Excitement and Disappointment at CROI as PrEP and Gel Data Break

In the moments leading up to the packed session where new PrEP and gel data were presented, longtime activist and Body editor Julie Davids tweeted that there was an “Oscar-like” atmosphere—referencing the buzz, hum and readiness of the film awards ceremony that completed on Sunday. Unlike the Oscars, which ran three hours and forty minutes, this session was brief—under two hours—and yet the news that it brought will almost certainly change the world. AVAC’s own press release is here. And below is a quick summary of this historic day.

The bottom line from Partners PrEP, PROUD and IPERGAY is that oral PrEP using TDF/FTC provides protection. We knew this already, but the new data add nuance.

• The Partners Demonstration project among discordant heterosexual couples (where one partner is HIV-positive and one is not) in Kenya and Uganda showed that a program that delivers both PrEP for HIV-negative partners and/or antiretroviral treatment (ART) for HIV-positive partners reduced the risk of HIV infection by 96 percent. These results highlight the potential impact of combining PrEP and ARV treatment to slow the HIV epidemic.
• The PROUD Study among high risk men who have sex with men (MSM) in the UK showed that daily oral PrEP reduced the risk of HIV infection by 86 percent when delivered in existing public health clinics.
• IPERGAY, a French study, was the first to examine the efficacy of “event-driven” PrEP – in this case, a three-day dosing strategy involving four pills around the time of sex – among high risk MSM who reported frequent sex. Overall, PrEP reduced the risk of HIV infection by 86 percent in the trial. Based on reported pill use by men in the trial, the regimen that most participants took amounted to at least four doses a week. Previous studies of daily oral PrEP have shown that this may be enough to be protective. However, it is not clear how well the event.

There are a range of press statements, a statement from the US CDC and—starting on 2/25, the webcasts for the sessions will be available. You can find all of those links here.

The PrEP data are terrifically exciting findings insofar as they reinforce that this is a strategy that works when taken as prescribed. In gay men and other men who have sex with men, this means it even works when the instructions for use involve coitally-related dosing. It is really important to remember that the data so far about PrEP, protection and vaginal sex suggest that this type of strategy might not work as well for women. As we discussed in AVAC Report 2014/5, now is the time to invest in an oral PrEP-driven paradigm shift. We made this statement even before the data were out—and now we mean it more than ever.

If anything, emotions ran even higher as the FACTS 001 data were presented. Here, it was news everyone had hoped to avoid.

• FACTS 001 was a trial of a tenofovir-based vaginal microbicide gel to be used before and after sex among young women in South Africa. FACTS 001 found no effect for 1% vaginal tenofovir gel overall in the trial. While it appeared that most of the participants used the product at some point, there was not enough correct and consistent use in the trial to provide significant levels of protection. There was a trend of modest protection among the small proportion of women in the trial who appeared to have used the product consistently. This was similar to trends seen in previous studies of tenofovir gel among women, but not enough to change the overall outcome of the trial.

Statements and facts sheets from the FACTS consortium, other microbicide stakeholders and CONRAD are all available here.

The world has far more work to do to find additional tools, above and beyond oral PrEP—which should be rolled out to all who want and could benefit from it—to reduce rates of HIV acquisition among women worldwide.

AVAC will be working with partners to convene webinars and in-country discussions in a range of locations to talk through the implications of all of these data. We will announce the schedule in the coming weeks. If you have a specific question or would like support in organizing around these data, please contact us.

Our recently-released AVAC Report: Prevention on the Line provides background and analysis that anticipates and contextualizes these developments.