Dr. Jenell Stewart (University of Minnesota, Hennepin Healthcare) joined The Choice Agenda to discuss and analyze recent research on HIV PrEP and implications for event driven PrEP across sex and gender.
Avac Event
Do Vaginas Demand Perfection? Implications for Event-Driven PrEP
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.
- The Dual Prevention Pill: Market Preparation and Introduction Strategy, informs priorities and planning for DPP rollout. See the Strategy Executive Summary here.
- Equipping Providers To Offer Novel MPTs: Developing Counseling Messages for the Dual Prevention Pill in Clinical Studies and Beyond
- Cost-Effectiveness of the Dual Prevention Pill for Contraception and HIV Pre-Exposure Prophylaxis
- How Might We Motivate Uptake of the Dual Prevention Pill? Findings From Human-Centered Design Research with Potential End Users, Male Partners, and Healthcare Providers
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
Working with colleagues, AVACers Cat Verde Hashim and Kate Segal published this research article in the Journal of the International AIDS Society. The researchers undertook qualitative research in Kenya, South Africa and Zimbabwe to prioritize private sector service delivery approaches for the introduction of the DPP.
Avac Event
PrEP Your Booty – The Launch of HPTN 106 “Rev Up”
HPTN 106 (REV UP) is 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 among cisgender men and transgender women who have sex with men. This webinar featured researchers leading the study.
Speakers:
Dr. Craig Hendrix, Johns Hopkins University School of Medicine
Dr. Mark Marzinke, Johns Hopkins University School of Medicine
Moderator:
Jim Pickett, The Choice Agenda
Co-sponsor:
HIV Prevention Trials Network
Avac Event
Let’s Talk LEN: What global advances in HIV prevention mean for Black communities in the US
Groundbreaking results from the PURPOSE 1 trial conducted among cisgender Ugandan and South African women have changed the injectable PrEP global landscape. This webinar explored the implications of these findings for US Black populations.
This webinar was co-hosted by PrEP in Black America, Black Public Health, Federal AIDS Policy Partnership (FAPP), AVAC, and APHA.
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.
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.
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.