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Px Wire ([link removed]) is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and features upcoming events.

May 25, 2023

** PrEP Tracker Data / Progress in PrEP Uptake
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Q1 2023 marked 481,237 new global PrEP initiations, which can be attributed to the scale-up of national programs and PEPFAR’s commitment to support and closely track PrEP investments. Key countries including Kenya, Nigeria, South Africa, Uganda and Zambia have led in these investments and show marked increases in PrEP initiations. However, discrimination and oppression of basic human rights, including proposed anti-gay legislation in Uganda, Kenya, and Tanzania threaten lives and livelihoods and could roll back substantial progress in the scale-up of PrEP programming.

[link removed] Check out the PDF version ([link removed]) of this issue and scroll for important updates.

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** Trajectory of Countries with Most PrEP Initiations in SSA, 2016-2023
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* The Medicines Patent Pool announced the granting of voluntary sub-licenses to three India-based generic manufacturers (Aurobindo, Cipla, and Viartris/Mylan). Importantly, Cipla said they plan to manufacture in South Africa as well. Depending on technology transfer and market demand, it is estimated that the generic product could be available in low- and middle-income countries (LMICs) in three to five years.
* In May 2023, the PrEP Ring study in Eswatini officially opened for enrollment. In addition, the Catalyzing Access to New Prevention Products to Stop HIV (CATALYST) study ([link removed]) is launching in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe. This product introduction study of the MOSAIC project will assess the implementation of an enhanced service delivery package that provides a choice of oral PrEP, PrEP ring, and injectable cabotegravir for PrEP among women at PEPFAR delivery sites.

As of May 2023, there are 29 planned or ongoing implementation science (IS) studies exploring injectable cabotegravir for PrEP and/or the dapivirine vaginal ring in 22 countries looking at one or more populations. Botswana, Ukraine, and Zambia are the latest countries to plan IS studies and South Africa continues to lead with nine studies planned.

Not all studies have established sample sizes. Of the 25 that do, only five have over 5,000 participants—MOSAIC’s five-country CATALYST study, Wits RHI’s Project PrEP, Desmond Tutu Health Foundation’s FASTPrEP, African Health Research Institute’s Theta Nami Ngithethe Nawe (“Let’s Talk”), and Path to Scale for CAB-LA in Malawi.

Inclusion of diverse populations in implementation studies is critical to gather evidence around important outcomes like safety and patterns of use across different types of users. Cisgender men and women and gay and bisexual men who have sex with men are all well represented across the planned and ongoing CAB for PrEP and ring studies. Sex workers, trans men, and gender non-conforming people are less well represented, and there are currently no studies planned for people who use drugs or prisoners. See AVAC’s Integrated Study Tracker ([link removed]) for this data.

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** The HIV Prevention Pipeline: The latest in research, development and more
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The HIV prevention pipeline has seen major movement in the early part of 2023, with much new data presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2023 ([link removed]) and elsewhere. See AVAC’s CROI roundup for more ([link removed]) .

Data on the Mosaico vaccine efficacy trial, which was stopped early due to non-efficacy ([link removed]) , confirmed this finding, as well as an alarmingly high HIV incidence rate in both arms of the study, 4.1 percent. The table below summarizes results from multiple HIV prevention placebo-controlled trials, highlighting the persistent high incidence—and the need for new prevention options.

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Also this quarter:
* Two studies from the Microbicides Trials Network (MTN)—B-Protected and DELIVER—found the dapivirine vaginal ring (DVR) to be safe for pregnant and lactating people and their babies. An analysis of cabotegravir drug levels in women from the HPTN 084 efficacy trial of injectable CAB for PrEP suggest that women who experienced delays in receiving their dose due to COVID-19 (normally every two months as directed by the protocol) may still have protection against HIV. Delays were up to 6 weeks, and offer potentially some relief for women who cannot adhere perfectly to their dosing schedule.
* New data show that a rectal suppository combining the antiretrovirals tenofovir alafenamide and elvitegravir was safe in humans, with high concentrations of drug present in rectal tissue. This suppository is also being tested vaginally.


** Prevention Playlist
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The most effective advocacy is based on smart analysis and accurate information. AVAC develops a wide range of materials to inform decision making and action. Be sure to read, join or listen to the resources below to stay up to date and join the conversation.

Join
* As anti-LGBTQIA+ legislation gains momentum in the US, Africa and elsewhere, Convening for Equality/Uganda, where draconian legislation has been approved, is leading advocacy to champion LGBTQIA+ rights. Follow @CFE_Uganda ([link removed]) on Twitter and reach out to get involved at [email protected] (mailto:[email protected]) .
* What’s All the Buzz About: mRNA, manufacturing, vaccines access. Thursday, June 1 at 10am ET/4pm SAST. Register here ([link removed]) .
* To bNAb or not to bNAb? The case for broadly neutralizing antibodies, June 7, 7am PST/10am ET/4pm SAST. Register here ([link removed]) .
* PrEP That Booty: The latest on rectal microbicide research for the back door. Thursday, June 29 at 9:00am-10:30am ET, Register here ([link removed]) .

Read
* A new series of articles, Multipurpose Prevention Technologies for HIV, STIs & Pregnancies ([link removed]) published in Frontiers in Reproductive Health.
* From the Lab to the Jab Overview ([link removed]) , a review of a series of upcoming briefs on emerging issues for vaccines R &D and equitable access.
* An updated FAQ on the DPP ([link removed]) highlighting the latest updates and key questions on the DPP and project plans.
* The DPP Consortium’s strategy for delivering the DPP in the private sector ([link removed]) in Kenya and Zimbabwe.
* Advancing HIV Prevention Research in Pregnant and Lactating People (PLP): Think Tank Report and Action Plan. ([link removed])
* Prevent, Prepare, and Respond: An Analysis of Global Health Architecture for Pandemic Preparedness. ([link removed])
* Advocates’ Guide for PPPR in 2023. ([link removed])
* AVAC Condemns Uganda’s Anti-Homosexuality Bill 2023. ([link removed])
* Highlights from CROI 2023. ([link removed])

Listen
* Global PPPR Equity: Why do we need agreements on IP and tech transfers?, Recording ([link removed]) , Fifa Rahman Slides ([link removed]) / Fitsum Lakew Slides ([link removed]) / Esteban Burrone Slides ([link removed]) .
* Px Pulse Podcasts
+ Evolving Strategies for an HIV Vaccine: One researcher explains where the field is going and why? ([link removed])
+ LGBTQIA+ Advocacy in Uganda: Facing down fear and fighting for justice. ([link removed])
+ PPPR Advocacy 101: Find out what it means to you. ([link removed])
+ The Shape of Pandemic Preparedness is Being Decided. Now is the Time for Collective Action. ([link removed])
* The Choice Agenda Webinars
+ PrEP (In)equity: Documenting, measuring, and flipping the script towards justice, Recording ([link removed]) / Slides ([link removed]) / Resources ([link removed])
+ HIV Prevention Plus Plus: Developing options that meet the full range of our sexual and reproductive health needs, Recording ([link removed]) / Slides ([link removed]) / Resources ([link removed])
+ How to Communicate about Sexual Health and STIs: Sex positivity vs. risk-based language, Recording ([link removed]) / Slides ([link removed]) / Resources ([link removed])
+ Mpox — Sexual Networks, HIV and Activism, Recording ([link removed]) / Slides ([link removed]) / Resources ([link removed])
+ Been There, Did That — Research Reflections from CROI 2023, Recording ([link removed]) / Dr. Monica Ghandi’s Slides ([link removed]) / C ([link removed]) ommunity Educator Slides ([link removed])

Best,
AVAC
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