The Monday Press

October 2024 

HIV Prevention News Around The Globe

Long-Acting Injectables for the Prevention or Treatment of HIV

In recent years, long acting injectables (LAIs) have been introduced into clinical practice for the treatment and prevention of Human Immunodeficiency Virus (HIV) infection. These agents present another option for patients who may struggle with adherence to a daily oral medication, have difficulties swallowing oral medications, and those who generally prefer a long-acting agent. There are currently two LAIs approved for the treatment of HIV: cabotegravir co-packaged with rilpivirine (CAB/RPV) and lenacapavir (LEN). CAB/RPV was FDA approved in 2021 and is a complete regimen for the treatment of HIV-1 infection. It is administered as two gluteal intramuscular injections either every four or eight weeks. Lenacapavir is a first-in-class capsid inhibitor and was FDA approved in 2022 for use in heavily-treatment experienced adults with multidrug resistant HIV-1 infection in combination with other antiretrovirals. Lenacapavir is administered as two subcutaneous injections into the abdomen every 6 months, and at initiation patients must also take oral tablets based on 1 of 2 dosing strategies.

Implementation of LAIs in the clinic setting requires a robust multidisciplinary approach, including providers, nurses, pharmacists, social workers, case managers, and support staff. Before initiating LAIs, patients should be thoroughly evaluated for drug interactions, history of drug resistance, hepatitis B infection, and willingness to regularly attend clinic visits. Additionally, patients should be counseled on the importance of receiving medication doses on time to avoid the development of drug resistance or loss of protection against HIV acquisition. Once initiated, LAIs may significantly improve medication adherence by avoiding the need for a daily oral tablet, increase patient satisfaction, and improve patient outcomes. A number of organizations have resources online to assist clinics interested in utilizing LAIs, including the American Academy of HIV Medicine (AAHIVM) which has a Long-Acting Agent Resource Center.

You can read more about the article here

How Artificial Intelligence Could Transform The AIDS Fight

Amid the Covid-19 pandemic, the National Institutes of Health earmarked roughly $75 million for the Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) to spur health innovation and data science on the continent. What came next was a chatbot that scientists hope will navigate data sharing regulations from 12 African countries. Beginning this fall, the free resource will help make research more easily shareable and accessible, which could produce greater breakthroughs and impact in global health.

The rise in AI will impact every continent on earth, but none stand to benefit more than Africa. One in four people on the planet will be African by the middle of this century. AI will play a key role in helping empower this population and strengthen healthcare systems–which could be a game changer for the global AIDS fight. AI is already transforming the diagnostic landscape. Modules that are trained on thousands of x-rays now produce sophisticated algorithms that identify abnormalities that appear on X-ray, MRI and CT scans.

Companies like Qure.ai have played a huge part in delivering life-saving diagnoses to people living with tuberculosis in a matter of minutes, giving them rapid access to care and treatment–an essential part of curbing the spread of TB. And that same technology can also detect other diseases like lung cancer, enabling patients to be screened for multiple diseases at once, reducing medical visits and, in some instances, providing early detection that otherwise would have gone unnoticed. This is an invaluable tool in advancing global health care, particularly in places where fragile health systems and a lack of trained medical professionals exist.

You can read more about the article here

Long-Acting Injectable Cabotegravir For HIV Prevention Safe In Pregnancy, Suggests Study

Gilead Sciences, Inc. has entered into non-exclusive, royalty-free licensing agreements with six pharmaceutical manufacturers to produce and distribute generic versions of lenacapavir, a promising drug for HIV prevention and treatment. These agreements will cover 120 high-incidence, resource-limited countries, primarily in low- and lower-middle income regions, pending regulatory approvals.

This bold move is part of Gilead’s strategy to provide broad access to lenacapavir, particularly for pre-exposure prophylaxis (PrEP), in its mission to end the HIV epidemic globally. The agreements were finalized before regulatory submissions, aiming for a rapid rollout of generic lenacapavir for HIV prevention, if approved. The agreements also cover lenacapavir for heavily treatment-experienced (HTE) adults with multi-drug resistant HIV.

Daniel O’Day, Chairman and CEO of Gilead, noted the importance of swift action “Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest.” He further added that the company has been working urgently with high-volume generic manufacturers to ensure a seamless transition once the drug is approved for PrEP.

You can read more about the article here

The Lens on LEN: The Basics on Injectable Lenacapavir as PrEP

In 2024, Gilead Sciences released findings from the PURPOSE 1 and PURPOSE 2 trials testing lenacapavir (LEN) as HIV prevention. The PURPOSE 1 trial found 100% efficacy in preventing HIV in 5,300 cisgender women in Uganda and South Africa, and the PURPOSE 2 trial showed a 96% reduction in HIV incidence among cisgender men, trans, and non-binary individuals across multiple countries. Both trials demonstrated LEN’s safety and effectiveness in reducing HIV transmission. This advocates’ primer provides background on the product and trials; a summary of the early findings of PURPOSE 1 & 2; key questions and next steps.

You can download the report here

Soundbytes

Lenacapavir: The case for investing in delivering HIV prevention

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.

You can listen to the podcast here

Opportunities

2nd African Workshop on Women & HIV 2025

The second edition of the African Workshop on Women & HIV will take place in a live format on 27 - 28 February 2025 in Nairobi, Kenya.

This exciting initiative is a regional workshop paired to the annual “International Workshop on Women & HIV”. It is an outstanding opportunity for both local and international healthcare providers, researchers, government, industry, and community representatives to discuss and further increase their knowledge on the issues related to HIV and women living in Africa.

The primary purpose of this workshop is to support changes that will provide a better quality of life for women living with HIV and reduce HIV transmissions in the region.

The format of the workshop enables attendees to learn from renowned HIV experts, discuss challenges, gaps, and opportunities for further learning and research. It also provides a forum for early-career investigators to present their research and to personally meet with experts they view as mentors and inspiration for their work.

Registration link: https://virology.eventsair.com/african-workshop-on-women-hiv-2025/registation/Site/Register

Abstract Submission link: https://virology.eventsair.com/african-workshop-on-women-hiv-2025/abstracts

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