Dual Prevention Pill: Integrating services and expanding choices

Advocates are coming together from several fields to plan for the introduction of the Dual Prevention Pill (DPP). Currently in development, this daily pill would prevent both HIV and pregnancy. Once approved, the DPP would be an important new option in a menu of choices for contraception and HIV prevention, paving the way for additional multi-purpose prevention technologies (MPTs) in the pipeline. Advocacy to ensure these options become real choices will be essential.

In April, AVAC and FP2030 convened a consultation with family planning (FP) and sexual and reproductive health (SRH) stakeholders to understand their unique perspectives on the DPP. The consultation put a spotlight on key questions and issues that will inform planning for DPP introduction, the development and delivery of future MPTs and, hopefully, accelerate the integration of SRH and HIV prevention programs.

The consultation identified key issues including the need to:

  • Understand the market for the DPP. Demand is expected from a segment of the market of women looking for contraception and HIV prevention.
  • Program health services to allow for method switching. Individual women may change what contraception they prefer at different times in their lives.
  • Educate providers, partners and communities about the DPP in the context of HIV prevention and contraception. Overcoming stigma and community acceptance are fundamental to supporting women to use the DPP and other prevention methods.
  • Expand, integrate and demedicalize health services now, and include access to oral PrEP in particular, which will create a model for increasing access to the DPP and other MPTs.

Learn more with the resources below!

New Resources on the Science from CROI, the Ring, DPP and More!

In this week’s roundup, you’ll find details on an upcoming webinar covering the stand-out science from CROI 2022; an important read on vaccine equity; new resources to support advocacy for the dapivirine vaginal ring; resources for learning about and advocating for the Dual Prevention Pill; and a special tribute to Zena Stein.

Webinar: The most notable science at CROI

Wednesday, April 27, 2022 at 9:30am ET/15:00 SAST
Join us, the CROI Community Liaison Subcommittee, and European AIDS Treatment Group for a webinar to debrief on this year’s CROI. A fabulous panel will unpack findings from the conference, share perspectives, and offer advocacy suggestions. Topics will span science presented on HIV prevention and treatment, HIV and aging, HIV cure, and COVID-19. Register here. Recorded sessions from CROI 2022 are now available on demand. For context on the sessions, the recordings from the Margarita Breakfast Clubs explore findings from the research of the day at CROI.

Read Vaccine equity: The rollout that needs a booster shot

An opinion piece in The Hill newspaper by AVAC Executive Director Mitchell Warren points out connections in global health that cut across disease and must be addressed for biomedical products to reach those who need them most. “COVID-19 has shown us the fragility of our efforts to end diseases in places where poverty is entrenched…. We invest hundreds of millions in large trials but nothing similar on how to disseminate the results…. This is not unique to any one disease: We have seen it in the lack of global vaccine equity in the COVID-19 response and we’ve seen it in TB and HIV…. We are achieving breakthroughs in developing new medicines and vaccines, but we are failing to deliver them with equity and with impact. It is well past time to do better.”

Important Voices: Ring user speak out

A video series, developed by the USAID-funded MOSAIC Project, features the voices of women from trials in Kenya, South Africa, Zambia and Zimbabwe that tested the dapivirine vaginal ring. Trial participants explain why the ring works for them and their need for future access to this HIV prevention method.

Watch This Space: HIV and unintended pregnancy prevention

Last week, AVAC and FP2030 held a consultation on the Dual Prevention Pill (DPP), a daily pill that is currently being developed for the simultaneous prevention of unintended pregnancy and HIV acquisition. The webinar brought in dynamic perspectives from the family planning and sexual & reproductive health communities. Be sure to keep this on your radar, as there will be more opportunities at AIDS2022 to learn more, get your questions answered and develop advocacy priorities for this promising multipurpose technology. Currently, the DPP is moving through the R&D process and could be available as early as 2024. It would be the first MPT available. Get more details on the DPP on PrEPWatch.org.

Listen: Life and legacy of Zena Stein

To reflect on the legacy of Zena Stein, a public health, human rights and HIV prevention champion who influenced so many working in HIV prevention, the editor of the American Journal of Public Health produced a video-podcast conversation with CAPRISA’s Quarraisha Abdool Karim and AVAC’s Mitchell Warren.

Join Us This Week for Important Conversations

Three important conversations are happening this week: in HIV cure research, in COVID vaccines and in Good Participatory Practice (GPP). These discussions help set agendas and direct resources, so please consider joining one or all of them. We’ve also included links to important news and publications.

Breaking Down the Latest in HIV Cure Research
Tuesday, 5 April at 11am ET/5pm SAST
At CROI 2022, a number of exciting updates on HIV cure research were announced, including the most recent case of HIV remission after a stem cell transplant. Join a conversation with researchers as they break down the recent case of HIV cure, which is the first such cure in a woman. Speakers will also provide updates from an ongoing trial studying pediatric remission. Join to learn what these advances mean for science and for people living with HIV. Register here.

COVID-19 GPP Resources
Wednesday, 6 April at 9am ET/3pm SAST
While there are some resources that address stakeholder engagement in COVID-19 research, they may not adequately reflect the needs of advocates. Join AVAC and partners for a conversation to discuss advocates’ needs and shape the development of future resources. Register here.

New COVID-19 Vaccines Trials in Sub-Saharan Africa
Wednesday, 6 April at 10am ET/4pm SAST
Join us for a special webinar on the Ubuntu trial, hosted by the COVID Advocates Advisory Board (CAAB) and our Coalition to Accelerate and Support Prevention Research (CASPR). Led by the COVID-19 Prevention Network (CoVPN), Ubuntu is a new, landmark COVID-19 vaccine trial in sub-Saharan Africa investigating the efficacy of mRNA vaccines in people living with HIV against the omicron variant. Register here.

Must Reads

Now Open Access: Stakeholder Engagement Must Overcome Tokenism and More
The ethics review process is a crucial opportunity for stakeholder engagement. A new article by AVACer Jessica Salzwedel, CASPR partner Cathy Slack and other co-authors appears in the Journal of Empirical Research on Human Research Ethics and explores three themes that can make or break effective engagement: “It’s Almost as if Stakeholder Engagement is the Annoying ‘Have-to-do’…”: Can Ethics Review Help Address the “3 Ts” of Tokenism, Toxicity, and Tailoring in Stakeholder Engagement?

Possibility of Voluntary Licensing for Injectable Cabotegravir for PrEP
Over the past month AVAC has worked with a wide range of advocates calling for faster and more strategic introduction of injectable PrEP, and several public statements were released. Read statements from a leading group of Southern African Women Advocates and two from AfroCAB: Communities demand ViiV/GSK accelerate access to CAB-LA in LMICs and ViiV continues to not meet our demands to ensure CAB-LA is accessible for our communities. Then today, Viiv Healthcare, the maker of injectable cabotegravir, announced that it is working with the Medicines Patent Pool (MPP) to outline a path forward for voluntary licensing of their product. ViiV said this path will include “an assessment of future demand and necessary manufacturing capacity and capability as well as upstream requirements for potential generic manufacturing partners.” Stay tuned for our updated call to action and roadmap to ensure injectable PrEP and the dapivirine vaginal ring get introduced faster and more strategically.

New Episode of Px Pulse: Getting Rollout Right for Ring and Injectable PrEP

At AVAC, we’ve been calling for coordinated planning to introduce and rollout new prevention products, while expanding access to existing options. We’ve said that these efforts must move much faster than they have in the past, and learn from the lessons of rolling out oral PrEP. So what matters right now for rolling out the Dapivirine Vaginal Ring and injectable cabotegravir as additional PrEP options? Find out in our latest episode of Px Pulse!

Until now, daily oral PrEP, first approved in 2012, has been the only drug-based strategy for HIV prevention. So now it’s time to take the next steps to deliver these new options.

In this episode of Px Pulse, Linda-Gail Bekker from South Africa’s Desmond Tutu Health Foundation and Lillian Mworeko from the International Community of Women Living with HIV East Africa (ICWEA) join host Jeanne Baron and AVAC’s Executive Director Mitchell Warren to discuss innovative models for scale-up and delivery. Taking the right steps now could mean HIV prevention options fulfill their life-saving, epidemic-ending potential, and to do so requires working faster and more efficiently than ever before. We dive into what lessons the field has learned, what’s still off-track, and the steps advocates, policy makers, drug makers and funders should each take right now to turn efficacious options into effective choices.

For the full podcast episode, highlights, and the archive of previous episodes, visit avac.org/px-pulse. And subscribe on Apple Podcasts, Spotify or wherever you get your podcasts!

Reading, Resources and Webinars

At AVAC, we are seeing remarkable new developments and opportunities to engage in HIV and COVID research, development and advocacy. Here is a round-up of what’s been happening, essential reading and resources to help in your advocacy efforts, and some upcoming webinars to join.

In PrEP

Dapivirine Vaginal Ring Approved in South Africa

The South African Health Products Regulatory Authority (SAHPRA) approved the monthly dapivirine vaginal ring for use by women to reduce their HIV risk. South Africa joins Zimbabwe as the first countries to announce approval of the ring, which is already recommended by the World Health Organization as an additional prevention option. The ring’s developer, the International Partnership for Microbicides, has also submitted additional applications for review by several other Eastern and Southern African countries, and advocates are actively engaged in making the ring accessible, including the fabulous new EmpoweRing campaign from our colleagues at ICWEA. AVAC’s Nandi Luthuli told Herald Live, “we know that the most effective intervention is the one someone picks for themselves among an array of effective choices.”

Updates on Injectable Cabotegravir for PrEP

Following US FDA approval of injectable cabotegravir for PrEP in December, there has been a cascade of activities—and a huge need for advocacy! Multiple additional regulatory agencies are reviewing the application; WHO convened their Guidelines Review Group meeting earlier this month, and guidelines are expected mid-year; and Unitaid announced funding for the first two implementation science projects to introduce injectable PrEP, in Brazil and South Africa. A key lesson from oral PrEP over the past decade has been the essential role of civil society; and advocates released a number of important statements—AfroCAB released two sign-on statements: Communities demand ViiV/GSK accelerate access to CAB-LA in LMICs and ViiV continues to not meet our demands to ensure CAB-LA is accessible for our communities, and a leading group Southern African women’s health advocates released a statement by Southern African Women Advocates in Advance of ViiV Convening. Stay tuned for our updated call to action and roadmap to ensure injectable PrEP and the ring get introduced faster and more strategically.

In Vaccines

New HIV Vaccine Study Using mRNA Platform Launched

The NIH also announced a new study to test three mRNA-based HIV vaccine candidates. This study follows an announcement in January from IAVI about another mRNA-based HIV vaccine study. AVAC is preparing a suite of materials on the latest in HIV vaccine research, development and advocacy for HIV Vaccine Awareness Day in May, so stay tuned. In the meantime, check out this snapshot that compares the two studies.

In COVID

New Resources for Journalists

The COVID-19 pandemic spawned an infodemic inside the onslaught of COVID-related information. Journalists struggle to identify reliable information in the everchanging pandemic landscape. With support from the Rockefeller Foundation, AVAC is expanding our partnership with Internews and our Media Cafe program conveners to support journalists covering HIV prevention science to include reporting on COVID. Check out the curated resources to help journalists find high-quality, understandable information.

WEBINAR: COVID-19 GPP Resources, 6 April at 9am ET/3pm SAST

While there are some resources that address stakeholder engagement in COVID-19 research, they may not adequately reflect the needs of advocates. Join AVAC and partners for a conversation to discuss advocates’ needs and shape the development of future resources. Register here.

WEBINAR: New COVID-19 Vaccines Trials in Sub-Saharan Africa, 6 April at 1oam ET/4pm SAST

Join us for a special webinar on the Ubuntu trial, hosted by the COVID Advocates Advisory Board (CAAB) and our Coalition to Accelerate and Support Prevention Research (CASPR). Led by the COVID-19 Prevention Network (CoVPN), Ubuntu is a new, landmark COVID-19 vaccine trial in sub-Saharan Africa investigating the efficacy of mRNA vaccines in people living with HIV against the omicron variant. Register here.

In Cure

WEBINAR: Breaking Down the Latest in HIV Cure Research, 5 April at 11am ET/5pm SAST

At CROI 2022, a number of exciting updates on HIV cure research were announced, including the most recent case of HIV remission after a stem cell transplant. Join a conversation with researchers as they break down the recent case of HIV cure, which is the first such cure in a woman. Speakers will also provide updates from an ongoing trial studying pediatric remission. Join to learn what these advances mean for science and for people living with HIV. Register here.

In Integration of Sexual Reproductive Health and HIV

WEBINAR: Consultation on the Dual Prevention Pill, 12 April at 8:30am ET/2:30pm SAST
Join FP2030 and AVAC for a conversation about The Dual Prevention Pill (DPP), a daily oral pill that is currently being developed for the simultaneous prevention of unintended pregnancy and HIV acquisition. This consultative webinar will highlight unique perspectives from stakeholder in the fields of family planning and sexual & reproductive health. Register here.

Just Published: Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment

We’re excited to announce this new publication – Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment – in the Global Health Action journal. This publication builds on the partnership between our HIV Prevention Market Manager project, ministry of health officials in Kenya, Malawi and Zimbabwe, and Georgetown University’s Center for Innovation in Global Health, and is a call to catalyze actions by development partners in support of national strategies to integrate HIV and SRH information and services.

We hope these resources offer you the context and tools you need to use your passion and add your voice to the work ahead.

Essential Reading and Resources

AVAC and our partners have been busy the first couple of months of 2022. Here is a round-up of essential reading and new and updated resources including HIV treatment studies, PrEP, stakeholder engagement, research fundamentals and more.

Highlights From CROI

Our coverage of week one at CROI featured updates on data related to the Dapivirine Vaginal Ring, injectable cabotegravir (CAB) as PrEP, vaccine science and cure research. And our week two summary looked at symposia that explored how to reach key populations, the critical role of choice in effective HIV prevention, and the status of research on preventing sexually transmitted infections (STIs).

HIV Treatment Studies During COVID-19

A February commentary in JIAS, coauthored by AVACer Maureen Luba with a host of other experts on the topic, offered recommendations for the ethical continuation of treatment research among people living with HIV in the context of COVID-19: Mitigation strategies to safely conduct HIV treatment research in the context of COVID-19.

Transgender Voices: Call to action

The Lancet’s February publication included a public letter from leading voices in the transgender community working in HIV research and public health. Titled, Research on transgender people must benefit transgender people, it called out exploitation in academic research and “called in” researchers to pursue priorities that offer direct benefit to transgender communities and to rely on resources such as No Data No More: Manifesto to Align HIV Prevention Research with Trans and Gender Diverse Realities.

Stakeholder Engagement Must Overcome Tokenism and More

The ethics review process is a critical opportunity for stakeholder engagement. AVACer Jessica Salzwedel, CASPR partner Cathy Slack and other co-authors explore three themes that can make or break effective engagement in a new article in the Journal of Empirical Research on Human Research Ethics: “It’s Almost as if Stakeholder Engagement is the Annoying ‘Have-to-do’…”: Can Ethics Review Help Address the “3 Ts” of Tokenism, Toxicity, and Tailoring in Stakeholder Engagement?

South Africa Is Talking About Injectable CAB As PrEP and Getting Rollout Right

Leading South African publication on public interest health journalism, Spotlight, reported on the excitement among advocates – and the need to plan now – to add injectable CAB as PrEP to the HIV prevention options currently available. Check out two new stories: Start planning HIV prevention injection rollout, experts say and Prioritise HIV prevention injection, activists say.

Many Angles On PrEP And Resources For Advocacy

For context on injectable CAB as PrEP, resources to support the rollout of the ring, and a look at the research and development pipeline of next generation PrEP, check out PrEP and more PrEP: An update and important resources.

Research Fundamentals

What is an endpoint in clinical research and why does it matter? POZ magazine’s February issue featured a transcript of AVAC’s Px Pulse podcast on this question. Hear the original nine-minute podcast here. And you can find the Px Pulse archive here.

We hope these resources offer you the context and tools you need to use your passion and add your voice to the work ahead.

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.