CROI 2018: Highlights and what’s next for advocates

[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.

What’s Next

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.

What’s Next

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.

What’s Next

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.

What’s Next

A continued fight for health equity as part of a broader social justice agenda in America-and around the world.

Undetectable=Untransmittable

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.

What’s Next

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.

What’s Next

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!

And stay tuned for announcements on additional webinars!

Map of HIV Prevention Research and PrEP Demonstration Sites in Kisumu, Kenya

This map demonstrates the breadth of HIV prevention research and demonstration projects in the Kisumu region of Kenya by site and type (e.g. daily oral PrEP, preventive Vaccines, etc.). This map was developed by Wits RHI with support from AVAC as part of the Coalition to Accelerate and Support Prevention Research.

Tracking the Fast-Changing Status of PrEP Around the World

A few weeks ago, South Korea became the latest country to introduce oral PrEP, bringing the number of countries offering PrEP to more than 50. With more people using PrEP every month, AVAC and its HIV Prevention Market Manager project has created the Global PrEP Tracker to help keep track of the fast-changing status of PrEP around the world.

The tracker, housed on the PrEP Watch online clearinghouse, is a single source offering a variety of information, including:

  • Estimated PrEP initiations compared to targets by country.
  • Specifics on PrEP programs by population, service delivery model and funder.
  • Status updates on country registration of tenofovir-based medications for prevention.
  • Up-to-date information on daily oral PrEP inclusion in national policy guidelines.

The tracker provides a global snapshot of PrEP statistics by country. PrEP Watch also houses Country Update Pages, which provide an overview of the status of daily oral PrEP in countries where PrEP is rolling out or being considered.

The numbers provided in the Global PrEP Tracker are estimates, as monitoring systems vary by country and are in early stages. Right now, the estimate is of individuals initiated on PrEP in ongoing projects. The tracker does not estimate the number of people actively taking PrEP at a given moment.

Updated quarterly, the estimates in PrEP Watch are derived by review of and outreach to implementers of oral PrEP studies, implementation initiatives and large-scale national programs. AVAC is grateful to the projects who contribute their data–these contributions make the tracker possible! If you notice data are missing, please let us know.

We hope this resource will bring some clarity to the fast-moving field of oral PrEP–and we look forward to working together to continue to improve the tracker in the future!

Three Perspectives, Two Trials and One Big Goal

With more efficacy trials underway today than ever before in HIV prevention research, this episode of Px Pulse zooms in on two that have most recently launched: one of two trials testing a long-acting injectable antiretroviral called cabotegravir (HPTN 084), and the study of a “mosaic” vaccine developed by Janssen Pharmaceuticals (HVTN 705/HPX2008).

Three Perspectives on Two Big HIV Prevention Trials in Latest Px Pulse Podcast

The February episode of the Px Pulse podcast is up and brings you three perspectives on two recently launched major trials in HIV prevention: HPTN 084 testing a long-acting injectable antiretroviral called cabotegravir and HVTN 705/HPX 2008 testing a “mosaic” vaccine.

  • What opportunities stand out in an advocate’s eyes as these trials enroll?
  • What’s a mosaic vaccine?
  • What’s the status of ethical standards at trial sites?

Explore these issues and more in this episode of Px Pulse, AVAC’s podcast on HIV prevention research today.

You’ll hear from Malawi’s veteran advocate Maureen Luba, Zimbabwe-based bioethicist Paul Ndebele and leading scientist Dan Barouch.

In a hurry? Select among the podcast highlights.

And don’t forget to tell us what you think!

Px Wire January-March 2018, Vol. 11, No. 1

In this issue of Px Wire, we take a hard look at a host of major milestones coming up toward ambitious global targets for ending the epidemic. We also include detailed infographics on showing the status of oral PrEP rollout in the countries where trial sites are located, explaining the demographics of Africa’s “youth bulge” and its implications for the global response and more.

Target Tracking for Epidemic Control

Calculating progress toward the UNAIDS Fast Track Goals is complex but ambitious targets are the best kind. AVAC has long argued they propel action even if they aren’t met. But when it comes to achieving epidemic control, progress must be properly calculated, and can never be confused with success.

Appearing in Px Wire, this is a modified version of a graphic appearing in AVAC Report 2017.

New Px Wire — 2018: Countdowns and counting what matters

The first issue of AVAC’s quarterly newsletter for 2018 is here! It’s designed to help you mark your calendars and make your advocacy plans for critical events in the next 12 months. These include:

  • The upcoming country deadlines for creating roadmaps to implement the priorities laid out by the UNAIDS’ Global Prevention Coalition. This work is supposed to jump-start primary prevention and bring down the rate of new diagnoses by 75 percent by 2020. Will it? Only if you get involved!
  • In the coming weeks, PEPFAR and many stakeholders will gather to develop targets, service delivery approaches and comprehensive plans for testing, prevention, treatment and virologic suppression in PEPFAR countries. It’s a key process for civil society to track. Find out how!
  • In 2019, the ECHO trial is expected to release its results on whether three different contraceptive methods impact women’s risk of HIV—but preparation for these trial results is starting now! Get involved!
  • Seven major efficacy trials of biomedical prevention tools are currently underway—read on to find out where, what and how to learn more.

This issue of Px Wire also includes a detailed infographic showing the status of oral PrEP rollout in the countries where trial sites are located. And don’t miss the infographic explaining the demographics of Africa’s “youth bulge” and its implications for the global response.

Find the full issue of Px Wire and the archive of past issues at www.avac.org/pxwire.

Standard of Care in the Era of PrEP

Every research trial of a new HIV prevention option offers a package of services to protect participants from HIV. This standard of care is essential to the design of an ethical trial.

So what do we do now that oral PrEP has hit the world: It works if you take it; roll out is reaching some places and populations better than others. And people on PrEP often need support to stick with it. All this makes adding Oral PrEP a paramount question for trials. This month’s Px Pulse follows a recent summit in Cape Town South Africa where advocates, researchers and regulators confronted the high stakes of post-PrEP prevention research.

Video Series: Lessons from the Field

Six short videos spotlight lessons learned at PrEP demonstration projects run by LVCT Health in Kenya. The series explores key issues from the introduction of PrEP and managing symptoms to adherence and the role of support groups.