Developments in the HIV Biomedical Prevention Pipeline & PrEP Implementation Issues
An Update for Community Educators and Advocates
The European AIDS Treatment Group published a report covering two online discussions on the HIV biomedical prevention research & PrEP implementation issues for community educators and advocates. The report covers developments from the PREVENIR Cohort study, on long-Acting intramuscular PrEP, DoxyPEP, vaccine, as well as STI-PEP research. It also reviews challenges in the uptake of PrEP among women and in particular migrant women from sub-Saharan Africa and trans people.
The More We Know: Evolving our understanding of PrEP for cisgender women
Science and real-world experience continue to demand a re-assessment of our collective understanding of the safety and effectiveness of PrEP options for women, including oral, vaginal ring, and injectable options. For instance, a new paper in the Journal of the American Medical Association by Dr. Jeanne Marrazzo (HIV Pre-Exposure Prophylaxis with Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women) challenges the notion, baked into policies, programs and “conventional wisdom”, that cisgender women need to be “super-adherers” to achieve protection utilizing oral PrEP. In this webinar, we discussed this important paper and more.
Speakers: • Dr. Jeanne Marrazzo, National Institute of Allergy and Infectious Diseases • Joyce Ng’ang’a, WACI Health
MOSAIC Global PrEP Learning Network – Building a Brand for PrEP: Positioning PrEP in the Hearts and Minds of Young People
With choice of PrEP products on the horizon – including oral PrEP, the PrEP ring, and injectable cabotegravir for PrEP (CAB PrEP) – PrEP marketing and demand generation must evolve with the availability of new PrEP products. Young people, in particular, need PrEP demand generation campaigns tailored to their needs and aspirations. In this webinar, we will hear from teams working to change the landscape of PrEP marketing by applying private sector approaches to brand the PrEP category. We will also hear how they are developing fresh, dynamic, and evidence-informed campaigns to increase PrEP awareness and encourage PrEP use among young people in Africa.
This webinar is being hosted by PEPFAR, USAID, and MOSAIC.
Cumulative PrEP Initiations
2016-2025
In 2020, the world missed the UNAIDS’ goal of reaching 3 million PrEP users. The updated target for 2025 is 10 million. Is the 2025 target achievable based on the current trends in PrEP uptake? Excerpted from an issue of PxWire.
PxWire Volume 14, Issue No. 1
A Quarterly Update on HIV Prevention Research
PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events.A PDF version of this report is also available.
Progress in PrEP Uptake
In 2020, the world missed the UNAIDS’ goal of reaching 3 million PrEP users. The updated target for 2025 is 10 million. Is the 2025 target achievable based on the current trends in PrEP uptake? Applying an Autoregressive Integrated Moving Averages (ARIMA) model to data from the Global PrEP Tracker since Q3 2016, we forecasted cumulative PrEP initiations through 2025. Based on this model, the world will surpass 10 million global cumulative PrEP initiations by Q1 2025, and by Q4 it will reach 12.4 million. This data reflects oral PrEP initiations, not continued use.
PrEP users and PrEP initiations are different. Data on initiations do not distinguish between new versus repeat PrEP users. We are unable to predict if the UNAIDS goal of achieving 10 million PrEP users by 2025 will be successful. This forecast shows the possibility and the promise of current momentum. But fulfilling this promise is not certain. It depends on overcoming key challenges around access and choice.
These updates from AVAC’s Global PrEP Tracker analyze trends and showcase data reflecting Q4 2023 updates.
Global Milestones from October-December 2023
The PrEP Tracker documented 6,220,507 cumulative initiations of some form of PrEP worldwide: 6,216,310 oral PrEP (including TDF/FTC, event-driven oral PrEP, and F/TAF), 2,695 injectable cabotegravir (injectable CAB), and 1,502 dapivirine vaginal ring (DVR).
Global PrEP uptake increased by about 500,000 PrEP initiations this quarter, modestly slower than in the last two quarters. Last year at this time, global PrEP initiations stood at 3.8 million, so this year’s increase demonstrates relatively high uptake compared to the previous year.
Country-level Milestones
South Africa surpassed 1.3 million oral PrEP initiations; Zimbabwe surpassed 250,000 initiations. In less than a year, Malawi more than doubled its oral PrEP initiations and now stands at over 100,000. Rwanda surpassed 30,000, Cote d’Ivoire surpassed 20,000, and Sierra Leone surpassed 10,000 initiations.
Other countries outside of Africa had modest increases in oral PrEP uptake: Brazil counted over 150,000 initiations; the Philippines surpassed 20,000 initiations.
PrEParing for New Products
Product Updates
In February, Zambia launched its injectable CAB program, making it the first country outside the US to include injectable CAB in its HIV prevention services. And the Desmond Tutu Health Foundation in South Africa also announced “the first jab” of injectable CAB administered in its FASTPrEP study. As these programs get underway, more country approvals and product launches are anticipated.
This quarter, Namibia approved the dapivirine vaginal ring (DVR), bringing the total to 11 approvals in the region.
Uruguay approved F/TAF (Descovy). Additionally, Descovy is under review in Mexico.
PrEPWatch added 35 new country pages detailing the status of drug registration for PrEP products, data on PrEP initiation by product, country-level PEPFAR targets, and links to key policy documents and guidelines.
At ICASA, the Population Council presented preliminary results from a dual prevention pill (DPP) acceptability study with adolescent girls and young women (AGYW) in Zimbabwe. The study found 2/3 of participants preferred a proxy for the DPP (which combines contraceptives and PrEP) compared to 1/3 who preferred taking oral PrEP and oral contraceptive pills separately. Results from another DPP acceptability study in South Africa are forthcoming and the HPTN 104 study is expected to kick off later this year, expanding the evidence on end-user experiences.
Alongside oral PrEP, introduction of the dapivirine vaginal ring (DVR) and injectable cabotegravir (CAB) will play a role in the scale of PrEP uptake. At least 1.2 million vials of CAB are now available for procurement and prevention programming in low-and middle-income countries over the next two years. At the same time, one million vaginal rings are projected to be distributed over the next two years. But even with these additional options, oral PrEP will continue to play a big role in PrEP uptake in the short term.
For a full global perspective on product introduction, check out the Integrated Study Tracker and Country Planning Matrix and see our graphic on the status of implementation scient studies on the next page.
The Latest R&D in the Prevention Pipeline
In 20 years of research and across 12 trials, only two positive signals have been observed in HIV vaccine and antibody studies.
In December 2023, the PrEPVacc team announced no efficacy from the vaccine candidates in the study. This was folowing a review by the independent data monitoring committee. PrEP interventions in the study, comparing TAF/FTC (Descovy) to TDF/FTC (Truvada) will continue. The termination of vaccine arms of the PrEPVacc study represents the most recent HIV vaccine or antibody trial to end without efficacy.
Ensuring equitable access to safe, effective, and affordable vaccines involves advocacy across multiple areas. AVAC covers the issues in a series of advocates’ guides, From the Lab to the Jab.
Prevention Playlist
AVAC develops a wide range of materials and resources to inform decision making and action. Check out the latest:
Basics of Injectable Cabotegravir for HIV Prevention
This wide-ranging presentation introduces advocates to cabotegravir injectable PrEP. The slides provide a background on clinical research, what users think, regulatory status and prepares advocates for implementation.
Coalition to Accelerate Access to Long-Acting PrEP
The Coalition to Accelerate Access to Long-Acting PrEP is an initiative that brings together leading donors, agencies, and advocates to ensure an accelerated, equitable, sustainable and collaborative approach to making longer-acting PrEP options accessible as quickly and as equitably as possible. The Coalition is convened by Unitaid, WHO, UNAIDS, Global Fund and PEPFAR, with AVAC as the Secretariat.
Coalition to Accelerate Access to Long-Acting PrEP
The Coalition to Accelerate Access to Long-Acting PrEP brings together leading donors, agencies, and advocates aimed at a practical goal: jointly develop strategies and take coordinated action to identify and overcome access challenges to just-approved and future PrEP options. AVAC serves as the Secretariat.
What is PrEP Access Right Now and What’s Next in 2024?
AVAC is thrilled to see the launch of injectable cabotegravir for PrEP (injectable CAB) in Zambia—the first program outside of the US to do so. And the Desmond Tutu Health Foundation in South Africa recently announced “the first jab” of injectable CAB administered in its FASTPrEP study.
Webinars to Look Out for in February!
2024 is off and running and a slew of webinars are on the calendar. This selection of topics is both broad and deep, providing updates on the pipeline from cure to vaccines, insights on critical advocacy, a conversation with the new director of NIAID, and opportunities for you to engage. Scroll down for what’s coming up and recordings of webinars from December and January that you may have missed.
WACI Health and The Choice Agenda invite you to join us for a webinar introducing key initiatives of the Africa CDC and the African Union. It will illuminate roles for civil society and community engagement. Register here.
Join The Choice Agenda for an overview of the newest cycle of the Adolescent Medicine Trials Network! This webinar includes highlights of: ATN 165: Linking Youth to PrEP Services, which tests an innovative mobile delivery and mHealth intervention for PrEP adherence and persistence among sexual minority men; ATN 167: Legal, Economic, and Affirming Peer Support (LEAP) for transgender and gender diverse youth; and how the network prioritizes and amplifies the voices of youth directly impacted by the ATN’s pivotal research. Register here.
This webinar is intended for anyone interested in applying to participate in AVAC’s Advocacy Navigator program. The session will provide an overview of the program, expectations, eligibility, and application process, followed by Q&A with the AVAC team.
Through the Media Science Café Program, AVAC partners with health media associations in Kenya, Tanzania, Uganda, Zambia and Zimbabwe to bring journalists together with researchers, implementers, civil society, policy makers, regulators and policy makers to build relationships that will foster accurate reporting of HIV, COVID and other science or health stories in those countries. Learn about the model! Recording, slides and resources.
This webinar reviewed key aspects of PrEPVacc, including its innovative study design, implementation, integrated social science, and data analysis plans. An engaging conversation about what we’ve learned from PrEPVacc, what we can still learn, and what this may mean for the HIV prevention field. Recording, slides and resources.
Check out our 4-part webinar series on cervical cancer, which featured a deep dive on: what cervical cancer is, who is impacted, and prevention and treatment options; advocacy strategies to bring more attention to cervical cancer and its impact on communities; options for screening and treating cervical cancer along with ongoing research; and the impact of cervical cancer on key populations and those vulnerable to HIV infections. Recording, slides and resources.
Learn more about the townhall discussion on Black Gay Men and HIV in the US featuring influential figures in the Black Gay community, including Ace Robinson, Daniel D. Driffin, and Kenyon Farrow by checking out highlights on AVAC’s Twitter page and watch the full recording.
Thanks for checking out these conversations. We hope you will join us in these rich discussions and watch this space for future webinars!
