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 the first large-scale clinical study 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(link is external)) 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.

Both the Baltimore and Pune, India, sites from the Johns Hopkins Baltimore-India Clinical Trials Unit participated in this important effort to reduce heart disease among people with HIV.

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