July 22, 2015
It speaks volumes about the, well, volumes of PrEP data emerging from the International AIDS Society meeting in Vancouver that we can’t even try to summarize all the findings here in P-Values. Excellent round-ups can be found on the NAM website and you can access some of the PrEP sessions online. In this post, we offer up a birds-eye view of what is known and what is anticipated in the coming weeks and months.
Guidelines are … coming!
On July 17, the Friday before the conference opened, UNAIDS released two new documents: a “Q and A” document on oral PrEP, and WHO/UNAIDS released a background paper, developed jointly with AVAC, titled “Oral Pre-exposure Prophylaxis: Putting a new choice in context”.
What context, you ask? Well, there’s the rub… at least for now. In the cover note from UNAIDS and in the actual text of the latter document, reference is made to a forthcoming recommendation from WHO on PrEP. This guidance is, “likely to be significantly broader than previously and creates real opportunities for moving forward with implementing PrEP as part of comprehensive HIV programmes.”
Exactly what the recommendation will be, and when in 2015 it will be released, remains to be seen (although at the meeting, WHO leadership has alluded to an expedited process—mentioning a September release in one public session). But the “PrEP in context” document spells out the scope: PrEP works for men and women when it’s taken correctly. It’s an important option for people at risk of HIV. It’s safe, needed and should be introduced in close collaboration with civil society and communities in need and at risk. In the absence of the actual recommendation, there may be little action—but this preview could and should catalyze action to be ready for when the recommendation comes as well as for action that can happen in the meantime.
The picture is getting clearer
Guidelines don’t turn into programs over night. And it’s important to anticipate the questions—many already being asked—that will only become more urgent when there is an official recommendation on PrEP. The conference provided some concrete info to consider and feedback to various partners on how PrEP is working in the real(-ish) world of open-label access and demonstration projects. Here are some key takeaways from sessions that can be found by the abstract numbers here:
PrEP is a needed, additional option. An unofficial (aka from a seat in the session) analysis of the baseline characteristics gay men and other men who have sex with men who participated in PrEP studies shows that the vast majority reported condomless anal sex at the time of trial enrollment. Some of these trials had prior condomless sex as an entry criteria, and self-reporting of sex acts can be unreliable. But with these caveats, it’s still useful to note where PrEP trial participants were, in terms of ability to negotiate condom use with every sex act, when they began research.
One concern some have raised is that PrEP is going to cause people to abandon condoms, and these data are a reminder that suggest that PrEP needs to be there for is going to be sought out by people who are already not able to use condoms all the time. The information shared by these participants bears out the argument that PrEP is an additional, needed option.
PrEP is feasible—with support. Data from the US PrEP demonstration (Demo) project in San Francisco presented by Albert Liu (San Francisco Department of Public Health) show that those gay men and other MSM at highest risk based on reported behaviors were able to adhere to PrEP regimens sufficiently well to achieve protective levels. Adherence happens in an environment—family, community, country—and the parameters of this environment need to be taken into account as PrEP rolls out. Sybil Hosek (Stroger Hospital of Cook County and ATN) also called for “more in-depth understanding of the historical, societal, behavioral, and attitudinal barriers to PrEP access and adherence among those most impacted in the US—young black MSM.” Dr. Liu also noted that participants in the Demo Project received a financial incentive (USD$25 per study visit). Retention was good in this trial, but the role of incentives need to be interrogated—see our blog here for more on this issue.
People can figure out whether they need PrEP. Beatriz Grinsztejn (Fundação Oswaldo Cruz (Fiocruz)) reported on a Brazilian demonstration project that is the first in a middle-income country in a trial-naïve population (i.e., not post-trial access.) Among gay men and other men who have sex with men, and transgender women offered PrEP, roughly half opted to use the strategy. Uptake was higher among those who self-referred (as opposed to learning about PrEP during an HIV testing visit). These data reinforce that people in some contexts can recognize risk and be interested in PrEP. Is 50 percent uptake success—e.g., people are assessing what will work for them? Or will patterns of uptake change over time? That’s exactly the kind of question that further investigation as PrEP rolls out.
PrEP works in women and men AND women and men are not the same. As we discussed in a blog on Tuesday, there have been various statements at the conference that PrEP doesn’t work as well in women. These need to be tempered and nuanced. No prevention strategy works all the time for every individual and sometimes this is related to biology, other times to culture, context and society. A poster presentation on barriers and facilitators to PrEP use from the ADAPT open-label study of PrEP in young women in South Africa, provides a fascinating, multi-faceted look at how many parameters affected participants’ choices. These sorts of investigations are crucial to introducing PrEP in ways that do work for both men and women. On the biological plausibility front, data reported from the Botswana TDF2 open-label extension trial in men and women found high levels of protection in both sexes—though the numbers were small. As Gus Cairns explains in a terrific post on PrEP for vaginal versus rectal exposure, there are areas for further investigation and a need for careful messaging. But when PrEP is taken by women in many settings, these women are protected. Let’s remember, and act, on that.