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Presentations Address Frailty, Inflammation, Asymptomatic Heart Muscle Damage, and Mental FunctionLOS ANGELES, March 12, 2025 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today presented findings from the REPRIEVE trial about the use of statins among people living with HIV with frailty and the relationship between major adverse cardiovascular events (MACE) and measurements of inflammation and asymptomatic heart muscle damage. These results were shared in two oral abstracts: “Frailty is Associated with Higher MACE Incidence but Does Not Appear to Modify Pitavastatin Effects” and “Plaque, Inflammation, Subclinical Myocardial Injury and MACE in the REPRIEVE Mechanistic Substudy” at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, California. REPRIEVE (The Randomized Trial to Prevent Vascular Events in HIV) was the first large-scale clinical trial to test a primary prevention strategy to reduce the increased risk of cardiovascular disease among people living with HIV. It found that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of MACE by 36 percent compared with those receiving a placebo over a median duration of five years of follow up. “We are eager to share data from REPRIEVE at CROI about the relationship between frailty and major cardiovascular events, the importance of inflammation and asymptomatic heart muscle damage, and the impact of statin therapy on neurocognition (mental function) and heart failure risk,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “REPRIEVE was a groundbreaking study that has informed a multitude of international guidelines, which now recommend statins to prevent cardiovascular disease in many people living with HIV and we expect that it will continue to generate meaningful findings that improve the care of people living with HIV.” Frailty is Associated with Higher MACE Incidence but Does Not Appear to Modify Pitavastatin EffectsToday’s presentation examined whether frailty is associated with MACE among people living with HIV and whether statins may prevent MACE across a spectrum of frailty. Researchers found that higher levels of frailty were associated with increased risk of MACE among participants. They also determined that while adults living with HIV and frailty were routinely under-prescribed key preventive therapies such as statins, frailty status did not appear to modify the protective effects of pitavastatin that were seen in the primary trial. While further research is needed, the study concluded that incorporating frailty assessments such as the frailty index may help identify people living with HIV who are at risk of MACE. “The strong association in this analysis between the age-related syndrome of frailty and major adverse cardiovascular events may suggest similar underlying mechanisms and, further, that screening for frailty can help identify the participants at highest risk for cardiovascular events,” said Presenting Author Kristine Erlandson, M.D., University of Colorado Anschutz Medical Campus. “While providers and patients may question the added benefit of statins in patients with numerous comorbidities, the data presented today support the use of pitavastatin among adults living with HIV and frailty.” Plaque, Inflammation, Subclinical Myocardial Injury and MACE in the REPRIEVE Mechanistic SubstudyThis secondary analysis presented today assessed for the first time the relationship between coronary plaque and measurements of inflammation and asymptomatic heart muscle damage with MACE. Today’s presentation demonstrated that among participants in REPRIEVE’s mechanistic substudy, individuals with noncalcified coronary plaque (buildup of plaque in the arteries that can cause a heart attack) and higher blood levels of inflammation and heart muscle injury at study entry were at higher risk of having a cardiovascular event over six years of follow up even though they did not have symptoms. In exploratory analyses, plaque and biomarker (blood proteins associated with cardiovascular disease) combinations further improved the accuracy of predicting the risk of MACE beyond traditional risk scores. The data also suggested that the benefit of pitavastatin to prevent MACE may be greater among individuals who have noncalcified coronary plaque and evidence of low-grade myocardial damage, which may precede symptoms. Additional investigation is necessary to determine how pitavastatin can be most effective for these individuals. “These data suggest that key plaque, inflammatory, and asymptomatic heart muscle damage markers are strongly related to MACE, even among people living with HIV who are not experiencing cardiac-related symptoms,” said Presenting Author and Study Chair Steven Grinspoon, M.D, Harvard Medical School and Massachusetts General Hospital. “These data highlight the need for additional studies to identify people living with HIV who might benefit most from statin therapy and to identify new mechanistic pathways to target,” said REPRIEVE Mechanistic Substudy Protocol Chair and Lead Author Michael Lu, M.D., M.P.H., Harvard Medical School and Massachusetts General Hospital. ACTG also presented two posters at CROI reporting on additional REPRIEVE findings: No Evidence of a Detrimental Effect of Pitavastatin on Neurocognitive Function Among People with HIV found no evidence to suggest that pitavastatin impacted neurocognitive function among people living with HIV at low to moderate cardiovascular disease risk, even among those who entered the study with some existing level of impairment.“Concerns about potential detrimental cognitive effects of statins are often raised when considering statin therapy,” said Presenting Author Dr. Erlandson. “The results from this randomized, blinded study, which show no relationship between statin therapy and change in neurocognitive function, should provide reassurance to patients and providers.” Heart Failure Risk and Events In People with HIV: The Randomized Trial To Prevent Vascular Events In HIV (REPRIEVE)” (Gerald Bloomfield, et al.) found that the number of heart failure events among people living with HIV in REPRIEVE was consistent with the low estimated PREVENT (Predicting Risk of Cardiovascular Disease Events) heart failure risk rates. Participants who were Black, female, lived in sub-Saharan Africa, had pre-existing hypertension, and/or elevated body mass were more likely to experience heart failure. REPRIEVE began in 2015 as cooperative agreements (HL12339, HL123336, HL164284, and HL164285) and was a collaborative effort between the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), two of the largest NIH institutes, and ACTG (AI068636). It received additional funding from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc. (providers of pitavastatin calcium and placebo), Gilead Sciences, Inc., and ViiV HealthCare. The study is led by Dr. Grinspoon and Pamela S. Douglas, M.D., Duke University School of Medicine (Co-chair), who led the Clinical Coordinating Center and Heather Ribaudo, Ph.D., Harvard School of Public Health (Lead Statistician) and Dr. Lu, who led the Data Coordinating Center. ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice-Chair). To learn more, please visit www.reprievetrial.org. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Rachel Reiss, ACTGRLReiss@mednet.ucla.edu

Cardiovascular disease (CVD) has stubbornly remained the leading cause of death in the world for over three decades. Many of these deaths are caused by coronary artery disease (CAD), and roughly 21 million American adults live with the disease today. Unfortunately, many patients living with CAD could go years undiagnosed because they do not experience symptoms. It is common to receive a diagnosis only after a major event like a heart attack. A poll conducted in 2023 found more than half of people surveyed did not correctly identify CVD as the leading cause of death, suggesting that people at risk for this disease may not be aware of its severity or the risk factors. Knowledge is power since early detection and treatment can be the difference between managing a chronic condition and facing life-altering consequences. Why it matters presented by Artificial Intelligence What Keeps Healthcare CIOs Up at Night: Balancing Technology Investments with Consumer Expectations When it comes to managing inbound phone calls, underperformance has devastating cost implications. By Stephanie Baum As the epidemic has grown, our industry has been racing to find new ways to accurately diagnose and treat CVD earlier. When coronary computed tomography angiography (CCTA) was introduced, it marked a major advancement with its ability to provide anatomical assessment of the arteries for plaque burden. CCTA is a noninvasive diagnostic test that combines X-ray and other technology to produce detailed, three-dimensional images of the heart’s arteries. Leveraging artificial intelligence (AI) has streamlined the assessment of stenosis detected on CCTA, helping determine whether an interventional procedure to treat a blockage is necessary. Furthermore, new AI tools offer insight into the type and volume of plaque present in the arteries. These advancements provide physicians with more accurate, personalized information about their patients’ heart health and can inform treatment plans. Despite the valuable information these new tools can provide, they have historically been under-reimbursed, creating a barrier to adoption for health systems and clinicians. The relatively low reimbursement for CCTA has been puzzling for the cardiology community, especially when considering the limitations of other diagnostic tools which historically were more highly reimbursed. Conventional methods can yield a false negative rate of up to 20-30%, leading to undetected disease, and a false positive rate of up to 55%, leading to additional unnecessary procedures. All of this can lead to delays in treatment, increased risks for complications, rising costs to the healthcare system, and a poor patient experience overall. Support for coronary CTA is growing Recently, after advocacy by the Society of Cardiovascular Computed Tomography (SCCT), the American College of Cardiology (ACC), and the American College of Radiology (ACR), which believe in the value of the technology, recommend it in their guidelines, the U.S. Centers for Medicare and Medicaid Services (CMS) enhanced reimbursement for these CCTA-based technologies (which began on January 1, 2025), more than doubling the CCTA payment rate. Sponsored Post Tips for Greater Healthcare Practice Success in 2025 Join us on February 26 at 3 pm ET, and we’ll dive into the key areas where practices are losing time and money and provide solutions to overcome them. By Elation Health and MedCity News When we can diagnose CAD earlier, helping patients lead longer and healthier lives while saving our healthcare systems time and money, there’s a lot to celebrate, as SCCT noted in a statement following the ruling, it’s a “huge win” that will bring us closer to earlier detection, more accurate diagnoses, and more efficient care pathways. Impacting patient care The increased CCTA accessibility is a win for both patients and healthcare providers. Patients will benefit from accurate, comprehensive, actionable diagnostics that can help direct them to more timely interventions and therapies. Healthcare providers can feel confident in adopting these technologies as a first-line approach to assess patients suspected of having CAD, reducing the need for unnecessary invasive procedures and ultimately streamlining the pathway to diagnosis and treatment. Additionally, the broader application of these tools means that patients who previously might have had difficulty reaching a CAD diagnosis can now receive a clear view of their heart health without invasive imaging and get the care they need earlier in their disease journey. As more providers implement CCTA into their practices, doctors will have a clearer picture of their patients’ overall heart health in the early stages of CAD. This can set the stage for productive conversations about lifestyle changes, additional risk factors, and management techniques that can drive better decision-making. Implications for health systems Incorporating non-invasive, advanced diagnostics like CCTA into standard care practice has the potential to reduce strain on healthcare system resources and patient burden by minimizing unnecessary cath lab visits, as well as improve outcomes on a broader scale. Hospital systems now have a financially viable way to adopt advanced imaging technologies that can lead to earlier diagnosis and, as a result, potentially reduce the need for emergency interventions when CAD has advanced. Looking ahead The ruling from CMS is an encouraging step forward on our long, shared journey toward more equitable, effective, and earlier CAD detection and treatment. With better access to tools like CCTA and diagnostic tools that leverage CCTA, clinicians can better support their patients in managing overall cardiovascular health, patients will benefit from less invasive care and enhanced quality of life, and health systems could ultimately see reduced costs and streamlined workflows. For all of us in the cardiovascular care space, this update should be viewed as not just a policy change, but also a call to action. We must use this moment to address disparities in care, adopt evidence-based technologies, and ensure that every patient has access to the tools needed for accurate diagnosis and effective treatment. We should support these advancements and the development of groundbreaking innovations to better manage, treat, and prevent CAD.

Johnson & Johnson announced on Monday that in a late-stage clinical trial, the company's oral drug for the treatment of specific skin conditions has achieved its primary goal of significantly improving the condition of the skin to a point where it is clear or near clear and reducing the formation of skin plaques. The drug, icotrokinra, is a once-daily pill whose efficacy has been demonstrated in patients with moderate to severe plaque psoriasis. Plaque psoriasis is a skin disease that causes dry, itchy patches of skin. Johnson & Johnson is working to develop new treatments because its current top-selling drug, Stelara, is about to expire and a cheaper biosimilar will be available. In the pharmaceutical industry, companies such as AbbVie and Johnson & Johnson (J&J) are competing for market share in an increasingly crowded market for treatments for inflammatory diseases. At week 16 of the trial, icotrokinra demonstrated significant skin clearance in 64.7% of patients, while a reduction in plaque severity was observed in 49.6% of subjects. That compared with 8.3 percent and 4.4 percent for the placebo group. The drug works by targeting IL-23, a protein associated with inflammation. Johnson & Johnson developed icotrokinra with partner Protagonist Therapeutics. Based on the trial results, Protagonist Therapeutics is now eligible for a milestone payment of up to $165 million. Johnson & Johnson also said it plans to initiate a late-stage clinical trial of icotrokinra for psoriatic arthritis in early 2025. In the United States, about 7.5 million people have psoriasis, and 80 to 90 percent of these cases are plaque psoriasis, the most common type of the disease.