March 23, 2018
[UPDATED: slides and audio from our webinar series are now available below.]
Historically, the Conference on Retroviruses and Opportunistic Infections (more commonly known as CROI) is heavy on basic science and early-phase research. Data from these types of studies were still prominent in 2018 (see Jon Cohen’s excellent Science article on new animal data informing cure and vaccine research). This year the meeting also broadened its lens from the lab to the ways that different strategies are, or might, have an impact in the context of people’s complex lives.
Dapivirine Ring: Guess what, women use it when they know what works!
The dapivirine vaginal ring is a silicone ring containing an antiretroviral that is released slowly over time. It’s been designed to be worn by women for around a month. Two years ago, at CROI 2016, the ASPIRE and Ring Study results showed that the dapivirine vaginal ring is safe and reduces the risk of HIV infection by around 30 percent overall among women enrolled in the study. At CROI 2018, interim data from the open-label extension (OLE) trials of the ring—HOPE and DREAM—showed that the ring reduced risk by 50 percent. In the open-label studies, all participants have been given access to the dapivirine ring to use monthly for up to 12 months. There is no placebo and all participants are told about the safety and efficacy data. Presenting on behalf of the HOPE study team, Jared Baeten (MTN) remarked that the ring data are similar to the oral PrEP OLE data-in those studies too, people were more adherent once they knew the results from prior trials. Final data from HOPE and DREAM, including findings on how well it works in those who use it consistently, will be available in late 2018/early 2019.
The European Medicines Agency (EMA) is reviewing available data on the ring under a framework that allows it to provide regulatory guidance for developing countries. Its decision is expected in late 2018. Will the world be ready with investments, introduction plans and advocacy? Experience to date says: only if advocates work at local, regional and global levels to demand advance planning and action.
Women’s Vaginas: They’re amazing and important to HIV (duh!)
A biome is a large naturally occurring group of plants or animals in a given habitat. The vaginal microbiome is the naturally occurring group of bacteria that live in women’s vaginas and-depending on the proportion of different bacteria present at a given time-keep us healthy or may make us uncomfortable or even put us at risk. The relationship between the vaginal microbiome and HIV acquisition has been a focus at several recent conferences. It was highlighted again in a plenary presentation at CROI.
Nichole Klatt (University of Washington) presented data on what happens when there is an imbalance between good and bad bacteria, a condition known as vaginal microbiome dysbiosis. When researchers looked at vaginal bacteria and different antiretrovirals in lab studies (in vitro), they found that microbiomes with an imbalance towards bad bacteria showed some degradation of topical tenofovir and dapivirine. In other words: it could be that women with such imbalances who are adherent to a vaginal microbicide or the dapivirine ring might still have lower levels of drug in their genital tissue than what is needed for adherence.
It’s incredibly important to understand how the microbiome impacts HIV risk and vaginal health, including the presence of topically applied ARV-based prevention. It’s also incredibly important to remember that these data do not say anything about how oral tenofovir-based PrEP works for women. Oral PrEP arrives in genital tract cells in completely different ways than topical PrEP. To date, data from the human trials of both oral PrEP and dapivirine ring haven’t shown any difference in effect in women with bacterial vaginosis, which is good news. Additional data will continue to shed light on this important and continuing story. And in the meantime, the take-home is still that oral PrEP works for women and that so far there has been no difference in levels of protection in the ring studies linked to dysbiosis.
Advocates need to be on the frontlines of explaining what these vaginal microbiome data do and don’t tell us. We can’t afford misinformation suggesting that oral PrEP doesn’t work in women. We also can’t afford to ignore the complexities of all bodies-female, male and trans-and how they impact prevention and treatment.
Pregnant and Post-Partum Women Need HIV Prevention
A presentation from Renee Heffron (University of Washington) provided more evidence that pregnant and post-partum women are at increased risk of HIV infection. She and colleagues analyzed data from two studies of over 2,700 serodifferent couples. They found that women who were pregnant or post-partum were 3-4 times more likely to acquire HIV. Implications for care and prevention include counseling, more testing, treatment for male partners and woman-controlled prevention options like oral PrEP.
2018 will see many discussions of pregnancy, contraceptives and HIV risk as the many stakeholders prepare for data from the ECHO trial. ECHO is looking at three different methods (DMPA, copper IUD and Jadelle implant) to see if any have an impact on women’s HIV risk. These data are an essential reminder that HIV risk is driven by many things-including pregnancy. Advocates need to push for PrEP in the ante- and post-natal context, contraceptive choice, programs that diagnose male partners and link them to effective ART-and more. Data and global and national guidelines on the use of oral PrEP (e.g., the WHO technical brief on preventing HIV during pregnancy and breastfeeding in the context of PrEP) and the dapivirine ring for pregnant and post-partum women are essential.
PrEP Use Increases but Disparities Persist
Access to PrEP was woven throughout the CROI program, as data on PrEP programs and use continues to accumulate. Findings from San Francisco and Australia both showed a significant uptick in PrEP use and reduced infections (primarily in men who have sex with men) but across both of the studies racial and ethnic disparities in access remained largely unchanged. A new analysis from the US Centers for Disease Control and Prevention (CDC), also presented at CROI, found that two-thirds of those who could benefit from PrEP are African-American or Latino and yet prescriptions for these populations remain stubbornly low. Gaps in access were seen across racial groups but were most stark among non-white populations.
A continued fight for health equity as part of a broader social justice agenda in America-and around the world.
In a meeting known for a focus on basic science, conversations about the Undetectable=Untransmittable campaign and its role in reducing stigma were frequent and welcomed. And for the first time there was a plenary session on mental health at which presenter Robert Remien (HIV Center for Clinical and Behavioral Studies, Columbia University) called for stepped up mental health services to achieve the 90-90-90 goals.
Advocates have consistently been at the frontlines of demanding a holistic approach to prevention and treatment—here’s more data to fuel the fight.
Products in the Pipeline
While there was an increased focus on implementation work this CROI, true to form the meeting also featured plenty on data from early-stage research. Among the hundreds of posters and oral abstract presentations a couple stood out including a non-ARV vaginal insert-designed to prevent HIV, HSV-2 and HPV infection-from PopCouncil and the long-acting ARV from Merck (MK-8591) to prevent HIV. Given favorable animal data, both products are being considered for clinical development.
A major scientific-literacy and agenda-setting push so that advocates can join researchers and product developers to guide decisions about how these trials will be designed and when and where they will happen.
Keep the Conversation Going
Join us for a post-CROI webinar series! Dig into the data with researchers and discuss with fellow advocates how these findings can inform our advocacy work moving forward. Register today!
- Latest on the Dapivirine Ring with Zeda Rosenberg and Jared Baeten; Thursday, March 29 — slides and recording available
- Risk of HIV for Pregnant and Post-Partum Women with Renee Heffron and Kerry Thomson; Wednesday, April 11 — slides and recording available
- Introducing Oral PrEP: A step-by-step framework, tools and updates; Wednesday,
April 18 — slides and recording available
And stay tuned for announcements on additional webinars!