HIVR4P Ushers in 'Next-Gen' Prevention

CHICAGO — The next generation of biomedical HIV prevention will be a hot topic here at HIV Research for Prevention (HIVR4P) 2016.

Long-acting novel antiretrovirals delivered through shots or implants, vaginal rings loaded with antiretrovirals and hormonal contraception, infusions of antibodies against HIV, and new HIV vaccines are all on the table — and in the works — said Myron Cohen, MD, director of the Institute for Global Health and Infectious Diseases at the University of North Carolina in Chapel Hill.

"HIV prevention in 2016 is a new ball game," Dr Cohen told Medscape Medical News. "This is not about giving out more condoms and giving them out better. We're much more concerned now about the who, what, when, where, why, and how of HIV prevention, and about creating more tools for the people at greatest risk."

Dr Cohen, principle investigator of the groundbreaking HIV Prevention Trials Network (HPTN) 052 study on the ability to reduce transmission through treatment, will be speaking at the conference's opening plenary. His topic? What's next.

Using PrEP in Prevention Trials

HIV prevention is at a crossroads: a flurry of trials begun more than a decade ago have reported final results, and results from a half dozen new trials set to begin before the end of 2017 won't be reported until the 2020s.

The oral PrEP combination of tenofovir disoproxil fumarate and emtricitabine (Truvada, Gilead) has received approval in the United States, South Africa, and other countries, and has been codified in HIV prevention recommendations from the World Health Organization and the Centers for Disease Control and Prevention (CDC).

As new HIV prevention trials begin, oral PrEP must be offered as a backup method of prevention to participants, said Mitchell Warren, executive director of the HIV advocacy group AVAC, and a member of the HIVR4P organizing committee.

This changes fundamentally how HIV prevention trials work, he told Medscape Medical News.

For instance, studies might need larger cohorts to account for participants who elect to use PrEP. This could yield insights into PrEP adherence, even though that will not be the primary end point of those studies.

"These trials are happening in a dynamic space," Warren said. "This creates complex challenges and exciting times in HIV prevention research."

It should come as no surprise, therefore, that the noncommercial satellite conference, held in advance of the scientific program, will feature a symposium on designing clinical trials in the era of oral PrEP.

In addition to grappling with the future of HIV prevention trials, HIVR4P will build on findings presented at previous conferences, such as the Conference on Retroviruses and Opportunistic Infections (CROI) and the International AIDS Conference, said Sharon Hillier, PhD, from the University of Pittsburgh, who is also a member of the organizing committee and who cochaired the first HIVR4P meeting in 2014.

For instance, nearly a dozen presentations will build on the ASPIRE trial and the Ring Study, both of which tested a flexible vaginal ring loaded with dapivirine, the topical antiretroviral for HIV prevention. Data showing the ring to be moderately effective were reported at CROI, but a subanalysis of people who reported better adherence, presented at the International AIDS Conference, showed the ring to be effective more than 75% of the time.

Researchers will report on the effect of the ring on drug resistance, cervical abnormalities in participants, and social harms in the ASPIRE trial. And, of course, data on adherence, both qualitative and quantitative, will be presented.

Next-generation vaginal rings loaded with dapivirine and hormonal contraceptives will be discussed during sessions on the pharmacokinetics of so-called multipurpose technologies related to HIV, pregnancy, and herpes simplex virus.

"Rings that include an antiretroviral and a contraceptive are a big emphasis among next-generation products for women," said Dr Hillier, who is principal investigator of the Microbicide Trials Network, which is running ASPIRE and other trials. "I just attended a consultation with young women from South Africa, Zimbabwe, and Kenya, and the message was clear: 'We want a product that will do both'."

There will also be reports on the use of cabotegravir as a long-acting PrEP injection and on the role of anti-HIV antibodies in vaccine development.

In addition, researchers from Canada and the United Kingdom will present data on the effect of specific vaginal bacteria on HIV prevention agents that are even newer than the data presented at the International AIDS Conference.

But new technology won't matter if it does not get to the people who need it, Dr Cohen explained.

Investing in Implementation

A number of posters will focus on the translation of science to the clinic, covering areas such as the leveraging electronic health records to improve early HIV diagnosis, HIV vaccine trials, and lessons learned from PrEP demonstration projects around the world.

And in an oral presentation, researchers from the United Kingdom will present hopeful data on the effect of antiretroviral therapy for people living with HIV and on new cases of HIV in men who have sex with men in Baltimore.

The presentation comes on the heels of a CDC report that the HIV rate is dropping slightly in the United States, but not in specific populations, such as men who have sex with men.

Lessons learned by Kenyan officials and healthcare providers who have put a risk-based HIV prevention approach in place at scale will be presented during an implementation session.

The combination of research into novel prevention approaches and real-world experiences with these strategies makes HIVR4P unique among HIV conferences, Warren explained, because advocates and researchers work together to find solutions to the global epidemic.

"For a long time we thought research and development was the science, and once we had that, then the solution for implementing it would magically appear. That's not the case," he pointed out. "I'd argue that research into effective implementation is as important, if not more important, than the initial efficacy data," Warren said. "It's not enough to develop new technology. We've got to figure out how to deliver it."

Dr Cohen reports receiving advisory board honorariums and/or travel reimbursement from Janssen Global Services, Roche Molecular Systems, and Merck Research. Mr Warren and Dr Hillier have disclosed no relevant financial relationships.

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Cite this: HIVR4P Ushers in 'Next-Gen' Prevention - Medscape - Oct 12, 2016.