Avac Event

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

Moderator:
Raniyah Copeland, Equity & Impact Solutions

Materials:
Recording / Ukrainian AudioSlides / Resources / Audio Transcript (English/Ukrainian)

Avac Event

Updates on Pediatric HIV Cure Research From CROI

Researchers Deborah Persaud and Gabriele Cromhout join AVAC’s Jessica Salzwedel to discuss the latest from CROI on pediatric cure.

Recording / Gabriele Cromhout Community Slide

CROI Roundup – Highlights from Monday

The highs and lows of great science but profound inequities were front and center on the first official day of CROI 2024.

Avac Event

STI Awareness Week Webinar Series (April 16 and 18)

Syphilis in the US: The current state of the epidemic and how it’s being addressed  

Tuesday, April 16, 1:00PM ET

This webinar examined the current state of the syphilis epidemic in the US and how the National Syphilis and Congenital Syphilis Syndemic Federal Task Force is addressing the response.  

Speakers included: Kate Miele and LCDR Neelam Gazarian 

This webinar was co-hosted with ASHA (American Sexual Health Association).

Recording / Slides

DoxyPEP: Prevention, effectiveness, and AMR

Thursday, April 18, 3:00PM ET

This webinar focused on sharing the latest scientific insights on DoxyPEP, its effectiveness in preventing STIs, and considerations around AMR.  

Speakers included: Fabian Kong, Annie Luetkemeyer, and Connie Celum 

Recording / Fabian Kong Slides / Connie Celum Slides

Sexually Transmitted Infections: What You Should Know About STIs and Testing

Friday, April 26, 10:00AM ET

AVAC and ASHA hosted a webinar to discuss STIs and testing with Chase Cannon, MD, MPH and Stacey Grinder, PhD, MPH.

Recording

CROI Roundup – Highlights from Monday

The highs and lows of great science but profound inequities were front and center on the first official day of CROI 2024. From increasing data on demonstrating the efficacy of DoxyPEP (doxycycline as post-exposure prophylaxis) against some sexually transmitted infections (STIs); and advances in the promise of long-acting PrEP; to data that reinforces the reliability of affordable rapid testing to screen for HIV— Monday showcased vitally important scientific insights.  

Sessions throughout the day, as well as at Sunday’s opening session, reminded all participants that every one of the scientic advances presented at CROI will fail, unless the voices of people who need solutions are heard, amplified and elevated and allowed to lead the discussions.  

Social and behavioral researchers discuss equity with R&D during CROI Community Breakfast Talk   

Monday’s Community Breakfast Club focused on social and behavioral science at CROI – disciplines that have often been marginalized. Speakers pointed out the ongoing need for more of this essential research at CROI. “As much as we try to discover new devices, they need to reach people to have impact. For example, long acting injectables have not worked in real life because we’ve neglected the complexity of rolling [them] out,” said LaRon Nelson, of the Yale School of Nursing. And Sari Reisner, an epidemiologist at the University of Michigan underscored that the outcomes of research are directly tied to the level of involvement from communities whom research is ultimately meant to serve. Don’t miss two more days of programming, sign up here

The HIV vaccine search continues 

Barney Graham and Julie McElrath both provided overviews of three decades of HIV vaccine research, and its current status. Graham explained in his opening session Fields Lecture how insights on HIV structure paved the way for rapid understanding of the SARS-COV-2 and resulting vaccines.  

And in her Monday plenary, McElrath summarized the collective knowledge gained from the ten vaccine efficacy trials that have been conducted over the past 20 years. (And check out our new summary graphic of the efficacy trials to date.) She then outlined the key strategies now moving forward–inducing broadly neutralizing antibodies (bNAbs), inducing supplementary CD8+ T-cell responses, and delivering bNAbs as passive protection while learning about vaccine design. Further sessions dug into finer details of early-stage investigations—updates on germline-targeting trials, which use a series of vaccines to prompt the body to develop precursors that lead to bNAbs; and newer adjuvants that enhance the germline targeting strategy 

Even longer long-acting PrEP products? 

A longer-acting injectable cabotegravir for prevention (injectable CAB) has made it through a phase 1 safety and tolerability study. ViiV, the maker of the currently approved injectable cabotegravir, presented findings on a new formulation that could double the time between intramuscular jabs, from two to four months, potentially making it a three-dose annual intervention, instead of six doses.  

Merck also presented data on the safety and pharmacokinetic profile of MK-8527, a product that they are hoping to develop as a monthly pill to prevent HIV. They reported the dose was safe, well-tolerated and sufficient to show anti-viral activity against HIV. The product is currently in a phase 2 trial in several countries globally; and later phase studies would be needed to demonstrate efficacy. Check out our prevention product timeline here

DoxyPEP brings down incidence of some STIs. But what else do we need to know? 

Studies corroborated the promise of DoxyPEP to bring down STIs. The DoxyVAC study showed reduced incidence of chlamydia and syphilis and some reduction of gonorrhea. But a vaccine against meningococcal disease (the 4CMenB vaccine) did not show a reduction in gonorrhea incidence, which was seen in an earlier phase of the research. Studies out of San Francisco of men who have sex with men and trans women showed a high demand for DoxyPEP among PrEP users and STI incidence decline. But there remain many questions on DoxyPEP. More data is needed for use among cisgender women, as well as research among communities in low-income countries. Many researchers and advocates are calling for more data on DoxyPEP’s potential to increase antimicrobial resistance (AMR)—which needs more attention as guidelines accelerate DoxyPEP use. Join us in April for an STI Awareness week webinar series where Fabian Kong, Annie Luetkemeyer, and Connie Celum will lead a discussion on AMR, DoxyPEP and more. Sign up here to receive updates, www.avac.org/signup

Can we eliminate HPV? 

In what proved to be one of the most elegant plenaries ever delivered, Nelly Mugo from the Kenya Medical Research Institute (KEMRI) provided a remarkable presentation on Shall We Reach Human Papillomavirus Elimination in the Face of Inequity? Her presentation reinforced the essential need to link the best possible science with deep and durable community engagement. And it was quite fitting that she delivered her talk on HPV Awareness Day, when AVAC, TogetHER for Health and partners launched a call to action for global leadership to increase access to lifesaving HPV vaccines for people living with HIV. 

Stay tuned for more updates from AVAC as we track the research and discussion at #CROI2024, and don’t forget to join us Tuesday and Wednesday for the Community Breakfast Clubs

Avac Event

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.
  • Peru, Nigeria, Thailand, and Uganda have approved injectable CAB.
  • Injectable CAB is under review in the United Kingdom, Cote d’Ivoire, Mozambique, Rwanda, Tanzania, and Canada. CAB was granted WHO prequalification status, finding it to be safe, effective, and supported by studies.
  • 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:

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Join us for CROI 2024!

AVAC and partners have worked to follow and explain the research presented at CROI for many years, making the science more accessible, connecting the findings to community priorities, and ensuring civil society and affected communities are represented within the program, and ultimately the research.

Join us at CROI 2024!

Dear Advocate, 
 
The 31st annual Conference on Retroviruses and Opportunistic Infections (CROI) kicks off this weekend, and runs from March 3-6 in Denver, Colorado. CROI is the go-to forum for groundbreaking science in the HIV field, and this years’ program is full of exciting new research.  

At AVAC, we’re tracking data and discussion on long-acting, injectable PrEP; the dapvirine vaginal ring (DVR) in pregnancy; doxycycline as post-exposure prophylaxis (DoxyPEP) to prevent sexually transmitted infections (STIs); and the latest in HIV cure and control. We’re also very excited for this year’s Martin Delaney Presentation – Unveiling the Power of Uganda’s LGBTIQ Advocacy in Shaping HIV Response and Health Care Access – that will be delivered by Frank Mugisha of Sexual Minorities Uganda (SMUG) in Uganda and couldn’t be more timely. Be sure to check out the conference program.  

AVAC and partners have worked to follow and explain the research presented at CROI for many years, making the science more accessible, connecting the findings to community priorities, and ensuring civil society and affected communities are represented within the program, and ultimately the research. For those attending or not, this email shares ways to follow along and join in the discussion and debate. 

 Follow Along 
 Be part of the conversation by following AVAC on X (Twitter) at @hivpxresearch for real-time updates using the conference hashtag #CROI2024, and be sure to sign up and follow our partner, Aidsmap, who will be reporting from the conference. 
 
Community Breakfast Clubs (CROI registration not required 
 Join the CROI Community Liaisons, AVAC, the European AIDS Treatment Group, and partners for daily Community Breakfast Clubs. These virtual webinars feature researchers and advocates discussing some of the most consequential science being presented at CROI. They are open to all, CROI registrants and non-registrants alike.  
 

Monday, 4 March, 7:00am – 8:00am MT (Click here to determine the time in your location.) 

Spotlight on Social and Behavioural Science at CROI 2024 

Tuesday, 5 March, 7:00am – 8:00am MT (Click here to determine the time in your location.) 

Living with HIV for a Lifetime – It’s Complicated 

Wednesday, 6 March, 7:00am – 8:00am MT (Click here to determine the time in your location.) 

Research Roundup: Scientists and Advocates Offer Fresh Perspectives and Seasoned Analyses of CROI 2024 Research 

Looking forward to seeing you at the daily Breakfast Club sessions and to working together to unpack the research and be sure it is applied! 

 
Best, 
AVAC