At CROI 2023, researchers presented several studies on new and existing treatments for HIV, which offered hope to people living with the virus. One of the studies looked at integrase inhibitors, a class of drugs that has previously been linked to an increased risk of cardiovascular disease. However, this new study found that integrase inhibitors did not raise cardiovascular risk in people starting HIV treatment.

Another study found that a combination of dolutegravir and darunavir/ritonavir is superior to a boosted protease inhibitor regimen in second-line treatment. This finding is significant because previously, darunavir with ritonavir was recommended due to a lack of evidence about the second-line use of dolutegravir.

A third study explored the use of lenacapavir and broadly neutralizing antibodies (bnAbs) as a treatment option for people living with HIV. The study found that the combination of lenacapavir and bnAbs resulted in an undetectable viral load in 90% of participants six months after stopping their existing antiretroviral therapy.

However, the conference also highlighted potential side effects of certain treatments. For example, a study found that combinations of antiretroviral drugs containing tenofovir alafenamide (TAF) and cobicistat were linked to physical symptoms of depression in women with HIV.

Finally, a study from a safety-net HIV clinic in San Francisco showed that long-acting cabotegravir and rilpivirine may be feasible for people without viral suppression. The injectable regimen was given to people who had been unable to achieve or maintain viral suppression due to challenges with adherence to oral therapy. With extensive support from the clinic, the study found that 55 of the 57 people with a detectable viral load were able to achieve viral suppression.

Overall, the studies presented at CROI 2023 offer hope for new and improved treatments for people living with HIV, while also highlighting potential side effects and the need for continued research and support for those living with the virus.

There is a lot of news from the recently ended CROI and we wanted to share some highlights of the media coverage. You can (and should!) watch the great speakers – including Kevin De Cock. Tony Fauci and activist Yvette Raphael in the opening session on the CROI homepage and see some of the conversation around the research and conference sessions on twitter with #CROI2023. You can also search CROI abstracts online.
AIDSMAP’s conference coverage is here.  Videos of the press conferences are here.
Watch videos of the Margarita Breakfast Club discussions:
Listen to A Shot In the Arm Podcast: Live From CROI 2023 with co-hosts Yvette Raphael & Ben Plumley:
Watch roundups from the conference:
Contagion’s Live coverage is here.
Also keep an eye on your inbox for AVAC’s take on much of the important research presented at the conference later this week.
Media highlights
Opening session talks
Pharmacy Practice News (US) reports on activist Yvette Raphael’s Martin Delaney Lecture, noting: “Ms. Raphael outlined the ‘years of struggle for Black women, for ourselves, our daughters, our nieces, our mothers to get what we need to keep our bodies safe and healthy. I’m talking about HIV prevention and the unfinished work of meeting women’s needs.’ Ms. Raphael said women ‘have been asking for [this] for frankly too long…. ‘For years, the scientific establishment, the research establishment has listened to us some of the time, engage with us some of the time, followed our priorities some of the time and has for the rest of the time pushed us aside, taken our work, our labor, taken our Black statistics and our data without giving us what we ask for, which is simply this—a choice, a voice and power.’”
Pharmacy Practice News (US) reports on Tony Fauci’s addressing young scientists at the opening session: “’The point I want to make specifically to the young people in the crowd—the pre-docs, the postdocs, the young investigators—is that what happens in this meeting in a very incipient form over a period of time becomes the reality of what we are dealing with and then the implementation of something that’s clinically actionable,’ he said.”
Mosaico results and vaccine research
The TAG HIV Basic Science, Vaccines, and Cure Project Blog (US) outlines what was presented at the conference on the Mosaico results and notes, “the HIV vaccine field is now working to solve the complex challenge of inducing broadly neutralizing antibodies (bNAbs), which have demonstrated protective efficacy in a subset of participants in the Antibody-Mediated Prevention (AMP) studies (which delivered the bNAb VRC01 directly via infusion). There have been signs of progress and several trials are now underway to assess if it’s possible to nudge human B cells down the tricky pathway toward bNAb production.”
Washington Post (US) Live conversation looks at “the quest for an HIV vaccine” with IAVI’s Mark Feinberg, Clover L. Barnes of the DC DoH, Cecilia Chung of the Transgender Law Center and Demetre Daskalakis who coordinated the White House mpox response. Feinberg says, “It is a constant battle where the immune system is chasing after the virus, and the virus is always one step ahead. But because it’s so difficult for the immune system to actually get access to the vulnerable domains on the surface of the HIV virus particle, that’s why it’s been so difficult to develop a vaccine against it. Ms. Barnes notes, “I worry about the medical mistrust in the Black community, and we saw vaccine hesitancy with the Mpox vaccine, with covid, and then the rates of infection more severely affect the Black community. So I think we need to–while we’re working on a vaccine, I think we need to work on building more trust and building more, better relationships with the Black community so that we can work to dispel some of the misbeliefs that are out there and also so that we can get better uptake, because we know that the highest rates of HIV infection right now are in the Black community. And so if we can’t make the biggest impact on the community that’s most affected, then I don’t think the vaccine will have the impact that we all hope it will.”
An ISDE video features Larry Corey talking about the way forward with vaccine research. “The field is really moving forward with what we call immune approaches to preventing HIV, passive installation of antibodies, or making a vaccine that would elicit these broadly neutralizing antibodies—that is going to take still a little bit longer. But there’s a very active investigative community that is working on an HIV vaccine.”
Long Acting PrEP
AIDSMAP (UK) reports on new data from HPTN 084 which found that “drug levels persist long enough in women to mean that an injection every three months, as opposed to every two months as in HPTN 084, might still be effective. As well as simply being more convenient, quarterly dosing would mean PrEP injections could be given on the same schedule as injectable contraceptives.” More on the study results at NATAP.
AIDSMAP (UK) reports, “In people who acquire HIV despite taking injectable cabotegravir as PrEP, the course of infection is quite distinct to that seen in people who aren’t taking PrEP, Professor Susan Eshleman of Johns Hopkins University told [CROI] last week. People may not feel unwell, viral load is often unusually low and the infection may not be picked up by diagnostic tests for several months, meaning there is a real risk of developing resistance to integrase inhibitors.”
PrEP and Women
In a video for Helio (US) Jeanne Marrazzo talks about cis women and PrEP adherence: “An analysis of data from more than 6,000 women collected over nearly a decade in sub-Saharan Africa and Asia found that for most, adherence declined over time. ‘We obviously need other options for women who want to initiate PrEP — they’re really urgently needed,’ said Marrazzo.”
Dapivirine ring
Daily Maverick (South Africa) reports, “A vaginal ring used to prevent HIV infection is safe to use during late pregnancy and while breastfeeding, according to findings presented at a major international HIV conference in Seattle in the United States. The news comes as South Africa prepares for a likely national rollout of the ring and as more research confirms the safety of an HIV prevention pill during pregnancy. It is estimated that offering these products to pregnant and breastfeeding women could avert up to 136,000 new infections in roughly the next decade.”
Pharmacy Practice News (US) reports, “The phase 3b B-PROTECTED study (MTN-043), which was conducted in Malawi, South Africa, Uganda and Zimbabwe, found that although the drug could be detected in breast milk, the absolute levels were very low and the amount of drug ingested by infants were even lower, thus posing no safety concerns. ‘We believe this favorable safety profile, along with the data demonstrating extremely low concentrations of dapivirine transferred to infants, supports the inclusion of breastfeeding populations in global and national guidelines on the use of the dapivirine vaginal ring for HIV prevention,’ said Jennifer E. Balkus, PhD, MPH, an associate professor of epidemiology at the University of Washington School of Public Health, who also is the protocol co-chair of the B-PROTECTED study and presented its findings.” Read the MTN release.
The BodyPro (US) interviewed Katherine Bunge about the results of the DELIVER trial. “While presenting her findings at CROI 2023, Bunge commented that her team conducted the DELIVER study because, ‘We know that pregnant people need HIV prevention products,’ but that, ‘For years, we’ve suffered from a lack of high-quality data about whether a drug is safe or not to use in pregnancy.’ Read the MTN release.
PEP/PrEP Suppository
AIDSMAP (UK) reports, “An insert (suppository) designed for PEP or PrEP and containing the antiretrovirals elvitegravir and tenofovir alafenamide (TAF) was safe to use and produced drug levels in rectal tissues that stayed well above protective levels for over a day, and in the case of tenofovir, for over three days…. The insert is designed to be gently inserted in the vagina or rectum, where it dissolves within a few hours. It looks like an oral tablet and is quite small – about 1.5cm long and less than 1cm wide. The insert contains 60 milligrams (mg) of elvitegravir and 20mg of TAF.”
Spotlight (South Africa) reports, “Scientists are planning to conduct a larger study of the suppository’s vaginal use among 60 women across the United States, Kenya, and South Africa. It will be the first trial of the suppository in Africa. If future trials prove the antiretroviral-based suppository works to prevent HIV, it will become the newest form of pre-exposure prophylaxis (PrEP) or products that use antiretrovirals to prevent HIV infection. Jim Pickett is quoted: “I absolutely love that it’s being tested in the vagina and the rectum. Anal sex is a human behaviour, practiced by humans of all kinds. What could be more lovely than a little insert that you can pop into the very place where all the action takes place – front or back door – and you get the peace of mind and pleasure that comes with protection….“Unfortunately, most of our healthcare systems require people to do double back-flips and walk on their hands to gain access to any kind of healthcare, let alone HIV prevention. If you are a person of colour, or a ciswoman, or a transperson, or a queer person – your barriers are even higher. Powerful tools are worth nothing if people can’t get those tools with ease.”
Pharmacy Practice News (US) reports, “A quickly dissolving suppository being developed as an “on-demand” HIV prevention method was found to be safe and well tolerated, according to a presentation at CROI 2023, in Seattle. The results also found that the insert delivered high levels of the antiretroviral drugs tenofovir alafenamide (TAF) and elvitegravir (EVG) to rectal tissue and fluid, with little drug circulating elsewhere in the body (presentation 164). Sharon Riddler is quoted:  “PrEP uptake particularly with orals and injectables, is much lower than we’d like. This is because of cost, availability, desirability and potential side effects. Currently, the only on-demand product offered for PrEP is the 2-1-1 regimen, which really has only been tested in cisgender men.” Read the MTN release.
HIV Cure
Nature (UK) reports on the Düsseldorf patient, “at least the third person with HIV to be declared clear of the virus after a procedure that replaced his bone marrow cells with HIV-resistant stem cells from a donor…. The man…stopped taking ART in 2018 and has remained HIV-free since…. But it’s unlikely that bone marrow replacement will be rolled out to people who don’t have leukaemia, because of the high risk associated with the procedure, particularly the chance that an individual will reject a donor’s marrow. Several teams are testing the potential to use stem cells taken from a person’s own body and then genetically modified to have the CCR5Δ32/Δ32 mutation, which would eliminate the need for donor cells.”
The TAG HIV Basic Science, Vaccines, and Cure Project Blog notes the confusion in the media about the number of documented cases of functional cures. “The news headlines are potentially confusing because some state Marc is the third case to reflect the chronological sequence (after Timothy Ray Brown and Adam Castillejo) while others designate him the fifth to reflect the total number of cases described to date, which include two more recent examples in New York City and at the City of Hope in Los Angeles. The first scientific description of the Düsseldorf Patient was in a poster presentation at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI), prior to interruption of ART. Two post-interruption follow up posters were presented at CROI in 2019 and 2020. The HIV cure research field has thus been aware of the case for a long time, and there was frustration and confusion last year when the announcement of a fifth similar possible HIV cure at the City of Hope mistakenly referred to it as the fourth based on the unnecessarily prim rationale that information on the Düsseldorf Patient hadn’t yet been published in a journal. Today’s publication will hopefully put any uncertainty to rest.”
Mpox and HIV
Mpox has largely fallen out of media coverage as the cases have fallen drastically in most of the world. But the virus persists in some parts of Latin America and elsewhere and the WHO last week said it continues to be a global emergency. Now new evidence presented at the Conference on Retroviruses and Opportunistic Infections shows the potentially devastating link between mpox and HIV. The New York Times (US) reports, “In people with advanced H.I.V. disease, the mpox virus — formerly known as monkeypox — often causes severe illness, with a death rate of about 15 percent. The seriousness of the infection warrants the inclusion of mpox among the opportunistic conditions that are particularly dangerous to people with advanced H.I.V.” The Times quotes Dr. Chloe Orkin, who led the study: “These findings make it very, very clear that every single person with mpox should have an H.I.V. test.” 
In The Lancet(UK) Orkin and colleagues write, “people with HIV and high risk of mpox infection should be prioritised for a preventive vaccine. Moreover, two-thirds of the deaths that we reported had occurred in Latin America. Our findings are particularly pertinent for countries with low levels of HIV diagnosis or without universal free access to ART and intensive care units, where the interaction of uncontrolled HIV infection and mpox is more prevalent.”
Read more about the study on NATAP. 
Doxy PEP
Medscape (US) reports, “The benefits of doxycycline postexposure prophylaxis (Doxy PEP) in preventing the transmission of sexually transmitted infections (STIs) in men and transgender women do not appear to extend to cisgender women, who have disproportionately high rates of infection in many regions.” Author Jenell Stewart is quoted: “Unfortunately, our primary outcome was not statistically significant — we did not see a reduction in STIs among cisgender women, which is in stark contrast to [reported effects] among cisgender men and transgender women.”
The news is better for cis men and trans women. Helio (US) reports, “Studies continue to show that taking doxycycline after having unprotected sex can prevent STIs in transgender women and men who have sex with men. Jean-Michel Molina, MD, PhD, a professor of infectious diseases at the University of Paris, and colleagues found that MSM were 84% less likely to contract chlamydia or syphilis and about half as likely to contract gonorrhea if they received doxy-PEP within 3 days of having condomless sex, compared with study participants who did not. The study, which enrolled more than 500 MSM who were already taking PrEP for HIV prevention and had at least one STI in the past year, was stopped early on the advice of a data and safety and monitoring board because of how effective the intervention was.”
AIDSMAP (UK) reports, “Using the antibiotic doxycycline to prevent the bacterial STIs gonorrhoea, chlamydia and syphilis (‘doxyPEP’) has sparked fears that it may lead to widespread drug resistance, especially in the gonorrhoea bacterium. However, an analysis of gonorrhoea resistance seen among participants in the US DoxyPEP study, whose main findings were reported last year, shows that while resistance to doxycycline and other drugs of its class is not uncommon, only modest increases in the proportion of gonorrhoea infections with significant resistance were seen, and that there was little difference in resistance rates between people taking doxyPEP and not taking it.”
AIDSMAP (UK) reports, “A vaccine against gonorrhoea halved the rate of repeated infections in gay and bisexual men, according to a study presented today by the French research agency ANRS…. ‘This is the first vaccine that shows some level of efficacy against a bacterial sexually transmitted infection,’ principal investigator Professor Jean-Michel Molina of the University of Paris told aidsmap. The DOXYVAC study, as its name implies, also looked at the effectiveness of taking the antibiotic doxycycline as post-exposure prophylaxis (‘doxyPEP’) against bacterial STIs in general. It cut the rates of chlamydia and syphilis by 88% and 87%. The antibiotic also ‘unexpectedly’ cut the rate of gonorrhoea by 51%, independently of the effect of the vaccine.”
Islatravir Implant
NATAP has published the abstract and slides for the presentation: ULTRA LONG-ACTING REFILLABLE ISLATRAVIR IMPLANT FULLY PROTECTS NHP AGAINST SHIV, noting “In the session Dr Grattoni mentioned 3-4 years of possible ‘ultra-long’.”
Pharmacy Times (US) reports, “Lenacapavir combined with the investigational broadly neutralizing antibodies (bNAbs) teropavimab (GS-5423) and zinlirvimab (GS-2872) was well-tolerated for patients with HIV, according to the results from a phase 1b clinical trial presented at [CROI]. After 6 months, 90% of patients experienced virologic suppression of HIV, the study found. ‘Novel long-acting HIV treatment options will drive the next chapter in care and may help meet the therapy needs and preferences of people living with HIV. In this study we found that lenacapavir and bNAbs in a combination approach may have a significant role to play in the future treatment of HIV,’ said Joseph Eron, MD, lead study investigator and the chief of the Division of Infectious Diseases at the University of North Carolina School of Medicine, in a press release.”
Medscape (US) reports, “Long-acting antiretroviral therapy (ART) for HIV involving injections every 1 or 2 months not only shows non-inferiority to a standard daily oral treatment regimen, it also suppresses HIV even in patients who do not already have virologic suppression, as is typically required before initiation, results from two new studies suggest. Meanwhile, a third study shows early promise of a long-acting ART regimen that could require injections only twice yearly.”
Poz (US) reports, “Long-acting Cabenuva (cabotegravir and rilpivirine) injections may be an option for people who struggle to stay engaged with traditional HIV care and who have been unable to maintain an undetectable viral load on oral antiretroviral treatment, researchers reported this week at [CROI].”
AIDSMAP (UK) reports, “Nearly one in ten people on antiretroviral treatment in rural Uganda report having shared medication, according to a population-based study presented at [CROI]. The research is the first population-based study to document the phenomenon in Africa and reveals new insights into whether this undermines or supports viral suppression.”
In other news
Nature (UK) reports, “The US Food and Drug Administration (FDA) will soon require researchers and companies seeking approval for late-stage clinical trials to submit a plan for ensuring diversity among trial participants…. The diversity requirement arrives in the wake of a 2022 report from the US National Academies of Sciences, Engineering and Medicine, which found that, although the representation of white women in clinical trials has improved, progress has “largely stalled” for minority racial and ethnic groups. Older adults, pregnant people and individuals with disabilities remain severely under-represented — and, in some cases, excluded — from US clinical research, the report found.”
VOA (US) reports, “Uganda has said it will not renew the mandate of the United Nations’ human rights office in the East African country, citing the development of its own sufficient capacity to monitor rights compliance. In a letter by Uganda’s Foreign Affairs Ministry sent to Office of the U.N. High Commissioner for Human Rights (OHCHR) on February 3 and seen by Reuters on Wednesday, the ministry noted progress Uganda had made in developing a domestic capacity to monitor rights as the main reason for its decision.”
Devex (US) reports, “Dr. Jean Kaseya is the first director general of the Africa Centres for Disease Control and Prevention. He is a Congolese medical doctor with over two decades of experience in public health, working at both international institutions and the government of the Democratic Republic of Congo.”
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