Pitavastatin Calcium Linked to 35% Reduced CVD Risk In People With HIV

The REPRIEVE study—a large-scale global trial investigating the effects of a daily statin on individuals with HIV with low-to-moderate risk of cardiovascular disease (CVD)—was stopped ahead of schedule due to interim findings suggesting the medication substantially lowered the risk of heart attacks, strokes, and other significant cardiovascular events, the National Institutes of Health (NIH) announced.

In the REPRIEVE trial, participants with HIV were randomly assigned to receive 4 mg of the daily statin pitavastatin calcium or placebo daily. They were monitored for major adverse cardiovascular events and any adverse reactions to pitavastatin, which is considered safe for use in conjunction with all prescribed antiretroviral therapy regimens.

According to the interim results, individuals with HIV who took pitavastatin calcium experienced a 35% reduced risk of major adverse cardiovascular events compared with those who received a placebo.

Additionally, the adverse drug events observed in the study were similar to those commonly observed in the general population undergoing statin therapy. The interim analysis presented compelling evidence, leading the study's independent Data Safety and Monitoring Board (DSMB) to recommend early termination of the study due to adequate efficacy, which the NIH accepted.

“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 Hugh Auchincloss, MD, acting director of the National Institute of Allergy and Infectious Diseases (NIAID). “These new data suggest that a common cholesterol-lowering medicine could substantially improve cardiovascular outcomes in people with HIV.”

The REPRIEVE study began in 2015 and was conducted in 12 countries across Asia, Europe, North America, South America, and Africa. The trial included 7769 participants aged between 40 and 75 years, with over 30% of them being women. All participants were receiving antiretroviral therapy and had CD4+ cell counts higher than 100 cells/mm3 of blood at the time of enrollment. These individuals also had low-to-moderate risk for traditional CVD, which typically would not warrant statin treatment.

The study’s independent DSMB conducted regular reviews of safety and efficacy data at planned intervals throughout the trial. In its latest meeting, the DSMB concluded that the advantages of using pitavastatin daily outweighed the risks, and recommended the early termination of the study, with full data collection to be conducted across all sites for final analysis. Participants in the study are being informed of the findings, and their health will continue to be monitored for several months. The results of the DSMB review are expected to be published in the coming weeks.

“These latest findings represent the culmination of an unprecedented eight-year effort to generate evidence that can help clinicians better support the unique cardiovascular health needs of people living with HIV,” said Gary H. Gibbons, MD, director of the National Heart, Lung and Blood Institute (NHLBI). “REPRIEVE is important because there are limited existing interventions to help prevent adverse cardiovascular outcomes in this population.”

The REPRIEVE study is primarily supported by the NIAID and NHLBI, with additional funding from the NIH Office of AIDS Research, and was conducted by the AIDS Clinical Trials Group.