Px Pulse

The promise of long-acting PrEP has been super-charged this year by studies showing the powerful efficacy of an antiretroviral known as lenacapavir (LEN). 

This episode of PxPulse goes deep on LEN for PrEP. Recorded just days before Gilead’s announcement that PURPOSE 2 also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right. 

The PURPOSE1 trials announced findings in June that a twice-yearly injection of LEN was 100% effective among cisgender women, with zero new cases of HIV. And the PURPOSE 2 trial among cisgender men, and trans and non-binary people, was shown to reduce the risk of HIV by 96%. 

LEN now enters a select category, one of five ARV-based options for PrEP that all protect against HIV if you take them.  But many of the people applauding the results from PURPOSE 1 and 2 will tell you that breakthrough science like this is, as hard as it is, is still the easy part. To break the back of the HIV epidemic demands overcoming an altogether different challenge—coordinating and accelerating every step in rolling out new products so that everyone who needs HIV prevention can get it.   

Listen to this podcast to learn what must be done to finally deliver on the promise of highly effective HIV prevention, from pills to rings to injectable PrEP and beyond.  

Resources 

Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective: PURPOSE 2 Trial Among Gay Men, Trans and Nonbinary People, AVAC Press Release 

The Lens on LEN: The basics on injectable lenacapavir as PrEP, AVAC 

Country planning matrix, PrEPWatch 

Moving a Product to the Real World, AVAC 

The long wait for long-acting HIV prevention and treatment formulations, Lancet 

A game-changer for PrEP if access is adequate, Lancet 

Allocation of Non-Commercial CAB for PrEP Supply in Low- and Middle-Income Countries, 2023-2025, AVAC 

Generic Cabotegravir Timelines, AVAC 

UNAIDS Exec Summary, UNAIDS 

Lenacapavir: What it would it take to get the 6-monthly anti-HIV jab to SA, Bhekisisa 

On this episode of PxPulse:The Advocacy Chronicles, Mandisa Tyadi Dukashe, Treatment Technical Lead at the South African National AIDS Council (SANAC) describes her work in helping to inspire and launch a National U=U Campaign in South Africa in 2024.  

On this episode of the Advocacy Chronicles:  A look at advocacy in Uganda for the Dual Prevention Pill (DPP), a new product combining oral PrEP and oral contraception.

Ruth Akulu is a member of the DPP Civil Society Advisory Group, part of the Uganda Country Coordinating Mechanism Board for Global Fund,  and a 2022 AVAC Advocacy Fellow. Akulu talks about her work to mobilize regulatory authorities to prepare for the DPP. And while she was at it, the establishment of a groundbreaking new initiative, the Product Regulator’s Engagement Committee, which is supporting ongoing engagement between government regulators and young women representing their communities. 

To support your advocacy for the DPP and other multipurpose prevention technologies check out AVAC's Advocates' Guide on MPTs  https://avac.org/resource/advocates-guide-to-multipurpose-prevention-technologies-mpts/

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In this episode,  Nsubuga Allan Mwasa a Ugandan activist, a clinical psychologist,  and a representative of Sexual Minorities Uganda, or SMUG, an organization that has been at the forefront of the fight for LGBTQ rights, talks about how advocates are organizing to survive and challenge Uganda's Anti-Homosexuality Act (AHA), passed one year ago.  A donation to SMUG supports the work of the Strategic Response Team documenting civil rights violations and intensifying persecution of LGBTQI+ Ugandans. Funds have reached a critical low,  click here to donate to SMUG. 

 

SMUG is part of Convening For Equality CFE, a coalition of civil society groups dedicated to challenging Uganda's AHA and other legislation that discriminates against LGBTQI+ individuals. The law has significantly increased discrimination and violence against the LGBTQI+ community, despite widespread international condemnation and ongoing legal challenges.

A new report by the CFE's Strategic Response Team (SRT), UNWANTED, OUTLAWED AND ILLEGAL: THE CRY OF LGBTIQ+ UGANDANS, documents evictions, arrests, imprisonment, forced anal examaminations, and community violence against LGBTQ+ people since the passage of AHA.  

It’s considered one of the most important and most difficult scientific enterprises in the history of modern medicine—the hunt for an HIV vaccine.  It has led to vast knowledge of HIV and the immune system, and to breakthrough technology. But developing an effective HIV vaccine is still out of reach, while HIV incidence remains high in hard-hit places in the world. In this episode, Nina Russell of the Bill & Melinda Gates Foundation talks about where she sees promise in the science, the goals for an HIV vaccine, and why it has an essential role to play alongside the scale-up of PrEP. Go to https://avac.org/resource/an-hiv-vaccine/

Our debut episode of the Advocacy Chronicles features Yvette Raphael, the Executive Director of Advocacy for Prevention of HIV and AIDS (APHA) in South Africa, and a leader in the development of The Choice Manifesto, supported from start to finish by CASPR.

As co-chair of the African Women Prevention Community Accountability Board (AWPCAB), Yvette and other board members launched the manifesto in Kampala, in September 2023, calling for choice in HIV prevention options for women — such as oral and injectable cabotegravir for PrEP, the dapivirine vaginal ring and the Dual Prevention Pill — and a commitment to expanding access to them. A call heard by UNAIDS Executive Director Winnie Byanyima, who was on hand at the launch to endorse the manifesto.  

Yvette, who is also a 2014 AVAC Advocacy Fellow and celebrated as one of South Africa’s leading human rights activists, lays out why The Choice Manifesto matters and how advocates are leveraging it. 

In this episode of PxPulse, we talk about why and how the decisions that shape global health must be made by those facing the greatest risks. As the world evaluates the pandemic response and debates on decolonizing global health gain momentum, equity in global health has never been more urgent. 

This conversation features global health leader and critic, Dr. Madhukar Pai. And two members of the transnational coalition COMPASS Africa, Francis Luwole and Barbra Ncube, offer an up-close look at the coalition’s pioneering new model for power-sharing.

Get more details and resources at https://avac.org/resource/decolonizing-global-health/

People who are pregnant or lactating (PLP) have historically been excluded from research because of concerns for the developing fetus. But this has led to a dearth of data on new interventions against health threats for this population. In the case of HIV, pregnancy raises the risk of acquiring HIV by up to three times, but providers often do not have the data to know whether a new intervention is safe or how it will work for pregnant patients. As a result, PLP and their physicians are left to make difficult decisions around the use of proven HIV prevention products as they await more data specific to pregnancy and lactation. 

But change is in the air. Champions for the inclusion of PLP in research are paving the way for a paradigm shift— one that will redefine this population from needing protection from research to being better protected through research. In this episode of Px Pulse, AVAC’s Manju Chatani-Gada takes us through conversations with a trial participant who became pregnant, researchers, policy-makers, and donors to understand why this population gets excluded, the impact it has, and what to do about it.

2023 is a big year for PEPFAR. PEPFAR’s considered one of the greatest US foreign policy and global development achievements of the century; the program has saved upwards of 25 million lives since it launched in 2003. But PEPFAR is marking its 20th anniversary while fighting for its future. Its authorization expires Sept. 30th. Until a couple of months ago, most expected smooth sailing for a five-year reauthorization of the program, which has enjoyed deep and broad bipartisan support since its founding. Evangelical Christians, staunch conservatives, DC Democrats, progressive HIV activists, and public health leaders have championed PEPFAR year in and year out. But a handful of Republicans, including past PEPFAR allies, are pulling reauthorization into American abortion politics— despite US laws on the books that prohibit PEPFAR dollars from funding abortions. Supporters across the political spectrum, including many Christian conservatives, are now rallying to ensure this uniquely effective program continues. 

In this episode, Px Pulse talks to some of the people who put PEPFAR dollars into action, bringing life-saving medicines, prevention and healthcare to people living with HIV, orphans and other vulnerable communities. And we talk to health leaders who explain why PEPFAR’s approach represents a gold standard in advancing global health, and what’s at stake in this debate.

With several large HIV vaccine trials in the last few years finding no efficacy, the field is in transition. There are diverse ideas in vaccine research, but there's no clear concept that's ready to test in a late-phase trial or move toward product development currently. Researchers are back to testing new ideas in early-phase research.

In this episode of our Px Pulse podcast, Dr. Katy Stephenson explores the implications of recent trial results, the big questions driving next-generation vaccine development, and new strategies underway in early-phase research. Katy is a doctor, a researcher, a professor of medicine at Harvard Medical School, affiliated with Beth Israel Deaconess Medical Center, and part of the Center for Virology and Vaccine Research.