The Global Forum on MSM & HIV supports FDA review of pre-exposure prophylaxis (PrEP)
AIDS Healthcare Foundation campaign to block agency review is misguided and counterproductive
March 21, 2011 – The Global Forum on MSM & HIV (MSMGF) joins other HIV prevention advocates in repudiating the recent AIDS Healthcare Foundation (AHF) campaign to stop the U.S. Food and Drug Administration (FDA) from reviewing Truvada for use as pre-exposure prophylaxis (PrEP). It is irresponsible for AHF to call for a halt to the FDA’s review process. Instead, the MSMGF supports principled inquiry into the safety, efficacy and applicability of a potential new addition to our HIV prevention toolkit.
Anticipating that Gilead Sciences, Inc. will soon seek FDA approval for use of its AIDS drug Truvada as a form of PrEP to prevent HIV infection, AHF has launched a communications offensive to stop the FDA review process. AHF’s campaign focuses on results from the iPrEx study, which evaluated the safety and efficacy of Truvada used as PrEP among men who have sex with men (MSM) and transgender women. The iPrEx study reported that daily use of Truvada reduced the risk of HIV infection by 44 percent when taken as part of a robust package of prevention interventions. The FDA should undertake a careful review of the iPrEx study results as well as Gilead’s application for approval of Truvada as an HIV prevention tool.
At the MSMGF, we believe there is no silver bullet for stopping the spread of HIV and that comprehensive approaches represent the best option for HIV prevention. Evidence suggests that PrEP has the potential to be a valuable addition to the current set of available interventions. United States law authorizes the FDA to carry out a careful review and evaluation to assess whether a drug is safe and effective in its proposed uses, and whether the benefits of the drug outweigh the risks. The MSMGF supports this type of rigorous, objective, regulatory review. Unfortunately, AHF’s obstructionist efforts are based in misguided politics and organizational self-interest. The fight against HIV cannot move forward in this manner. What MSM and transgender people deserve is strong advocacy that is informed, balanced, ethical and forward thinking.
FDA review of Truvada is only one small step in a long chain of actions still needed to reinforce and reinvigorate HIV prevention efforts for MSM and transgender people. Further research is required to understand which implementation practices are safest and most effective for PrEP among MSM and transgender women in a diversity of contexts. PrEP also reminds us that we continue to face difficult questions regarding stigma, adherence, and cost of and scale-up to sustained universal access to care. Significant work remains to be done in order to achieve access to even the most basic HIV-related prevention, treatment and support services. An estimated 90% of MSM around the world currently lack such comprehensive services despite their proven efficacy.
MSM and transgender people deserve full access to existing prevention and care resources. Shutting down research, evaluation and knowledge production only hinders our progress toward more complete and nuanced understandings of how to approach these complex challenges. Individuals, communities and advocates must be afforded all the information possible in order to make the most informed choices about our own health. The MSMGF strongly urges HIV prevention activists to adopt a big-picture approach to HIV prevention – one that is balanced and responsive to the respective local realities of MSM and transgender people.
The Global Forum on MSM & HIV (MSMGF) is an expanding network of AIDS organizations, MSM networks, and advocates committed to ensuring robust coverage of and equitable access to effective HIV prevention, care, treatment, and support services tailored to the needs of gay men and other MSM. Guided by a Steering Committee of 20 members from 18 countries situated mainly in the Global South, and with administrative and fiscal support from AIDS Project Los Angeles (APLA), the MSMGF works to promote MSM health and human rights worldwide through advocacy, information exchange, knowledge production, networking, and capacity building.
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- About iPrEx, the Pre-Exposure Prophylaxis Initiative
- US CDC Interim Guidance on the use of pre-exposure prophylaxis (PrEP) for the prevention of HIV among MSM
- Pushing the PrEP Agenda: AVAC’s Take and a Report from CROI
- AHF’s Sign-on Letter to Gilead on PrEP
- HIV Prevention Justice Alliance’s Sign-on Letter in Support of FDA Review of PrEP
Previous MSMGF Statements on PrEP
- MSMGF Welcomes CDC’s Interim PrEP Guidance for MSM in the United States
(Feb 2, 2011)
- New PrEP Findings Represent Important Progress, Point to Daunting Challenges in HIV Prevention for Gay Men
(Nov 23, 2010)