Daily Statin Reduces Heart Risk for Those With HIV

WASHINGTON — Taking a daily statin medication has been found to reduce the increased risk of cardiovascular disease among those living with HIV, the National Institutes of Health announced Tuesday.

The positive outcome was identified during an interim analysis of data from a large-scale clinical study to test a new cardiovascular disease prevention strategy.

That analysis found that study participants who took pitavastatin calcium, a daily statin, lowered their risk of major adverse cardiovascular events by 35% compared with those receiving a placebo. 

The findings were so compelling that the study’s independent Data Safety and Monitoring Board recommended it be stopped early given adequate evidence of efficacy. The NIH subsequently accepted that recommendation.

REPRIEVE began in 2015 and enrolled 7,769 volunteers who were 40-75 years of age, of whom more than 30% were women. 

“The REPRIEVE study reflects the evolution of HIV science, and progress from focusing mostly on approaches to treat and control the virus to finding ways to improve the overall health of people living with HIV,” said Dr. Hugh Auchincloss, acting director of the National Institute of Allergy and Infectious Diseases, in a written statement. 

“These new data suggest that a common cholesterol-lowering medicine could substantially improve cardiovascular outcomes in people with HIV,” Auchincloss said.

Study 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. 

Statins are a class of medicines routinely prescribed to lower cholesterol and are known to prevent cardiovascular disease in those at risk in the general population. 

But it was not clear if statins would have the same effect in people living with HIV and who have premature cardiovascular disease despite having low-to-moderate traditional risk.  

In the REPRIEVE trial, participants were randomly assigned to receive a daily dose of 4 mg of pitavastatin or placebo. 

They were monitored for major adverse cardiovascular events and adverse reactions to pitavastatin, which is considered safe for use with all prescribed antiretroviral therapy regimens.

The study’s Data and Safety Monitoring Board 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, 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.

The trial was conducted in 12 countries in Asia, Europe, North America, South America and Africa.

The study was primarily supported by the National Institute of Allergy and Infectious Diseases and the National Heart, Lung and Blood Institute with additional funding from the NIH Office of AIDS Research.

Dan can be reached at [email protected] and @DanMcCue