For Your Advocacy – A Research Agenda for Pregnant and Lactating People

For prevention options to meet the real life circumstances of the people who need them, we need an inclusive research agenda. Advocacy for the inclusion of pregnant and lactating populations (PLP) in research has been gaining traction in recent years, building on growing evidence, several global and national initiatives and an increased focus from prevention advocates. AIDS 2022 in Montreal featured exciting discussions advancing this work. If you’ve been taking part or just getting up to speed on the issue, AVAC has resources for you—including An Advocate’s Guide to Research in Pregnant and Lactating Populations; a dedicated page on AVAC.org with background and further resources; and a four-point action plan, Advancing HIV Prevention Research in Pregnant and Lactating Populations: Priority Advocacy objectives and Next Steps.

Pregnancy and the post-partum period after giving birth are times of heightened HIV risk. Cisgender women are two to three times more likely to acquire HIV during pregnancy and four times more likely post-partum than otherwise. Women who acquire HIV during pregnancy have an 18 percent chance of transmitting HIV to their newborn, which goes up to a 27 percent chance if they acquire HIV while breastfeeding. But HIV prevention options for (PLP) are limited, and their inclusion in research has been inadequate, resulting in evidence gaps across the research landscape for new prevention products.

(Image from AVAC’s Advocates Guide)

An approach based on principles of reproductive justice is reframing the research agenda for PLP. But action is needed from a variety of stakeholders to promote ethical inclusion rather than exclusion of pregnant people from clinical trials. A multi-stakeholder think tank led by AVAC and the PHASES project brought together advocates, researchers, ethicists, regulators and donors and resulted in a four point action plan, with additional contributions from Pangaea Zimbabwe AIDS Trust. The plan identifies next steps and four priority goals:

1) Embrace a reproductive justice framework:

(Reproductive Rights Framework, Image from PHASES, 2020)

2) Engage stakeholders in an early and sustained process in the design and conduct of clinical trials

3) Develop the necessary regulations to generate needed data for PLP to safely use new therapeutics

4) Ensure sound ethics reviews that include adolescent girls and young women in HIV prevention research.

An inclusive research agenda for PLP is essential for the HIV response, elemental to equity in global health, and key to having an impact on the epidemic. If you are interested in getting involved in AVAC’s work in this area, contact [email protected]

For other resources toward an inclusive research agenda, check out

The Choice Agenda list serve: a global forum for advocacy on the latest in HIV prevention research, with monthly webinars on the hottest topics.
No Data No More: A Manifesto to Align HIV Prevention Research with Trans and Gender-Diverse Realities
Good Participatory Practice Guidelines: systematic guidance on effective stakeholder engagement in HIV prevention research.

Px Wire Volume 12, Issue 1

Newly relaunched, PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Download for a quick look at where we are in HIV prevention.

New Issue of PxWire!

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes news, emerging issues and features upcoming events.

The HIV field gathers for its first hybrid International AIDS Conference (IAC) since the start of COVID-19 pandemic at a pivotal moment in HIV prevention. Across research to rollout – accelerated product access, new products reaching the market, new trials starting (and pausing) and recent research results – the ability to deliver two new proven PrEP methods will be determined by conversations and decisions happening now.

After initial approval ten years ago, oral PrEP initiations have surpassed 2M globally, reaching 2,797,304 – with significant progress over the past year, but still well below UN targets.

Check out the full issue of PxWire here and scroll down for important updates.

A Plan for Accelerating Access and Introduction of Injectable CAB for PrEP (Summary)

AVAC published Translating Scientific Advance into Public Health Impact: A Plan for Accelerating Access and Introduction of Injectable CAB for PrEP to provide a comprehensive view of all the moving parts and identify specific priority actions and actors responsible for ensuring time is not wasted and opportunity not squandered in introducing injectable cabotegravir for PrEP. ViiV, policy makers, normative agencies, donors, program implementers, researchers, generic manufacturers, civil society, advocates and communities each have critical roles to play in the coming months, and this summary provides an overview of the plan.

Message from Montreal: Which way will we go?

A string of announcements today coming from AIDS 2022 mark a potential turning point for HIV prevention and for the global health field at large, but a grave question hangs in the balance: which way will we go?

The big news yesterday was a dire warning: the launch of the UNAIDS report, In Danger, documenting what HIV advocates have known: that during the earliest phases of the COVID-19 pandemic, progress against HIV did not just stall, it actively lost ground.

The news today included: promising developments with new data from the HPTN 083 and 084 trials testing injectable cabotegravir for PrEP, which re-confirmed its safety and efficacy; WHO announced new guidelines adding injectable PrEP as an additional prevention option; the drug-maker for the first approved product of injectable PrEP (cabotegravir as PrEP), ViiV, announced an agreement with the Medicines Patent Pool to provide a voluntary license and begin the process of identifying generic manufacturers; and a new coalition was announced, convened by Unitaid, WHO, UNAIDS and the Global Fund, with AVAC serving as the secretariat, to collaborate with civil society, normative agencies, governments, and funders, in accelerating access to affordable longer-acting PrEP.

In the whiplash of announcements and headlines, it’s vital to understand how much is at stake at this moment.

Will proven biomedical options become feasible choices for people who need and want them? Will policies, programs and investments come together for equitable access? It’s up to all of us.

PrEP has an important role to play in reaching targets and accelerating an end to the epidemic. But new AVAC data show only around 2.7 million people have initiated use of oral PrEP since it was introduced ten years ago, falling short of the 2020 target of three million users – and representing only a fraction of the estimated number of people who need it and could benefit from it. Now, the dapivirine vaginal ring and injectable cabotegravir (CAB for PrEP) offer additional options – and an opportunity to re-imagine HIV prevention.

The news from Montreal show promise and potential to develop and deliver new PrEP options faster, smarter and with greater equity than ever before.

AVAC’s Plan for Accelerating Access and Introduction of Injectable CAB for PrEP provides a comprehensive view of all the moving parts involved in delivering this new PrEP option and identifies priorities for ensuring time is not wasted and opportunity is not squandered. The plan focuses on learning the lessons from the first ten years of delivering oral PrEP. It shows how to move faster, more strategically, and with greater coordination— to maximize the impact of injectable CAB for PrEP today, and to overcome access challenges for new PrEP options in the future.

thumbnail of the CAB plan

There is enormous work ahead, and it will require all proven prevention methods be available in a marketplace of choice. And these efforts must integrate the involvement of all stakeholders, including civil society, to hold each other accountable. We encourage you to read the plan, or our summary of it, and follow events in real time on Twitter at #AIDS2022. And learn more about the dapivirine vaginal ring and injectable cabotegravir (CAB for PrEP).

Press Release

AVAC, BMGF, CIFF, MedAccess, Unitaid and ViiV Healthcare announce collaboration to catalyse more affordable access to long- acting injectable cabotegravir for HIV prevention

logos of partners in the Coalition

Montreal, 28 July 2022 – At the 24th International AIDS Conference, AVAC, the Bill & Melinda Gates Foundation (BMGF), the Children’s Investment Fund Foundation (CIFF), MedAccess, Unitaid, and ViiV Healthcare announced a strategic collaboration to speed equitable access to injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). This collaboration demonstrates the commitment of global health partners and ViiV to work together to accelerate access to a new HIV prevention option as part of a comprehensive response to reduce the number of new HIV infections and advance efforts to end the HIV epidemic by 2030.

Cabotegravir long-acting (LA) is an injectable form of PrEP that is given every two months by trained healthcare workers. Cabotegravir LA for PrEP, which was approved by the U.S. Food and Drug Administration (FDA) in December 2021, is the first and only long-acting injectable PrEP option available.

Global health partners and ViiV are committed to making cabotegravir LA for PrEP more accessible in resource-limited settings in the near term, while working in parallel to accelerate market entry of quality-assured generic products. This two-pronged strategy is fundamental to meeting current demand for the product and establishing a sustainable longer-term market.

In order to increase access to cabotegravir LA in the near term, ViiV, AVAC, BMGF, CIFF, MedAccess, and Unitaid will:

Hold discussions on pricing, with the aim of identifying a pathway for cabotegravir LA for PrEP to be offered to public sector purchasers at a more affordable price
Examine the potential role of innovative financing mechanisms to deliver on this goal
Include civil society in planning and decision-making to accelerate equitable access
Share responses to frequently asked questions on procurement channels and requirements
Track and share regulatory submissions and approvals across priority countries

“Stagnating rates of new HIV infections underline the importance of getting effective prevention tools to the people who need them as quickly as possible,” said Michael Anderson, CEO of MedAccess. “By combining expertise in science, innovative finance and global health, this collaboration has the potential to catalyse access to cabotegravir LA at a sustainable price. MedAccess will work urgently with all partners to find solutions that unlock access for thousands of people as quickly as possible.”

Efforts to increase access to cabotegravir LA for PrEP will be especially impactful for key populations such as women and girls, who account for a disproportionate number of new HIV infections. Every week, 5,000 adolescent girls and women (15-24 years) contract HIV globally. For key populations, who have a 13-30 times higher risk of acquiring HIV infection as compared to the rest of the population, a long-acting prevention method could help overcome pill fatigue, stigma, and adherence issues.

“Cabotegravir for PrEP has the potential to transform HIV prevention efforts by offering people an additional option for HIV prevention, but only if we can make it available with urgency, with equity and at scale. While no one method will work for all people – or for any one person all of the time – this new approach significantly reduces frequency of dosing and may be easier for some people versus taking a pill a day,” said Mitchell Warren, Executive Director of AVAC.

Deborah Waterhouse, CEO of ViiV Healthcare said: “We are pleased to join this ambitious new collaboration as an active partner, working to find solutions to enable at-scale access to innovative HIV prevention options as quickly as possible. Together with our new voluntary license agreement with the Medicines Patent Pool, we are making significant progress towards our common goal of expanding access to cabotegravir LA for PrEP, which we believe has the potential to be a game changer in HIV prevention and to play an important role in ending the HIV epidemic.”

In response to civil society’s calls to make cabotegravir LA equitably available as soon as possible, global health partners and ViiV Healthcare are stepping up their collaboration to accelerate product access. HIV community groups, advocates and ministries of health are eager to add cabotegravir LA for PrEP to the HIV prevention toolkit, as choice is critical to meeting the needs of those most at risk of acquiring HIV.

“We are thrilled to join this important collaboration, which can help ensure that this transformative prevention tool is made available to those most in need as quickly as possible,” said Nina Russell, Director, TB and HIV Prevention at the Bill & Melinda Gates Foundation. “It takes all of us – companies, foundations, governments, civil society and those affected by HIV – working together to overcome the market failures that keep people in resource-limited settings from benefitting from innovation.”

These efforts build on the recent announcement that ViiV and the Medicines Patent Pool (MPP), which was founded by Unitaid, have agreed a voluntary license for cabotegravir LA. This will enable generic cabotegravir LA for PrEP to come to market in the coming years and should significantly expand the reach of this important prevention tool in low- and lower middle-income, least developed, and sub-Saharan African countries.

The collaboration announced today and the voluntary license agreement between ViiV and MPP, are part of a broader package of interventions being discussed by a coalition of partners to accelerate affordable and equitable access to long-acting PrEP in low- and middle-income countries. The coalition, currently being formalized, will comprise a wide range of partners including funders, communities, civil society organizations, ministries of health, and United Nations agencies, and will be co-convened by Unitaid, the World Health Organization (WHO), the Global Fund and UNAIDS. These partners will jointly identify barriers to access for cabotegravir LA and develop a roadmap to overcome them.

“Oral PrEP took over a decade to be accessible in low- and middle-income countries. This strategic partnership and the broader coalition being formed will ensure that we leverage lessons learned from past experiences to make this promising long-acting solution for PrEP quickly available at an affordable price for everyone who could benefit from it,” said Dr Philippe Duneton, Executive Director of Unitaid.

ViiV Healthcare is also donating product to support initial implementation science projects that will provide critical information on the feasibility, acceptability, and future adoption of cabotegravir LA for PrEP into national programmes in access markets. The partners in this collaboration will ensure these projects are coordinating to address critical questions across the widest possible range of populations and geographies.

“People need more ways to protect themselves from HIV that fit with their lifestyles and environments,” said Miles Kemplay, Executive Director of Sexual and Reproductive Health and Rights at CIFF. “Cabotegravir promises to be one of those choices – but only if it is available at a cost that health systems can afford. We are looking forward to working with ViiV to figure out how to make cabotegravir accessible to those who need it today.”

About the Partners

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

The Bill & Melinda Gates Foundation (BMGF): Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman, under the direction of co-chairs Bill Gates and Melinda French Gates and the board of trustees.

The Children’s Investment Fund Foundation (CIFF) is an independent philanthropic organisation, with offices in Addis Ababa, Beijing, London, Nairobi and New Delhi. Established in 2002, CIFF works with a wide range of partners seeking to transform the lives of children and adolescents in developing countries. Areas of work include adolescent sexual health, maternal and child health, opportunities for girls and young women, tackling child slavery and exploitation, and supporting smart ways to slow down and stop climate change.

MedAccess is a UK-based social finance company with a mission to make global healthcare markets work for everyone. Its core purpose is to make medical supplies more widely available at lower prices in under-served markets. By applying the rigour and skills of business finance, it provides a novel solution to the challenge. MedAccess offers financial guarantees and debt products that reduce commercial risk and allow medical manufacturers to accelerate supplies into new markets at affordable and sustainable prices. In this way, vaccines, medicines, diagnostic tests and medical devices can reach patients far sooner than existing market forces would allow.

Unitaid is a global health organization engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, affordably, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV/AIDS, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities such as cervical cancer and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator. Unitaid is hosted by the World Health Organization.

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK and Pfizer dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined as shareholders in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

AVAC Comments to FDA in Support of PrEP Approval

Comments delivered to the FDA’s Antiviral Drugs Advisory Committee (AVDAC) Meeting by Mitchell Warren, Executive Director, AVAC.

Download

CAB-LA Trials at a Glance

This infographic shares a breakdown of the current injectable CAB for PrEP trials including ongoing sub-studies.

Welcoming Amb. John Nkengasong to PEPFAR, and 3 Priorities

Yesterday, Dr. John Nkengasong was sworn-in as the US Global AIDS Coordinator and Special Representative for Global Health Diplomacy overseeing PEPFAR, the largest funder of HIV/AIDS programming in the world. We are confident that with Ambassador Nkengasong’s ambitious leadership, vision and experience, PEPFAR and the global community can maintain the urgency and impact in ending the AIDS pandemic, continue responding to COVID, and build the sustainable health infrastructure that we so desperately need.

We also want to thank Angeli Achrekar for her steadfast commitment to end the AIDS pandemic and her terrific leadership over the past two years.

At AVAC, our eyes are on three major actions to help us get there these next few months – and urge Ambassador Nkengasong’s and PEPFAR to take immediate and bold actions to:

Leverage new biomedical prevention options to re-boot primary prevention – and make sure these new options become viable choices for all people who can benefit from them. Accelerating access and introduction of injectable CAB for PrEP and ensuring political and financial support to also introduce the dapivirine vaginal ring provide an opportunity to build comprehensive, sustainable and integrated prevention programmatic platforms to deliver choice today and build for a future of even more options.

Center communities in the prevention response. Generating deeper, more consistent community engagement in prevention requires restructuring community engagement. Community input must move beyond “consultation” on specific questions or challenges to a deeper, more meaningful, sustained, strategic engagement that supports the full navigation of challenges from research to rollout, in all their complexity.

Imbed the AIDS response into the future of global health security and pandemic preparedness and response (PPR). The certainty of more complex and challenging health crises on the horizon demands rights-based public health approaches that focus on health systems strengthening, comprehensive integration of key health priorities including HIV, TB, malaria, sexual and reproductive health and non-communicable diseases and lay effective groundwork for addressing emerging health priorities in the future. And efforts to build a global pandemic response capacity must leverage the organizational capacities, investments, and reach of PEPFAR and the Global Fund to Fight AIDS, TB and Malaria.

There remain enormous challenges and opportunities ahead. We are very excited to welcome Ambassador Nkengasong back to PEPFAR and for his leadership in the global AIDS response. We look very forward to working with him toward our shared goals of ending the AIDS epidemic and ensuring global health equity.

Accelerating Access and Introduction of Injectable CAB for PrEP

Late last month, ViiV Healthcare, the maker of injectable cabotegravir (CAB) announced that it is “actively negotiating voluntary licensing terms” of CAB for PrEP to the Medicines Patent Pool (MPP) and is “committed to supplying” the product at a non-profit price for public programs in low-income and all sub-Saharan African countries until a generic is available. This announcement comes after months-long pressure from advocates and others, demanding that ViiV does its part to make good on the promise of injectable CAB for PrEP to advance HIV prevention and global health equity – see a number of important statements from advocates emerging from these discussions.

While this is an important step forward, and an example of advocacy at its best, this is only one piece of the puzzle that will make CAB for PrEP available to all who need and want it. Advocates have much more work ahead to ensure swift and equitable access to CAB.

And AVAC has a plan.

AVAC’s Plan for Accelerating Access and Introduction of Injectable CAB for PrEP provides a comprehensive view of all the moving parts involved in delivering this new PrEP option and identifies priorities for ensuring time is not wasted and opportunity is not squandered. The plan focuses on learning the lessons from the first ten years of delivering oral PrEP and how to move faster, more strategically, and with greater coordination to maximize the impact of injectable CAB for PrEP.

AVAC’s plan calls on ViiV, policy makers, normative agencies, donors, program implementers, researchers, civil society, advocates and communities to act on a range of key activities, which include:

A transparent commitment from ViiV, and a negotiated guarantee from donors, to a cost-effective and affordable price and volume of CAB for PrEP to support early launch, introduction and rollout.
Inclusion of injectable CAB for PrEP in WHO guidelines, which are expected ahead of AIDS 2022.
National programs in priority countries complete CAB for PrEP registration or secure relevant waivers.
Voluntary licensing from ViiV to select generic manufacturers, including technology transfer as required.
Donor investments in generic manufacturing capacity.
Market assessments and demand forecasts are updated with data from initial projects, to inform programming, manufacturing and cost.
Operational research and implementation science studies identify successful, scalable delivery channels; a testing algorithm that balances resistance risk with the needs of users and providers; ongoing engagement with communities and civil society; and a mechanism for independent coordination.

The plan also lays out advocacy priorities and calls on advocates to hold decision-makers accountable, for the rollout of CAB for PrEP – and on prevention generally. Is there clarity about next steps? Are there targets and milestones in place? Is there adequate funding to support strategic and accelerated rollout? How might decisions be made about who would get the product first, if it’s licensed and introduced through phased rollout?

In the days, weeks and months to come, advocates will continue to engage with ViiV, WHO, donors and other decision-making bodies focused on the future of CAB for PrEP and HIV prevention at large. Read our full statement here. AVAC hopes this plan will be the guide. As always, we will be tracking the progress, investing support, and keeping you informed.

About the Partners

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