ACTG Announces Publication of REPRIEVE Trial in New England Journal of Medicine and Presentation at IAS 2023

LOS ANGELES, July 23, 2023 (GLOBE NEWSWIRE) -- The AIDS Clinical Trials Group (ACTG), a global clinical trials network focused on HIV, tuberculosis, hepatitis B and emerging infectious diseases, today announced the publication of "Pitavastatin to Prevent Cardiovascular Disease in HIV Infection" in the New England Journal of Medicine. Today's publication coincides with the symposium "The REPRIEVE trial: Developing a Cardiovascular Disease Prevention Strategy for People Living with HIV," taking place today at IAS 2023, the 12th IAS Conference on HIV Science, in Brisbane, Australia. The publication and presentation report the key findings from REPRIEVE that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of major adverse cardiovascular events by 35 percent compared with those receiving a placebo over a median duration of five years of follow up.

"REPRIEVE is an extraordinarily important study because it addresses the need for interventions to prevent cardiovascular events in people living with HIV," said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles. "The ACTG is honored to have played a pivotal role in REPRIEVE ? 52 of our sites enrolled more than half of all participants and ACTG investigators played key leadership roles in the core REPRIEVE team ? and we are excited about the potential these findings have to improve care for people living with HIV."

Today's publication and presentation describe data on 7,769 participants living with HIV on antiretroviral therapy with low-to-moderate risk for cardiovascular disease who were between the ages of 40 and 75 years old. Participants were randomized to receive either pitavastatin calcium or placebo every day. Participants were 65.2 percent non-white and 31.1 percent female and enrolled at 145 sites in 12 countries across Asia, Europe, North America, South America, and Africa.

The trial's primary endpoint was the development of major adverse cardiovascular events (MACE), which was defined as a combination of cardiovascular death; myocardial infarction; hospitalization for unstable angina; stroke; transient ischemic attack; peripheral arterial ischemia; coronary, carotid, or peripheral arterial revascularization; or deaths of undetermined cause. The 35 percent reduction in MACE was consistent across key study groups, including sex, race, and global burden of disease region. In addition, there was a significant 21 percent reduction in MACE or death in the pitavastatin group vs. placebo. Adverse event-related treatment discontinuation occurred in 82 participants receiving pitavastatin calcium (2.1 percent) and 46 participants assigned to placebo (1.2 percent). These conclusions are based on a review of the data by an Independent Data and Safety Monitoring Board, which stopped the trial early. Effects on muscle-related symptoms were low grade, and pitavastatin calcium was generally well tolerated.

These results are generalizable to the global population of people living with HIV between the ages of 40 and 75 years old, taking ART, and at low-to-moderate risk for cardiovascular disease, for whom statin therapy is not usually considered based on current guidelines.

"While people living with HIV who have cardiovascular disease or are at higher risk should already be receiving statin therapy, until now there was not sufficient evidence to support recommendations for prescribing statins to people living with HIV with low and moderate risk," said Steven Grinspoon, M.D., REPRIEVE Protocol Chair and Professor of Medicine, Harvard Medical School. "The benefits demonstrated by REPRIEVE have established the need to expand this recommendation to ensure that people living with HIV have access to statins, which will allow them to live longer with better cardiovascular health."

REPRIEVE is 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. Statins are known to prevent cardiovascular disease among those at high risk in the general population and REPRIEVE sought to understand whether they would have the same effect among people living with HIV who may not traditionally be candidates for them. People living with HIV are 50-100 percent more likely to develop premature cardiovascular disease, including heart attacks and strokes, compared to people who do not have HIV. This is the case even among people living with HIV who have only low-to-moderate traditional cardiovascular disease risks.

REPRIEVE began in 2015 as cooperative agreements (HL12339, HL123336, HL164284, and HL164285) and was a collaborative effort between the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), two of the largest institutes within the National Institutes of Health (NIH). 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.

About REPRIEVE
REPRIEVE (the Randomized Trial to Prevent Vascular Events in HIV) has enrolled 7,769 people living with HIV at 145 sites in 12 countries around the world, in collaboration with the ACTG. The trial is led by Dr. Grinspoon (Chair) and Pamela S. Douglas, M.D. (Co-chair), who led the Clinical Coordinating Center and Heather Ribaudo, Ph.D. (Lead Statistician) and Michael Lu, M.D., M.P.H. (Protocol Chair, Mechanistic Substudy of REPRIEVE), who led the Data Coordinating Center. To learn more, go to www.reprievetrial.org.

About the ACTG
The AIDS Clinical Trials Group (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, the 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 hundreds of 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 the ACTG and does not necessarily represent the official views of the NIH.

Media Contact:
Jenna Conley, AIDS Clinical Trials Group (ACTG)
[email protected]