing campaign to Gilead Sciences Inc. (Gilead), regarding the potential application by Gilead for approval of a labeling change to address use in preventing HIV infection for Truvada® (emtricitabine; tenofovir disoproxil fumarate) – NDA no. 021752 (approved August 2004).

Our principal concern is that the AHF ad and letter substitute speculation and fear, rather than scientific review of the currently available evidence, especially regarding adherence, risk compensation, and drug resistance in place of the evidence-based decision-making that FDA must engage in to review this application. Only a thorough review of available evidence would enhance the scientific community’s ability to consider demonstrations of and allow appropriate use of the drug in high-risk situations.

Under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and FDA regulations, the agency makes decisions based on a comprehensive scientific evaluation to consider whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks, along with appropriate labeling and manufacturing quality assurances. In reviewing Gilead’s application, the FDA will benefit from a growing body of scientific evidence regarding the efficacy, safety and benefits to patients of Truvada® for this new preventive indication. Initially reported trial results combined with a number of new papers presented at the 18th Conference on Retroviruses and Opportunistic Infections in Boston (February 27-March 3, 2011) are relevant to these approval criteria.  The FDA must review this evidence for itself under its objective procedures.  While issues such as cost are of concern to all, this consideration cannot be part of the scientific review process.

Many of the issues raised by the AHF ad and letter are the same issues the public health community has acknowledged for years and have been the topic of ongoing conversations and investigations.  Recent CDC interim guidance to medical providers states clearly that “PrEP has the potential to contribute to effective and safe HIV prevention for MSM if ….it is delivered as part of a comprehensive set of prevention services, including risk-reduction and PrEP medication adherence counseling, ready access to condoms, and diagnosis and treatment of sexually transmitted infections; and … it is accompanied by monitoring of HIV status, side effects, adherence, and risk behaviors at regular intervals.” [1]  Questions remain about how PrEP might be safely and effectively rolled out, but we need to find a way to find answers and strategies to address these issues without shutting off further consideration of what could be an important new HIV prevention option.

The new National HIV/AIDS Strategy identifies men who have sex with men (MSM) as comprising approximately half of new infections in the US. Moreover, young MSM and transgender women who have sex with men (TSM), especially those from Black and Latino communities, are among the groups at greatest risk of acquiring HIV, yet there are few prevention approaches that work for these populations, and more options are needed to reduce new transmissions. We believe that these communities deserve the benefit of FDA’s thorough and evidenced-based review of Gilead’s application.

Very truly yours,  (list in formation as of 4/14/2011)

list in formation

We seek organizational endorsements on an ongoing basis, but please reply as soon as possible.


PLEASE NOTE:

If this is an INDIVIDUAL endorsement, DO NOT enter your organization.

If it is an INDIVIDUAL and ORGANIZATIONAL endorsement, enter your ORGANIZATION AND TITLE