This blog is adapted and cross-posted from HIV.gov. 

On March 6 as the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) was winding down, HIV.gov spoke with Carl Dieffenbach, Ph.D., director of NIAID's Division of AIDS, about highlights of long-acting HIV treatment research discussed at the conference. He spoke with Brian Minalga, M.S.W., deputy director of the NIH-supported Office of HIV/AIDS Network Coordination. Watch their conversation below:

Research Suggests Possible Expanded Options for Long-Acting HIV Treatment

Dr. Dieffenbach highlighted findings from several clinical trials and a plenary session presented at CROI about current and future options for long-acting antiretroviral treatment (ART) for HIV.

First, he discussed a NIAID-supported randomized clinical trial that found that long-acting ART with cabotegravir and rilpivirine was superior in suppressing HIV replication compared to daily oral ART in adults who had been unable to maintain viral suppression through an oral daily regimen. The LATITUDE study enrolled participants in 31 sites in the United States. Last month, the trial’s Data and Safety Monitoring Board conducted a planned review of interim data and recommended halting randomization and offering all eligible study participants long-acting ART based on its observed superior viral suppression of HIV. At CROI, study leaders reported that the interim analysis of data from 294 participants showed that the chance of experiencing unsuppressed HIV was 7% among people taking long-acting ART compared to 25% among those taking daily oral ART. The likelihood of discontinuing the assigned regimen due to adverse events or experiencing unsuppressed HIV was 10% among people taking long-acting ART compared to 26% among those taking daily ART. These findings were statistically significant. Dr. Dieffenbach observed that these results may support expanding the use of long-acting ART among a broader population. Read the study abstract. Read more in this NIAID news release.

Another ongoing clinical trial reported initial findings on the safety of the same long-acting injectable treatment regimen for adolescents with HIV with a suppressed viral load. The NIH-supported MOCHA study enrolled participants aged 12 to 17 who were virally suppressed in Botswana, South Africa, Thailand, Uganda, and the United States. In what he characterized as very encouraging results, Aditya Gaur, M.D. of St. Jude Children's Research Hospital, one of the trial’s co-chairs, reported that after the first six months all participants remained virally suppressed, and the level of the ART in their systems was comparable to what has been shown as efficacious in adult studies of the same drug. He also reported that, while about one-third of the participants reported an injection-site reaction, there were no surprising or unanticipated adverse events. These data support the use of cabotegravir and rilpivirine in virally suppressed adolescents, according to Dr. Gaur and colleagues. Dr. Dieffenbach noted that NIH will continue to support safety and dosing studies to determine the proper doses for adolescents and that these studies could eventually expand access to this long-acting HIV treatment to more people.
Read the abstract. Read NIAID’s news release about the study.

In addition, Dr. Dieffenbach mentioned an industry-sponsored Phase 2 trial that presented 24-week results of an oral once-weekly investigational combination of two drugs (islatravir and lenacapavir). Researchers reported that the investigational combination maintained a high level of viral suppression among study participants and was well tolerated. The study will continue to gather data and suggests that a weekly oral HIV treatment regimen could someday be possible. Read the abstract.

Finally, Dr. Dieffenbach discussed Wednesday’s plenary session by Charles Flexner, M.D. of The Johns Hopkins University School of Medicine, which was titled “The End of Oral? How Long-Acting Formulations Are Changing the Management of Infectious Diseases.” In his big picture, future-focused presentation exploring long-acting drug delivery, Dr. Flexner observed that there is a need for HIV products with less frequent dosing, greater convenience, and greater likelihood of viral suppression, as well as for the prevention and treatment of other diseases, including tuberculosis, malaria, and viral hepatitis. He discussed recent advances in formulation science that are going to help make available better replacements for daily oral drugs for HIV and many other infectious diseases. Dr. Dieffenbach underscored Dr. Flexner’s point that these novel products must be developed with access and equity in mind so that people who need them, especially in resource-limited settings, can use them.

Key Takeaways

Reflecting on key takeaways from the entire conference, both Dr. Dieffenbach and Brian pointed to the importance of partnership between the HIV community and scientists in all aspects of HIV research, a theme also discussed in HIV.gov’s conversation with Dr. LaRon Nelson from the conference. In terms of research highlights, Dr. Dieffenbach pointed to the results reported from the IMPAACT P1115 study in which several children who started HIV treatment within hours of birth later surpassed a year of HIV remission after a treatment pause. (See HIV.gov’s interview with Dr. Deborah Persaud about this study.) He also noted that the additional data accumulating on the effectiveness of Doxy-PEP is encouraging and will hopefully soon be reflected in clinical guidelines that help to reduce the incidence of syphilis, chlamydia, and gonorrhea in men who have sex with men and transgender women.

Catch Up on More HIV Research Updates

HIV.gov has shared other interviews from CROI 2024 with federal HIV leaders, participating researchers, and community members. You can find all of them on HIV.gov’s blog and social media channels.

About CROI

More than 3,600 HIV and infectious disease researchers from 73 countries gathered in Denver and virtually from March 3-6 this year for CROI, an annual scientific meeting on the latest research that can help accelerate global progress in the response to HIV and other infectious diseases, including STIs and viral hepatitis. Over 1,000 summaries of original research were presented. Visit the conference Web site for more information. Session webcasts and more information will be published there for public access.

This blog is adapted and cross-posted from HIV.gov. 

On the final day of the 2024 Conference on Retroviruses and Opportunistic Infections (CROI), HIV.gov spoke with Deborah Persaud, M.D., professor of Pediatrics at the Johns Hopkins University School of Medicine and director of the Division of Pediatric Infectious Diseases at Johns Hopkins Children's Center, who reported findings from a study about whether very early initiation of antiretroviral therapy (ART) may limit the establishment of HIV reservoirs in newborns, potentially enabling ART-free remission. Dr. Persaud spoke with Catey Laube of NIAID’s Office of Communications and Government Relations. Watch their conversation below:

Four Children Achieve ART-free HIV Remission

The study Dr. Persaud presented at CROI began 10 years ago. HIV.gov spoke to Dr. Persaud at CROI 2013 when she presented the case of an infant born with HIV in Mississippi who initiated treatment at 30 hours of life, was taken off their ART at 18 months of age and remained in remission with no evidence of detectable HIV for 27 months. This was an uncommon finding because, typically, an interruption in treatment will lead to rapid resumption of HIV replication and detectable virus in the blood within weeks. Dr. Persaud and colleagues then began the NIH-supported study she reported on at CROI this year to carefully replicate that result in a research setting to determine whether the ART-free remission the “Mississippi baby” experienced was due to the very early start of HIV treatment within hours after birth and could be effective in other children.

Dr. Persaud reported on the experience of six children, all aged 5 years, who met multiple criteria to be eligible for a closely monitored ART interruption and whose parents consented. Four of the six children experienced HIV remission, defined as the absence of evidence of replicating virus for at least 48 weeks off ART. One of them had detectable HIV after 80 weeks. Two children did not experience remission, and their HIV became detectable within a few weeks after ART interruption. Children whose HIV became detectable resumed ART. The other three remain in remission. These promising findings will be followed by additional research to better understand the biological process that enabled the children to experience HIV remission off ART and to study early ART with newer drug regimens than were used in this initial study. Dr. Persaud cautioned that much more evidence is needed before this approach could be possible outside of the strictly monitored research setting. Read the study abstract. Read NIAID’s summary of the study findings.

Other Studies of Interest Presented on Wednesday

Some of the other NIH-supported research presented at CROI included a study that identified sex-based differences in latent HIV reservoirs, highlighting unique aspects of reservoirs in women. The findings point to the importance of including cisgender women in HIV cure studies. Read the study abstract. Another showed that a novel hepatitis B vaccine achieved up to 99% protection in people with HIV who had previously not responded to conventional hepatitis B vaccines. Read the study abstract.

Catch Up on More HIV Research Updates

HIV.gov has shared other interviews from CROI 2024 with federal HIV leaders, participating researchers, and community members. You can find all of them on HIV.gov’s social media channels and recapped here on the blog this week and next week.

This blog is adapted and cross-posted from HIV.gov. 

On Tuesday at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI), HIV.gov spoke with Carl Dieffenbach, Ph.D., director of NIAID’s Division of AIDS, about research on common health complications of HIV and the safety of an HIV prevention tool during pregnancy. He spoke with Miss Molly Moon, M.S.W., Deputy Director of the NIH-supported Office of HIV/AIDS Network Coordination. Watch their conversation below: 

Liver and Cardiovascular Complications of HIV

Dr. Dieffenbach highlighted research findings presented at CROI about addressing both liver and cardiovascular complications among people with HIV. First, researchers reported that a weekly injection of semaglutide was safe and reduced the amount of fat in the liver by 31% in people with HIV and metabolic dysfunction-associated steatotic liver disease (MASLD) after 24 weeks. An estimated 30-40% of people with HIV experience MASLD, which was previously known as nonalcoholic fatty liver disease. MASLD is characterized by the accumulation of excess fat in the liver that is not caused by alcohol consumption or viral hepatitis. The pilot study involved 49 participants whose HIV viral load was suppressed by treatment who took low weekly doses of semaglutide, which is FDA-approved for treatment of type 2 diabetes and weight loss but had not previously been studied for its effect on MASLD in people with HIV. Read the CROI 2024 study abstract. Read NIAID’s summary of the study findings.

Second, researchers shared new analysis resulting from the NIH-supported REPRIEVE trial, which  enrolled thousands of participants in 12 countries. Their analysis reveals that a standard tool used by health care providers to estimate the risk of cardiovascular events in people and determine whether they should be prescribed preventive statin therapy was moderately effective in predicting cardiovascular death, heart attack, or stroke over five years among people with HIV. However, the tool under-predicted cardiovascular events in women, Black/African Americans, and participants from high-income regions. The researchers suggested that the performance of this tool in these subgroups should be considered when using it to guide prescribing statins for cardiovascular prevention among people with HIV. Read the CROI 2024 study abstract. Last summer, REPRIEVE reported its key finding that statins, a class of cholesterol-lowering medications, may offset the high risk of cardiovascular disease in people with HIV by more than a third, potentially preventing one in five major cardiovascular events or premature deaths in this population. Informed by those findings, new clinical guidelines, Recommendations for the Use of Statin Therapy as Primary Prevention of Atherosclerotic Cardiovascular Disease in People with HIV, were recently published. (View HIV.gov’s 2023 conversations about REPRIEVE trial findings.) 

Safety of Dapivirine Ring for HIV Prevention During Pregnancy

Dr. Dieffenbach also discussed new data presented at CROI on the safety of the dapivirine vaginal ring used for HIV prevention. The dapivirine ring is made of flexible silicone, continuously releases the antiretroviral drug dapivirine into the vagina, and is replaced monthly by the user. Its use is approved for HIV prevention in several African countries where adolescent girls and young women are among the groups most likely to benefit. The new data from an NIH-supported study found the ring to be safe throughout pregnancy, a period during which pregnant people are three times more likely to acquire HIV through sex. Dr. Dieffenbach observed that these findings expand HIV prevention choices for women at various stages of their lives. Read the CROI 2024 study abstract. Read NIAID’s summary of the study findings. 

Other Studies of Interest Presented on Tuesday

Some of the other studies presented included a trial showing that offering participants a choice and an opportunity to switch between long-acting injectable cabotegravir, daily oral PrEP, or post-exposure prophylaxis (PEP) increased the amount of time people were using a biomedical HIV prevention method and reduced HIV acquisition compared to offering only oral PrEP and PEP. Read the CROI 2024 study abstract. Another study of antiretroviral therapy during menopause found that switching to a drug regimen with an integrase strand transfer inhibitor (INSTI, a category of antiretroviral drugs) was associated with early accelerated increases in waist circumference and body mass index when compared to people who did not switch to an INSTI-based regimen during late peri-menopause and post-menopause. Read the CROI 2024 study abstract.

Stay Tuned for More HIV Research Updates

HIV.gov will be sharing additional video interviews from CROI 2024 with Dr. Dieffenbach, CDC’s Dr. Jono Mermin and Dr. Robyn Neblett Fanfair, and others. You can find all of them on HIV.gov’s social media channels and recapped here on the blog. 

This blog is adapted and cross-posted from HIV.gov. 

During the first full day of presentations at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI), HIV.gov spoke with Carl Dieffenbach, Ph.D., director of NIAID’s Division of AIDS, about research presented on Doxy-PEP for sexually transmitted infections (STIs) and HIV vaccines. He spoke with Louis Shackelford of the HIV Vaccine Trials Network. Watch their conversation.

Louis also spoke with LaRon Nelson, Ph.D., R.N., F.N.P., F.N.A.P., F.N.Y.A.M., F.A.A., about community-engaged research, HIV prevention at CROI, and a new study (HPTN 096) he is leading to reduce HIV rates among Black men who have sex with men (inclusive of cisgender and transgender men) in the southern United States. Dr. Nelson is a professor and the associate dean at the Yale School of Nursing. Watch their conversation.

Insights from Doxy-PEP Use in Real World Settings

At last year’s CROI, researchers presented results from an NIH-supported study on using a preventive dose of the antibiotic doxycycline as post-exposure prophylaxis within 72 hours after condomless sex to prevent bacterial STIs, an approach that has become known as Doxy-PEP. (View last year’s Doxy-PEP discussion with Dr. Dieffenbach.) Here at CROI 2024, Dr. Annie Luetkemeyer of the University of California, San Francisco, shared additional findings from the open-label extension of that original study, which found sustained reduction of bacterial STIs among men who have sex with men and transgender women living with HIV or on PrEP in Seattle and San Francisco. The San Francisco AIDS Foundation (SFAF) was one of the first organizations in the United States to roll out Doxy-PEP, beginning in late 2022 when it was offered to all active PrEP clients at their visits at the Magnet clinic. SFAF medical director Dr. Hyman Scott reported that there was high uptake among clients and that bacterial STIs decreased by nearly 60% in less than a year at SFAF’s clinic. The decline was highest for syphilis (78%) and chlamydia (67%). 

The San Francisco Department of Public Health (SFDPH) presented the first findings to measure the effect of Doxy-PEP at the population level. Their analysis, presented by epidemiologist Madeline Sankaran, showed a substantial and sustained decline in the number of chlamydia and early syphilis infections in San Francisco among men who have sex with men and transgender women over the 13 months after the Department released guidelines for the use of Doxy-PEP. As in the other studies presented, SFDPH did not see corresponding significant declines in gonorrhea. Doxy-PEP is not recommended for cis-gender women because there is not yet evidence to suggest it is effective for them.

HIV Vaccine Trials Continue

Dr. Dieffenbach also discussed ongoing research to find a vaccine to prevent HIV, the topic of several presentations at the conference so far. Since there are a number of Phase I HIV vaccine trials currently underway, he and Louis spoke about what those smaller trials do. Then they discussed what some of the HIV vaccine trials currently underway are exploring.

Other Studies of Interest Presented on Monday

Some of the other studies presented centered on broadly neutralizing antibodies (bNAbs), including bNAbs as part of HIV therapy and how different HIV variants can affect bNAb efficacy as a treatment method. A new analysis from the pivotal HVTN 083 study of long-acting PrEP with cabotegravir found no significant risk of hypertension in people using the method, which had been a concern in some previous clinical studies of the same class of antiretroviral drugs.

Community-Engaged Research

The importance and significant benefits of involving community in all aspects of HIV research was the first topic Dr. Nelson and Louis discussed. “If we don’t have community voices or engaged communities, we aren’t going to be asking the right questions or designing the studies in the best ways that will produce the outcome that we need, and we won’t end up with answers that are as relevant as they could be,” Dr. Nelson observed. He pointed to the dapivirine vaginal ring as an example of better outcomes because communities were involved in research. He said he hopes that community engagement in research continues to become more and more common, but it requires that researchers be willing to listen and, when needed, change their plans based on what they hear from community.

HIV Prevention Research at CROI

Dr. Nelson highlighted some of the HIV prevention topics at CROI that have caught his attention, such as increasing equitable use of long-acting injectable forms of HIV PrEP and treatment among different populations and in different countries. Other discussions of interest have included early studies on potentially very long-acting forms of HIV PrEP and exploration of possible dual prevention tools that would provide users with both HIV PrEP and contraception.

HPTN 096 Study

Finally, Dr. Nelson discussed an example of community-informed research that will soon be underway: the NIH-supported study through the HIV Prevention Trials Network (HPTN) known as HPTN 096. It aims to reduce HIV rates among Black men who have sex with men in the southern United States using a strategy developed based on what communities have told Dr. Nelson and colleagues is needed to do so. As a result, the study includes a package of four interventions which simultaneously address social, structural, institutional, and behavioral barriers to HIV prevention and care. HPTN 096 will soon launch in Atlanta, south Florida, Montgomery, Memphis, and Dallas.

More HIV Research Updates to Follow on HIV.gov

HIV.gov will be sharing additional video interviews from CROI 2024 with Dr. Dieffenbach, CDC’s Dr. Jono Mermin and Dr. Robyn Neblett Fanfair, and others. You can find all of them on HIV.gov’s social media channels and recapped here on the blog.

This blog is adapted and cross-posted from HIV.gov.

HIV.gov opened their coverage of the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) today with a conversation with NIAID Director Jeanne Marrazzo, M.D., M.P.H. Before the conference formally opened, she spoke with Miguel Gomez, director of HIV.gov about what she’s looking forward to hearing about at the conference, how the studies presented at research conferences ultimately get translated into clinical practice or HIV prevention or treatment services, and the important roles of early-career investigators. Watch their conversation with Dr. Marrazzo below:

Wide Variety of Study Findings Anticipated at CROI 2024

Dr. Marrazzo shared that she’s looking forward to presentations across the spectrum of HIV research – from discovery science to implementation studies. Among the topics she highlighted were data on infants who acquired HIV in utero and began antiretroviral treatment very soon after birth, findings on long-acting HIV treatment in populations with barriers to taking daily oral treatment, and results of a study on the safety of the dapivirine vaginal ring for HIV prevention during pregnancy. She observed that these and other studies at CROI have the potential to change practice, just as the findings from the REPRIEVE study that were shared at another recent scientific meeting resulted in the new guidelines on the use of statins to prevent cardiovascular events in people with HIV. Researchers are continuing to analyze the findings from REPRIEVE and they will be sharing additional insights at CROI. 

Important Roles of Early-Career Investigators in HIV Research 

Dr. Marrazzo also shared that she was spending part of the day at the conference’s large workshop for new investigators and trainees. She shared why she believes it is critically important to support – personally and institutionally – early-career investigators in HIV science. She observed that the interdisciplinary nature of the field can be particularly rewarding to new investigators. Ultimately, Dr. Marrazzo noted, “we really need people to take our jobs someday.” 

The NIH Office of AIDS Research will hold a virtual workshop for students, postdocs, and new HIV investigators on Wednesday, April 24, 2024, from 11:00 AM – 4:00 PM (ET). Follow HIV.gov later this year for more information on the work of early-career investigators.

About CROI

CROI is an annual scientific meeting that brings together leading researchers and clinical investigators from around the world to present, discuss, and critique the latest studies that can help accelerate global progress in the response to HIV and AIDS and other infectious diseases, including STIs and viral hepatitis. More than 3,635 HIV and infectious disease researchers from 73 countries are gathered in Denver and virtually this year for the conference. More than 1,000 summaries of original research are being presented at CROI. Visit the conference website for more information. Abstracts, session webcasts, and e-posters will be published there for public access in 30 days.

More HIV Research Updates to Follow on HIV.gov

HIV.gov will be sharing additional video interviews from CROI 2024 with NIH’s Dr. Carl Dieffenbach, CDC’s Dr. Jono Mermin, and others. You can find them on HIV.gov’s social media channels and recapped here on the blog. Be sure to watch, comment, and share! 

This blog is adapted and cross-posted from HIV.gov.

The Department of Health and Human Services Guidelines Panel for the Use of Antiretroviral Agents in Adults and Adolescents with HIV (the Panel) has developed recommendations for the use of statin therapy in people with HIV, in collaboration with representatives from the American College of Cardiology, the American Heart Association, and the HIV Medicine Association. The new guidelines, Recommendations for the Use of Statin Therapy as Primary Prevention of Atherosclerotic Cardiovascular Disease in People with HIV, were published on February 27, 2024, and can be found online at ClinicalInfo.hiv.gov.

Findings from Large Clinical Trial Informed New Statin Guidelines

The new guidelines were informed by findings from the NIH-supported Randomized Trial to Prevent Vascular Events in HIV or REPRIEVE trial. REPRIEVE found that a statin (pitavastatin), a cholesterol-lowering medication, may offset the high risk of cardiovascular disease in people living with HIV by more than a third, potentially preventing one in five major cardiovascular events (e.g., heart attacks, strokes, or surgery to open a blocked artery) or premature deaths in this population. The study findings were published in the the New England Journal of Medicine last summer. The Panel and representatives of the three professional medical societies translated those research findings into the clinical practice guidelines published this week.

HIV.gov discussed findings from the REPRIEVE trial in some of our video conversations from last summer’s IAS Conference on HIV Science. Watch Carl Dieffenbach, director of NIAID's Division of AIDS, and the study’s principal investigator Steven Grinspoon discuss the REPRIEVE Study.