Wednesday’s CROI Roundup

March 8, 2024

The presentations on the last day of CROI 2024 highlighted yet again that research conducted in ethical partnership with communities is about developing products and delivering them with speed, scale, equity and impact. Advocacy to build better systems to support the health and wellbeing of people all over the globe is a form of optimism about the future. From cure research findings to racial disparities in health, to regional Mpox responses, to a hard look at rollout challenges with existing HIV prevention options, CROI ended on a provocative note—challenging researchers and advocates alike to leverage what we have while developing what we need.  

Please enjoy our roundup from the final day of CROI and check out our summaries from Monday and Tuesday. And stay tuned for a full update on all the cure research coming next week! 

Community Breakfast Club research roundup 

More than 100+ advocates joined the final Community Breakfast Club meeting. Advocates Natasha Mwila and Moses Supercharger and researchers Carlos del Rio and Christina Farr offered highlights from sessions on the links between HPV and HIV; the latest cure research showing the potential of early treatment in children to control HIV; the potential of injectables for both treatment and prevention; and the need to accelerate access, especially following Tuesday’s SEARCH results. As one advocate on the call said, “We need to demand that access provisions are spelled out by innovators, as early as possible in the product development. Yes, choice is about the options that best suit your needs at any given time. But we can’t have choices when the options are out of reach.” There was also a clarion call to ensure mentorship for the next generation of scientists and advocates. 

The promise and pitfalls of biomedical prevention 

CROI ended on a powerful call to action to better understand the options that exist today and solve the problems of access. At one of the final sessions, Promise and Pitfalls of Biomedical Prevention: Beyond Phase III, three presentations put a spotlight on the status of approved products and the need for choice.  

Rupa Patel from the CDC took attendees through a maze of access barriers facing injectable cabotegravir – from insurance to personnel issues – in the U.S.— the only country with a commercial market at this time. Rollout in other countries is just beginning with initial, limited supply (1.2 million doses for low- and middle-income countries through 2025). Still, it’s moving faster than oral PrEP, where it took more than three years after FDA approval before a single African country approval. In contrast, just two years post-FDA approval, seven African countries have approved injectable cabotegravir, with several others pending. (Check out AVAC’s PrEP tracker for details.) But these gains are still too slow. Patel concluded by offering future solutions, including accelerating the entry of generics in the market, pursuing scientific and regulatory efforts in parallel, and expanding models that build up community delivery of HIV services.  

Leila Mansoor laid out the complex journey of the dapivirine vaginal ring (DVR). Initial efficacy trials reported approximately 30% efficacy, but Mansoor presented additional exploratory analyses that estimated risk-reduction could actually be 75-91% with high adherence. In addition, the REACH study showed that when young women are offered high-quality counseling and choice, it results in high adherence; the young women in REACH preferred DVR to oral PrEP by 2 to 1. Data presented earlier this week expanded the evidence of the DVR’s safety for people who are pregnant and lactating. And 11 countries have approved it. Mansoor’s call to action: women need and want DVR as an option, and it is now being added to the SEARCH study.  

Jenelle Stewart then faced down the doubters of event-driven PrEP by marshalling evidence that the intervention works in men and may work in women. Stewart referenced a JAMA article by Jeanne Marrazzo just last week that high-but-imperfect adherence (4-6 pills per week) was protective for women. She followed with a clear call for event-driven PrEP for women without needing to go through another large, randomized trial. Stewart made several other provocative points, concluding that event-driven PrEP is desired by some, effective, and should be incorporated in public health guidelines.

Latest in Treatment

Wednesday’s news also included exciting late-breaking data about HIV treatment. An interim analysis of the LATITUDE Phase III trial of monthly injectable cabotegravir and rilpivirine showed superior efficacy of viral load suppression compared to daily oral ART in participants with adherence challenges. The Data Safety and Monitoring Board for this study, based on review of various endpoints, recommended that all eligible participants be offered the combination injectable.  

In addition, results of a Phase II study of weekly oral islatravir and lenacapavir showed safety and non-inferiority of viral suppression to daily ART. Take home message: this product has the potential to become the first weekly oral regimen for treatment.  

Race and HIV, STIs and Mpox 

Pandemic racial disparities were on full display during the session, Using Data to Inform Interventions: Epidemiology of HIV, STIs, Mpox, and COVID-19. While much of the research showed the potential to use epidemiological data to better address public health problems, it was clear that health systems and infrastructure aren’t keeping pace.  

Andre Dailey, from the U.S. Centers for Disease Control & Prevention (CDC), presented a study that observed an overall decrease in Black/White racial disparities in U.S. HIV diagnoses between 2017 and 2021, but showed that for some key populations, including Black/White MSM, people who inject drugs, and others, disparities in diagnoses either did not change or increased. This is not good news for health equity. Sonia Singh also from the CDC, presented data on the lifetime risk of HIV diagnosis among MSM in the U.S., 2017-2021. She found that overall lifetime risk of HIV diagnosis improved among MSM (1 in 7), but there are great racial disparities. That number is 1 in 15 among White and Asian MSM, 1 in 11 among Native Americans and Alaskan Native MSM, 1 in 7 among Native Hawaiian/Pacific Islanders, 1 in 5 among Hispanic/Latino MSM (of any race) and 1 in 3 among Black MSM.  

Mayara Secco Torres da Silva of the Instituto Nacional de Infectologia Evandro Chagas presented data on the two Mpox outbreaks in Rio de Janeiro, Brazil, pointing to the need for enhanced community surveillance, integration of HIV and STI services and access to preventive vaccines. Brazil had the second worst Mpox outbreak in the Western Hemisphere, after the U.S. In studying the two outbreaks from 2022 and 2023, several patterns emerged demonstrating several disparities in Mpox diagnoses. Those who were disproportionately diagnosed with Mpox were Black Brazilians, people having a secondary school or less education, and MSM. The second outbreak in 2023 saw a higher proportion of PLWP and PrEP users diagnosed with Mpox than in the first outbreak. Da Silva called for better Mpox surveillance systems. She said ensuring more people with HIV are sustained in care is necessary to prevent worsening Mpox outcomes, and reminded the audience that Brazil, and other low- and middle-income countries (LMICs) still have not had access to the smallpox vaccine that was a primary tool in virtually ending these outbreaks in the U.S. and Western Europe.  

HIV cure and upcoming webinars 

There was a wealth of news and updates on cure research at CROI 2024. Keep watch for the latest research on the HIV reservoir and cure strategies from AVAC next week. 

And mark your calendars for a host of webinars that will follow up on many of the questions raised at CROI 2024,