AVAC Calls on Gilead and Global Stakeholders to Accelerate Access to Generic Lenacapavir Following License Agreements

AVAC welcomes Gilead Sciences’ announcement in granting multiple, non-exclusive licenses to generic manufacturers to produce lenacapavir, their investigational twice-a-year injectable for PrEP, while it is still in clinical trials. This reflects longstanding community advocates’ calls to speed up access to PrEP options immediately following regulatory approval.  

On October 2, Gilead Sciences announced their plan to work with six generic medicines manufacturers to produce and market injectable lenacapavir for PrEP in 120 countries. This process of granting licensing agreements with generic manufacturers prior to regulatory submissions could reduce the time to market for generic products by up to three years.  

“Today’s announcement from Gilead is positive momentum in moving forward with injectable lenacapavir for PrEP. But while voluntary licenses are essential, they are not sufficient on their own to translate exciting science into public health impact,” said Mitchell Warren, AVAC’s executive director. “The six licenses announced today demonstrate that the field is learning what needs to go faster, and pharmaceutical companies are listening and acting.”  

“This is notable improvement both in timelines for licensing and in geographic coverage, with LEN licenses being granted before regulatory approval, compared to the two-year gap after approval for injectable cabotegravir. Additionally, the six generics for LEN come from three different countries, whereas the three cabotegravir licenses were concentrated in one country. Expanding manufacturing across multiple regions can hopefully further enhance efforts to accelerate global access,” Warren added. 

However, key countries with significant HIV incidence, including several of those hosting the PURPOSE 2 trials of lenacapavir, are left out of the license geographies. This challenges the field’s ability to use this new option at the scale needed to drive down HIV incidence as quickly as possible to meet global targets. In addition, the price of lenacapavir for prevention – for both the originator product and the future generics – is still unknown, another critical piece of information in building a sustainable, impactful market. 

Various cost-effectiveness analyses have shown that injectable PrEP must be priced in the range of generic daily oral TDF/FTC to be considered cost-effective. Modeling studies suggest that the generic price of LEN for PrEP could be as low as $100 per person year of protection, but only when the number of vials produced is equivalent to those needed for one million LEN users.  

This represents a significant increase in the current PrEP market and would require scaling up additional investment in product procurement and programming by donors and governments. While this may not be possible at product launch, the field needs to collaborate to reach this price point as quickly as possible and then move to the price of daily oral PrEP, as the number of LEN for PrEP users rises to over ten million people per year.  

To reach these price points, it is essential to build volume in the global market with supplies from Gilead at close to $100 per person per year of protection beginning next year. Simultaneously, donors must procure and program large quantities and support generic manufacturers to prepare for production at scale, with market entry by 2027 to catalyze even lower prices.    

“Advocates must push for equitable and speedy PrEP access, including pricing transparency from Gilead and generics, accelerated investments by donors to design and implement integrated programs that offer LEN as part of choice of product and service delivery models, for everyone, everywhere, based on public health imperatives, and not on World Bank country classifications or geographical location,” said Wawira Nyagah, AVAC’s director of product introduction and access.  

AVAC will continue to monitor the research, approval processes and product implementation of lenacapavir as part of its quarterly Long-Acting PrEP Status Updates. Please read our Lens On LEN Advocates’ Guide, which will be updated as the process toward lenacapavir access moves forward and stay tuned for our forthcoming comprehensive plan to accelerate introduction and access.

Restrategizing Civil Society Engagement for Pandemic and Global Governance 

Ministries of health, researchers, advocates, academics and civil society members came together on the sidelines of UNGA79 to discuss strategies for more meaningful and impactful engagement of civil society in global governance for health, climate, and other development sectors, particularly in the context of the Pandemic Accord negotiations at Center for Indonesia’s Strategic Development Initiatives’ (CISDI) event, Restrategizing Civil Society Engagement for Pandemic and Global Governance. 

After two years of negotiations, countries did not reach an agreement around the Pandemic Accord and therefore agreed to continue negotiations for up to one year. The Pandemic Accord is meant to represent a global agreement on coordination, equity principles, financing expectations, and a range of capacity areas, including disease surveillance, healthcare workforce, lab facilities, and resources for non-pandemic related healthcare.  

However, “there’s been no other process where they so systematically ignored civil society,” said Nina Schwalbe, CEO of Spark Street Advisors. AVAC’s Sam Rick who moderated the event reminded the audience that for pandemic prevention, preparedness and response (PPPR) to succeed, lessons from the HIV response must be integrated into the architecture being built for PPPR. Meaning, the principles of equity must be embedded into every level of these agreements, and governments and civil society must be empowered to hold them accountable.

Schwalbe and colleagues expressed their deep concern and dissatisfaction with the ongoing Pandemic Accord negotiations. See the recent statement from the Coalition of Advocates for Global Health and Pandemic Preparedness. “With decades of experience in the global HIV and NTD movements, we have demonstrated through our work the crucial role that civil society and communities play in advancing multilateral governance and their impact on health outcomes, as pandemics start and end with community and as such, communities and civil society must be at the center of, and included in all pandemic negotiations… We urge Member States to agree to a governance structure for the Accord moving forward that institutionalizes meaningful civil society and community engagement.” 

The panel highlighted the disparities in vaccine distribution and the necessity for self-reliance in health systems. They emphasized the need for a unified message and strategic coordination among civil society organizations to influence global health policies effectively. 

“You need global health, that is, you need the highest possible health outcomes for as many people around the world, and you need all of those benefits to be equitably distributed… And I think it’s up to us in civil society, pressing our governments, pressing the WHO, pressing the United Nations to actually make this happen.” – Lawrence Gostin, Faculty Director of the O’Neill Institute for National and Global Health Law 

The panel made clear calls to action:  

  • Read and provide comments on the draft pandemic agreement text to identify gaps and push for stronger civil society participation. 
  • Engage with national authorities responsible for pandemic preparedness and response to ensure meaningful civil society participation at the country level. 
  • Support a unified message that can be widely endorsed by civil society organizations. 
  • Advocate for the establishment of formal, funded, and representative civil society engagement mechanisms in the pandemic agreement negotiations and other global health governance processes. 
  • Explore opportunities to leverage upcoming events like the COP meetings to amplify civil society voices and push for greater inclusion. 

For More on Pandemic Accord Negotiations, Read:  

Explore STIWatch.org and get the latest resources to navigate the IUSTI & STI Prevention meetings!

Dear Advocate, 

AVAC is delighted to share its all-new STIWatch.org website just as advocates, clinicians, researchers and partners convene in Atlanta, GA for the Centers for Disease Control and Prevention STI Prevention Conference, and in Sydney, Australia for the 25th International Union Against Sexually Transmitted Infections (IUSTI) World Congress.  

Rates of sexually transmitted infections (STIs) continue to rise globally with too little public health intervention and investment. While many STIs are curable, they often go undiagnosed and untreated because they tend to cause few or no initial symptoms. Available diagnostics are often too costly to use for routine screening and testing in many low to middle-income countries (LMICs), and few vaccines exist to address the most common STIs. 

Discover STIWatch.org!

STIWatch.org is an updated platform designed to enhance understanding and advocacy for STI vaccine and diagnostics research, development, and rollout. It offers comprehensive information on common STIs, a clinical trials dashboard, advocacy priorities, and a range of resources and tools to support STI prevention and treatment efforts. 

Scroll down for more STI prevention resources advocates need to navigate these two conferences.

Resources

Follow the STI Prevention Conference events in real time in Atlanta on Twitter at #STIConf24 and on AVAC’s feed at @HIVpxresearch

STI Clinical Trial Dashboard: shares the latest STI research on diagnostics and vaccines

STIs: A Review of the 2022 Vaccine and Diagnostic R&D Pipeline and Investments: provides an annual analysis of global funding trends for STI prevention research

Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP): explores and addresses the explore and address the critical questions around who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access. 

STIWatch.org is an initiative of AVAC with funding and support from the World Health Organization, the Bill & Melinda Gates Foundation and the National Institutes of Allergy and Infectious Diseases.  

Contact [email protected] for more information. To receive email updates from AVAC, signup here. 

HIV leaders say it’s time to end the long wait for long acting products

Dear Advocate, 

How do we translate recent scientific advances in long-acting HIV prevention and therapy into public health impact? Read answers in this new The Lancet HIV commentary from a distinguished group of authors including our Executive Director, Mitchell Warren, AVAC board members, Linda-Gail Bekker, Solange Baptiste Simon, with partners Francois Venter, Kenly Sikwese, and others: The long wait for long-acting HIV prevention and treatment formulations. 

Major advances in long-acting HIV treatment and prevention, including the latest PURPOSE 1 results of lenacapavir for PrEP, hold great promise for achieving global targets. However, planning to coordinate among stakeholders, including pharmaceutical companies, governments, and multilateral organizations to deploy and ensure equitable access to these products, particularly in low- and middle-income countries, requires immediate action.  

“Civil society organisations and HIV activists have been instrumental in holding pharmaceutical companies, financial donors, governments, and international organisations accountable for commitments to the international HIV treatment response for decades,” the authors write. “These organisations and activists are needed to promote transparency in pricing, challenge restrictive patent practices, advocate for affordable and widespread availability of drug innovations, prevent companies from restricting broad access to medications, and require funding to allow this work to be done independently.” 

Key Messages

  • Long-acting antiretrovirals are perhaps the greatest advance in HIV care in over a decade and provide great promise towards achieving global HIV prevention and control programme targets. 
  • Current long-acting agents are firmly under the control of originator pharmaceutical companies and remain unavailable or cost-prohibitive across much of the globe. 
  • If action from the broader HIV community is stagnant, the populations who are most in need of these long-acting agents are unlikely to receive any benefit until well into the 2030s, resulting in a large number of preventable HIV infections. 
  • Coordination by international agencies, with assistance from relevant financial donors and stakeholders, will be needed in the complex research and access programmes required to provide widescale use of these indispensable products to people living with HIV or affected by HIV. 

Resources on Long-Acting HIV Prevention

The Lens on LEN: this primer for advocates shares the basics on injectable lenacapavir as PrEP.

Long-Acting PrEP Status Update: this webpage shares graphics and information synthesizing the current status of long-acting PrEP products. It’s updated quarterly.

PrEP Products Overview: this page on PrEPWatch shares the status of PrEP products in development and approved.
Injectable Cabotegravir Evidence Gap Tracker: this webpage summarizes the latest insights from the Biomedical Prevention Implementation Collaborative (BioPIC) on injectable CAB for PrEP, links to learn more, and information on where evidence is still needed, mapped against priority evidence gaps.

Years Ahead in HIV Prevention Research: Time to Market: this downloadable graphic shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.

New Peer-Reviewed Articles, Upcoming Webinars & More!

Dear Advocate,  

AVAC and partners authored three new peer-reviewed articles this month on a range of HIV prevention issues. From the potential and challenges of long-acting formulations in HIV care, to the benefits of delivering family planning AND PrEP using pharmacies, e-pharmacies and private sector clinics, to the necessity for gender-transformative approaches to ensure effective and equitable participation of women in biomedical prevention trials, these are must-read pieces. Scroll down for more and mark your calendars for four webinars coming up, including this week!

The Long Wait for Long-Acting HIV Prevention and Treatment Formulations

This commentary in The Lancet HIV calls on WHO, financial donors, manufacturers, and governments to take coordinated action to make long-acting HIV prevention and treatment available at scale in lower- and middle-income countries.

Harnessing Private Sector Strategies for Family Planning to deliver the Dual Prevention Pill

The latest edition of the Journal of the International AIDS Society features newly published research by AVAC and partners on the benefits of delivering family planning and PrEP using pharmacies, e-pharmacies and telemedicine, in addition to private sector clinics. The research demonstrates why these delivery methods should be prioritized for rolling out the Dual Prevention Pill (DPP), a daily pill that combines oral PrEP with an oral contraceptive to prevent both unintended pregnancy and HIV. 

Meta-analysis of Pregnancy Events in Biomedical HIV Prevention Trials in Sub-Saharan Africa: Implications for Gender Transformative Trials

CASPR partners authored new research published in AIDS and Behaviorhighlighting the need for clinical trial teams to balance the goals of generating scientific evidence with participants’ fertility choices. The authors argue that to better support participants, trials should adopt strategies that accommodate changing fertility preferences, plan for pregnancies, and consider the ethical implications of allowing pregnant participants to continue in studies. This approach would contribute to a more gender-transformative approach to pregnancy in HIV prevention trials.

Mark Your Calendars: Upcoming Webinar

TOMORROW, August 27: Opportunities to Expand Equitable Access to HIV Prevention Services through Community Pharmacies 
Join The Choice Agenda and RxEACH, a national coalition effort working to expand and sustain access to HIV prevention and linkage to care services in community pharmacies for a webinar discussing the opportunity to expand equitable access to HIV prevention services, including PrEP, and what is needed to grow and sustain community-based HIV prevention service programs in pharmacies. 

August 29: Let’s Talk LEN: What global advances in HIV prevention mean for Black communities in the US
Join PrEP in Black America, Black Public Health, Federal AIDS Policy Partnership (FAPP), AVAC, and APHA, this webinar will explore the implications of the groundbreaking results from the PURPOSE 1 trial of Lenacapavir for US Black populations.
 
August 29: PrEP Your Booty
Join The Choice Agenda and HPTN 106 (REV UP), an innovative clinical trial from the HIV Prevention Trials Network that will investigate the safety and acceptability of a tenofovir-based rectal douche for HIV prevention, for a discussion with researchers leading the study.
 
September 11: Innovations in GPP
Join AVAC and champions of Good Participatory Practices (GPP) as they illustrate the evolution of GPPS from CABs and town hall meetings to more innovative and partnership-based approaches.

What’s Next for the Dual Prevention Pill (DPP)

Dear Advocate,  

The latest edition of the Journal of the International AIDS Society features newly published research by AVAC and partners on the benefits of delivering family planning and PrEP using pharmacies, e-pharmacies and telemedicine, in addition to private sector clinics. The article, Harnessing private sector strategies for family planning to deliver the Dual Prevention Pill, the first multipurpose prevention technology with pre-exposure prophylaxis, in an expanding HIV prevention landscape, demonstrates why these delivery methods should be prioritized for rolling out the Dual Prevention Pill (DPP), a daily pill that combines oral PrEP with an oral contraceptive to prevent both unintended pregnancy and HIV. 

The DPP is the Multipurpose Prevention Technology (MPT) closest to market and the first-ever with PrEP. Following the recent successful conclusion of a bioequivalence study, where researchers demonstrated the active ingredients functioned in the body the same as when PrEP and oral contraception are taken separately, the DPP could be approved by regulators by late 2025. The DPP could be a desirable choice for women seeking an option that will meet multiple needs in their sexual and reproductive health (SRH). 

The research found that a significant proportion of family planning (FP) services in Kenya (22%), South Africa (11.4%) and Zimbabwe (17.3%) are delivered using the private sector (such as private provider networks, pharmacies, e-pharmacies and telemedicine). But these channels remain underutilized and represent a largely untapped — yet growing — delivery channel with great potential to expand access to PrEP.

“Addressing the underlying reasons why this is the case will be a prerequisite to DPP rollout, not just in these three countries, but in all countries with high HIV incidence where the private sector is a popular source for FP, such as Eswatini, Lesotho, Malawi, Namibia, Uganda and Zambia”. 

The authors write.

Based on these findings, regulators should update national guidelines to allow for more diverse PrEP delivery. Training on PrEP delivery could be expanded among nurses and other providers, as well as doctors. Clinics, pharmacies, telemedecine and e-pharmacies could offer PrEP.  Implementers and researchers should also undertake research to better understand willingness and ability to pay, how these factors align with the cost of DPP delivery, and what additional subsidy may be needed to ensure successful rollout of the DPP. 

This research supports a Market Preparation and Introduction Strategy that is guiding plans for how, where and to whom the DPP is introduced. Providing users a range of options to access the DPP in non-traditional channels will minimize stigma, improve convenience, and offer discretion — all of which are features that will increase overall uptake and continuation. See our resources on the DPP below. 

Choice, Access and Equity at AIDS 2024

Choice, access, and equity were central themes during the sessions and discussions at #AIDS2024 on Wednesday and Thursday. Highlights included new data on long-acting cabotegravir, a plenary calling out the need to move with speed, scale and equity in the rollout of new PrEP options, updated guidelines to improve access to post-exposure prophylaxis (PEP), a renewed commitment to the African Women’s Choice Manifesto, new data highlighting the omission of key populations from sustainability planning, and much more.

Click below to access AVAC’s daily reports from #AIDS2024 and read on for Wednesday and Thursday highlights.

Key Steps for Choice

The African Women’s Prevention Accountability Board (AWPCAB) continued to raise their voices and call on the international community to prioritize expanded access to existing products such as the dapivirine vaginal ring and injectable cabotegravir and developing new methods to ensure a range of prevention options for women and girls. Winnie Byanyima of UNAIDS pointed to her commitment to the Choice Manifesto, a declaration put forward by AWPCAB calling for sustained political and financial support for more choice in HIV prevention.  

At a Thursday satellite, HIV Prevention in the Time of Choice, Michelle Rudolph from WHO said they are “supporting PrEP options, also PrEP choice, prevention choice, and that includes the [dapivirine] ring, and we’ll continue to include the ring in all of our guidance moving forward.” Next steps for making choice a reality included curricula for training healthcare workers; more PrEP options for pregnant and lactating people; reducing costs through local manufacturing and technology transfers; and of course, community engagement.  

2 for the Price of 1: DPP as the next MPT 

In a workshop on the Dual Prevention Pill (DPP), Two for the price of one: Simplifying access to HIV prevention and contraception with multipurpose prevention technologies (MPTs), attendees brainstormed how to address real-world dilemmas that may come with rolling out the DPP, such as how to train HIV and family planning providers to deliver it; how will governments and donors balance the delivery of all proven methods for HIV prevention, including CAB for PrEP and the ring. Proposed solutions touched on the role of stakeholder engagement, models for demand creation and more. To learn more about the DPP and the full pipeline of MPTs, see AVAC’s Advocates’ Guide to MPTs. 

Pushing for Equity in Access: All PrEP & PEP

As the international community hailed the results of the PURPOSE 1 trial of injectable lenacapavir for PrEP in Wednesday’s Co-Chairs’ Choice session and called on its maker and international partners to plan for equitable access in its rollout (pending additional data and regulatory reviews), WHO published updated guidelines aimed at expanding access to post-exposure prophylaxis (PEP), a critical and under-used intervention in reducing new infections. These guidelines come on the heels of UNAIDS’ newest report showing an estimated 1.3 million new HIV infections in 2023, with increases seen in countries where  investment in prevention was lower. 

“We cannot say that we are doing well until we are doing well,” Jhpiego’s Elizabeth Irungu shared in Thursday’s plenary, HIV Prevention Strategies, speaking to the current state of PrEP choice, access and uptake globally. Irungu decried the historical delays in the rollout of oral PrEP and called on all stakeholders to break the 12-year cycle of squandering opportunities in prevention. 

The Inclusion of KPs in Country Planning for Sustainability: A report on pseudo engagement

The voices of key populations (KPs), such as gay men, other men who have sex with men, sex workers and people who inject drugs, are too often left out of sustainability planning, a process pushed by PEPFAR and UNAIDS. This was a finding from an analysis in six countries conducted by the Key Population Trans-National Collaboration (KP-TNC). From the session Integrating social enterprise for sustainability of key population programmes, AVAC’s Richard Muko, talked about some the causes behind this finding. These include cultural and religious beliefs that stigmatize KPs; reactionary policy moves that exclude KP voices; punitive laws targeting KPs; insufficient guidelines on how KP communities will be included in the sustainability framework; lack of political will and lack of understanding of KP needs in relation to HIV programming. “Some minimal communication can amount to pseudo involvement of KPs. But we see a signal that KP needs may be missing from the final sustainability roadmaps under development now.” The abstract on the study, Country HIV response sustainability roadmaps: where are key populations in the conversations?, calls for PEPFAR, Global Fund and UNAIDS to step up with frameworks for KP engagement in the development of sustainability roadmaps. 

Making the Case for an HIV Vaccine

Leaders in HIV prevention voiced unwavering support for vaccine development notwithstanding the scientific challenges, even as the world watches ARV-based interventions making enormous strides. In his plenary talk, Devin Sok of the Global Health Investment Corporation equated the HIV epidemic with a fire that can get out of control at any time. “We really need to reduce the embers to the point that we won’t have a fire… a vaccine will be essential for supporting epidemic control and eventually eliminating HIV as a public health threat.”  

Later in the day, the satellite session Ending the Epidemic: The role of a vaccine in the era of long-acting PrEP. Participants said the science in broadly neutralizing antibodies is accelerating with implications for vaccine research; investments in vaccine science have yielded unimaginable and enormous benefits (including COVID vaccines); and ultimately the choice of a vaccine remains essential to a sustainable and durable end to pandemic. As NIAID leader Jeanne Marrazzo said, “to understand any process that we can eventually apply to cure or to eliminate HIV, it’s got to involve an HIV vaccine.” And, ultimately, she said, there are populations of people who may never be as comfortable with ARV’s as a vaccine and vice versa.

AVAC’s AIDS 2024 Resources for Advocates

Stay tuned for more ways to unpack the new data, reports and discussion from AIDS 2024 including an upcoming webinar focused on what’s next in lenacapavir for PrEP advocacy. 

LEN in the Spotlight at AIDS 2024

Zero Infections!

Midpoint at #AIDS2024 in Munich, one of the most significant advances in HIV prevention in the history of the response, the efficacy of lenacapavir as PrEP, was presented at the Co-Chair’s Choice session. The findings, zero infections and 100% efficacy among the trial participants in the PURPOSE 1 trial, brought a standing ovation.

Presented by Linda-Gail Bekker of the Desmond Tutu Health Foundation, and published in the New England Journal of Medicine, PURPOSE I enrolled 5,300+ cisgender adolescent girls and young women (ages 16-26) in South Africa and Uganda. PURPOSE 1 also evaluated daily oral emtricitabine/tenofovir alafenamide (F/TAF) for PrEP, which was shown to be safe. Overall adherence in the F/TAF arm of the trial was low and the intervention did not show overall efficacy. But, among those trial participants with medium to high adherence (2-4 doses per week), data showed a significantly lower chance of HIV infection compared to participants with low adherence.

The introduction of oral PrEP has changed the lives of more than 6 million people globally who have accessed it. Despite the promise of PrEP, many young women have found the uptake of daily adherence and persistence to daily PrEP a social, emotional and physical challenge. We need new and diverse PrEP options,” said Bekker.

For more on PURPOSE 1 and the rest of the PURPOSE program evaluating lenacapavir across diverse populations, see AVAC’s primer for advocates, The Lens on LEN.

So now the work must accelerate.  

New UNAIDS data released at the meeting calculated that 44% of all new HIV acquisitions were among women and girls in 2023 globally, and young women in Africa accounted for 62% of new HIV acquisitions, making the case that there are millions of women in urgent need of HIV prevention and who must be given the opportunity to benefit from every proven method of HIV prevention. 

Data for key populations is just as stark. The latest data from UNAIDS points to marginalization, discrimination and criminalization as drivers pushing the median prevalence of HIV in 2023 to be much higher than the global average among sex workers, gay men and other men who sex with men, and transgender people (3%, 7.7% and 9.2% higher respectively than the global adult prevalence of .8%).  

All these populations represent individuals with unique and evolving needs. No single prevention product will ever be a miracle drug. People need real choices in programs tailored to reach them. Implementers, policymakers, donors, advocates and communities must collaborate for the speedy, reliable delivery of every option. Check out AVAC’s statement calling for early planning to accelerate LEN’s regulatory review and for ambitious introduction plans, and the joint civil society call to action with specific priorities about what needs to happen next. 

In a satellite session with advocates Wednesday, Winnie Byanyima of UNAIDS recommitted to the Choice Manifesto, a powerful declaration calling for continued political and financial support for more choice in HIV prevention. As Angeli Achrekar also of UNAIDS said at a subsequent session, “Both data and services need to be precisely tailored to the people who need prevention most, and we have to make solutions more affordable. We need a new HIV prevention revolution.”  

We couldn’t agree more. 

AIDS 2024 Preconference Highlights

AIDS2024, this year’s annual conference of the International AIDS Society opened with a spotlight on troubling trends. A series of preconferences took on critical topics including supporting key populations in a time of increasing discrimination; new and novel research and implementation of STI prevention and treatment, witnessing a soaring rise in incidence; and the importance of implementing new PrEP options to create more choice for people who need HIV prevention most.  

Key Populations at the Center of the Response

Breaking Barriers: Insights and Realities from Key Populations in HIV Prevention, organized by Global Black Gay Men Connect (GBGMC) and AVAC, featured the voices of speakers representing migrants, people who inject drugs, sex workers and LGBTQI+ people and the release of a new report, Making Rights a Reality: A GBGMC Roadmap. GBGMC executive director and former AVAC staffer, Micheal Ighodaro said the report challenges the “misinformation and complacency that assume the world can achieve HIV sustainability, biomedical HIV prevention progress and global health security without key populations’ leadership and insight.”

AVAC’s Cindra Feuer offered context on impending reductions in global spending on the HIV response, occurring not because resources are limited but because of waning interest. Inform your advocacy with AVAC and GBGMC’s 2023 Global HIV Prevention Roadmap for Key Populations.  

AVAC’s Kenyon Farrow presented on why researchers, implementers and community advocates can and should all play a role in shaping the PrEP pipeline, and how innovation in the pipeline should be implemented.  

Why STIs Matter

The preconference, Mobilize for Action on Sexually Transmitted Infections addressed the urgent need to confront the global spike in STI rates, particularly syphilis, gonorrhea, chlamydia, and trichomoniasis. Epidemiological data shows alarming growth in STI rates, and speakers discussed the morbidity and mortality that they’re causing, and an underfunded infrastructure for researching new diagnostics, antibiotics, vaccines and other treatments.  

Perhaps no more sobering of a statement was made than by Dr. Jeanne Marrazzo, director of NIAID, when discussing the number of global deaths from something as treatable as syphilis. “I think some of the more staggering statistics here, in addition to the sheer number of new infections, is the fact that we had in 2022 over 200,000 syphilis-associated deaths, which to me is practically medieval.”  

In addition to research for new treatments and increases in STI program funding, Alison Footman, AVAC’s senior program manager of STIs said it’s equally important to strengthen the capacity and role of community advocates in fighting STIs. 

“AVAC partners with many organizations across East and Southern Africa who are raising the profile of STI advocacy. From their guidance, we know there’s a need for community advisory boards [to be] involved in STI research. It can and will improve essential research.” 

Alison Footman, AVAC

A rigorous debate explored the question of implementing DoxyPEP, given there’s no efficacy data for cisgender women in light of fears of creating drug resistant strains of STIs from wider use of doxycycline. Strong arguments were made on both sides, but this controversy is one of the reasons AVAC recently published an Advocate’s Guide to Doxycycline to Prevent STIs. 

Cure and the Next Berlin Patient

With researchers announcing what appears to be the seventh person potentially cured of HIV following a stem cell transplant, a preconference on cure research, Towards a Truly Global HIV Cure, captured a feeling of momentum driving cure research today. Donors discussed new investments in African-based infrastructure and initiatives. Scientists explained where cure research is headed in both adult and pediatric populations. But none of these topics were more important than comments from a South African participant in the FRESH cohort trial that includes an analytic treatment interruption, one of the first in Africa, emphasizing that a strong commitment to communication was the foundation to building the trust necessary for these trials. ”Sharing strategies for communication and advocacy across the field of HIV cure research will be essential for it to advance.” 

PrEP Choice

With interim results of the PURPOSE 1 HIV prevention study of injectable lenacapavir (LEN) for PrEP among cisgender women and adolescent girls recently announced, the expanding landscape of PrEP options was the focus of Welcome to the Era of PrEP Choice. Organized by the Gates Foundation, Unitaid, USAID, and the World Health Organization, the message from this session echoed throughout the various presentations: Everyone has a role to play in expanding access to real choices for all who need and want them. Putting in place the right programs, policies and investment to deliver choices at scale and bend the curve of the epidemic utterly depends on a commitment to integrated, equitable, people-centered, and community-led approaches. See the latest quarterly update from The Coalition to Accelerate Access to Long-Acting PrEP, AVAC’s recent webinar on monitoring for PrEP choice to improve and simplify data, and the new Lens on LEN, an advocates guide explain the findings from Purpose 1 and next steps for advocacy.

Stay tuned for more highlights from AIDS 2024 and visit our curated conference webpage for new resources and ways to navigate #AIDS2024 including our roadmap.

A Champion for the Dual Prevention Pill

The Advocacy Chronicles with Ruth Akulu

We’ve got PrEP. We’ve got contraceptives. But what impact would there be on reducing HIV diagnoses if PrEP and contraception were rolled into one? The development of products and programs that integrate HIV prevention with other critical health-care needs is on the cusp of a new chapter. With advances in the development of the Dual Prevention Pill (DPP), a focus now on the role of multipurpose prevention technologies (MPTs) and how to integrate HIV services with sexual & reproductive health (SRH) is a must. The right conversations and the right commitments will speed investment and innovation in delivering a new paradigm in prevention: one that offers an integrated, person-centered experience for people who need prevention and want solutions that work for them.  

So, what are MPTs, and what is the DPP? 

An MPT refers to a single product (think condoms) designed to simultaneously address more than one health need (think prevention of both pregnancy and sexually transmitted infections). Condoms are the only MPT on the market today. But the DPP may soon change that. Now in late-stage development, the DPP combines an oral PrEP formulation with an oral contraceptive, preventing both transmission of HIV and pregnancy in one pill. 

Our next episode of the Advocacy Chronicles features the work of an unstoppable advocate who mobilized government action to prepare for the introduction of the DPP while also establishing a groundbreaking new initiative for ongoing engagement between regulatory authorities and young women representing their communities.

The field has arrived at a moment when advances in research and development for integrated products can and must be supported and sustained. And these integrated products must be matched with integrated programs, designed by and for the people who need them most. We hope these resources support and inspire your work.