Last week’s 30th Conference on Retroviruses and Opportunistic Infections (CROI) showed an energized field- with scientific advances galvanizing research across a host of disease areas. The findings highlighted in this round up offer a look at standout research — and, at AVAC, we know it must be matched with informed advocacy.

Scroll down to learn about new interventions for sexually transmitted infections (STIs), expanding evidence for widespread use of long-acting products for HIV prevention, pipeline updates for user-controlled short-acting products for HIV prevention, new insights about the impact of mpox, discussion of what’s ahead for HIV vaccine science and more.

To put it all in context, CROI’s opening session included two unforgettable voices: former head of NIAID, Anthony Fauci recounted 30 years of struggle and progress toward HIV treatment, prevention and cure; and APHA’s Yvette Raphael, a passionate advocate and long-time AVAC partner, connected the science to the advocacy — particularly the relentless efforts of African women — to fight for justice, equity, access and inclusion in research, planning and programs (check out our Advocate’s Network from last week for more on this incredible opening session and watch it here). Yvette’s message was ringing through every CROI session. It informed the ever-popular Margarita Breakfast Club sessions over Zoom (find the recordings and other resource materials here), where connecting the science and the advocacy happened early every morning before CROI’s opening plenary, because pioneering science is only half the effort. It’s fierce advocates and tireless advocacy that brings the fruits of science to those who need them most.

So, read on and get ready.

Table of Contents

• DoxyPEP for STIs, and a Vaccine for Gonorrhea: Important answers, important questions
• Mosaico and the Future of HIV Vaccines
• Women and Choice: The data say yes!
• Getting PrEP to the People: Lessons in innovation from Kenya and South Africa
• An Evolving Pipeline for HIV prevention
• Cure Research Highlights
• Important Findings on MPox
• COVID-19 and Misinformation

Doxy PEP for STIs, and a vaccine for Gonorrhea: Important answers, important questions

The potential impact of doxycycline (doxy), a long established and inexpensive antibiotic, to prevent a handful of STIs was the subject of several studies.

The DoxyVAC study, presented by Jean-Michel Molina of the University of Paris Cité, (building on a study from last year) had a “DoxyPEP” arm that provided doxycycline to gay men and other to men who have sex with men (MSM) and who were on PrEP and had an STI diagnosis within the last year. These participants took a prescribed dose within 72 hours after condomless sex. Doxy as a post exposure prophylaxis (PEP) significantly reduced cases of syphilis and chlamydia with an incidence of 5.6 percent, compared to 35.4 percent without the intervention. It also reduced incidence of gonorrhea — incidence of 20.5 percent on PEP versus 41.3 percent without it. But Molina warned that gonorrhea develops antibiotic resistance quickly, highlighting the importance of the vaccine arms of this study, which showed that a 2015 vaccine for meningococcal B, a common cause of bacterial meningitis, reduced incidence of gonorrhea from 19.7 percent to 9.8 percent. The results led to an early end to the trial for efficacy, with all participants receiving both interventions. Molina stressed how few options exist today to address gonorrhea, and called for more research. “There’s no safety concern [with the vaccine]. We don’t know how long the protection lasts. We need more data.” AVAC wholeheartedly agrees — an end to the HIV epidemic also means preventing other sexually transmitted infections that can increase risk for HIV and certain cancers and can have other serious consequences. Check out the comprehensive story at aidsmap.com; the recording of last Tuesday’s Margarita Breakfast Club: and certain Moving Forward: Upcoming Strategies on STI Prevention (Recording and Slides); and for more on STI vaccine R & D, go to STIwatch.org.

But DoxyPEP in cisgender women had another story. Jenell Stewart from the University of Washington reported findings from dPEP Kenya, an open-label trial in Kenya among cisgender women who were already adherent to HIV PrEP. Stewart reported that participants had high incidence of STIs at 27 percent, and reported strong but not perfect adherence to DoxyPEP (200 mgs of doxycycline with 72 hours of sex) but there was no reduction in the incidence of syphilis, chlamydia or gonorrhea. Is perfect adherence required; are biological factors at work; or is doxy resistant bacteria the challenge? Stewart called out the urgent need for STI prevention for women and a deeper look at the causes behind these results. For more insight, watch NAM’s Roger Pebody speak with Stewart.

The question of resistance surrounds these findings. There’s international alarm about antimicrobial resistance and the overuse of antibiotics. Research at CROI looked at this issue but did not resolve these questions, with the researchers involved saying much more data is still needed. The momentum behind these findings has brought calls for normative guidance on offering doxyPEP. The Centers for Disease Control (CDC) issued a statement on Monday, February 20 promising to review the data and offering considerations for providers until more detailed guidance is finalized.

Mosaico and the Future of HIV Vaccines

Susan Buchbinder, a leader of the Mosaico Vaccine Trial, the third large-scale trial in recent years to stop early for non-efficacy, released data for the first time showing zero efficacy, as well as an alarmingly high incidence rate in both arms of the study, 4.1 percent. Buchbinder explained in the Monday session of the Margarita Breakfast Club that the Mosaico vaccine relied on prompting non-neutralizing antibodies to work in concert with T-cells to thwart infection.

Buchbinder said “It appears from the series of recent efficacy trials, including Mosaico, that non-neutralizing antibodies are not very useful.” She also said T-cells will continue to be studied as a likely important element in an HIV vaccine alongside neutralizing antibodies.

Mosaico enrolled 3900 cisgender gay men, other MSM and trans women, and offered PrEP at enrollment. Those who wanted PrEP were referred to programs and not enrolled in the study. Those who initially declined PrEP and enrolled in the vaccine arm could opt for PrEP at any point in the study. PrEP use rose over the duration of the study but did not exceed 10 percent of study participants. With all these findings taken together, the study concluded that “despite ongoing risk reduction counseling and linkage to PrEP, HIV incidence…was very high. This is a population in great need of additional effective HIV prevention modalities.” As AVAC has said repeatedly, the Mosaico results highlight why the world still needs a vaccine AND to simultaneously re-double efforts to deliver the prevention options that exist today.

In a special session on the Mosaico results, the head of the HIV Vaccine Trials Network (HVTN), Larry Corey, underscored the message that the field has successfully answered a fundamental question about non-neutralizing antibodies. Corey said they are not a viable strategy for an HIV vaccine, and it’s time to build on the promising results of the AMP studies and continue the development of broadly neutralizing antibodies (bNAbs). “It’s a very rich field, with a rich portfolio.” One key to accelerating that portfolio will be Experimental Medicine Vaccine Trials (EMVT) to quickly identify — and weed out – vaccine candidates. (See AVAC’s May 2022 webinar and resources on EMVTs.) Knowing early which candidates show promise, and which do not, should help the field make better decisions about where to make future investments, in both research and development of next-generation vaccine, antibody and PrEP products and in the delivery of those options that have already been shown to be safe and effective.

Women and Choice: The data say yes!

Despite the sobering news from the dPEP Kenya study, CROI 2023 included lots of good news for women and choice.

Two studies from the Microbicides Trials Network (MTN), found the dapivirine vaginal ring (DVR) to be safe for pregnant and lactating people and their babies. The B-Protected study looked at drug levels in breast milk and was designed to answer questions that would support regulatory authorities and national programs to make the ring available and enable women to make an informed choice. Final results, presented in a late-breaking poster, showed extremely low concentrations of dapivirine detected in infant plasma samples, and that participants used the ring in high numbers. “This favorable safety profile, along with data demonstrating low dapivirine transfer to infants, supports updates to WHO and national guidelines to include breastfeeding people when recommending the DVR as an additional HIV prevention choice,” said Jennifer Balkus, protocol co-chair of the study.

The MTN’s DELIVER study issued similarly favorable interim findings after comparing the ring to oral PrEP during pregnancy. Researchers found dapivirine “posed no safety concerns when used in the third trimester of pregnancy”. The final stage of the study is ongoing and will evaluate safety and acceptability of the ring among people between 12 and 29 weeks of pregnancy. DELIVER is one of very few HIV prevention studies ever conducted in pregnant cisgender women. The risk of acquiring HIV for cisgender women is three times higher during pregnancy. Designing inclusive prevention studies for pregnant and lactating people is imperative; learn more about the issue and advocacy here.

The presentation on the DELIVER study by Katherine Bunge of University of Pittsburgh also called out the role of Good Participatory Practice in robust stakeholder consultations conducted with AVAC in support of the study. For a deep dive on what made these consultations effective check out our blog, Anatomy of Effective Stakeholder Consultation: A look at best practices from a consultation for MTN 042.

Jeanne Marrazzo of University of Alabama at Birmingham School of Medicine reported on data related to PrEP adherence and HIV status. This study pooled data over ten years from 6,296 cisgender women across 11 oral PrEP demonstration projects in six countries. It is the largest assessment to date of real world adherence to PrEP and HIV incidence among cisgender women. The analysis showed 17 percent of 2,954 individuals with adherence data were highly adherent at 7 pills a week. People self-reported higher adherence than researchers objectively measured, but effectiveness was still evident at 4-6 pills per week. This finding offers evidence that cisgender women can have the same peace of mind that men have known for some time: perfect pill taking is not essential. But the data Marrazzo highlighted also points to the need for both more options and innovation in programming. Adherence to PrEP was declining or consistently low for as many as 60 percent of those tracked.

Moses Kamya from the Makerere University, Kampala, Uganda, reported compelling findings from the SEARCH study offering real choices to women who need prevention in rural Uganda and Kenya. In one arm of the study, participants were offered a choice of PrEP or PEP; a choice of access to services at a clinic or off-site; and a choice to use HIV self-testing. The providers working with them were trained in patient-centered care, and these participants were given 24/7 access to a clinician. Kamya reported that “biomedical coverage” increased from 29 percent to 70 percent in the study arm provided with this menu of choices. Self testing went from 34 percent to 59 percent, use of off-site locations went from 22 percent to 61 percent. Kamya said the intervention more than doubled prevention coverage, but this is still far too low for this population. He called for the urgent need to scale up injectable cabotegravir (CAB) for PrEP.

Finally, further analysis of cabotegravir drug levels in women from the HPTN 084 efficacy trial of injectable CAB for PrEP suggest there just might be another win for choice, down the road. Mark Marzinke of Johns Hopkins University presented findings from women in the study who, after dosing every two months as directed by the protocol, experienced delays in dosing for some period of weeks, especially during the early period of COVID-19. Marzinke’s data suggest that doses delayed up to 6 weeks may still provide protection against HIV. Much more data is needed to explore this possibility, but, if confirmed, quarterly injections of CAB for PrEP would align with schedules for injectable contraceptives. Check out the aidsmap story here.

Getting PrEP to the People: Lessons in innovation from Kenya and South Africa

A study in Kenya suggests that trained pharmacists in private pharmacies could be a promising strategy to scale up PrEP, especially among hard-to-reach, unmarried young men. Stephanie Roche of the Fred Hutchinson Cancer Research Center said Kenya’s private pharmacies represent a highly professionalized sector, and the Ministry of Health is seeking evidence to support offering PrEP, PEP and STI testing outside of clinics. The study saw a dramatic increase in demand when fees were waived. Overall, 87 percent of 863 clients used one of the three services, with PrEP uptake at 69 percent. PrEP continuation was 72 percent at month one and 51 percent at month four. Of these participants, 46 percent identified as men and 78 percent were unmarried. A pilot of this study that will offer the ring and CAB for PrEP is under consideration.

Ingrid Bassett of Massachusetts General Hospital presented a study from South Africa that embedded services for PrEP and contraception at three hair salons. Stylists were trained to offer the services. An onsite nurse provided HIV and pregnancy testing, and dispensed PrEP and either oral or injectable contraception. Researchers found very high uptake of contraception, 87 percent. PrEP uptake was 39 percent. Bassett said many of the stylists and clients had never heard of PrEP before. Self assessment of risk was not associated with initiating PrEP, neither was the perception that a partner had other sex partners. But reported intimate partner violence did predict PrEP initiation. Bassett said there was a demand for STI testing as well. This work confirms experiences from the earliest female condom programs in the late 1990s and early 2000s in Zimbabwe which pioneered distribution of female condoms and safer sex information via hair salons — this in turn was built on the mid-1900s delivery of male condoms in barbershops. Clearly, differentiating and simplifying delivery is a concept that can work.

An Evolving Pipeline for HIV Prevention

In 2021, Merck paused treatment and prevention studies using islatravir (ISL) after observing decreased levels of lymphocytes and CD4 T cells, among participants. In 2022, the treatment program re-started, but the prevention studies, testing monthly oral ISL for PrEP, were discontinued. Merck’s Kathleen Squires reported that by 12 months after stopping ISL, lymphocyte and CD4 T cell counts matched the range seen in the control arm, and had returned to normal levels. An examination of a lower dose for treatment showed lymphocyte changes comparable to standard of care antiretroviral therapy. These data along with modeling studies, Squires said, have identified a threshold dose “below which decreases in lymphocyte cell counts are not expected.” While clinical studies for ISL as treatment have resumed, ISL as monthly oral PrEP is “still being looked at” but is not going forward at this time. Merck is looking at alternate drugs that could be delivered on a monthly oral basis.

But ISL could, possibly, be considered as an implant. Squires confirmed that Merck’s ISL implant remains on clinical hold, but a separate research group from Houston Methodist Research Institute presented a small study in macaques that showed a biodegradable implant with ISL offered protection to five out of six animals from a vaginal SHIV infection, with low drug levels detected in the animal with break though infection. Read more on this study here. Of course, animal studies are just the beginning of the process.

Sharon Riddler from the University of Pittsburgh presented data showing 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. While the injectables and implants often draw the most excitement (and funding), suppositories and other user-initiated, non-systemic products that might deliver protection “right where the action is” could be essential options for people. Researchers called for continued evaluation. Read more on this study and on the potential role for a much wider array of prevention options in this article from Spotlight in South Africa.

Cure Research Highlights

Research presented at CROI 2023 contributed significant evidence that eliminating CCR5, a receptor on T cells that HIV exploits, is a validated approach to control and cure of HIV. Researchers at Emory University provided an update on two trials that used gene editing technology to remove the CCR5 receptor from T cells, making those cells immune to HIV infection. Of the nine participants who had cells modified and went on a treatment interruption, five experienced control for at least one year. One participant remains undetectable six years later, after the single infusion of his own modified T cells. This approach offers a potentially safe and scalable intervention to control HIV without treatment. But questions remain about the quantity of T cells that may need to be altered and if other biological processes are involved in preventing viral rebound.

CROI 2023 also saw the announcement of the Duesseldorf Patient, the third of five individuals cured of HIV through a stem cell transplant. Similar to the other cases, the Duesseldorf Patient received donor cells to treat cancer from a person with a natural immunity to HIV, a mutation that resulted in T cells with no CCR5.

During a plenary on the status of cure research, Janet Siliciano suggested that reducing the size of the reservoir (latent HIV in the body), rather than eliminating it entirely, could be an element in controlling the virus without ART. While approaches to control are making strides, this is one of the questions research still needs to answer.

Just prior to the start of CROI, AVAC joined with a number of partners to convene the 2023 Pre-CROI Community HIV Cure Research Workshop. The 2023 workshop was dedicated to the memory of our friend and colleague Giulio Maria Corbelli, who was instrumental in organizing the first pre-CROI community HIV cure workshop in 2012. The agenda with links to videos of the sessions and downloadable PDFs of slide presentations is available here.

Important Findings on Mpox

A global snapshot on mpox was provided by the CDC’s John Brooks. In 2022, what had been a virus that was mostly isolated to seven countries in west and central Africa spread to 100 countries around the world, resulting in more than 85,000 cases. A new variant of the virus was detected in the majority of these cases and for the first time mpox was highly associated with sexual transmission, primarily among gay, bisexual, and other MSM. Brooks laid out data that showed in some cases people transmitted the virus four days before they developed symptoms. Cases have been declining since August. Brooks points to two possible factors in this decline. A US survey reported approximately 50 percent of respondents took steps to protect themselves by reducing their number of sexual partners. In addition, the CDC has determined that people who received a 2-dose smallpox vaccine were 10 times less likely to become infected. Vigilance against a resurgence must be continued, and randomly controlled trials to validate current treatments must be completed, said Brooks. He also pointed to the heightened severity of mpox among those who are immunosuppressed and the need to prioritize interventions to these populations.

A presentation by Chloe Orkin of Queen Mary University of London drove home these insights. The global case study looked at 382 cases from 19 countries and found the severity of mpox in people living with HIV (PLHIV) who have very low CD4 counts extreme enough to classify it as an AIDS-defining opportunistic infection. A total of 27 people from these cases died. Orkin urged health authorities to add mpox to the 14 other opportunistic conditions that can be lethal to PLHIV who have very low CD4 counts, and for HIV testing for those who test positive for mpox. Get the details on this study from this just published Lancet article. Orkin said it was a matter of equity to get the mpox vaccine more widely distributed: “We must do better.” Stay tuned for a Choice Agenda webinar on March 29 at 9:30 ET that will focus on mpox; Lancet details posted here.

COVID-19 and Misinformation

A symposium on Science Communication in the Age of Misinformation reported on a number of lessons for broader public health and pandemic response. A meta-analysis found that 33 percent of all vaccine information on publicly available social media is misinformation. Another study found almost eight in 10 Americans were uncertain about at least one fact about COVID-19 or the vaccines. Scott Ratzan from City University of New York reported that it’s estimated half of COVID deaths were preventable. Ratzan highlighted a recent study in Nature.com documenting increasing vaccine acceptance in 23 countries including the US, now at 79 percent. Ratzan explored the importance of thinking beyond vaccine hesitancy to understand how fluid opinions and beliefs may be, and he listed a range of trust-building approaches, from early connection with policy makers to long term relationships with communities and greater investment in communication and engagement.

Emily Vraga from the University of Minnesota built on these themes. In addition to debunking bad information, she discussed the idea of prebunking. This includes preparing people to recognize misinformation, identify recycled myths, and call out frequent offenders. Vraga cited Under the Hood of The Debunking Handbook 2020 by Stephan Lewandowsky. Finally, Heidi Larson of the London School of Hygiene and Tropical Medicine and founder of the Vaccine Confidence Project, highlighted issues of identity, belief, grievance, trust and mistrust that fuel the spread of misinformation and strategies to address it. For lots of well-sourced information for your advocacy sign up for AVAC’s weekly NewsDigest and COVID News Brief.

You can delve deeper into all these highlights and more in March when CROI makes these sessions available to the public, and register here for AVAC’s post-CROI webinar, Been There, Did That – Research Reflections from CROI 2023, Thursday March 23rd at 10 am ET. In the coming days and weeks, these scientific advances will help to shape discussions and define action. Watch this space for opportunities to join the conversation.

Last night in Seattle (and world-wide via a public live-stream), the 30th annual Conference on Retroviruses and Opportunistic Infections (CROI) kicked off with what was on all accounts a remarkable opening session. At the first in-person meeting of this high-science meeting since 2019, the energy and inspiration could be felt in the room.

The opening session featured Alan S. Perelson, a mathematician and one of the founders of the field of viral dynamics, who showed CROI’s history in presenting landmark discoveries, using math theory and basic science, that ultimately led to effective treatment for AIDS. Kevin DeCock, formerly of the US Centers for Disease Control and Prevention (CDC), discussed a decades-long global struggle against global health threats from disease, the ongoing challenges from forces such as climate change, and global conflict, and the unfinished commitments that will advance global health security.

But it was Yvette Raphael of APHA, a passionate advocate and long-time AVAC partner, who provided the Martin Delaney Presentation, and who captured the attention of the 3,000 people in the room. Yvette reminded everyone that these unfinished commitments still land most heavily on African women. She reminded everyone of the essential power of activism to demand justice and equity.

Read Yvette’s full presentation here and watch her remarkable slide presentation that played while she spoke here, which gave voice to the women on whose behalf Yvette spoke. You can also hear Yvette on A Shot in the Arm Podcast with Ben Plumley: Live from CROI 2023!

The session concluded with a history lesson from Anthony Fauci, former head of National Institute of Allergies and Infectious Diseases (NIAID), who took attendees through 30 years of collaboration fostered at CROI and research and breakthroughs presented at CROI, including antiretroviral therapy, treatment as prevention, oral PrEP, Undetectable = Untransmittable, cure, vaccines and a look ahead to long-acting PrEP. And he reached out especially to the young scientists and advocates in the room with a message of confidence and plea: we can end the HIV epidemic if we follow the science and apply the science, but it must come from you, he said, it depends on you. More from Anthony Fauci on the future in this AVAC webinar, Much Accomplished, Much to Do: A Conversation Looking Back & Looking Ahead.

Both Yvette and Tony referenced each other in their talks and both received standing ovations, and that makes sense because their messages cannot be separated. Science and advocacy need each other today as much as they ever have.

Stay tuned for a summary of CROI highlights from AVAC next week and follow the action on Twitter here and here.

P.S. Don’t forget to register for the daily Margarita Breakfast Club sessions (CROI registration not required)

Tuesday, February 21, 7:00 AM PST – 8:00 AM PST
Moving Forward: Upcoming Strategies on STI Prevention
Zoom registration link: https://tinyurl.com/movingforwardsti

Wednesday, February 22, 7:00 AM PST – 8:00 AM PST
The Data Gap: Filling in the Missing Perspectives on Women and Children in HIV Research
Zoom registration link: https://tinyurl.com/datagap

The annual Conference on Retroviruses and Opportunistic Infections (CROI), kicks off February 19 and runs through February 22 in Seattle, Washington. This will be the first in-person CROI since 2019, but will also include the virtual component honed during COVID, with 3,000+ individuals registered to participate in-person and 500+ online.

Since CROI began 30 years ago, it has served as the go-to forum for the latest research on HIV, tuberculosis (TB), hepatitis, COVID-19 and, more recently, monkeypox (mpox). Years of advocacy from AVAC and partners have made its research more accessible to non-research audiences, and ensured the voices and perspectives of affected communities are represented within the program, and ultimately the research.

For those attending or not, below are ways to follow along and join in the discussion and debate.

Follow Along

Conference coverage is available via aidsmap, AVAC on Twitter at @hivpxresearch and the conference hashtag #CROI2023.

Preview CROI

The Choice Agenda hosted the webinar, Ready, Set, CROI 2023: Prepare for the 30th Year of CROI on February 13. Researchers previewed the program, veteran CROI advocates offered tips for navigating the conference, and researcher, Victoria Walker-Sperling broke down key features for lay audiences on understanding scientific presentations. Watch the full recording here.

Participate in Daily Research Updates at the Margarita Breakfast Club

AVAC, the CROI Community Liaison Subcommittees, European AIDS Treatment Group, and other partners will host virtual Margarita Breakfast Clubs (MBCs) open to all. Next Monday, Tuesday and Wednesday 7:00–8:00am PT (time converter), researchers and community advocates will discuss the hottest #CROI2023 presentations. CROI registration not required to participate.

Monday, February 20, 7:00–8:00am PT
Arrested Development: Discontinuation of the MOSAICO Trial, its Legacy and Expectations for HIV Vaccine Research
Zoom registration link

Tuesday, February 21, 7:00–8:00am PT
Moving Forward: Upcoming Strategies on STI Prevention
Zoom registration link

Wednesday, February 22, 7:00–8:00am PT
The Data Gap: Filling in the Missing Perspectives on Women and Children in HIV Research
Zoom registration link

Community Networking Zone

This year, for the first time, CROI will offer a Community Networking Zone in the poster area. Watch AVAC’s page on CROI 2023 for more details. For registered participants.

CROI 2023 Roadmap

Check out the sessions we’re most excited about below and review the full CROI program here.

Saturday, February 18, 9am-4pm PT
Pre-CROI Community HIV Cure Research Workshop
At the Crowne Plaza Seattle-Downtown, with a streaming option available. More information and registration for the workshop can be found here.

Sunday, February 19, 5:00-7:20pm PT
Opening Session, including:

• Martin Delaney Presentation: Community and Advocates Are Equal Partners in Research and Development, from Yvette Raphael
• CROI: A 30-YEAR Chronicle of HIV/AIDS Research Progress, from Anthony Fauci

The opening session will be live streamed from the CROI website; no registration required.

Monday, February 20

• Plenary: 20 Years of PEPFAR: Looking Back, Striding Forward, from ambassador Dr. John Nkengasong; 8:30-9:30am PT
• Oral Abstract Session 3: HIV and STI Prevention: New Tools and Approaches; 10:00am-12:00pm PT
• Oral Abstract Session 4: Insights Into Prevention and Treatment of HIV in Women and Children; 10:00am-12:00pm PT
• Themed Discussion 1: HIV and the Microbiome: New Themes; 1:30-2:30pm PT
• Themed Discussion 5: New Insights Through Recency Testing; 1:30-2:30pm PT
• Symposium Session 3: Delivering on the Success of Injectable PrEP; 4:00-5:30pm PT

Tuesday, February 21

• Plenary 2: HIV Reservoirs: Obstacles to a Cure from Janet Siliciano; 8:30-9:30am PT
• Oral Abstract Session 8: All Modes Lead to PrEP; 10:00-12:00pm PT
• Oral Abstract Session 9: Late-breaking Clinical Studies on COVID-19 and MPOX; 10:00-12:00pm PT
• Themed Discussion 9: Advances in PrEP Delivery in Sub-Saharan Africa; 1:30-2:30pm PT
• Symposium 6: Getting PrEPped (AND PEPped) For Sex: From HIV to STIs to Monkeypox; 4:00-5:30pm PT
• Special Session–1: Results from the Mosaico HIV Vaccine Trial and Future Directions for HIV Vaccines; 5:40-6:00pm PT

Wednesday, February 22

• Themed Discussion 10: Cellular Immune Control of HIV; 1:30-2:30pm PT
• Themed Discussion 13: Preclinical Studies of New Prevention Interventions; 1:30-2:30pm PT
• Symposium 9: Science Communication in the Age of Miscommunication; 4:00-5:30pm PT

Looking forward to seeing you at the daily Margarita Breakfast Club sessions!

Our new issue of PxWire is here and shares the latest PrEP updates including new data from the PrEP Tracker, the HIV prevention pipeline, the prevention playlist and more! Check out the full issue here.

As the US President’s Emergency Plan for AIDS Relief (PEPFAR) marks its 20th year as one of America’s most effective global programs in history, advanced with bipartisan support, the US Congress will be considering its reauthorization this year.

Yesterday, US President Joe Biden singled out the success of PEPFAR in his State of the Union address. Countless others including Bill Gates, former PEPFAR head Debbi Birx, former AVACer Emily Bass and Friends of the Global Fight’s Mark Lagon, have written about its impact in recent days – and the opportunities and challenges for its future. PEPFAR has to date saved 25 million lives by delivering life-saving antiretrovirals; it is credited with keeping 5.5 million babies HIV free and contributing to a 68 percent decline in AIDS-related deaths globally since their peak in 2004, just to highlight a few statistics that tell the story: PEPFAR’s impact has been monumental. Now what?

AVAC appreciates the Biden Administration’s recent promise to continue support for PEPFAR, as other presidential administrations have since its inception. However, it’s imperative that such promises are fulfilled through Congress’s unwavering, fully-funded support for the reauthorization of PEPFAR for the next five years – see these important principles to guide this process from the Global AIDS Policy Partnership (GAPP).

As the world begins to deliver on the commitment to end AIDS as a public health threat AND grapple with how best to build a platform for pandemic prevention, preparedness and response (PPPR), a strong PEPFAR will be critical. AVAC Senior Program Manager for Policy John Meade, Jr. spelled out some crucial connections in his recent blog, Global Fund and PEPFAR’s Essential Collaboration.

PEPFAR’s decades of experience using data and building systems, programs, and infrastructure to confront HIV, and instilling community trust, are unmatched as a global model for pandemic preparedness. Staying on track in the fight against HIV, through PEPFAR and other investments, secures a foundation for facing down future health threats, as a number of our colleagues just wrote in PLOS Global Public Health: Leveraging the HIV response to strengthen pandemic preparedness. Fulfilling this role depends on providing new money, policy-setting authority, and clearly defined leadership to PEPFAR. Without these measures, instead of building on and extending PEPFAR’s strength, decision-makers risk serious damage to what has been singular success in global health.

As PEPFAR marks its groundbreaking accomplishments in this anniversary year, we will be applauding its successes, tracking the process toward reauthorization, and keeping advocates connected to opportunities to add their voices to the process.

We are only a month into the New Year and so much has happened in HIV prevention. Below are links to important resources on the latest developments.

Opinion Piece: The Fight to Decriminalize Sex Work in South Africa

South Africa-based AVAC Fellow, Liyema Somnono published an opinion piece in Health-e News, Decriminalization of sex work can help prevent HIV, which unpacks the reasons for reforming South Africa’s outdated legislation that criminalizes “sex work” and legitimizing and recognizing sex work as work. AVAC’s Cindra Feuer then authored a blog post sharing AVAC’s support of possible reform: Decriminalization of Sex Work Prevents HIV: South Africa could overturn its outdated laws.

Publication: New Lancet HIV Publication Evaluates the Future of Injectable CAB for PrEP

The HIV Modelling Consortium along with representatives of AVAC and a number of partners recently published modelling study in The Lancet HIV. The new study, Predicted effects of the introduction of long-acting injectable cabotegravir pre-exposure prophylaxis in sub-Saharan Africa: a modelling study here, analyzes the potential benefits and risks from scaling up CAB for PrEP, with important implications for advocacy.

Mosaico Trial and What’s Next in HIV Vaccine Research

AVAC co-hosted with the HVTN the webinar, Where Are We Now and What’s Next in HIV Vaccine R&D. A link to the recording is here. On the webinar, the group shared details about the Mosaico HIV vaccine trial, which found no efficacy, including characteristics of the 3,800 participants, Mosaico’s approach to its PrEP, and community input throughout the trial. For more insights, check out these articles: The Only Late-Stage HIV Vaccine Study (Mosaico) Just Tanked. What’s Next? in The Body and Why inventing a vaccine for AIDS is tougher than for COVID in NPR’s Goats and Soda.

Webinar: Trans Inclusion and TG Scorecard

The Choice Agenda hosted its first webinar of 2023, Trans Inclusion: Charting HIV Research into the Future: A Manifesto and Scorecard for Advocates and Researchers with Leigh Ann van der Merwe, Brian Minalga, and AVAC’s own Cindra Feuer joined by over 80+ participants. Panelists unpacked the No Data No More manifesto and discussed preliminary findings from the TG scorecard, which looked at transgender representation in clinical trials over time. Watch the full recording of the webinar and check out the slides and resources here.

P.S. As a reminder, there are three upcoming webinars this month:

• The Power Of PrEP: Pleasure and Prevention In The Black Community on Tuesday, February 7 at 2:00 PM ET from the PrEP in Black America Coalition on National Black HIV/AIDS Awareness Day

• Ready, Set, CROI 2023 – Prepare for the 30th Year of CROI on Monday, February 13 at 9:00 AM ET / 2:00 PM GMT

• Decolonizing Global Public Health – What Will it Take to Dismantle Racism and White Supremacy? on Thursday, February 16 at 9:00am ET / 2:00 pm GMT

South Africa could possibly reform its outdated and misguided criminal legislation that punishes consenting adults who offer or procure sexual services for money. AVAC supports the move toward decriminalization as evidence shows that its social, legal and economic injustices create a perfect storm for sex workers’ increased HIV risk. South African HIV and human rights activists deserve credit for their advocacy in bringing the Sexual Offenses Act of 1957 and its follow-on Amendment Act of 2007 up for a repeal vote.

AVAC Fellow, Liyema Somnono, authored an opinion in Health-e News (Jan 27), Decriminalization of sex work can help prevent HIV, unpacking the reasons for legitimizing and recognizing sex work as work, rather than as a stigmatizing crime with broad, negative effects that exacerbate an environment of social exclusion, violence and HIV. Liyema lays out a powerful case for repeal:

• Sex work is work. It’s an income-generating activity. Sex workers are not criminals, victims, vectors of disease, or sinners.
• Sex workers support between five and eight other people with their earnings.
• Under the current punitive laws, sex workers face human rights violations in their treatment by police officers, health practitioners, clients, and other members of society.
• Stigma and discrimination prevent most sex workers from accessing quality HIV prevention and HIV care services.
• Criminalization deems it difficult to negotiate safer sex or report abuse from clients, partners, police or health providers.
• Repeal of the legislation that punishes sex workers would have a profound impact on the course of HIV epidemics across all settings. A third to half of HIV infections would be averted in a decade.

For those residing in South Africa, please voice your opinion in favor of the Criminal Law Amendment Bill of 2022 at bills1@justice.gov.za. The comment period is open through 31 January.

Liyema is a 2022 Fellow, hosted by Passionate Unlimited Peers in Action, in South Africa where she partners closely with SWEAT and Sisonke, a national movement of sex workers working towards a South Africa where people who choose sex work are able to enjoy freedom, rights and human dignity. As part of her rights-based advocacy, Liyema works to integrate access to HIV prevention choices for sex workers and other women in the rural Eastern Cape.