A National Institutes of Health (NIH) clinical trial was stopped early because a daily statin medication was found to reduce the increased risk of cardiovascular disease among people living with HIV in one of the first large-scale clinical studies to test a primary cardiovascular prevention strategy in this population.
A planned interim analysis of data from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study found that participants who took pitavastatin calcium, a daily statin, lowered their risk of major adverse cardiovascular events by 35% compared with those receiving a placebo. Adverse drug events observed in the study were like those in the general population taking statin therapy. The interim analysis was sufficiently compelling that the study’s independent Data Safety and Monitoring Board (DSMB) recommended it be stopped early given adequate evidence of efficacy. The NIH accepted the DSMB recommendations.
REPRIEVE began in 2015 and enrolled 7,769 volunteers who were 40 to 75 years of age, of whom more than 30% were women. REPRIEVE volunteers were all taking antiretroviral therapy, with CD4+ cell counts greater than 100 cells/mm3 of blood at enrollment and had low-to-moderate traditional cardiovascular disease risk that would not typically be considered for statin treatment. The trial was conducted in 12 countries in Asia, Europe, North America, South America and Africa.
The study was conducted by the AIDS Clinical Trials Group (ACTG).
The study’s DSMB met at planned intervals throughout the study to review safety and efficacy data. In its most recent meeting, the DSMB determined that the benefits of daily pitavastatin use outweighed any risks and recommended that the study terminate early, and that a full data collection be conducted across sites for final analysis. Study participants are being notified of the findings and will continue to be monitored for several months. Study results from the DSMB review are expected to be published in the coming weeks.
