New release

Tuesday, April 11, 2023

The National Institutes of Health (NIH) clinical trial was stopped early because a daily statin was found to reduce the increased risk of cardiovascular disease among people living with HIV in the first large-scale clinical study to test a primary cardiovascular prevention strategy in this population. A planned interim analysis of data from the Randomized Trial for the Prevention of Vascular Events in HIV (REPRIEVE) found that participants taking pitavastatin calcium, a daily statin drug, reduced their risk of major adverse cardiovascular events by 35% compared to those receiving the drug imaginary. The adverse drug events observed in the study were similar to those that occurred in the general population taking statin therapy. The interim analysis was compelling enough that the study’s independent Data Safety and Monitoring Board (DSMB) recommended stopping it early given insufficient evidence of efficacy. The National Institutes of Health has accepted the DSMB’s recommendations.

REPRIEVE started in 2015 and enrolled 7,769 volunteers between the ages of 40 and 75, more than 30% of whom were women. All REPRIEVE volunteers were receiving ART with a CD4+ cell count greater than 100 cells/mm3 of blood at enrollment, and had a conventional low-to-moderate cardiovascular risk that is not normally considered for statin therapy. The trial was conducted in 12 countries in Asia, Europe, North America, South America and Africa.

The REPRIEVE study is supported primarily by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI) with additional funding from the NIH Office of AIDS Research. The study was conducted by the AIDS Clinical Trials Group (ACTG).

Decades of research and advances in HIV treatment have led to a significant decrease in AIDS-related complications and deaths. As people living with HIV live longer, premature heart disease and other chronic conditions have emerged as major causes of morbidity and mortality, contributing to persistent age gaps between people with HIV and the broader population.

“The REPRIEVE study reflects the evolution of the science of HIV, the progression from focusing mostly on ways to treat and control the virus to finding ways to improve the overall health of people living with HIV,” said NIAID Acting Administrator Hugh Auchincloss, MD. The data suggests that a common cholesterol-lowering drug can significantly improve cardiovascular outcomes in people living with HIV.”

Statins are a class of medications that are routinely prescribed to lower cholesterol and are known to prevent cardiovascular disease in people at risk in the general population. It is not clear if statins have the same effect in people with HIV who have early-onset cardiovascular disease despite having low to moderate conventional risk. In the REPRIEVE trial, participants were randomly assigned to receive a daily dose of 4 mg of pitavastatin or placebo. They were monitored for adverse cardiovascular events and adverse reactions to pitavastatin, which is considered safe for use with all prescribed antiviral regimens.

The study DSMB met at planned intervals throughout the study period to review safety and efficacy data. At its most recent meeting, the DSMB determined that the benefits of daily pitavastatin use outweighed any risks and recommended that the study be terminated early, and that full data collection be performed across sites for final analysis. Study participants are notified of the results and monitoring will continue for several months. Study results from the DSMB review are expected to be published in the coming weeks.

NHLBI Director Gary H. said there are limited interventions that exist to help prevent adverse cardiovascular outcomes in this population.”

The REPRIEVE study was funded by a grant to Massachusetts General Hospital led by Stephen Grinspoon, MD, professor of medicine at Harvard University, associate chair in endocrinology and metabolism and chief of the Metabolic Unit at Massachusetts General Hospital, who directed the clinical department of the study. Coordination center. Pamela Douglas, MD, Ursula Geller Research Professor of Cardiovascular Diseases in the Duke University Department of Medicine, was an associate principal investigator in the Clinical Focal Point. Michael T. Law, MD, co-director of the Cardiovascular Imaging Research Center at Massachusetts General Hospital, and Heather Ribaudo, PhD, principal research scientist in the Center for Biostatistics in AIDS Research and the Department of Biostatistics at Harvard University, served as data focal points for the REPRIEVE study. . The study was conducted by the NIAID-funded ACTG. Additional implementation support was provided by the London-based NEAT ID Foundation and Kowa Pharmaceuticals America, Inc. and Gilead Sciences, Inc. and Viiv Healthcare.

NIAID conducts and supports research—at the National Institutes of Health, throughout the United States, and around the world—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing, and treating these diseases. Newsletters, fact sheets, and other NIAID-related materials are available on the NIAID website.

About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI is the worldwide leader in conducting and supporting research in heart, lung, blood, and sleep disorders that advance scientific knowledge, improve public health, and save lives. For more information, visit www.nhlbi.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation’s medical research agency, includes 27 institutes and centers and is part of the US Department of Health and Human Services. The National Institutes of Health is the primary federal agency that conducts and supports basic, clinical and multidisciplinary medical research, investigating causes, treatments, and cures for both common and rare diseases. For more information about the National Institutes of Health and its programs, visit www.nih.gov.

The National Institutes of Health… Turning Discovery into Health®


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