Thursday, September 22, 2022
Hear the latest updates from African advocates leading the advocacy for access to the dapivirine ring. Plus tune in for the Population Council’s plans for moving the ring forward on multiple fronts, from roll-out of the monthly ring to research around the 3-month ring and multipurpose ring.
As a global organization dedicated to health as a human right, to social justice, and to individual autonomy and choice, AVAC condemns the decision by a federal judge in Texas who ruled in favor of a historically homophobic, misogynistic, and discriminatory plaintiff. A conservative activist sued on behalf of a Texas company claiming that adhering to a provision of the Affordable Care Act requiring employers to provide coverage for HIV pre-exposure prophylaxis (PrEP) drugs violates their religious rights.
“This shocking ruling defies evidence, logic, public health and human rights and sets back enormous progress made in the fight to end the HIV epidemic in the US and globally,” said Mitchell Warren, AVAC’s executive director. “It is a blatantly homophobic and misogynistic ruling that will endanger the lives of many gay men and others who rely on PrEP to protect themselves from HIV.”
“This ruling is the latest blow in a campaign to roll back bodily autonomy and human rights for a wide swathe of the American people. The Supreme Court overturning of Roe v. Wade earlier this year was a wake-up call that individual rights are under attack by the far right,” Warren added. “This decision likely won’t be the last we see in a campaign to impose some individuals’ religious beliefs on the broader population. Access to contraception, vaccinations, routine health screenings, prevention services and patient privacy are all under attack.”
While this latest decision is for now limited to the Northern District of Texas, it has ramifications for the rest of the country and for global programs to provide PrEP to people of all genders and sexual orientations who need and want to use it. These kinds of decisions often test the ground for cases that go to the Supreme Court, where the current makeup of the court means such a decision may be upheld and even expanded upon nationally.
“Deciding to use PrEP is a decision between an individual and their healthcare provider, no one else. Another person’s religious beliefs have no place in determining the right to use a safe, highly effective, FDA-approved, life-saving drug,” said Suraj Madoori, AVAC’s director of policy and advocacy.
“Daily oral PrEP was approved by the US FDA a decade ago and still has not reached nearly all of those who would benefit from its use. This decision throws up another substantial barrier between a life-saving intervention and individuals and communities most vulnerable to HIV, further capping the untapped potential of an important prevention option,” Madoori added.
This decision creates enormous, unnecessary barriers for LGBTQ+ people in Texas, as well as heterosexual women who are HIV-vulnerable, from the healthcare they need and is yet another example of oppressive or criminalizing policies in countries around the world that set barriers to health and human rights. We know these barriers drive poverty, epidemics and disenfranchisement from civil society. Policies like this don’t advance anyone’s freedom to live full, healthy lives; rather they undermine community resilience, individual autonomy and public health.
“At a time when science has given us the tools to advance towards the end the HIV epidemic and rational evidence-based public health policies and programs can implement those tools to save millions of lives around the world, one judge’s biased and discriminatory decision could endanger programs and lives far beyond northern Texas,” Warren added. “As advocates, activists and citizens, we at AVAC stand in solidarity with those whom this decision affects. We firmly believe that the ruling must be called out as homophobic and dangerous and that every effort must be made to ensure that it does not stand.”
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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.
Press Release
As a global organization dedicated to health as a human right, to social justice, and to individual autonomy and choice, AVAC condemns the decision by a federal judge in Texas who ruled in favor of a historically homophobic, misogynistic, and discriminatory plaintiff. A conservative activist sued on behalf of a Texas company claiming that adhering to a provision of the Affordable Care Act requiring employers to provide coverage for HIV pre-exposure prophylaxis (PrEP) drugs violates their religious rights.
“This shocking ruling defies evidence, logic, public health and human rights and sets back enormous progress made in the fight to end the HIV epidemic in the US and globally,” said Mitchell Warren, AVAC’s executive director. “It is a blatantly homophobic and misogynistic ruling that will endanger the lives of many gay men and others who rely on PrEP to protect themselves from HIV.”
“This ruling is the latest blow in a campaign to roll back bodily autonomy and human rights for a wide swathe of the American people. The Supreme Court overturning of Roe v. Wade earlier this year was a wake-up call that individual rights are under attack by the far right,” Warren added. “This decision likely won’t be the last we see in a campaign to impose some individuals’ religious beliefs on the broader population. Access to contraception, vaccinations, routine health screenings, prevention services and patient privacy are all under attack.”
While this latest decision is for now limited to the Northern District of Texas, it has ramifications for the rest of the country and for global programs to provide PrEP to people of all genders and sexual orientations who need and want to use it. These kinds of decisions often test the ground for cases that go to the Supreme Court, where the current makeup of the court means such a decision may be upheld and even expanded upon nationally.
“Deciding to use PrEP is a decision between an individual and their healthcare provider, no one else. Another person’s religious beliefs have no place in determining the right to use a safe, highly effective, FDA-approved, life-saving drug,” said Suraj Madoori, AVAC’s director of policy and advocacy.
“Daily oral PrEP was approved by the US FDA a decade ago and still has not reached nearly all of those who would benefit from its use. This decision throws up another substantial barrier between a life-saving intervention and individuals and communities most vulnerable to HIV, further capping the untapped potential of an important prevention option,” Madoori added.
This decision creates enormous, unnecessary barriers for LGBTQ+ people in Texas, as well as heterosexual women who are HIV-vulnerable, from the healthcare they need and is yet another example of oppressive or criminalizing policies in countries around the world that set barriers to health and human rights. We know these barriers drive poverty, epidemics and disenfranchisement from civil society. Policies like this don’t advance anyone’s freedom to live full, healthy lives; rather they undermine community resilience, individual autonomy and public health.
“At a time when science has given us the tools to advance towards the end the HIV epidemic and rational evidence-based public health policies and programs can implement those tools to save millions of lives around the world, one judge’s biased and discriminatory decision could endanger programs and lives far beyond northern Texas,” Warren added. “As advocates, activists and citizens, we at AVAC stand in solidarity with those whom this decision affects. We firmly believe that the ruling must be called out as homophobic and dangerous and that every effort must be made to ensure that it does not stand.”
###
About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.
The Choice Agenda, a global forum for advocacy on the latest in HIV prevention, has two webinars coming up you won’t want to miss:
CROI and Community and YOU – Preparing for CROI 2023
Wednesday, September 7 at 10:00-11:00am ET; 2:00-3:00pm GMT
Join the conversation with co-chairs of the Conference on Retroviruses and Opportunistic Infections (CROI), as well as researchers, advocates, community educators and members of the Community Liaison Subcommittee. The discussion will touch on what to expect at CROI 2023, which features some of the most consequential research on HIV, monkeypox, SARS-CoV-2 and more. The webinar will also cover how to apply for a Community Scholarship, and key dates and deadlines for engaging with the conference. Remarks from:
RINGing the bell for Choice: Actions and Solutions on Dapivirine Ring Access
Thursday, September 22 at 9:00-10:30am ET; 1:00-2:30pm GMT
This webinar will offer the latest from African advocates leading efforts to demand access to the dapivirine vaginal ring. In recent weeks, advocates have been pressing PEPFAR and others to do more to deliver the ring to women who want it. The Population Council will also discuss their plans for moving forward a full agenda for ring technology, including rolling out the approved monthly PrEP Ring, and continuing research on a three-month ring and multipurpose technology. In July, the Population Council announced it had acquired the ring technologies from the International Partnership for Microbicides, the ring’s developer. Speakers include:
For previous webinars from The Choice Agenda, check out our archive here! And join more than 600 advocates on the TCA listserve by reaching out to Jim at [email protected].
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
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.
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.
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.
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.
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
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:
“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.”
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.