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PxWire Vol 13, No 2

A Quarterly Update on HIV Prevention Research

May 2023: Volume 13, Number 2

PxWire Cover

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 updates, emerging issues and features upcoming events.

arrow showing research to rollout steps

PrEP Tracker Data/Progress in PrEP Uptake

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.

Trajectory of Countries with Most PrEP Initiations in SSA, 2016-2023

PrEParing for New Products

  • 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 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 for this data.

CAB for PrEP and DVR Implementation Science Studies

The HIV Prevention Pipeline: The latest in research, development and more

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 and elsewhere. See AVAC’s CROI roundup for more.

Data on the Mosaico vaccine efficacy trial, which was stopped early due to non-efficacy, 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.

HIV Incidence in Placebo-Controlled Prevention Trials chart

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

The most effective advocacy is based on smart analysis and accurate information. AVAC develops a wide range of materials and resources to inform decision making and action. Be sure to read, join or listen to these essential resources for HIV prevention and global health equity.

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 on twitter and reach out to get involved at coordinator@ugandakpc.org.
  • What’s All the Buzz About: mRNA, manufacturing, vaccines access. Thursday, June 1 at 10am ET/4pm SAST. Register here.
  • To bNAb or not to bNAb? The case for broadly neutralizing antibodies, June 7, 7 am PST/10am ET/4pm SAST. Register here.
  • PrEP That Booty: The latest on rectal microbicide research for the back door. Thursday, June 29 at 9:00am–10:30am ET. Register here.

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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.