The AIDS Clinical Trials Group (ACTG) has reported results from the REPRIEVE trial of Pitavastatin to prevent cardiovascular disease in HIV infection.
A total of 7,769 participants aged 40 and 75 years were enrolled at 145 sites in 12 countries, including South America, Africa, Europe, North America, and Asia.
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Patients with HIV and who are on antiretroviral therapy with low-to-moderate risk for cardiovascular disease were included in the study.
Every day, participants received either pitavastatin calcium or a placebo.
The development of major adverse cardiovascular events (MACE) was the primary endpoint of the study.
Key study groups, including sex, race, and global burden of disease region, showed a 35% reduction in MACE.
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By GlobalDataA significant 21% reduction in MACE or death in the pitavastatin group, compared to the placebo group, was also observed.
Despite this, 82 participants receiving pitavastatin and 46 subjects treated with the placebo showed adverse events, leading to the early discontinuation of the trial.
An Independent Data and Safety Monitoring Board reviewed the data.
ACTG chair Judith Currier said: “The ACTG is honoured 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.”
Initiated in 2015, the REPRIEVE trial was carried out in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), and the National Heart, Lung, and Blood Institute (NHLBI).
The trial received funds from ViiV HealthCare, Gilead Sciences, the NIH Office of AIDS Research and Kowa Pharmaceuticals America, which supplied pitavastatin calcium and the placebo for the study.
