Prevention revolution or miles away from our targets? A look back at HIV Research for Prevention

The biannual HIV Research for Prevention (HIVR4P) conference is a high point of the HIV prevention field, typically gathering thousands of scientists, researchers, advocates, and activists in person to share and discuss the latest research developments. Due to COVID-19 restrictions, host the International AIDS Society (IAS) rebranded the 4th HIVR4P as the first-ever HIVR4P // Virtual — a series of webinars held Jan. 27-28 and Feb. 3-4. Throughout the virtual event, participants couldn’t help but draw parallels between HIV and COVID-19 and called on the field to pause, reflect, and translate the speed of COVID-19 research and development (R&D) into a reenergized HIV/AIDS response.

That energy is sorely needed if UNAIDS statistics are any indication. Though annual new infections and deaths are at their lowest since the epidemic began, Winnie Byanyima, executive director of UNAIDS, offered this sobering reality check: “…let us not be so complacent that 1.7 million new infections and 690,000 deaths per year starts to feel like progress — and when every one of those AIDS-related deaths was preventable,” she said. “The truth is we are failing. We have missed our targets for 2020 by a wide margin and we need a wake-up call to get back on track to end AIDS by 2030.”

This dismal forecast will no doubt be compounded by the ongoing COVID-19 pandemic. But for all the challenges of the last year, scientists and communities have prevailed spectacularly to produce more potent alternatives for oral pre-exposure prophylaxis (PrEP), innovations in long-acting injectable HIV prevention, promising antibody studies that could get us closer to a vaccine, woman-controlled options, and proof-of-concept for a new generation of HIV vaccines. All were discussed at length over WiFi.

The biggest missing piece in the HIV prevention puzzle remains a vaccine. But hope appears to be on the horizon if we commit to focusing on three key areas:

1. Access. In the absence of a vaccine, treatment and PrEP have played an outsized role in the HIV/AIDS response. Just under a million people have started PrEP so far, which represents about one-third of the UNAIDS target for 2020¹. This category of life-saving drugs has been dogged by poor country-level introduction and low individual uptake and adherence. Research showcased at HIVR4P targeted those challenges with advances toward making PrEP more discreet and user-friendly: skin patches, implants, long-acting injections, and monthly pills. One highlight was the outcome of a landmark study undertaken in seven African countries in which cisgender women who received injections of the PrEP drug cabotegravir every eight weeks experienced 89% fewer HIV infections compared with those taking Truvada, the daily oral PrEP pill². To succeed in the real world, however, both injectable PrEP and other prospective long-acting tools, such as broadly neutralizing antibodies (bnAbs), will require significant advance planning to optimize regulatory capacity, policies, investment, and delivery. An oral abstract session titled “Mapping policy: Accelerating progress locally, nationally and globally,” highlighted IAVI’s new Evolving access pathways for long-acting HIV prevention products report, which provides recommendations to reduce bottlenecks and ensure rapid introduction and equitable access to new HIV prevention. The same session featured the Biomedical Prevention Implementation Collaborative, which aims to do more in parallel so the missteps of PrEP introduction aren’t repeated for new interventions.
2. Innovation. There is perhaps no better illustration of “return on innovation” in HIV R&D than the COVID-19 pandemic. “HIV vaccinology has literally paved the way for COVID vaccines,” Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH), said during the opening plenary. Two areas IAVI and our partners have championed — HIV bnAb discovery and optimization and structure-based vaccine design — shined bright at HIVR4P. The long-awaited results of the two NIH-sponsored antibody-mediated prevention (AMP) trials, though nuanced, mark the first demonstration of the protective power of HIV bnAbs in humans; suggest that bnAb cocktails can and should be formulated; and provide important direction for HIV vaccine research. To that end, IAVI and Scripps Research announced promising Phase I study (IAVI G001) results showing that 97% of participants receiving a next-generation HIV vaccine candidate developed rare immune cells needed to start the process of generating HIV bnAbs. The multi-step development process will next harness mRNA technology, a game-changer for COVID-19 vaccines, to deliver the immunogen used in IAVI G001, followed by design and testing of additional, stepwise immunogens. Also in the pipeline are multi-purpose tools, which would combine an HIV prevention method such as the WHO-recommended dapivirine vaginal ring, for example, with birth control to help protect women against both HIV and pregnancy.
3. Community-rooted science. To achieve impact, all these innovations must prove to work for disproportionately affected communities, or key populations, who account for 62% of new HIV infections worldwide, according to UNAIDS. “The work that we all need to do — with and for, and in partnership with, key populations across the continent [Africa] — really is the undone work in HIV,” said Chris Beyrer, M.D., Desmond M. Tutu Professor of Public Health and Human Rights at the Johns Hopkins Bloomberg School of Public Health. His remarks came during an African key populations-focused satellite symposium co-hosted by IAVI, the Men’s Health Research Consortium, and the U.S. Military HIV Research Program. This was one of three showcasing work by the IAVI-Africa clinical research center partner network, which is supported by the U.S. Agency for International Development through the U.S. President’s Emergency Plan for AIDS Relief. A separate session introduced revised WHO/UNAIDS ethical guidance for HIV prevention trials, including changes to promote inclusion of key populations, attention to social and political contexts of vulnerability, access to PrEP during prevention trials, and post-trial access to proven prevention methods. “We must create a research climate that shows respect for all people,” said Elizabeth Bukusi, Ph.D., senior research officer at Kenya Medical Research Institute (KEMRI).

So, where does this leave us: the verge of a prevention innovation revolution or miles away from the finish line? The answer likely lies in the collective ability to execute in a fourth area, something Mark Feinberg, M.D., Ph.D., president and CEO of IAVI, calls “the science of partnerships.” The consensus expressed throughout HIVR4P by activists and CEOs alike is that we have a lot of work to do, and no one person, organization, or country can do it alone. Said Nyasha Sithole, regional lead for Young Women’s Advocacy Leadership, and Training, ATHENA Network: “Together we can do more, and we can do it now.”

Learn more about IAVI’s presence at HIVR4P, and watch an overview of the IAVI G001 trial results.

1. aidsmap: Nearly a million have started taking PrEP worldwide – only a third of UNAIDS’ 2020 target
2. aidsmap: A triumph for injectable PrEP, but a sobering result for oral PrEP