A Round Up From CROI 2022

The 2022 Conference on Retroviruses and Opportunistic Infections (CROI) concluded last week with dynamic sessions that put a spotlight on where and how HIV prevention must do better. It’s no surprise to many advocates that the answers involve a comprehensive commitment to informed choice, comprehensive & integrated responses, and the central importance of community-led interventions. These themes could be found throughout sessions from both weeks of CROI. Check out our highlights from week one for updates on the Dapivirine Vaginal Ring (DVR), injectable cabotegravir (CAB) for PrEP, vaccine science, cure research and more. And read on for highlights from the second week of CROI and from the Margarita Breakfast Club (check out the full MBC program and recordings here).

Week two of CROI covered key topics such as pioneering research on prevention of sexually transmitted infections, strategies to reach key populations, and the all important priority of choice at this historic juncture when two new HIV prevention options have been approved, the ring and injectable CAB.

CHOICE CHOICE CHOICE

The symposium, Bringing Choice in HIV Prevention, looked closely at how investing in healthcare systems, enhancing trust in providers, and offering an array of effective choices could meaningfully overcome some of the most significant barriers to delivering HIV prevention at scale.

Hyman Scott from the San Francisco Department of Public Health pointed to 2021 data from the US, where oral PrEP use is among the highest in the world, showing that only 25 percent of the population eligible for PrEP is using it. Those numbers plummet for women (10 percent), and for people who are Black (9 percent) or Latino (16 percent). Hyman said providers play a pivotal role as people seek an affirming, non-judgemental encounter with providers and look for them to “open the door to improve their engagement around their sexual health needs.” If those providers then connect people to real choices, it’ll lead to major advances in HIV prevention. Hyman also discussed data from a two decade study on contraception use, showing that each new option was associated with 4-8 percent increase in uptake. Data from the REACH Study, referenced in Scott’s presentation and in our round up from the first week of CROI, showed that people will act on diverse preferences for different forms of HIV prevention if given the opportunity.

Dominika Seidman from the University of California San Francisco offered another model from the field of contraception, a history lesson, and a warning. As long-acting contraceptives became available, a protocol referred to as “tiered effectiveness” instructed providers to emphasize efficacy above all else. Seidman reported that this method fueled mistrust as women experienced providers pushing one method over another. “The family planning world has been playing catch up ever since.”

Seidman offered three models for provider counseling, and flagged a clear favorite. “Method promotion” prioritizes one product based on its characteristics. “Informed choice” offers a menu of options with no guidance on how to choose among them. Seidman laid out the advantages of a third model for provider counseling, “shared decision-making”. Seidman said under this approach, providers offer information, elicit user preferences, facilitate decision-making, leave the door open for changes in plans and priorities, and foster trust in the relationship and in the broader health-care system. “Effectiveness is not the only variable people care about, in some cases it’s not even the primary one,” said Seidman.

The presentation by Kenyon Farrow of PrEP4All echoed the role of choice and the urgent need to establish trust between the users of HIV prevention and providers. “We have a trust problem and it’s getting worse,” said Farrow pointing to US data on the loss of public trust in health authorities since 2009. “We need to invest in this as much as in research and development.” Farrow called for research on practices that combat misinformation, more comprehensive efforts to demystify clinical research, greater support in navigating health systems, innovative public health campaigns, expanded community advisory bodies, and deep investment to improve the relationship between people and their providers.

STIs Are Part Of The Picture, Too

CROI 2022 put renewed attention on the six-year trend of increased sexually transmitted infections seen in the US and other countries. At the symposia, Sexually Transmitted Infections: Reversing the Tide, presenters explored the intersection with HIV prevention and provided updates on research in STI vaccines and drug-based prevention.

Leandro Mena of the US Centers for Disease Control and Prevention shared recent US data, where surveillance is strong, showing, for example, gonorrhea is up 10 percent since 2019 and 44 percent since 2016. And syphilis is up 3 percent since 2019 and 52 percent since 2016.

Sinead Delany-Moretlwe of Wits RHI in South Africa, in a presentation on the case for STI vaccines, said one million cases a day of curable STIs burden people, communities and governments. HIV and other STIs are tied to the same risk factors. An STI, in and of itself, increases the likelihood of HIV infection. But even more compelling, obtaining prevention or treatment for an STI is a critical opportunity for someone to be connected with HIV services for prevention or treatment.

The message from the session moderator, Connie Celum of the University of Washington: attention to better STI prevention is long overdue. What’s needed are better diagnostics, continued commitment to research on vaccines and anti-microbial prevention strategies, and access to affordable and integrated services in non-traditional settings. To be effective, interventions must go beyond past approaches, develop a paradigm where overall health and well-being are at the center of the response. “That’s the key to turning around the increase in STIs” said Mena.

The US launched its first STI national strategic plan in 2020, and its emphasis on raising awareness and making screening and treatment more accessible are a step on this path, more tools and advocacy for a community-led response remain urgent. Among those needed tools are vaccines. Delany-Moretlwe provided an update on the STI vaccine pipeline.

Lessons from a three dose vaccine for human papillomavirus (HPV) first approved in 2006 offered important context. Though highly effective, fewer than 5 percent of countries have succeeded in reaching target numbers of people at risk with the three dose vaccine, with delivery challenges hampering uptake. Delany-Moretlwe said research is moving in the right direction with several studies showing efficacy with a single dose HPV option, expected to be simpler to deliver. WHO is reviewing that data now. In addition, a host of studies are looking at therapeutic HPV vaccines. But effectiveness will not be decided by the efficacy seen in the data. Product attributes, such as the dosing schedule, will be critical considerations for any product to reach those who need it.

Delany-Moretlwe also described a proof-of-concept study for a gonorrhea vaccine that was developed after researchers saw a protective signal for gonorrhea from a meningitis vaccine. Further studies are underway. When it comes to herpes (HSV), a trial that reported findings in 2012 on a preventive vaccine showed no protection against disease. Since then, investors have shown more interest in the potential of therapeutic vaccines for HSV. Vaccines for other STIs, such as chlamydia and syphilis are not as far along, struggling with funding and questions of trial design.

Research on drug-based prevention for STIs is also underway. Elizabeth Bukusi from the Kenya Medical Research Institute discussed the potential of doxycycline as an STI PrEP or PEP, which is under investigation in several studies. Key questions remain including: the impact on HIV risk, the effect of doxycycline on people living with HIV, the drug’s impact on the vaginal and gut microbiome, and the risk of antimicrobial resistance. In answer to these important concerns, Bukusi said, “We need data on all these questions. We have to do the work to find out what will work and for whom. We have to find the answers. And then we have to implement, at scale.”

Paving The Road To HIV Prevention For Key Pops

The barriers to HIV prevention for sex workers, transgender people and people who use drugs remain overwhelming. A sample of HIV prevalence statistics tell the story: for transwomen the global average is 19 percent; for female sex workers in Zimbabwe it’s 52 percent by age 24. People who inject drugs have a global HIV prevalence of approximately 13 percent. The presentations in the symposium HIV Prevention in Special Populations showed a fundamental need for more data to answer a range of essential questions to finally reach these key populations with HIV prevention. For example, most health surveillance systems do not collect sex and gender data, the population size of trans communities is poorly documented, literature is just emerging on how people who inject drugs are engaging with PrEP, and little is known about how the life stage of a person engaging in sex work affects their relationship to prevention services.

A few key issues stood out: Sari Reisner, from Brigham and Women’s Hospital, highlighted the cross-cutting impact of gender affirming care as a central component to effectively offering HIV prevention services to transgender people. For more on this and other priorities for a transgender research agenda check out No Data No More: Manifesto to Align HIV Prevention Research with Trans and Gender Diverse Realities, written by by trans and gender-diverse global activists, with support and solidarity from AVAC. Reisner said gender affirmation demands a personalized approach that can encompass social, medical, legal and psychological factors that will be different for each individual.

Frances Cowan, from the Liverpool School of Tropical Medicine, reported on growing evidence that stigma, food insecurity and discrimination isolate sex workers who remain poorly engaged with HIV prevention and care services. But here again, the transformative and essential role of peer-led community based approaches was evident. A meta analysis of community based interventions, reported by Cowan, showed they not only improve the lives of sex workers, but improve their engagement with care. However the data is sparse on long-term outcomes. Cowan’s presentation also included the successful example of Ashodaya Samithi PrEP demonstration project, a sex worker-led initiative in Mysaore India. Self-reported PrEP adherence, confirmed by blood tests, was 80 percent or better.

Cowan’s final remarks addressed what has worked in Zimbabwe’s effort to bring PrEP to sex workers, and they reinforced the priorities AVAC has been calling for as loud as we can. What worked: Peer leadership, diverse places to access PrEP including home delivery and community drop-in centers, multi-month dispensing, and integration with STI and sexual and reproductive health services. And the final component we hope is just around the corner: adding to these peer-led community-based services, an array of proven options from which one can choose.

Looking forward to working with you all to help make this happen.

Virtual CROI 2022 Roundup for Advocates: It’s all about choice

Welcome to Virtual CROI week two!

Here’s a roundup of the exciting science heard last week across the spectrum of HIV prevention, and on cure research (more on this further down) with a groundbreaking new case of HIV remission. We also want to be sure you are all aware of the CROI Margarita Breakfast Club dialogues—both last week and this week. Superb discussions last week and three more this week are not to be missed—recordings from last week’s conversations and registrations for this week are here.

The overarching message coming from CROI last week was clear: no one biomedical strategy will do the job, the world needs multiple options and real choices. In this round up, the importance of choice leads our coverage. (And listen to Carlos del Rio from Emory University put it all in context in a terrific US National Public Radio interview here.)

Choice and the Ring

New data from the REACH study, which incorporated informed choice into its design, made this point unmistakable. Almost all (98 percent) of the 247 adolescent girls and young women in this study where both daily oral PrEP and the Dapivirine Vaginal Ring were offered, chose one of the products over none at all. All participants tried each product for 6 months, followed by 6 months where they could choose their preferred method. Kenneth Ngure, presenting on the REACH Study, said about ⅔ of the participants chose the ring. But most of the women who had very high adherence to the daily oral pill preferred the daily pills to the ring. Ngure said overall adherence in the REACH trial surpassed levels seen in previous studies. More findings on factors driving adherence is under analysis. “REACH is just a small example of what the potential impact could be in the real world of HIV prevention, simply by allowing young women and girls the ability to choose,” said Ngure.

Choice and Injectable PrEP

HPTN 083, evaluating injectable cabotegravir as PrEP among gay men, transgender women and other men who have sex with men (MSM), presented updated data that evaluated new infections that have occurred since the trial unblinded in May 2020. Raphy Landovitz, from UCLA and HPTN 083 protocol chair, reported that adherence went down during this phase of the trial, but break-through infections among those receiving on-time injections remained rare. (He reported a total of 7 such cases in the life of the study that covers 4,660-person years.) The data continue to confirm both the safety and efficacy of cabotegravir for PrEP. Reflecting on the significance of the drop in adherence to both daily oral PrEP and injectable cabotegravir during the unblinded phase, Landovitz said complex barriers to adherence make it clear that “no one biomedical prevention option will address all issues in HIV prevention”.

Additional data from Susan Eshleman of John Hopkins University School of Medicine and the HPTN 083 team deepened the discussion on effective and feasible testing. Detecting HIV is a crucial part of prevention strategies that rely on antiretrovirals (ARVs). Exposure to a single ARV, which is the protocol for PrEP (in contrast to combination ARV used in treatment), can lead to resistant HIV. Eshleman reported on data showing that using a highly sensitive RNA-based HIV test to confirm a person is HIV negative could reduce the risk of someone with undetected HIV developing resistance to first line treatment. But she said access to these tests should not limit access to this highly effective intervention, “In the context of proven high efficacy, CAB-LA should be considered for HIV PrEP in settings where HIV RNA screening is not readily available.”

Choice and Vaccines

IAVI’s Mark Feinberg summarized the state of vaccine science. One the one hand, two recent large-scale trials showed no efficacy (Uhambo and Imbokodo). On the other hand, Feinberg said cutting edge approaches offer “a strong and vibrant source of promise” for HIV vaccine development, particularly the development of broadly neutralizing antibodies (bNAbs). Looking ahead, Feinberg predicted the next major priority to make a large-scale trial a possibility will be validating a “correlate of protection”, a mark or sign in the immune system that can be linked to preventing HIV acquisition.

As this research evolves, the need for many options that deliver real choices remains clear. In a later session on immune responses, South Africa Medical Research Council and HVTN leader Glenda Gray said the high rate of HIV in hard-hit places (as high as 4 percent) will mean effective prevention may well require a combination of strategies. “We will likely need a combination of PrEP with vaccines to combat high rates—4 percent incidence rate is just too much for a vaccine alone to overcome.”

Another Step in the Journey Toward a Cure

A fourth person was reported to achieve HIV remission, the first case among women, according to data from Yvonne Bryson from the David Geffen School of Medicine at University of California. The New York woman has no detectable HIV since she stopped treatment 14 months ago. Her treatment interruption followed a stem cell transplant from a donor with an HIV resistant mutation. As in the other three cases, the stem cell transplant was an urgent intervention to treat advanced cancer. This stem cell transplant pioneered an innovation where a family donor provided stem cells in combination with stem cells from umbilical cord blood that had the needed mutation. One possible implication for cure research is confirmation of the role of a critical receptor on white blood cells known as CCR5. HIV relies on CCR5 to enter and infect the cells. Mutations to CCR5 have once again led to a case of remission, and two of these cases have endured long enough to be confirmed as a cure. Want to learn more? One of last week’s Margarita Breakfast Club discussion was River Deep, Mountain High: Pathways Toward a Cure for HIV, with a wonderful discussion about these findings.

There’s more CROI coverage coming and please continue to follow along with us this week, www.avac.org/croi-2022, and check out great summaries from our friends at aidsmap.

PrEP and more PrEP: An update and important resources

2022 is a critical year for the evolving role of PrEP, anti-retroviral drugs (ARVS) used to prevent HIV. Currently, two types of daily pills (FTC/TDF and F/TAF), injectable cabotegravir administered every two months (CAB-LA) and a monthly Dapivirine Vaginal Ring (DVR) are approved in some countries for at least some populations. But each face challenges that must be overcome for these proven interventions to effectively reach people who need and want them.

In addition, the pipeline of next-generation PrEP products in research and development is intensely dynamic. But if advocacy, global coordination, funding, and community-centered responses come together now, PrEP programs can be scaled, and these biomedical options can be translated into actual choices. This work is essential for the world to hit 2030 targets for ending the epidemic.

AVAC is tracking all things PrEP. Here are some resources to keep you up to date and to help frame key issues for your advocacy.

Global PrEP Tracker

Check out global trends in oral PrEP initiations with AVAC’s just updated PrEP Tracker, found on PrEPWatch.org. 2021 saw marked increases in global PrEP uptake, up 50 percent from 2020. Five countries in sub-Saharan Africa are driving this growth with expanding programs: Kenya, Nigeria, South Africa, Uganda and Zambia. Get details on the data here.

Overview of the Pipeline

These trends can be put into context with the Biomedical HIV Prevention Research in 2022 and Beyond which provides a concise update on the full landscape of biomedical interventions, including: PrEP products in the market, next-gen products in the pipeline, including multipurpose products (MPTs) and vaccines and broadly neutralizing antibodies. And check our handy cheat-sheet on Evolving Designs for HIV Prevention Trials.

Primer on Injectable Cabotegravir for PrEP

With the recent US FDA approval of CAB for PrEP, we’ve updated our advocates’ primer to outline what’s known and what’s next for this new prevention option.

Two Training Packages for Peer-led Product Introduction

The HIV Prevention Ambassador Training Package for adolescent girls and young women (AGYW) supports them to play a meaningful role in the rollout of PrEP products in their communities. Developed by the PROMISE & CHOICE consortiums, it includes a training manual on essential topics and session instructions, and a toolkit. This version of the Ambassador Training Package is intended for all priority populations, including men who have sex with men, people who inject drugs, serodiscordant couples, pregnant and breastfeeding people, sex workers, transgender people as well as adolescent girls and young women.

A Strategy for the Future of PrEP, From Research to Rollout

The Biomedical Prevention Implementation Collaborative (BioPIC) is developing a model for a comprehensive and coordinated global platform for the introduction of new biomedical products for HIV prevention. The BioPIC Adaptable Framework incorporates stakeholders from all stages of product development and delivery, from research to rollout. And watch this space for the upcoming launch of BioPIC’s online dashboard that will be tracking efforts to introduce CAB for PrEP.

Learning Lessons from Oral PrEP – and Implications for the Future

AVAC’s six-year HIV Prevention Market Manager program produced a wealth of insights on how to get rollout right. Learning the lessons from oral PrEP introduction is essential, and this series of issue briefs distills the priorities for advocates, implementers, funders, product developers and ministries of health. And in case you missed it, check out the recent webinar recording and summary.

Resources to Support the Introduction of the Dapivirine Vaginal Ring

This package of resources supporting the introduction of the Dapivirine Vaginal Ring includes: advocacy messages, an introductory slide deck, FAQ’s and more.

Are We PrEPared This Time?

Just last week, the AIDS Foundation Chicago, AVAC and partners hosted a webinar, Are we PrEPared this time? Ensuring a Swift Translation of Research into Community Impact, featuring presentations and debate on what must happen for positive research results to effectively reach communities without delay. A link to the recording is here.

The PrEP field is moving at an historic pace, but significant obstacles threaten to derail the potential PrEP holds for contributing to the end of the epidemic by 2030. Our joint work will confront these challenges. Keep watching this space for the information, resources, analysis and convening opportunities to keep this work on track.

Efficacy Study Design

This graphic details the trial design behind HPTN 083 and HPTN 084, two-large scale efficacy trials testing cabotegravir, an antiretroviral formulated as an injectable for long-lasting pre- exposure prophylaxis (PrEP).

To learn more, read An Advocates’ Primer on Long-Acting Injectable Cabotegravir for PrEP.

3 Weeks, 3 Webinars: An agenda for 2022

So much is happening (and not) in HIV prevention and the larger world of global health equity. AVAC is tracking it all, bringing together different perspectives and hosting global dialogues to help inform and set a powerful agenda for 2022.

In the first three weeks of January, AVAC hosted three important conversations for the year ahead. Global health leaders and stalwart advocates provide critical perspectives and compass points on the issues that will make and break advances in HIV prevention and global health equity this year. (And read to the end for info about the first webinar in February.)

We’ve synthesized the key messages of each of the three, and posted the recordings and slides:

Understanding—And Improving—COVID-19 Vaccine Uptake
Jan 10, 2022
Recording | Summary

In collaboration with the COVID Advocates Advisory Board (CAAB) and the Coalition to Accelerate and Support Prevention Research (CASPR), this webinar, moderated by WACI Health’s Rosemary Mburu, looked closely at how global health leaders are tackling public resistance to COVID-19 vaccines, and lessons for the HIV field. Speakers included: John Nkengasong, current director of the Africa Centres for Disease Control and Prevention; Heidi Larson, founding director of the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine; and Kate Hopkins, Director of Research, Vaccine Acceptance & Demand at the Sabin Vaccine Institute.

Ups & Downs in the Field: Setting an Agenda Together for HIV Prevention in 2022
Jan 13, 2022
Recording | Summary

This webinar reviewed the latest advances, opportunities and disappointments in HIV prevention and provided an opportunity to address key questions including: where we are with the introduction of injectable cabotegravir and the Dapivirine Vaginal Ring; the development status (including setbacks) of promising new PrEP agents; and how to ensure HIV prevention and equitable access to innovation do not fall further behind; and much more. This webinar featured the perspectives of Linda-Gail Bekker from South Africa’s Desmond Tutu Health Foundation (and AVAC’s board); Grace Kumwenda of Pakachere Institute of Health and Development Communication in Malawi and Kenneth Mwehonge, the new executive director of Coalition for Health Promotion and Social Development (HEPS-Uganda) — both former AVAC Fellows — and Rachel Baggaley from the World Health Organization.

Oral PrEP Implementation and Implications for Next Generation PrEP
Jan 19, 2022
Recording | Summary

This webinar discussed insights from oral PrEP programs and how these experiences can inform faster, smarter and more affordable rollout of next-generation HIV prevention products. It featured Saiqa Mullick of Wits RHI in South Africa, Joseph Murungu of Pangaea Zimbabwe AIDS Trust (PZAT), and Daniel Were of Jhpiego in Kenya.

And the conversations continue!

Join the AIDS Foundation Chicago, AVAC and partners February 3 at 1:00pm ET/12:00pm CT for: Are we PrEPared this time? Ensuring a Swift Translation of Research into Community Impact. This webinar will feature presentations and debate on what must happen for positive research results to effectively reach communities without delay. Register here.

We hope you’ll look at the summaries of these important conversations and/or listen to the recordings and share with your colleagues, partners and friends. With this round-up of webinars setting the stage for 2022, we at AVAC are preparing for a year of deep collaboration and action with you.

Jan 19 Webinar: Oral PrEP Implementation and Implications for Next Generation PrEP

[UPDATE]: Visit here for the recording and to read a summary.

On Wednesday, January 19, AVAC and partners shared critical insights and lessons from oral PrEP programs in Kenya, South Africa, and Zimbabwe. Learning from these efforts, and other key lessons from oral PrEP introduction to date, is essential to faster, smarter and more affordable rollout of future HIV prevention products, including the Dapivirine Vaginal Ring and injectable cabotegravir. These lessons are built on more than six years of analysis and collaboration with partners and reflect urgent priorities for the field. The world cannot afford to make the same mistakes twice as a growing number of tools for prevention gain regulatory approval.

Click here to watch Oral PrEP Implementation and Implications for Next Generation PrEP. You’ll hear Saiqa Mullick of WitsRHI, Joseph Murungu of Pangaea Zimbabwe AIDS Trust (PZAT), and Daniel Were of Jhpiego discuss what has worked and what must change to transform options into choices, to finally reach the targets that will end the epidemic of HIV.

These insights offer a unique opportunity to fulfill the potential of HIV biomedical prevention, demonstrate the impact of informed choice, and realize the full benefits of increasing the use of HIV prevention among those who need it most. As additional PrEP options come to market, they could transform the landscape of HIV prevention—offering more personalized options, increasing the number of PrEP users, and ultimately contributing to lower HIV incidence. These products must be accessible, acceptable and used effectively by those who need them.

This webinar follows the important discussion AVAC convened yesterday, where leading voices in the field of HIV prevention identified their priorities in 2022. Check out the recording of Ups & Downs in the Field: Setting an agenda together for 2022, and watch the January 19th discussion to focus on next steps for these priorities on getting rollout right in 2022.

AVAC Applauds FDA Approval of Injectable PrEP

Yesterday, December 20th, the US Food and Drug Administration (FDA) issued welcome news. It has approved injectable cabotegravir (CAB-LA, and brand name “Apretude”), the first injectable form of HIV PrEP. As another form of HIV PrEP that does not require taking a daily pill, CAB-LA is a much-needed addition to a proven HIV prevention toolbox that now also includes male and female condoms, daily oral PrEP, voluntary medical male circumcision (VMMC) and the Dapivirine Vaginal Ring.

“The approval of CAB-LA is a welcome and much-needed boost for HIV prevention,” said Mitchell Warren, executive director of AVAC. “With as few as six shots per year, this highly effective form of injectable PrEP can help bend the curve of the HIV epidemic – but only if its approval is accompanied by strategic, effective and equitable rollout that transforms the growing list of HIV prevention options into real and accessible choices for the people who need prevention most.”

CAB-LA is an injectable antiretroviral given to adults and adolescents who are confirmed to be HIV-negative at two-month intervals to reduce the risk of HIV. While today’s FDA action approves CAB-LA for use in the United States only, AVAC and its partners will be working in the months ahead to support the review of CAB-LA by regulatory authorities in other parts of the world where new HIV prevention options are sorely needed. AVAC is heartened that ViiV Healthcare, the developer of CAB-LA, has submitted applications to multiple regulatory authorities, including Brazil and several in sub-Saharan Africa that hosted the pivotal clinical trials led by the NIH-funded HIV Prevention Trials Network (HPTN).

“The experiences of oral PrEP for HIV prevention and from COVID vaccines are stark reminders that the US FDA approval is just one small, albeit important, step in translating exciting science into public health impact,” said Warren. “Without global regulatory approvals, clear guidance from WHO, a commitment to equitable access and fair pricing, and resources to deliver innovation, the best science does not prevent or end pandemics.”

The US approval of CAB-LA is an important and welcome milestone in HIV prevention, however, it is just the first in a series of steps needed to ensure that injectable PrEP can help reduce the 1.5 million new HIV infections that occurred in 2020. Supporting access to injectable PrEP, oral PrEP and the full range of proven prevention options requires programs that are strategically designed, user-centered, appropriately resourced, and promoted and designed to reach those who need prevention most, as outlined in the work of the Biomedical Prevention Implementation Collaborative (BioPIC). Lessons learned from nearly ten years of experience in supporting access to oral PrEP will be particularly important in shaping broad and effective access to injectable PrEP, alongside oral PrEP and the Dapivirine Vaginal Ring, and are detailed at prepwatch.org.

Effective global use of CAB-LA for HIV prevention will also require a significant and long-overdue upgrading of global HIV testing capacity, as injectable PrEP can only be used safely if the recipient is HIV-negative and is tested before every dose. It will also require advocacy around self-testing and lower age of consent to testing policies, which have been significantly correlated with oral PrEP initiations.

“Transparency and fairness in pricing, advocacy to accelerate global regulatory review, feasible testing policies, and upgrades to health systems are crucial to effective access to injectable cabotegravir and must all be part of the global HIV prevention agenda moving forward,” noted Warren. “Today’s approval announcement is warmly welcomed, but is also just the start of efforts to make long-acting injectable PrEP an accessible choice for all in need.”

PrEP’s Time has Come

Early planning for PrEP investment in PEPFAR countries is the next critical step for this intervention to fulfill its promise and bend the prevention curve of the epidemic in PEPFAR supported countries.

The President’s Emergency Plan for AIDS Relief (PEPFAR) has played a fundamental and unique role in bringing down the number of global deaths from AIDS and advancing global health, since it launched in 2003. But when it comes to preventing HIV, not just treating it, the world remains in crisis. Despite important declines in HIV rates in Eastern and Southern Africa, in others HIV is on the rise. A global health target to bring down new cases of HIV to 500,000 in 2020 was missed–by a lot, throwing off the global effort to end the epidemic by 2030 unless drastic action is taken now.

PEPFAR has an unparalleled ability to marshal data and support the development of effective programs, as it has done for treatment in countries hard hit by HIV. Today, PEPFAR must apply this capacity to HIV prevention in new and expanded ways. Some of the most crucial decisions about PEPFAR’s role in delivering prevention are too often overshadowed by the critical center-stage effort to achieve the 2025 treatment targets and reduce unacceptably high AIDS deaths in many countries. But some less known, behind-the-scenes decisions are also truly vital. One such issue involves PEPFAR budget codes that few may appreciate and love but have an outsized impact on whether the right commitments are made, and prevention reaches those who need it most. Currently, PEPFAR utilizes 19 budget codes for specific areas of HIV programming including testing, treatment, and prevention, including voluntary male medical circumcision.

PEPFAR’s budgeting approach to oral PrEP is a prime example of how HIV prevention must evolve and how PEPFAR’s long standing commitment to transparency can help lead the way. Oral PrEP is a daily pill that can be taken to prevent HIV. Despite its outstanding efficacy, not one of the budget codes PEPFAR uses for HIV programming tracks spending on PrEP. PrEP expenditures are only identified after they are allocated during the annual Country Operating Plan (COP) process used to develop individual country plans. Country programs designing prevention programming, and most importantly civil society advocating for PrEP as part of the COP process, don’t have a clear budget line as COP plans develop to measure and advocate against. As a result, PrEP programming, although a priority for PEPFAR, can sometimes get lost in the shuffle of COP planning. A budget code provides a benchmark to plan against and cements a program as a priority for PEPFAR.

The story of voluntary medical male circumcision (VMMC) rollout highlights the difference a dedicated budget can make. After the WHO and UNAIDS recommended VMMC for HIV prevention 2007, PEPFAR dedicated funds for countries to scale it up, and tracked the effort with an individual budget code. VMMC has since become a core component of prevention programs in PEPFAR supported countries. Investments in VMMC, totaling more than $1.5 billion according to 2017 information, are used for equipment, supplies, monitoring, evaluation, training and reporting. Since 2007, VMMC underwent a scale-up of historic proportions, reaching 15 million people, and contributing to lowering incidence in those countries. The budget code entailed more than funding and services, it incorporated planning, tracking, accountability, and impact. As the figure below suggests, the experience of PrEP roll-out now almost a decade after FDA approval without a designated budget code has been much slower.

PEPFAR’s track record in implementing HIV programs is historic. The program is credited with preventing infection in nearly 3 million babies, providing treatment to more than 17 million people who live with HIV, providing testing to 50 million people, and training 300,000 thousand new health workers. To finally end the epidemic, this same capacity can and must be brought to bear in prevention. PEPFAR’s strong call for programs to include oral PrEP and setting an overall goal of serving 1 million people with PrEP in 2021, become more difficult targets to aim at with vital planning tools missing. PEPFAR’s experience with VMMC taught us that establishing a designated budget code signals that a given program or product is a priority. PEPFAR supported countries are readying now to plan for COP22, to begin October 1, 2022. Getting a budget code for PrEP approved for COP22 would be an important step in planning for PrEP programs so that targets are met, and funding can succeed.

Ten years of effort to roll out PrEP has brought powerful lessons. The field has learned about complex barriers that inhibit HIV prevention. Stigma and economic hurdles put HIV prevention, such as PrEP, beyond reach for the millions who need it. Overcoming these forces will depend on critical investments that must be monitored for effectiveness. These include peer-led adherence support, marketing strategies to understand who must be reached and how to reach them, public campaigns to generate demand, reliable supply chains, specialized training for providers, and integrating HIV prevention with sexual and reproductive health services. Funding this full spectrum of support depends on clear dedicated budgets. The tools planners, advocates, policy makers and programmers need to be in place to double down on what works in HIV prevention, and, finally, end the epidemic.

Press Release

AVAC Applauds US FDA Approval of the First injectable Form of HIV Pre-exposure Prophylaxis

The First in a Series of Necessary Steps to Translate Exciting Science into Impact

Contact

Mitchell Warren, +1 (914) 661-1536, mitchell@avac.org
Kay Marshall, +1 (347) 249-6375, kay@avac.org

New York City, December 20, 2021 – AVAC welcomes the US Food and Drug Administration (FDA) approval of injectable cabotegravir (CAB-LA, and brand name “Apretude”), the first injectable form of HIV pre-exposure prophylaxis (PrEP). As another form of HIV PrEP that does not require taking a daily pill, CAB-LA is a much-needed addition to a proven HIV prevention toolbox that now also includes male and female condoms, daily oral PrEP, voluntary medical male circumcision (VMMC) and the Dapivirine Vaginal Ring.

Effective global use of CAB-LA for HIV prevention will also require a significant and long-overdue upgrading of global HIV testing capacity, as injectable PrEP can only be used safely if the recipient is HIV-negative and is tested before every dose. It will also require advocacy around self-testing and lower age of consent to testing policies, which has been significantly correlated with oral PrEP initiations.

“Transparency and fairness in pricing, advocacy for accelerate global regulatory review and appropriate and feasible testing policies, and supporting access programs and health system upgrades needed to support effective global access to injectable cabotegravir must all be part of the global HIV prevention agenda moving forward,” noted Warren. “Today’s approval announcement is warmly welcomed, but is also just the start of efforts to make long-acting injectable PrEP an accessible choice for all in need.”

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.

New Report: HIV Prevention R&D funding drops again

Today, we and partners are proud to release the annual HIV Prevention Research and Development Investments Report, with important findings for our collective advocacy. The report reveals a growing mismatch between the current promise of HIV prevention R&D, and continuing declines in the funding available. This decline affects both funding for research on new interventions and funding to expand access to existing prevention tools. The new report is based on outreach to 215 funders of HIV prevention R&D in the public, philanthropic and commercial sectors and includes 2020 funding data.

The latest data shows funding for HIV prevention R&D dropped by US$54 million (4.4 percent) in 2020. This second consecutive annual decrease is part of an eight-year trend of flat or declining funding for HIV prevention R&D.

The report also finds that financial support for HIV prevention R&D is almost entirely dependent on public sector funders, notably from the United States, and on one key United States-based philanthropic funder, the Bill & Melinda Gates Foundation. Commercial sector funding, already extremely low, dropped again in this year’s survey.

“These concerning trends in funding come at a promising but very demanding moment in efforts to control the pandemic,” said Mitchell Warren, executive director of AVAC, which coordinates the Resource Working Group with the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). “Funding is declining just as the field confronts a new generation of opportunities and challenges.”

This high stakes environment includes: new products readying for introduction, such as injectable cabotegravir for PrEP and the Dapivirine Vaginal Ring; international support for ambitious new global targets for ending the epidemic; initial proof of concept of antibody-based prevention; and urgently needed new thinking for HIV vaccine development as recent trials have experienced setbacks and new technologies such as mRNA succeed against COVID-19.

Key findings from the report include:

HIV prevention R&D is highly overdependent on a few key funders, and much of the world is not contributing at the levels seen in prior years:

HIV prevention R&D funding relies almost exclusively on the public sector, particularly the US public sector. The trend toward an overdependence on a small number of large investors, which the Working Group has surfaced and cautioned against in the past, intensified further in 2020.

Globally, the public sector accounts for 86 percent of prevention R&D funding, with 92 percent of that coming from the US public sector.
European public sector investments represent only 7 percent of the global total. While European public sector investment increased by 57 percent in 2020, it is still barely half of the US$124 million the European public sector contributed in 2009.
The entire rest of the world accounted for only US$14 million, or just 1 percent of total public sector funding.

Philanthropic funding, consisting almost exclusively of funding from the Bill & Melinda Gates Foundation, declined 20 percent in 2020 to US$127 million or 12 percent of the total global investment.
Reported commercial sector support for HIV prevention R&D, already the lowest segment of investment, fell by 55 percent to US$31 million, or just 3 percent of the total, in 2020. While total commercial investment may be underreported, trends over time from the data collected show commercial sector investments is, by far, the smallest piece of the funding pie for HIV prevention R&D.

Funding dropped in 2020 across a number of key segments, including:

Preventive vaccine R&D: With two large-scale HIV vaccine trials underway, and dozens of new approaches under investigation, funding for preventive HIV vaccine R&D decreased by 5.5 percent or US$46 million in 2020 to US$802 million. While different European countries have increased or decreased their investments, overall European public sector investment in HIV vaccine R&D decreased 31 percent in 2020, to US$48 million.

R&D for PrEP, including pills, implants, injections: While uptake of oral PrEP grew substantially in 2020, and multiple recent research studies have demonstrated the potential impact of a range of PrEP options including long-acting injections, pills and implants, global investment in PrEP R&D declined 2 percent in 2020 to US$107 million. While US public sector donors increased funding for PrEP R&D by 5 percent, and commercial sector investment increased by 21 percent to US$24 million, neither was enough to overcome a 42 percent decline in funding from the philanthropic sector.

Voluntary Medical Male Circumcision (VMMC): As a number of studies affirmed the efficacy of VMMC over a decade ago, funding in the field is focused on implementation science, behavioral studies and advocacy and policy, each of which is vital to extending the reach and impact of this highly effective prevention tool. Yet investment in VMMC decreased by 37 percent to just US$6 million in 2020, almost all of which came from a single donor, the Bill & Melinda Gates Foundation.

Preventing vertical transmission: Prevention of mother-to-child transmission of HIV (PMTCT) remains a key prevention priority, but funding for PMTCT R&D decreased by 29 percent in 2020, from US$35 million to US$25 million. The decline is attributed to the loss of the Bill & Melinda Gates Foundation from the list of PMTCT R&D funders, and to decreases in funding from public donors. US public sector funding for PMTCT R&D fell 22 percent to US$22 million in 2020. European funding also fell more than 60 percent, from US$3.4 million in 2019 to US$1.3 million in 2020.

Only two areas of prevention R&D funding showed small increases in funding, including:

Treatment as Prevention (TasP): Long neglected in HIV prevention investment, funding for treatment as prevention (TasP) R&D increased from $1.7million to US$9 million in 2020. The increase came from philanthropy, notably the Bill & Melinda Gates Foundation (US$5 million) and the Wellcome Trust (US$1 million).

While TasP R&D funding is small overall, this increase is a hopeful sign that TasP may once again receive its appropriate focus as priority for HIV prevention research.

Microbicides: After multiple years of decline, investment in microbicide R&D registered a very small increase (0.4 percent or US$0.6 million) to US$145 million in 2020. Concerningly, there is even less diversity in microbicide funding than in HIV prevention R&D overall, with the public sector providing 99 percent of microbicide R&D resources.

While this tiny increase is a hopeful sign, it does not match the scope of the promise of microbicides. One key product, the Dapivirine Vaginal Ring, is now recommended by the WHO as an additional HIV prevention option. In addition, a range of promising microbicide strategies are under investigation. One, a 90-day dual-purpose vaginal ring designed to confer both contraceptive and HIV protection, was found to be effective in early testing.

This is the 16th annual report from the Resource Tracking for HIV Prevention Research & Development Working Group. Go to HIVResourceTracking.org to explore the key findings, funding trends, and previous reports in depth and follow the conversation on Twitter #HIVResearchFunding.