• Steven K Grinspoon, Kathleen V Fitch, Markella V Zanni, Carl J Fichtenbaum, Triin Umbleja, Judith A Aberg, Edgar T Overton, Carlos D Malvestutto, Gerald S Bloomfield, Judith S Currier, Esteban Martinez, Jhoanna C Roa, Marissa R Diggs, Evelynne S Fulda, Kayla Paradis, Stephen D Wiviott, Borek Foldyna, Sara E Looby, Patrice Desvigne-Nickens, Beverly Alston-Smith, Jorge Leon-Cruz, Sara McCallum, Udo Hoffmann, Michael T Lu, Heather J Ribaudo, Pamela S Douglas, and REPRIEVE Investigators.
• From the Metabolism Unit (S.K.G., K.V.F., M.V.Z., M.R.D., E.S.F., S.E.L., S.M.), the Cardiovascular Imaging Research Center, Department of Radiology (K.P., B.F., M.T.L.), and the Yvonne L. Munn Center for Nursing Research (S.E.L.), Massachusetts General Hospital and Harvard Medical School, the Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health (T.U., J.L.-C., H.J.R.), and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School (S.D.W.) - all in Boston; the Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati (C.J.F.), and the Division of Infectious Diseases, Ohio State University Medical Center, Columbus (C.D.M.); the Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York (J.A.A.); the Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham (E.T.O.); the Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University (G.S.B.), and Duke University Research Institute, Duke University School of Medicine (P.S.D.) - both in Durham, NC; the Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles (J.S.C.); the Infectious Diseases Service, Hospital Clinic and University of Barcelona, Barcelona, and CIBER de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid - both in Spain (E.M.); DLH, Silver Spring (J.C.R.), and the Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute (P.D.-N.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases (B.A.-S.), National Institutes of Health, Bethesda - all in Maryland; and Cleerly, Denver (U.H.).
• N. Engl. J. Med. 2023 Aug 24; 389 (8): 687699687-699.

BackgroundThe risk of cardiovascular disease is increased among persons with human immunodeficiency virus (HIV) infection, so data regarding primary prevention strategies in this population are needed.MethodsIn this phase 3 trial, we randomly assigned 7769 participants with HIV infection with a low-to-moderate risk of cardiovascular disease who were receiving antiretroviral therapy to receive daily pitavastatin calcium (at a dose of 4 mg) or placebo. The primary outcome was the occurrence of a major adverse cardiovascular event, which was defined as a composite of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack, peripheral arterial ischemia, revascularization, or death from an undetermined cause.ResultsThe median age of the participants was 50 years (interquartile range, 45 to 55); the median CD4 count was 621 cells per cubic millimeter (interquartile range, 448 to 827), and the HIV RNA value was below quantification in 5250 of 5997 participants (87.5%) with available data. The trial was stopped early for efficacy after a median follow-up of 5.1 years (interquartile range, 4.3 to 5.9). The incidence of a major adverse cardiovascular event was 4.81 per 1000 person-years in the pitavastatin group and 7.32 per 1000 person-years in the placebo group (hazard ratio, 0.65; 95% confidence interval [CI], 0.48 to 0.90; P = 0.002). Muscle-related symptoms occurred in 91 participants (2.3%) in the pitavastatin group and in 53 (1.4%) in the placebo group; diabetes mellitus occurred in 206 participants (5.3%) and in 155 (4.0%), respectively.ConclusionsParticipants with HIV infection who received pitavastatin had a lower risk of a major adverse cardiovascular event than those who received placebo over a median follow-up of 5.1 years. (Funded by the National Institutes of Health and others; REPRIEVE ClinicalTrials.gov number, NCT02344290.).Copyright © 2023 Massachusetts Medical Society.

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