Community HIV prevention leaders are trying to figure out what role, if any, pre-exposure prophylaxis (PrEP) might play in helping to rein in the number of new HIV infections that occur each year. Those questions and passions were on display at a lively and free-flowing forum at the 2011 National HIV Prevention Conference in Atlanta.
PrEP uses antiretroviral drugs to protect from initial HIV infection. IPrEx, the first study proving the concept, was published last November. It showed that high risk gay and bisexual men who took the combination therapy Truvada as directed were 91 percent less likely to become infected with HIV compared with those who received a placebo. A subsequent study in heterosexuals also showed protection.
Further studies are needed to move beyond this proof of concept and figure out how PrEP might work in the real world—what at-risk groups might benefit the most from this expensive form of prevention and how programs might be structured to achieve the best results.
Grant Colfax said the situation requires a paradigm shift in thinking similar to that took place a decade ago prior to the large-scale rollout of treatment in sub-Saharan Africa.
"Building new systems of delivery in isolation just to provide PrEP is not a sustainable option. Moving forward the question is, where are the sites where this is most likely to be delivered? Is it STD clinics, HMOs, primary care settings? How do we integrate it into a medical structure that is sustainable over time," asked the head of HIV prevention at the San Francisco Department of Public Health.
"One of the fears I have is that PrEP will be looked as this thing that is being put upon given populations rather than something that the populations themselves are asking for," said David Evans with Project Inform. "That is particularly sensitive in some communities," he said alluding to the legacy of suspicion that remains within the African American community from the Tuskegee syphilis study.
"We know what [PrEP] looked like in the IPrEx study but we don't know what it is going to look like in the real world." Evans encouraged people to start having these discussions with the community and not "squander opportunities" to help shape the definition of what PrEP is.
Barriers
The NIH's Carl Dieffenbach fears "that PrEP, even in San Francisco, will not reach the people who will truly benefit from it" because people at highest risk for infection often do not get tested.
Testing is key to the use of PrEP because the drugs used probably are not sufficiently potent to completely suppress the viral load of someone already infected, and resistance will develop. Thus, testing negative is a prerequisite for using PrEP; those who test positive will be directed into care.
But testing also is a barrier to using PrEP. Dieffenbach asked, "Is it going to be so medicalized that it will end up being like a prescription where people just can't or won't fill it? We need to find a way of normalizing this, as radical as that sounds."
A participant from Washington, D.C., said physicians' views might be another barrier. "My doctor has told patients that he would not consider prescribing PrEP to anyone other than a person who was in a serodiscordant relationship. I guess because of fears of not using it properly."
"My big fear is that we are going to see rates of HIV go up because people are going to think this is the magic pill," said a man from New York's GMHC. That could be the result of poor adherence to the drug and/or an increase in risky behavior.
Perhaps the most commonly expressed theme was that inequitable access to PrEP might further worsen existing health disparities. Blacks are 13 percent of the U.S. population but about half of those infected with HIV.
Others supported the concern of a women from Miami who argued, how can one justify spending money on PrEP when more than 9,000 people are on ADAP waiting lists for drugs to treat their existing infection.
Groundswell
"My greatest hope is that [PrEP] ignites the HIV community on fire. It is one of the most radical, new HIV prevention technologies and approaches that has come along in 30 years," said Carey Johnson with the Fenway Institute in Boston. "My fear is that this is not happening, and I really wish I knew why."
"We've had a handful of people ask about PrEP; those who did were likely to have a seropositive partner or were in the IPrEx study," said Steve Gibson with Magnet, the San Francisco prevention effort aimed at gay men. "People are waiting to see what's next. How it can be integrated into their lives."
"I think it is odd we are lamenting that no one comes to our clinics asking for PrEP. Well, we haven't told them about it, so why are we surprised?" said New York City physician Wafaa El-Sadr. "It is incumbent upon us to generate the interest. We do it for other interventions."
"I know of five to 10 people on PrEP locally, all of whom are discordant couples, all of them have insurance," said Joanne Stekler with the University of Washington. She sees cost as the major inhibitor on interest. "If you took away the costs issue, and maybe the adherence issue to a little degree, everyone would want to be on PrEP."
Call to Action
Leading HIV prevention organizations have issued a "call to action" for the Department of Health and Human Services to develop a comprehensive plan of PrEP demonstration projects that identify how and where the intervention might best be used.
Initial groups behind the effort are the AIDS Foundation of Chicago, AIDS United, amfAR: the Foundation for AIDS Research, AVAC: Global Advocacy for HIV Prevention, the Black AIDS Institute, the International Rectal Microbicide Advocates, National Alliance of State & Territorial AIDS Directors, the National Minority AIDS Council, Project Inform, and the San Francisco AIDS Foundation.
The recommendations focused on public health administration of PrEP programs and largely avoided the role that health insurance and private purchase of PrEP might play.
Their statement and links to the full recommendations is available at
www.projectinform.org/news/leaders-press-feds-for-promising-hiv-prevention-tool/
