Pangaea Urges Support for FDA Review of HIV Drug for PrEP
- Created on Mar 21, 2011
Pangaea, along with many other AIDS organizations in the U.S. and internationally, has signed a letter supporting FDA review of an HIV medicine that has been studied for Pre-Exposure Prophylaxis (PrEP). A number of trials are being conducted around the world to assess whether HIV-negative people at risk of HIV can reduce their risk of becoming infected by taking antiretroviral medicines.
Results of one such trial were announced at the end of last year, and found that the HIV infection rate in HIV-negative gay men who were given a daily preventative pill containing two HIV drugs was reduced by 44 percent compared to men given a placebo.
There are important scientific and operational questions that remain to be answered, but Pangaea joins with the broader AIDS movement in supporting FDA review of these data. The FDA is better equipped than any other body to conduct the rigorous review of the evidence available from a range of studies and sources.
We are, therefore, disappointed that one U.S. group, AIDS Healthcare Foundation (AHF), has launched a communications campaign to block such a review. We join our Oakland neighbor, the MSM Global Forum,in calling AHF's campaign misguided and counterproductive.
We want to share with you the letter that we signed today, and ask that you consider signing it as well.
The response to AIDS over the last thirty years has at times been characterized by over-simplification and misunderstanding. Today it is more crucial than ever that our response to AIDS be driven by the evidence with full and transparent analyses of new data as they become available. We owe nothing less to the people we serve, people most affected by HIV.
Ben Plumley, CEO
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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.”  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,
 Interim guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men who have Sex with Men. MMWR Morb Mortal Wkly Rep. 2011 Jan 28; 60(3):65-8.