Colleen Kelley

It’s an exciting time in HIV prevention. This session covered the many neutralizing antibody and antiretroviral based prevention products in the development pipeline including long-acting products and novel delivery methods. Understanding how and why people at risk for HIV might use these new products is paramount to achieving efficacy.

The HIV prevention field is anxiously awaiting results of the fully-enrolled AMP studies that are testing the efficacy of passive infusion of a monoclonal broadly neutralizing antibody (BnAb; VRC01) for HIV prevention. Several next generation BnAbs with longer half-lives, higher potency, and combination antibodies to expand coverage of diverse HIV isolates are also in earlier phase trials. Concurrently, long-acting cabotegravir injected every 8 weeks compared to daily TDF/FTC for PrEP is also in ongoing global efficacy trials. Novel delivery methods of long-acting antiretroviral products including a TAF implant and cabotegravir microneedle patches are in development. The session closed with an update on topical and on-demand products including the dapivirine ring that showed approximately 30% efficacy in women as well as antiretroviral gels, douches, films, inserts, and multipurpose prevention products combining contraceptives with other prevention drugs. Finally, factors influencing uptake, delivery, and community acceptance of new prevention products were considered.

As of today, the only biomedical product available for HIV prevention is daily or on-demand TDF/FTC. Availability of multiple products with various modes of delivery and dosing strategies will enable choice in HIV prevention, which is absolutely paramount to achieving population efficacy. BnAbs and long-acting ART agents may be excellent options for those at ongoing risk who prefer products that do not require daily adherence, while on-demand products could be most useful for those at episodic risk. Ultimately, scientific advances will provide the options; communities and end-users will decide which products are the right products for HIV prevention efficacy.

Nicolette Naidoo

This session reviewed new biomedical HIV prevention products under development and examined data on their safety, pharmacokinetics, and efficacy. Data was also presented on the rationale for new product development and emphasized the need and approaches to incorporating end-user engagement in the development of new products.

Dr. Nyaradzo Mgodi presented data on the development of broadly neutralizing antibodies (BNAbs). AMP studies assessing safety, tolerability, and efficacy of VCR01 infusion shows high retention (96%) and adherence (up to 100%) but a next-generation monoclonal antibody (VCR07) shows higher potency at lower plasma concentrations. Dr. Myron Cohen reflected on the development of long-acting Cabotegravir (LA CAB) where HPTN 083 and 084 will examine the safety and efficacy of LA CAB vs. TDF/FTC for PrEP in HIV uninfected. Charles Flexner talked about LA prevention implants and transdermal delivery systems highlighting bio-erodable and inert implant candidates which have entered the clinical trial phase. Look out for the microneedle patch. Prof Jared Baeten affirmed that the PrEP pipeline is diverse but prevention technologies must integrate into life cycles and meet the varying contraception and prevention needs through MPTs or PrEP on demand. "Choice = Use but robust science on choice is needed."

This session highlighted the critical role of innovation in science. Prevention needs will vary based on the needs of those accessing interventions i.e. age and gender-targeted approaches but most of all investment for more prevention tools, people-oriented and collaborative approaches will enable us to stock the pipeline with options and ensure the success of the implementation. The session acknowledges planning for implementation of prevention technologies and the importance of answering key questions around STIs and efficacy.