Bernadette Hensen

The session included three presentations (one was cancelled) covering what we know about PrEP, from trials of efficacy to effectiveness and impact, what novel next-generation PrEP is in the pipeline, and a discussion about design choices of trials of novel delivery of ARV-based prevention.

Jared Baeten provided an overview of oral PrEP from efficacy trials, open label studies to implementation and scale-up. The >12 clinical trials with >20,000 participants across countries have shown that high adherence translates into high protection. Open label studies demonstrated effectiveness and PrEP was implemented at scale. Uptake has been low, but changing messaging and normalisation have increased uptake. Nyaradzo Mgodi stated that the success of PrEP “depends on adherence, access and preferences”. The Dapivirine vaginal ring, long-acting injectable PrEP, subcutaneous PrEP implants and broadly neutralizing antibodies are new in the PrEP pipeline. David Glidden asked why HPTN083, a study to evaluate efficacy of the long-acting injectable agent, cabotegravir, for PrEP has many more participants than previous PrEP studies. David argued that alternative assumptions are needed when designing studies where the aim is to determine whether the product works and could be an alternative to, rather than replace, oral PrEP.

Progress has been made in providing access to PrEP, but uptake is slow in many settings. Messaging around PrEP needs to change, Jared Baeten points out that messaging should address anxiety, fears, and increased sexual pleasure: “Sex without fear is extraordinarily powerful and has nothing to do with p values”. Stigma and lack of information, including among providers, need to be addressed if we are to increase uptake. People need choices though, and the pipeline of alternative PrEP delivery methods is exciting as they would provide people with different options at different times in their lives.

Pedro Carneiro

This session reported the current state of PrEP in scientific and real-life settings. The discussion included a dynamic review of the progress observed in PrEP cohorts across settings and populations, a look into the current and upcoming innovations in HIV prevention tools and a statistical discussion about sampling future trials.

Jared Baeten provided a review on the science and implementation of PrEP worldwide, underscoring the importance of adherence for optimal efficacy. However we are still short of the UNAIDS goals of linking 3 million persons to PrEP by 2020. Increased awareness and the roll-out of alternatives to daily PrEP could mitigate this. Nyaradzo Mgodi reviewed all currently available modes of biomedical prevention from daily PrEP to the dapivirine vaginal ring and implants. She also spoke about long term injectables, and raised concerns about fear of competition between dATP and Tenofovir. Cabotegravir studies are seeking to address this issue. David Glidden described the sampling method called 90/50 in discussing the future of sampling in prevention trials. Both DISCOVER and Cabotegravir studies have 3 times the sample size of the iPrEx study. Future research will seek further alternatives to Truvada.

This sessions was incredible in highlighting and reviewing in detail all the scientific achievements and real life implementation of PrEP around the world. Additionally we were able to take a look into the upcoming HIV prevention devices and methods, and understand the complexities in rolling these out. From a standpoint of study design, we were able to learn the implications of having daily PrEP as a standard of care when considering an alternative substance to study.