Avac Event

2024 IUSTI World Congress

The International Union Against Sexually Transmitted Infections (IUSTI) and ASHM are pleased to invite you to the 25th IUSTI World Congress, which will this year incorporate the Australasian Sexual and Reproductive Health Conference.

Taking place 17-20 September 2024 at the International Convention Centre in Gadigal Country, Australia, this conference will provide an opportunity to meet, discuss and learn about the latest research and innovation in sexual and reproductive health. The program will incorporate a range of world leading speakers and presentations, providing an opportunity to expand your professional knowledge through local and international insight.

Click here for registration and more info.

Avac Event

2024 STI Prevention Conference

The STI Prevention Conference is a biennial conference that brings together international leading researchers with government experts, clinical STD care providers, and state and local public health administrators. The 2024 STI Prevention Conference is organized by the American Sexual Health Association, the American Sexually Transmitted Diseases Association, the Centers for Disease Control and Prevention, and the National Coalition of STD Directors.

Join more than 1,200 conference attendees September 16-19, 2024, in Atlanta, Georgia, for four days of scientific updates and cutting-edge sessions on science, program, and policy.

Click here for registration and more info.

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.

MPT R&D Funding 2018-2021

This graphic tracks funding levels for a variety of multipurpose technologies for several years. Excerpted from our Advocates’ Guide to Multipurpose Prevention Technologies.

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. 

Avac Event

PrEP Justice: Updates on the US v. Gilead case and the fight for equitable PrEP access


In a major twist that could potentially result in as much as $1B for equitable PrEP access in the US, the government has just made the decision to appeal last year’s jury verdict in the US v. Gilead case. Following pressure from PrEP4All and HIV/AIDS advocates, the US government originally brought the case in 2019, alleging that Gilead had infringed on PrEP patents held by the Centers for Disease Control and Prevention and owed royalties to the government. While a jury verdict in May of last year went against the government, the judge in the case overturned a key part of that verdict just this March, setting the stage for a government appeal.

The stakes for communities in need of PrEP access could not be higher. Gilead’s patent infringement and price gouging have sabotaged equitable PrEP access in America. Royalties paid to the government could and should form the basis for a National PrEP Program that would help erase those disparities. Join The Choice Agenda and PrEP4All to discuss the origin of US v. Gilead, the reasons for the government appeal, and what the case means for PrEP users in the United States.

Moderator:

  • Michael Chancley, PrEP4All

Speakers:

  • Chris Morten, Columbia Law School
  • Jeremiah Johnson, PrEP4All

Recording / Slides / Resources

Global HIV Prevention Advocates Call for Accelerated Timeline for Widespread Access to Injectable Lenacapavir for PrEP

A Joint Statement

Today a global cadre of HIV prevention advocates is calling for an accelerated timeline for access to the HIV prevention drug lenacapavir. Gilead, the developer of the drug, announced topline results from a large study among cisgender African women on 20 June, followed shortly thereafter with a statement about access. 

There is much to do before this twice-yearly HIV prevention option can be included in comprehensive prevention programs, and this coalition of civil society groups is calling for all stakeholders to urgently come together to apply lessons of past PrEP introduction to accelerate the timeline for this important new option to become widely available to those who need and want to use it.

“This is an incredibly important day for African women. Twice-yearly injectable lenacapavir will be an important addition to HIV prevention choices and has the potential to expand access to more women who need and want effective prevention options.”

Ntokozo Zakwe, Community Media Trust in South Africa and a member of the PURPOSE 1 Global Community Advisory Group (GCAG)

“African women need and want new HIV prevention options. We need everyone who has a role to play in bringing lenacapavir to our communities to prioritize the most progressive timeline the world has seen for rollout of a new prevention option, while collaborating with civil society and advocates to ensure introduction plans will result in uptake and impact.”

Chilufya Kasanda Hampongo of Treatment Advocacy and Literacy Campaign in Zambia and a co-leader of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP

Leaders of the PURPOSE 1 Global Community Accountability Board (GCAG), the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP, the African Women Prevention Community Accountability Board, and the Coalition to Accelerate and Support Prevention Research (CASPR) have partnered with AVAC to identify the following actions for Gilead, regulators, normative agencies, funders and national policymakers:

  • All stakeholders must prioritize and uplift community voices and community choices for including lenacapavir in the range of HIV prevention options that offer the widest choice to the most people.
  • Gilead should prioritize and quickly share analysis of the data from PURPOSE 1 and begin submission to multiple regulatory agencies on an accelerated and parallel schedule, with the potential to add data from PURPOSE 2 (among other studies) on a rolling basis to the regulatory portfolio. At the same time, national regulatory agencies need to be ready to review the data once submitted and act swiftly in making regulatory decisions.
  • WHO must begin preparations now for including lenacapavir, once approved, in HIV prevention guidelines as swiftly as possible, in time for regulatory approval.
  • Gilead should transparently share clear plans for pricing of lenacapavir and access for communities most in need, and commit to providing enough drug to support early launch and rollout.
  • Following Gilead’s announcement last week that they are developing a direct voluntary licensing program for lenacapavir, it is imperative that Gilead grants non-exclusive licenses to multiple generic manufacturers in multiple geographies before the end of the year; that license agreements are made publicly available; and that the licenses include access to finished product based on public health imperatives, and not on World Bank country classifications or geographical location. 
  • PEPFAR and the Global Fund should work urgently with other donors and Ministries of Health to negotiate price and volume guarantees with Gilead to ensure there is a sustainable supply for the initial introduction period until generics are registered and readily available.
  • Funders, Ministries of Health, implementers and civil society partners need to collaboratively ​​design a comprehensive introduction strategy that breaks the sequential nature of traditional approaches to scale and speed up introduction. Part of accelerating speed is moving toward a parallel approach where research, implementation science, and scale-up programs are designed, funded and implemented in parallel. All stakeholders, working through the Coalition to Accelerate Access to Long-Acting PrEP, should commit to developing a robust introduction strategy ahead of regulatory approvals and WHO guidelines to ensure time is not lost.
  • Ministries of Health and policymakers must work together and with donors to ensure lenacapavir is integrated swiftly into national guidelines and prevention programs and made available to all populations for which the drug is approved and recommended.
  • Ministries of Health, policy makers and donors must work to ensure strategic demand creation and health-systems strengthening to support robust HIV prevention programs that provide a full range of HIV prevention options that allow people to choose what works best for them.
  • All stakeholders must commit to speeding long-term access to lenacapavir to trial participants and to the women in the communities that hosted the study in parallel with increasing access to a full range of HIV prevention options to those who need and want them.

Advocates know that there are many more actions that will be needed to ensure lenacapavir and other HIV prevention options are widely available. Transparency, speed, scale and cooperation are essential as we work to end HIV as a public health threat.

“We have never seen such a good outcome from an HIV prevention trial, and to see such a result first among African women is groundbreaking. Gilead listened to advocates and followed Good Participatory Practice Guidelines to include two of the populations most in need of  HIV prevention – adolescent girls and pregnant women – in the study. National prevention programs must also prioritize these populations in PrEP programs that will provide lenacapavir.”

Lillian Mworeko, ICW East Africa and a leader of the African Women Prevention Community Accountability Board

“Results like this are what we’ve been waiting for throughout decades of HIV prevention research. We know what is needed now to move this drug swiftly to communities. Civil society stands ready as watchdogs of the process and as essential partners in a successful rollout.”

Stacey Hannah, director of the Coalition to Accelerate and Support Prevention Research (CASPR) and AVAC’s director of research engagement

Results from the ongoing PURPOSE 2 study among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth are expected in late 2024 or early 2025. This second pivotal study will provide data, not just for gay men, but for trans and gender non-binary people, populations that have often been ignored by HIV prevention studies. Data for PURPOSE 2, along with PURPOSE 3, 4 and 5 studies, will provide the most comprehensive range of data across populations that has been seen to date. A schematic of the suite of studies is here.

“We eagerly await the PURPOSE 2 data and hope to see similar results for the populations represented in that study who also need new choices for HIV prevention. Lenacapavir has the possibility of transforming the HIV prevention landscape and changing the lives of millions of people around the world. There must be no delays in making it available globally. Now more than ever, we need speed, scale and equity to ensure we get impact.”

Mitchell Warren, AVAC’s executive director.

About

  • PURPOSE 1 Global Community Accountability Board (GCAG): The PURPOSE 1 and 2 efficacy trials each include Global Community Accountability Groups (GCAGs). Members of the GCAGs include leaders in HIV advocacy and experience with engagement in research and  development. Individual trial sites also have their own community-specific community advisory board, creating multiple layers of advocacy feedback.
  • Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP: Established in 2022 to ensure civil society expertise influences the rollout of long-acting PrEP options, this Caucus includes representation from many civil society groups working on longer-acting PrEP introduction. These include, but are not exclusive to, the following: African Women Community Prevention Accountability Board; AfroCAB; APCOM; AVAC; Coalition to Accelerate and Support Prevention Research (CASPR); Frontline AIDS; Global Black Gay Men Connect (GBGMC); the Global Key Population Advisory Group; and ITPC.
  • African Women Prevention Community Accountability Board: The Accountability Board led the development of the Choice Manifesto and works ensure that the manifesto is translated into reality for all women, and is composed of 12 women from 7 countries representing East and Southern African nations.
  • Coalition to Accelerate and Support Prevention Research (CASPR): CASPR is an Africa-led coalition of 13 partners, funded by USAID and supported by AVAC, working together to change how HIV prevention is pursued and delivered. CASPR activities are focused primarily in key African countries with the highest burden of new HIV infections, and where biomedical HIV prevention research is ongoing or planned.
  • AVAC: AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity.

Upcoming Webinars and a Roundup of New Resources

Last week’s interim result of the PURPOSE 1 HIV prevention study of injectable lenacapavir is captivating headlines. Check out AVAC’s statement here and one from the PURPOSE 1 Global Community Accountability Board and the African Women’s Prevention Community Accountability Board here. But there are LOTS of other things also happening in HIV prevention, and we’re delighted to share this roundup.

Upcoming Webinars

Responding to Project 2025’s Threats to Science, Rights and Resources

Project 2025 is part of an ongoing multi-pronged backlash to the sexual and reproductive health, gender and LGBTQ+ movements. Building on the experience of the HIV movement in fighting these same far-right forces, join this Choice Agenda webinar discussing potential responses through the lens of HIV affected communities and programs. Register here

You Get What You Measure: Why Monitoring for PrEP Choice Helps Tell Our Story

The data collected on a program determines its path and priorities. This Choice Agenda webinar will cover the current state of PrEP monitoring and evaluation, and efforts to improve and simplify data-gathering to better reflect how people use PrEP and to support choice amongst the growing array of PrEP methods. And the discussion will also focus on how data can be used to enhance the stories we tell about PrEP program implementation. Register here

Recordings and Resources

From The Lab To The Jab Webinar and Issue Briefs

Earlier this month, AVAC hosted a webinar highlighting our series of issue briefs, From The Lab To The Jab, covering research and development, mRNA technology, vaccine production, issues relevant to equitable global access to vaccines. The webinar featured panelists from the International Vaccine Institute, International Treatment Preparedness Coalition, and æqua, a think tank focused on equity and economic justice for health. Panelists discussed international initiatives for vaccine development, the current state of vaccine research and access, and how they can be improved. Read more

The GPP Body of Evidence: GPP Monitoring and Evaluation Frameworks, REAL and REAL2

GPP is an essential part of clinical trials research, and an ethical imperative to creating equitable and effective clinical trials. GPP is created by and for communities, so it looks different and takes multiple forms in different cultural contexts. This kind of responsiveness is inherent to GPP, but it also makes it difficult to measure and evaluate. In this webinar, participants will learn from the Realist Review of Community Engagement and the REAL2 review of participatory research. Each examined frameworks for evaluating community engagement efforts. We’ll also learn about the Global Health Network’s new course on evaluation, and other efforts in the field to evaluate the impact of GPP. View the recording

It’s Not Just about the Trial: GPP from discovery to delivery in TB research

GPP enhances every stage of the research lifecycle. In this webinar, our partners at TB Alliance, SMART4TB, and THINK shared experiences, lessons learned, and innovative approaches in integrating GPP at the organizational, network and situational level, from drug development through delivery. View the recording

Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP)

Doxycycline, an oral antibiotic, can be used as a post-exposure prophylaxis, commonly referred to as DoxyPEP, when used to prevent the acquisition of some bacterial STIs after sex. Doxycycline is inexpensive, easily tolerated, and widely available. However, questions remain regarding who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access and minimize antimicrobial resistance. This guide seeks to explore and address these critical questions. Read the guide

Episode 3: The Promising Science

Our Mitchell Warren speaks to ViiV’s Kimberly Smith in this episode of the Foreign Policy podcast series ‘can we end epidemics?’ about the future of HIV science and the challenges we need to overcome on our journey to finding a cure. Listen

We hope these conversations and resources are helpful in your advocacy. Stay tuned for our upcoming advocates’ primer on lenacapavir and our roadmap to the AIDS 2024 conference in Munich.

Avac Event

AIDS 2024: New Ways for the Next Wave: Innovative R&D for the future of women’s prevention

This session will be 9:30AM to 11:00AM Munich time.

Women need a range of HIV prevention options to meet different needs, preferences and life circumstances. Currently available pills, rings and injectables are necessary but insufficient. How might we accelerate the delivery of methods we have while developing additional ones – including systemic and non-systemic methods, short-acting and on-demand products, to complement longer-acting ones? Product developers and advocates are collaborating on new approaches to expedite R&D of additional HIV prevention options. Notably, MATRIX is taking a unique approach, endorsed by the CASPR network of advocates, that aims to improve the odds of success of new products – through development, delivery and use.

This session will focus on new efforts to identify and develop promising options, strategically engage all stakeholders, decolonize R&D and involve potential users in all their diversities throughout the process.

Speakers:

  • Jeanne Marrazzo, National Institute of Allergy and Infectious Diseases
  • Sharon Hillier, University of Pittsburgh / Magee-Womens Research Institute
  • Thesla Palanee-Phillips, Wits RHI

Followed by a moderated panel with:

  • Chimwemwe Chamdimba, African Medicines Regulatory Harmonization (AMRH) initiative- AUDA/NEPAD
  • Kelly Chibale, Holistic Drug Discovery and Development Centre -H3D, University of Cape Town
  • Nyaradzo Mgodi, University of Zimbabwe- Harare Health Research Centre
  • Jerop Ruth Limo, Ambassador for Youth and Adolescents Reproductive Health Program (AYARHEP)

Moderators:

  • Navita Jain, AVAC
  • Kenneth Ngure, Jomo Kenyatta University of Agriculture and Technology

Session Chairs:

  • Sharon Hillier, University of Pittsburgh / Magee-Womens Research Institute
  • Imelda Mahaka, Pangaea Zimbabwe

This satellite session will be co-hosted by CASPR and MATRIX, with support from USAID and PEPFAR.

Landmark Trial in South Africa and Uganda Finds Twice Yearly HIV Prevention Injection Safe and Highly Effective

AVAC Calls for Accelerated Regulatory Review and Ambitious Introduction Plans

AVAC welcomes the groundbreaking results of the PURPOSE 1 HIV prevention study among adolescent girls and young women in South Africa and Uganda. Preliminary safety and efficacy results were reported today by Gilead Sciences, the developer of the lenacapavir, one of the HIV prevention drugs that was being studied in the trial. An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with no infections seen among trial participants who received injectable lenacapavir. 

“This is one of the most important results we’ve seen to date in an HIV prevention study,” said Mitchell Warren, AVAC’s executive director. “Adding additional HIV prevention options means more people may find an option that is right for them. Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit.” 

“We are incredibly excited about this result, especially about what it can mean for women in Africa,” says Nandisile Sikwana, Regional Stakeholder Engagement Manager for AVAC, and a member of the PURPOSE 1 Global Community Advisory Group. “We applaud Gilead’s commitment to Good Participatory Practice in this and the other PURPOSE studies. While we wait for full data from the study, including adherence data of oral F/TAF, it is imperative that planning for rollout of lenacapavir be accelerated. We know that even with the most ambitious timeline, it will take time for lenacapavir to be rolled out,” says Sikwana.

The PURPOSE 1 study enrolled over 5,300 cisgender adolescent girls and young women ages 16-26 in South Africa and Uganda. The study is evaluating injectable lenacapavir for PrEP and daily oral emtricitabine/tenofovir alafenamide (F/TAF) for PrEP. A companion trial, PURPOSE 2, is underway in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US, testing twice-yearly lenacapavir for PrEP among cisgender men who have sex with men, transgender women, transgender men, and gender non-binary people. Results from PURPOSE 2 are expected by early 2025. Additional studies in critical populations, including PURPOSE 3 among cisgender women in the US and PURPOSE 4 among people who use injection drugs, are also underway, and it will be imperative to understand how today’s results influence these trials. A schematic of the suite of studies is here.

Gilead’s plans for submission to regulatory agencies and future access, including the US Food and Drug Administration (FDA), are not yet clear. But the results reported today make this urgent. “We expect to see a timeline that takes into account a full analysis of PURPOSE 1 data and the coming data from PURPOSE 2 from Gilead as soon as possible, and we urge regulatory agencies to prepare to fast track regulatory review,” Warren said. “We also call on WHO to be prepared to quickly include lenacapavir, if approved by regulatory agencies, in HIV prevention guidelines. There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact and expand the toolbox of HIV prevention choices.”

“We now know that lenacapivir for PrEP is safe and highly effective among women,” Sikwana added. “Even as we await the results of the trial among other essential populations and for regulatory submission and review, there is urgent work to be done now by communities, policy makers, funders and program implementers to design and build HIV prevention programs and prepare health systems to deliver the growing array of biomedical PrEP options, including the addition of twice-yearly injectable lenacapavir. The full range of PrEP products – including oral PrEP – must be made feasible choices for all people who need and want HIV prevention options.”

Lessons learned from roll out of daily oral PrEP, and more recently the dapivirine vaginal ring and injectable cabotegravir, can help speed regulatory approval and guideline development in key countries, design of effective programs, and community understanding of and acceptance of lenacapavir for PrEP.

“AVAC and a cadre of international partners have been working together to plan for successful, accelerated introduction of lenacapavir. Since oral PrEP was first shown to be safe and effective 14 years ago, the global health community has failed in delivering PrEP at scale and with equity – and we have, therefore, not seen the impact that we need. The lessons from the past are clear, and we now must act on them and move with speed, scale and urgency. There can be no excuses and no delays,” said Warren. “We look forward to working with civil society partners, Gilead, international donors, normative agencies and national governments to ensure that this groundbreaking HIV prevention option is made available as quickly as possible and that we don’t squander this opportunity to drive down new HIV infections.”