December 22, 2021
We close the year with the exciting news that injectable cabotegravir has gained FDA approval as PrEP. It’s an important achievement, adding another much needed HIV prevention option to the mix. But as we reflect on the many lessons of the year, we recognize this milestone sits within a larger, more complicated context. This regulatory approval is only one, albeit essential, step (for a single product among a much-needed pipeline of many) in a greater effort to transform options into real choices that have impact on epidemics and in people’s lives.
The story of 2021 is one of advances, disappointments, uncertainty, perseverance and solidarity. Through it all, we recognize themes that have been similar throughout AVAC’s 26-year history: follow the science, center community in the response, and lead with equity, always.
2021 brought no end to challenges in global health, and we hope that everyone finds time to reflect, and, hopefully, rejuvenate for the year ahead and the work that we hope to do collaboratively.
To start the new year right, please mark your calendars for Thursday, January 13 at 9:00 am EST for a webinar to discuss the latest ups and downs in HIV prevention, and set an advocacy agenda together for the future: Ups & Downs in the Field: Setting an Agenda Together for HIV Prevention in 2022; click here to register.
In the meantime, if you’re looking to catch-up on the year that was, planning for the year ahead, or just want to have some good holiday reading and listening, here are a few important reminders of 2021:
- On the heels of this week’s FDA approval of injectable PrEP, and with decisions from other regulatory bodies anticipated in early 2022, check out An Advocates’ Primer on Injectable Cabotegravir for PrEP and explore our Biomedical Prevention Implementation Collaborative (BioPIC) that is working to close the gap between research, regulatory approval and rollout for injectable cabotegravir and future products.
- In January, WHO officially recommended the Dapivirine Vaginal Ring (DVR) be included as a prevention choice for women at risk of HIV. The regulatory approval process has taken longer than we all wanted with various twists and turns, but happily WHO just this month restated their commitment to support countries as they consider whether to include the DVR as an additional prevention option for women.
- With the introduction of the new ring and injectable PrEP on the horizon in 2022, it has never been more important to reflect on the lessons we recently documented from the past decade of oral PrEP and their implications for these next generation PrEP products.
- Even as the new PrEP options rollout, the need to develop additional PrEP options continues. We have a full menu of resources related to the research agenda. New ethics guidelines support ongoing and future trials in an era of existing PrEP, which we reviewed earlier this year; our Px Pulse podcast series Research Fundamentals looks at the fundamental role of endpoints in trial design; our continued focus on next generation trial design includes this quick reference to critical updates on ethical guidance in HIV prevention trials; and a new fact sheet on Evolving Designs for HIV Prevention Trials that includes descriptions of new trials of the six-monthly injectable lenacapavir and once-monthly oral islatravir. Unfortunately, news in the past two weeks about holds on both the lenacapavir and islatravir trials (for very different reasons) are important reminders of the uncertainties of product development AND the enduring need for research literacy, ongoing stakeholder engagement and Good Participatory Practices to help navigate it all.
- Beyond ARV-based PrEP, what’s the future of antibody mediated prevention, following important results that were presented in January? Read our Understanding Results of the AMP Trials, and listen to our Px Pulse podcast with a Dive into the AMP Trials.
- Nothing about HIV vaccine research has ever been easy, and results of the Imbokodo study reminded us all both how difficult this research is and how essential it continues to be. Listen to our webinar from September to understand the results and their implications, and be sure to check out this special supplement on HIV vaccine R&D in the Journal of the International AIDS Society, including a number of critical articles from AVAC staff and partners. And if you want to learn even more about how HIV vaccine research paved the way for COVID mRNA vaccines—and how HIV might get paid back—be sure to watch this CNBC video with a number of leading researchers and advocates, including our Executive Director.
- Speaking of COVID-19, AVAC and many partners have spent the past two years developing the COVID Advocates Advisory Board (the CAAB), which is playing a critical role in engaging and convening essential conversations in responding to yet another pandemic. Check out the CAAB’s new website, and listen to a webinar on the global readiness for vaccine manufacturing with New York Times reporter Stephanie Nolen and another remarkable conversation on the Omicron variant with CAPRISA’s Slim Abdool Karim.
- In HIV or COVID or any area of public health, representation matters. It’s core to effective advocacy, and one of the reasons we are so excited about No Data, No More: Manifesto to Align HIV Prevention Research with Trans and Gender Diverse Realities. Developed in collaboration with trans and gender diverse activists from Cape Town to Berlin, this report takes critical steps toward a comprehensive research agenda for HIV prevention that serves trans and gender diverse people.
- Leadership also matters, which is why we are grateful to Acting US Global AIDS Coordinator Angeli Achrekar for her continued efforts to advance PEPFAR and excited about the nomination of John Nkengasong to lead PEPFAR going forward. Read more about our views here and here.
- Last but not least, 2021 got us at AVAC thinking not only about the larger field but our place in it. We undertook the most encompassing reflections on our work since AVAC was founded 26 years ago. As part of this process we reviewed our work from top to bottom and undertook a months-long process to forge a strategy for the years ahead that will advance HIV prevention in the broadest context necessary to advocate for global health equity. We are proud to share with you our strategic plan through 2026 and our commitment to equity, diversity and inclusion. We also issued a preview of our 2021 AVAC Report: Developing Options, Delivering Choices, which describes the concerted actions needed to transform prevention “options”, developed through research, into prevention “choices” that reach the people who need them most.
What a year—and what a “to do” list for our ongoing collaborations with all of you! We look forward to working with you to understand how the field is evolving, where it’s stuck, and what we will do together to advance HIV prevention and drive global health equity forward—so please do register to join us on Thursday, January 13 at 9:00 am EST to discuss the latest ups and downs and set an advocacy agenda together for the future.