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Daily statin medication was found to reduce the risk of cardiovascular disease by 35% among people living with HIV; substantial CVD risk in Young PWH - REPRIEVE Study
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The AIDS Clinical Trials Group (ACTG) is excited to share the news that the REPRIEVE study was stopped early after a daily statin medication was found to reduce the risk of cardiovascular disease among people living with HIV. REPRIEVE is the first clinical trial to study a preventive approach to cardiovascular disease among people living with HIV who were considered to be at low-to-moderate risk of cardiovascular disease events, including heart attack and stroke. A planned interim analysis found that participants who took pitavastatin calcium (a daily statin pill that reduces cholesterol) lowered their risk of major adverse cardiovascular events by 35 percent compared to those who took a placebo. These findings were compelling enough that REPRIEVE's independent Data Safety and Monitoring Board (DSMB) recommended that it be stopped early; the National Institutes of Health (NIH) accepted this recommendation.
The ACTG played a pivotal role in REPRIEVE, which began in 2015 - 52 of our sites enrolled more than half of the total 7,769 participants and ACTG investigators played key leadership roles in the core REPRIEVE team. REPRIEVE is primarily supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI), both part of the NIH, with 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. REPRIEVE was conducted in 12 countries in Asia, Europe, North America, South America, and Africa.
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 statins. People living with HIV often experience premature cardiovascular disease and REPRIEVE was an important effort to improve cardiovascular outcomes in this community.
"It is incredibly gratifying to see these results and to know that this study has the potential to change clinical practice and thus have a meaningful impact on the experiences and health of people living with HIV," said Carl Fichtenbaum, M.D., vice-chair of the REPRIEVE protocol. "This area of research has been a priority of the ACTG for 20 years and I want to congratulate the many individuals within the network and dedicated study participants who have contributed to making REPRIEVE such a success."
REPRIEVE has been led by Steven Grinspoon, M.D. (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. This study leadership expressed their gratitude to the ACTG for our partnership and support, which made REPRIEVE possible.
Tuesday, April 11, 2023.
Daily statin reduces the risk of cardiovascular disease in people living with HIV, large NIH study finds
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substantial prevalence of CAD even in young PWH with low traditional ASCVD risk
these baseline data from the mechanistic substudy of REPRIEVE provide useful information on the degree and type of CAD among this primary prevention group. Plaque was seen in nearly 50% and CAC in 35% of our population, despite a mean age of 51 years and a median ASCVD risk of 4.5%. Plaque characteristics in this group suggest a low prevalence of significant stenosis, but vulnerable plaque characteristics were seen in nearly one-quarter.
our study showed vulnerable plaque in 23% of participants compared with 15% in the much older PROMISE population of symptomatic patients with higher ASCVD risk, assessed in an identical fashion with contrast-enhanced CT by the same imaging core.
half of study participants, who were considered by traditional measures to be at low-to-moderate risk of future heart disease, had atherosclerotic plaque in their coronary arteries.
Today's publication describes baseline data on 755 participants between the ages of 40 and 75 years old, who were enrolled at 31 sites across the United States. The sub-study used coronary CT angiography to assess the amount of plaque in participants' coronary arteries and then correlated those findings with blood samples that measured inflammation and immune activation.
Nearly half the participants (49 percent) had plaque in their coronary arteries, though the plaques were mostly seen in just a few areas of the coronary arteries. The presence of plaque was associated with a higher burden of risk factors, but also with higher levels of inflammation independent of traditional risk scores. In almost all individuals (97 percent), the plaque was mild and did not cause a narrowing of more than 50 percent of the coronary artery. While significant narrowing was rare, about one-quarter of participants (23 percent) had plaque with features that could potentially cause problems in the future (also known as vulnerable plaque)..
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