Los Angeles, Calif. – The AIDS Clinical Trials Group, the largest HIV research network worldwide, announced today that results from a substudy of REPRIEVE, A5332/A5332s (an international clinical trial focusing on heart disease prevention for people living with HIV), were published in the Journal of the American Medical Association Network Open. According to traditional measures, approximately half of the study participants were at low-to moderate risk of developing heart disease in the future.Although it is known that HIV-positive people are more likely to suffer from cardiovascular events such as strokes and heart attacks, there is little information about the extent and prevalence of atherosclerosis in the heart blood vessels and other biological factors. The REPRIEVE Mechanistic sub-study was created to identify specific factors that can contribute to cardiovascular disease in HIV-positive people."This sub-study of REPRIEVE aims to better understand the reasons why HIV-positive people develop heart disease even though their HIV is under control and they don’t have any traditional risk factors," stated ACTG Chair Judith Currier. "REPRIEVE, the largest study on cardiovascular disease among HIV-positive people, is an important report that sets the foundation for important future findings."The baseline data for 755 participants aged 40-75 years, who were enrolled at 31 locations across the United States, is the basis of today's publication. This sub-study used coronary CT imaging to determine the plaque buildup in participants' coronary vessels. Blood samples were then taken to measure inflammation and activation.Nearly half (49%) of participants had plaque in their coronary vessels. However, the plaques were most often found in a small number of coronary arteries. Plaque was associated with increased risk factors and inflammation, independent of traditional risk scores. Nearly all people (97%) had mild plaque that did not cause any narrowing of the coronary vessels. Although significant narrowing was uncommon, approximately 25% of participants had plaque that could cause future problems (also called vulnerable plaque).Epidemiologic studies in the general population have shown that cardiovascular disease risk increases with higher ASCVDPCE (atherosclerotic cardiomyopathy pooled cohort equation), risk scores. This is an indicator of traditional risk. REPRIEVE identified participants who had low to moderate ASCVD risks and an average 10-year risk score below 4.5 percent. It is not known if mild plaque or significant plaque is clinically important in patients with low cardiovascular risk. This is also unknown about the effectiveness of statin therapy in this population to prevent heart disease. REPRIEVE will investigate these critical questions and follow these participants to find out if plaque found in REPRIEVE's Mechanistic substudy is clinically significant. This includes whether it can be related to future cardiovascular events, whether statin therapy can lower plaque and markers and if statin treatment can decrease the risk of stroke and heart attacks.Steven Grinspoon M.D., Massachusetts General Hospital, stated that "heart disease is a major cause for illness and death among HIV-positive people, even those who have well-controlled HIV disease receiving antiretroviral therapy." "Until now, we have had very little knowledge about coronary artery disease in HIV-positive people. These new findings are a significant expansion of our knowledge, and will provide valuable insights that will ultimately allow us to better support HIV-positive people's health and well being.###About REPRIEVEREPRIEVE (the Randomized Trial to Prevent Vascular Event in HIV) has enrolled 7,770 HIV-positive people at more than 100 locations in 12 countries. It was conducted in collaboration with ACTG. Dr. Grinspoon, Udo Hoffmann (M.D., M.P.H.), Massachusetts General Hospital, led the Mechanistic sub-study. REPRIEVE is supported in part by the National Institutes of Health (NIH), National Heart, Lung, and Blood Institutes (NHLBI), and National Institute of Allergy and Infectious Diseasess (NIAID), as well as KOWA Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare.About the ACTGThe AIDS Clinical Trials Group was founded in 1987 and is the first HIV research network. It is supported by NIAID and collaborating NIH Institutes. The ACTG conducts cutting-edge research to improve HIV treatment and its complications including tuberculosis, viral hepatitis, and reduce new infections. It also works to advance new methods to prevent, treat, cure, and eventually eradicate HIV from children and adults. ACTG researchers and units in 15 countries are major resources for HIV/AIDS treatment, research, care, training/education, and treatment. ACTG research has helped to establish the current paradigms of managing HIV disease and provided guidance for HIV treatment, resulting in dramatic reductions in HIV-related deaths worldwide.
