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Two new algorithms can identify patients at risk of HIV

The final risk prediction model included such variables as sex, race, living in a neighborhood with high HIV incidence, use of medications for erectile dysfunction, and sexually-transmitted infection (STI) testing and positivity.

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Two new studies developed algorithms that can identify patients who are at risk of acquiring HIV and may benefit from preventive care. Both studies appear in the July issue of The Lancet HIV.

Preexposure prophylaxis (PrEP) is an antiretroviral pill that is over 90% effective in preventing HIV acquisition when taken as prescribed. PrEP was recently given a Grade A recommendation from the U.S. Preventive Services Task Force but is vastly underutilized. There are nearly 40,000 new HIV infections annually in the United States, yet the Centers for Disease Control and Prevention estimates that only 7% of the 1.1 million individuals at substantial risk for HIV infection used the antiretroviral pill in 2016.

One barrier to use is the difficulty for providers in identifying patients who are at high risk of HIV acquisition. Providers often have limited time, may have limited knowledge about PrEP, and may lack training in how to talk to patients about sex or substance use. Risk prediction tools, a form of electronic clinical decision support using the data in patients’ electronic health records (EHRs), are often used in other areas of medicine. Researchers from both studies, one using a patient population in California and the other in Massachusetts, built HIV risk prediction models that could be used in EHRs as automated screening tools for PrEP.

The two studies looked back at the medical records of millions of patients who were HIV-uninfected and had not yet used PrEP. Researchers extracted demographic and clinical data from these patients’ EHRs on numerous potential predictors of HIV risk. A machine-learning algorithm automatically selected important HIV risk-related variables for the final models.

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In the California-based study, which used medical record data of 3.7 million patients at Kaiser Permanente Northern California, the final risk prediction model included such variables as sex, race, living in a neighborhood with high HIV incidence, use of medications for erectile dysfunction, and sexually-transmitted infection (STI) testing and positivity. The model flagged 2% of the general patient population as potential PrEP candidates and identified 46% of male HIV cases, but none among females.

“Although risk prediction tools are imperfect and cannot replace the clinical judgement of skilled providers, our algorithms can help prompt discussions about PrEP with the patients who are most likely to benefit from it,” said Julia Marcus, PhD, MPH, lead author of the California-based study and Assistant Professor of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School.

The Massachusetts-based study used a patient population of 1.1 million patients at Atrius Health as well as the population of Fenway Health, an independent community health center in Boston specializing in sexual health care, to test performance in a new setting with higher rates of new HIV infection. The final risk prediction model included sex, race, primary language, as well as diagnoses, tests, or prescriptions for STIs. The model flagged 1.8% of the general patient population at Atrius Health and 15.3% of the population at Fenway Health as potential PrEP candidates. The model also identified 37.5% of new HIV cases at Atrius Health and 46.3% at Fenway Health.

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According to Douglas Krakower, MD, lead author of the Massachusetts-based study and Assistant Professor at Beth Israel Deaconess Medical Center, the Harvard Pilgrim Health Care Institute, and Harvard Medical School, “integrating these prediction models into primary care with routine, comprehensive HIV risk assessments by clinicians could play an important role in increasing the prescription of PrEP and preventing new HIV infections.”

Jonathan Volk, MD, senior author of the California-based study and an infectious disease physician at Kaiser Permanente San Francisco Medical Center added that “a recent publication by the U.S. Preventive Services Task Force in JAMA cites the lack of effective prediction models as a major gap in research that is critical to improving PrEP delivery. Our model helps fill that gap.”

The California study, titled “Use of electronic health record data and machine learning to identify potential candidates for HIV preexposure prophylaxis: a modelling study”, is co-authored by investigators from: Harvard Pilgrim Health Care Institute, Kaiser Permanente Division of Research, Beth Israel Deaconess Medical Center, and Kaiser Permanente San Francisco Medical Center. The project was supported by the Kaiser Permanente Northern California Community Benefit Research Program, the National Institute of Allergy and Infectious Diseases, and the National Institute of Mental Health.

The Massachusetts study, titled “Development and validation of an automated HIV prediction algorithm to identify candidates for preexposure prophylaxis”, is co-authored by investigators from: Beth Israel Deaconess Medical Center, Harvard Pilgrim Health Care Institute, Massachusetts Department of Public Health, Boston Medical Center, Atrius Health, New England Quality Care Alliance, Brown University, The Fenway Institute, and Brigham and Women’s Hospital. The project was supported by the National Institute of Mental Health, Harvard University Center for AIDS Research, Providence/Boston Center for AIDS Research, Rhode Island IDeA-CTR, and the US Centers for Disease Control and Prevention through the STD Surveillance Network.

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HIV spreads through direct cell-to-cell contact

Despite over 30 years of research, many key aspects of how HIV, the causative agent of the acquired immune deficiency syndrome (AIDS) spreads are still not understood. One of these unresolved questions concerns the interactions between the virus with the environment in the human body.

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Microscopic recording and computer model of the interaction between infected cells (green) and non-infected cells (red) in collagen structures (grey). Credit: Oliver Fackler/Frederik Graw

The spread of pathogens like the human immunodeficiency virus (HIV) is often studied in a test tube, i.e. in two-dimensional cell cultures, even though it hardly reflects the much more complex conditions in the human body. Using cell culture systems, quantitative image analysis, and computer simulations, an interdisciplinary team of scientists from Heidelberg University has now explored how HIV spreads in three-dimensional tissue-like environments. The researchers’ results show that the tissue structure forces the virus to spread through direct cell-to-cell contact.

Despite over 30 years of research, many key aspects of how HIV, the causative agent of the acquired immune deficiency syndrome (AIDS) spreads are still not understood. One of these unresolved questions concerns the interactions between the virus with the environment in the human body.

Traditionally it has been assumed that infected cells release viral particles which then diffuse and eventually infect other cells. But it is also possible that viral particles are directly transferred from one infected cell to the next through close contact. Until now it was unknown which of these modes of transmission prevailed in tissue.

“Studies on HIV replication in the lab are mostly conducted in simple cell culture experiments in plastic dishes that do not reflect the complex architecture and heterogeneity of tissue”, explains study director Prof./Dr. Oliver Fackler of the Center for Integrative Infectious Disease Research (CIID) at Heidelberg University Hospital.

In their approach, the Heidelberg researchers took into account that the so-called CD4 T helper cells, the preferred cell type infected by HIV, are highly motile in their physiological environment. They used a novel cell culture system, in which a three-dimensional scaffold was generated with the help of collagen. This allowed for maintaining the cells’ mobility and monitoring primary CD4 T cells infected with HIV-1 in a tissue-like environment over the course of several weeks. Using this approach, the researchers measured a number of factors that characterize cell motility, virus replication, and the gradual loss of CD4 T helper cells.

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“This yielded a very complex set of data that was impossible to interpret without the help from scientists of other disciplines,” explains Dr. Andrea Imle, who worked on the project during her PhD at the CIID.

In analyzing the data, the scientists who conducted the experiments collaborated with colleagues from the fields of image processing, theoretical biophysics and mathematical modeling. Together they were able to characterize the complex behavior of cells and viruses and simulate it on the computer. This made it possible to make important predictions on the key processes that determine HIV-1 spread in these 3D cultures, which were confirmed by subsequent experimentation. “Our interdisciplinary study is a good example of how iterative cycles of experimentation and simulation can help to quantitatively analyze a complex biological process,” states Prof./Dr. Ulrich Schwarz of the Institute for Theoretical Physics at Heidelberg University.

The data analysis revealed that the 3D environment of the cell culture system suppresses infection with a cell-free virus while simultaneously promoting direct virus transmission from cell to cell. “Our models allowed us to integrate short single-cell microscopy films with long-term cell population measurements and thereby to estimate the minimal time span required for cell-to-cell contacts to transmit infection,” explains Dr. Frederik Graw of the BioQuant Centre of Heidelberg University. The researchers hope that these findings will eventually lead to new therapeutic approaches in the treatment of HIV.

The research was conducted within the Collaborative Research Centre, “Integrative Analysis of Pathogen Replication and Spread”, (CRC 1129) funded by the German Research Foundation and supported by the Center for Modelling and Simulation in the Biosciences (BIOMS) of Heidelberg University. The results were published in Nature Communications.

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Holes in the immune system left unrepaired despite HIV drug therapy

A study showed that ART leaves unrepaired holes in the immune system’s wall of defence. This suggests that some of these long-lasting defects may contribute to the lack of viral control once the antiretroviral therapy is interrupted.

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Photo by Drew Hays from Unsplash.com

If they don’t receive antiretroviral therapy (ART), most HIV patients see a progressive weakening of their immune system. But a very small percentage of patients–0.3%–spontaneously control the virus themselves, without ART. Could an explanation lay partly in the sets of genes expressed by scarce white blood cells that recognize HIV? Yes, according to a study published in Nature Immunology and conducted by researchers at the University of Montreal Hospital Research Centre (CRCHUM).

Critical for the coordination of immune responses, CD4 T cells are important white blood cells (lymphocytes) that help control chronic infections like HIV. But on average only about one cell in 1,000 in the CD4 T cell population can recognize the virus.

“With my research team and my collaborators, we comprehensively determined the entire set of genes expressed by these rare cells from the blood of people chronically infected with HIV in whom the virus was abundant prior to ART,” said Daniel Kaufmann, a CRCHUM researcher and an infectious disease specialist. “We then compared it to the cells of HIV controllers, infected people who control the virus in the absence of therapy. This type of powerful approach, also called genome-wide transcriptional profiling, measures the activity of thousands of genes at once, thus creating a global picture of cellular function.”

Using sophisticated cell analysis techniques, lead author Antigoni Morou, a postdoctoral fellow in Kaufmann’s lab, identified major functional differences between the two groups of patients in the study. The HIV controllers had much more robust immune responses, known as Th17 and Th22, which are important for the defense of the gastrointestinal tract, for example. But chronically infected patients with high levels of viral replication showed dysregulated CD4 T cells targeting HIV, and some of their cell subsets showed signs of abnormal functioning.

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Continuing their investigation, the CRCHUM scientists wondered whether ART leads to an immune response akin to the one found in HIV controllers. “We followed up chronically infected patients after control of the virus by ART and checked if the treatment can ‘repair their immune system’ and allow them to have CD4 T cells with features similar to those of the HIV controllers,” said Kaufmann, a professor at Université de Montréal.

The result was double-edged: some gene modules were sensitive to ART, while others turned out to be expressed very differently than in HIV controllers.

“We showed that ART leaves unrepaired holes in the immune system’s wall of defence,” said Kaufmann. “Our results suggest that some of these long-lasting defects may contribute to the lack of viral control once the antiretroviral therapy is interrupted. We now know which holes linger in the immune system. Do we have to fill them in, and if so, how? This is another science question.”

Paving the way to new therapies that could complement ART, Kaufmann’s team identified important features of an effective HIV specific immune response compared to a dysfunctional one and showed how the response can be affected by ART.

The next step will be to study the underlying programming of these CD4 T cells (epigenetics) in the hope of developing new targeted strategies to reverse immune dysfunction and complement ART. Kaufmann’s lab is now using the same approach to evaluate candidates for an HIV vaccine.

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In 2017, nearly 37 million people were living with HIV. Every day, 5,000 new infections are reported to health authorities around the world.

“Altered differentiation is central to HIV-specific CD4+ T cell dysfunction in progressive disease” by Antigoni Morou et al. was published July 15, 2019 in Nature Immunology. The research was funded by the US National Institutes of Health; the Canadian Institutes of Health Research; the AIDS and Infectious Diseases Network of the Fonds de Recherche du Québec-Santé; and a Canada Foundation for Innovation Program Leader grant.

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For children born with HIV, adhering to medication gets harder with age

Researchers found that from preadolescence to young adulthood, the prevalence of non-adherence increased from 31% to 50%. In addition, the prevalence of detectable viral load among the same age groups increased from 16% to 40%.

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Paolo (not his real name), now nine years old, doesn’t know he has HIV.

Ang alam niya lang, kailangan niya uminom ng gamot gabi-gabi (He just knows he has to drink his meds every night),” his aunt, Virginia, said. “‘Di niya alam para saan ‘yun; basta gamot lang na kailangan niya (He doesn’t even know what they’re for; just that they’re meds that he needs).”

Paolo calls Virginia “mama”, but his biological mother – Virginia’s younger sister Vicky* – already passed away over eight years ago. And when his biological mother died, Vicky’s child Paolo was given to Virginia, the ate (elder sister).

And now that Paolo is growing up, this – the taking of medicines – continues to be an issue that Virginia said is one of those that “we continue to face.”

Apparently, though, this issue is not exactly surprising.

A new study in the US found that children born with HIV were “less likely to adhere to their medications as they aged from preadolescence to adolescence and into young adulthood.” The study – led by researchers at Harvard T.H. Chan School of Public Health – found that additionally, the prevalence of detectable viral load – an indication that the virus is not being managed by medications and a factor that’s often associated with non-adherence – also increased with age.

The study is one of the first to examine why different age groups stop adhering to treatment (non-adherence). While the factors related to non-adherence varied by age group, youth who were concerned about side effects of the drugs were less likely to be adherent at most ages.

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“As they approach adulthood, many youth face challenges, such as entering new relationships, managing disclosure of their HIV status, and changing to an adult HIV care provider. Ensuring successful HIV medication adherence before and throughout adolescence is critical,” said lead author Deborah Kacanek, research scientist in Harvard Chan School’s Department of Biostatistics. “We found that the factors that either supported adherence and a suppressed (undetectable) viral load, or made it harder for youth to adhere to treatment, varied depending on their age.”

The study was published in AIDS.

This study is worth highlighting in the Philippines because HIV continues to also affect younger Filipinos.

In April 2019, there were 38 newly diagnosed adolescents 10-19 years old at the time of diagnosis. Further, two cases were 17 years old and 36 cases were 18-19 years old. Almost all (95%) were infected through sexual contact (six male-female sex, 19 male-male sex, and 11 had sex with both males and females), one was infected through sharing of needles and one had no data on mode of transmission. In addition, there were three diagnosed cases less than 10 years old and all were infected through vertical (formerly mother-to-child) transmission.

Globally, 1.8 million adolescents live with HIV; and adhering to regimens of antiretroviral therapy (ART) is key to managing the disease and reducing the risk of transmission. And yet “sticking to a daily regimen of medicine, however, is especially challenging for adolescents and young adults, who are navigating a range of physical, cognitive, social and emotional changes.

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“Adherence can be more complicated for youth growing up with perinatal HIV, whose lifelong experiences with HIV, stigma, and multiple antiretroviral medications may pose challenges to achieving viral suppression that are different from youth who acquire HIV later in life.”

To better understand these challenges and why young people may not adhere to their medications, the researchers followed 381 youth with perinatally acquired HIV for an average of 3.3 years. The youth were participants in the Pediatric HIV/AIDS Cohort Study, which follows children and youth born with HIV or born exposed at birth to HIV to determine the impact of lifelong HIV and the long-term safety of antiretroviral regimens.

The preadolescents, adolescents and young adults in the study ranged from age 8 to 22 and were recruited from 15 different clinical sites in the US, including Puerto Rico. As part of the study, the researchers examined results from blood tests that measured viral loads, and they examined nearly 1,200 adherence evaluations in which study participants or their caregivers self-reported any missed doses of medication in the prior seven days.

The researchers found that from preadolescence to young adulthood, the prevalence of non-adherence increased from 31% to 50%. In addition, the prevalence of detectable viral load among the same age groups increased from 16% to 40%.

For each age group, different factors were associated with nonadherence. For example, during middle adolescence (15-17 years old), alcohol use, having an unmarried caregiver, indirect exposure to violence, stigma, and stressful life events were all associated with nonadherence.

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“It is important to talk with youth about how to take medications properly, but our study highlights the need for those who care for these youths to focus also on age-related factors that may influence adherence,” Kacanek said. “Services to help support adherence need to address both the age-related risks and build on the sources of strength and resilience among youth at different stages of development.”

Other Harvard Chan School researchers who contributed to the study include Claire Berman, Yanling Huo, and Katherine Tassiopoulos.

Back in the Philippines, Virginia said that “mabuti ngang may gamot na (si Paolo)… pero marami pa ring isyu na di nasasagot, di nagagawan ng paraan (it’s good Paolo’s already taking antiretroviral medicine… but there are still numerous unanswered/unresolved issues).”

And with dealing with children living with HIV, this still continues to be the case…

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Antiretroviral agent such as rilpivirine could improve pre-exposure prophylaxis

In an ex vivo model of HIV PrEP using tissue samples in the laboratory, the drug was associated with significant inhibition of HIV replication in rectal tissue, which persisted for up to four months after the last dose of rilpivirine. The drug was not, however, associated with viral suppression in cervicovaginal tissue.

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A long-acting antiretroviral agent such as rilpivirine could further improve pre-exposure prophylaxis (PrEP), already shown to be safe and effective at preventing AIDS in high risk populations, as it could overcome problems with poor medication adherence.

This is according to a new study examining the safety, acceptability, and effectiveness of multiple doses of injected rilpivirine, published in AIDS Research and Human Retroviruses, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers.

The article entitled “A Multiple Dose Phase 1 Assessment of Rilpivirine Long Acting in a Model of Preexposure Prophylaxis Against HIV” was coauthored by Ian McGowan, Orion Biotechnology (Ottawa, Canada) and an international team of researchers from University of Pittsburgh (PA), Magee Women Research Institute (Pittsburgh, PA), Alpha StatConsult (Damascus, MD), University of Liverpool (U.K.), University of Pittsburgh Graduate School of Public Health, Janssen Research and Development (Beerse, Belgium), The Translational Science Corp. (Los Angeles, CA), and University of Miami, Miller School of Medicine (Miami, FL).

In this phase 1 study, women and men received three intramuscular doses of rilpivirine eight weeks apart. The injections were shown to be safe and well tolerated, with injection site pain being the most common adverse effect. In an ex vivo model of HIV PrEP using tissue samples in the laboratory, the drug was associated with significant inhibition of HIV replication in rectal tissue, which persisted for up to four months after the last dose of rilpivirine. The drug was not, however, associated with viral suppression in cervicovaginal tissue.

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Thomas Hope, PhD, Editor-in-Chief of AIDS Research and Human Retroviruses and Professor of Cell and Molecular Biology at Northwestern University, Feinberg School of Medicine, Chicago, IL states: “There is currently a significant effort to develop long-acting formulations of drugs that prevent HIV replication and can be utilized to prevent HIV acquisition (PrEP). PrEP works if properly taken. Long-acting formulations can eliminate problems when high risk individuals forget to take their pills every day. The development of successful long-acting PrEP formulations will decrease new HIV infections by providing improved protection from HIV acquisition by eliminating problems for individuals who don’t like pills or can’t remember to take their pill every day.”

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PLHIV who have compassionate care providers start, remain in treatment longer

Rutgers researchers find patients who perceive their primary care providers as lacking empathy and not willing to include them in decision making are at risk for abandoning treatment or not seeking treatment at all.

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Photo used for illustration purpose only. Photo by Vittore Buzzi from Unsplash.com.

Adults with HIV are more likely to continue life-saving treatments if their primary health care providers show respect, unconditional empathy without judgement and demonstrate an ability to partner with patients in decision making to address their goals, a Rutgers study finds.

The systematic review appears in the Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports.

The findings showed that the complexity of the illness, treatment regimen and overall healthcare system frequently overwhelms the patient and fear of stigma often prevents them from beginning or continuing treatment. The researchers found that patients need help in understanding their illness and care needs using understandable language to translate complex information, letting patients know what to expect and reinforcing that HIV is now a treatable, yet complex, chronic illness.

“Today, HIV is considered a chronic, treatable condition. However, this study found that many patients continue to view it as a death sentence,” said lead author Andrea Norberg, executive director of the François-Xavier Bagnoud Center at Rutgers School of Nursing, which provides care for people with HIV, infectious diseases and immunologic disorders. “We know that people who are knowledgeable about HIV, who are engaged in care and taking antiretroviral therapy medications remain relatively healthy. Our challenge is to reach those people diagnosed with HIV and who are not retained or engaged in ongoing care. In the United States, this is approximately 49 percent of the 1.1 million people diagnosed.”

The researchers included 41 studies published between 1997 to 2017. The sample populations included adults with HIV and their healthcare providers. All adults with HIV were between the ages of 18 and 65, represented diverse races and ethnicities, sexual orientations and gender identities. Healthcare providers included physicians, nurse practitioners, physician assistants, pharmacists, social workers and others. The included studies had 1,597 participants.

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They found that many patients experience stigma and a lack of compassion that is often grounded in primary care providers’ ignorance about HIV and transmission risks. The resulting poor communication between providers and patients results in many patients’ failure to seek or remain in care and adhere to antiretroviral therapy medications.

Patients reported feeling “grilled” by providers who often assumed they were not taking medications. Norberg suggested providers would be more successful in getting information from patients by allowing them to be honest, inquiring about their health goals and telling them how other patients have managed treatment.

Conversely, the researchers found that patients were more inclined to adhere to HIV treatment when their primary care providers showed empathy, true listening, trust, consideration of the whole person and involvement in decision making. However, many patients reported that healthcare providers viewed care only as “prescribing antiretroviral therapy medicine.”

“Providers should use common language, not medical jargon, to educate patients about HIV, medications and how they can live a healthy life,” Norberg said. “They should thoroughly teach them about the disease, the medications and side effects, and the meaning of the tests.”

The researchers noted that providers who help patients navigate the health system, offer one-stop location of services and provide connections to psychological support, health insurance, medicine, transportation and other services, can help their patients stay engaged in care.

Primary healthcare providers can enroll in professional education to improve their knowledge about HIV, use of motivational interviewing skills and seek opportunities for experiential learning, observation and hands-on practice working directly with patients with HIV, Norberg said.

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Other Rutgers authors included John Nelson, Cheryl Holly, Sarah T. Jewell and Susan Salmond.

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Persistent HIV DNA in spinal fluid may be associated with cognitive challenges

Individuals who harbored HIV DNA in the cerebrospinal fluid were more likely than other study participants to experience cognitive deficits on neurocognitive testing.

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Photo by Emiliano Vittoriosi from Unsplash.com

A study found that HIV DNA remained in the cerebrospinal fluid of half of participants with well-managed HIV (virologic suppression in the plasma), confirming that the central nervous system (CNS) is a major reservoir for latent HIV. Individuals who harbored HIV DNA in the cerebrospinal fluid were more likely than other study participants to experience cognitive deficits on neurocognitive testing.

This was disclosed by investigators from the AIDS Clinical Trials Group (ACTG), the world’s largest and longest-established HIV research network, as announced in the Journal of Clinical Investigation from the ACTG HIV Reservoirs Cohort Study (A5321).

“The persistence of HIV in sanctuary sites in the human body, even in the presence of long-term therapy, is a challenge to HIV remission and cure that the ACTG is actively working to address,” said ACTG Chair Judith Currier, M.D., MSc, University of California Los Angeles. “Because neurocognitive function can be compromised even in individuals whose HIV is well treated, it is very important that we understand HIV persistence in the CNS so that we can develop strategies to treat it. This study provides preliminary insights into these challenges.”

This substudy in the ACTG HIV Reservoirs Cohort Study (A5321) was led by Serena Spudich, M.D., Yale University, the late Kevin Robertson, Ph.D., University of North Carolina at Chapel Hill, and John Mellors, M.D., University of Pittsburgh.

The study included 69 participants with well-treated HIV who had their cerebrospinal fluid and blood collected and underwent neurocognitive assessments, which included tests of memory, learning, motor function, and more.

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Participants were mostly male (97 percent) and had been on HIV treatment for a median of almost nine years, with a good response to medications (HIV viral loads in the plasma were all <100 copies/mL and median CD4 counts were in the normal range).

Using highly sensitive methods to detect HIV, researchers found that almost half of these participants harbored viral DNA in cells found in the cerebrospinal fluid. Of those, 30 percent met the criteria for cognitive impairment.

While the study established an association between HIV DNA in cerebrospinal fluid with poorer performance on cognitive tests, researchers stressed that it did not establish a causal relationship, noting that there could be several explanations for the findings. Further studies will help determine strategies to reverse this persistence and improve neurological functioning in individuals with long-standing HIV.

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