March 7, 2011

Dear Advocates,

When does appropriate caution become an unnecessary delay? This question has been uppermost in our minds as AVAC participated in sessions and hallway conversations about pre-exposure prophylaxis (PrEP) at last week’s Conference on Retroviruses and Opportunistic Infections in Boston.

Some of the key PrEP data and discussion points from the meeting are summarized in an accompanying review available here. But first, some of AVAC’s concerns about the post-iPrEx process and discussions to date.

The bottom line as AVAC sees it is simple: donors, implementers, public health programs and, yes, communities need to move faster. This goes for microbicides and AIDS vaccines, too, and we will be devoting separate updates and briefing papers to these topics in the weeks to come.

While it is something of a relief that there has not been a groundswell of off-label or underground use of or demand for PrEP—at least based on anecdotal reports—it is a crying shame that so many obstacles exist to identifying individuals who might benefit most from PrEP. These include provider discomfort with taking sexual histories and yawning gaps in social and behavioral data on transgender women, gay men and other men who have sex with men.

Data presented at CROI emphasized that age, ethnicity and insurance status may be better predictors of HIV status and risk that individual risk behaviors. Young, uninsured gay and transgender men of color continue to bear the brunt of the epidemic in the US—and are underserved by prevention and research agendas. PrEP or no PrEP, these realities prevent effective HIV prevention programming and expanding access to products and services to those who need them most. There are related, equally troubling issues facing gay men in every corner of the globe.

Of course there are critical questions that remain to be answered about PrEP. The list is long, a little daunting, and includes unknowns about optimal dosing and delivery strategies, messaging campaigns, long-term safety and so on.

We’ve listed many of these questions in various documents and will continue to explore them. But here are a few more that deserve equal and urgent attention:

• Where is the coordinated plan of action for those filling information gaps that can help identify individuals who would benefit most from PrEP, implementing pilot projects and raising interest in and awareness of PrEP among gay men and other MSM, transgender women and their health providers in the US?
• Where is the public debate and discussion on how to develop models and gather information on PrEP use and, potentially, roll out PrEP in gay men, transgender women and other MSM in developing countries, including countries that did not host iPrEx?
• What are the opportunities for trial protocols combining PrEP and vaccines or other strategies—particularly those engaging gay men and other MSM?
• Where are the plans from developing countries—both those that hosted iPrEx and those with ongoing PrEP trials in other populations—about how PrEP might be introduced and incorporated into a strategy of universal access to treatment for HIV-positive people?

These questions—if they remain unanswered—are what lead to avoidable delays, unnecessary new HIV infections and, unfortunately, preventable deaths. At the top of our coverage, you’ll find a list of “top next steps” that emerged from a lively discussion at a Community and Research Forum on ARV-based Prevention Results and What Happens Next that we co-hosted with Fenway Health. Further on, you’ll find updates from a CDC PrEP symposium, a review of some basic science and preclinical data and more presented at CROI 2011.

Download "PrEP at CROI" here.

We hope as you read the coverage that you’ll add your own questions to our list—and we look forward to accelerating the pace of new, innovative HIV prevention programming together.

Onwards,
AVAC