ACTG REPRIEVE Study Early Stop Announcement
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.