Pitavastatin calcium linked to 35% reduction in CVD risk in people living with HIV

The REPRIEVE study, a large, global trial investigating the effects of a daily statin on people with HIV with low to moderate risk of cardiovascular disease (CVD) – was discontinued earlier than expected due to interim results suggesting the drug significantly reduced the risk of heart attack, stroke, and other major cardiovascular events, announced the National Institutes of Health (NIH).

In the REPRIEVE trial, HIV-positive participants were randomly assigned to receive daily 4 mg of the statin pitavastatin calcium or a placebo. 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, people with HIV who took pitavastatin calcium had a 35% reduced risk of major adverse cardiovascular events compared to those who received a placebo.

Additionally, the adverse events observed in the study were similar to those commonly seen in the general population on 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 has accepted.

“The REPRIEVE study reflects the evolution of HIV science and the progress made by focusing primarily on approaches to treating and controlling the virus to find 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 drug could significantly improve cardiovascular outcomes in people living with HIV.”

The REPRIEVE study began in 2015 and was conducted in 12 countries in Asia, Europe, North America, South America and Africa. The trial included 7769 participants between the ages of 40 and 75, more than 30% of whom were women. All participants were receiving antiretroviral therapy and had a CD4+ cell count greater than 100 cells/mm3 blood at enrollment. These people were also at low to moderate risk for traditional cardiovascular disease, which would generally not warrant treatment with statins.

The study’s independent DSMB performed regular reviews of safety and efficacy data at scheduled intervals throughout the trial. At its last meeting, the DSMB concluded that the benefits of daily pitavastatin use outweighed the risks and recommended early termination of the study, with full data collection to be performed on all sites for the final analysis. Study participants are notified of the results and their health will continue to be monitored for several months. The results of the DSMB review are expected to be released in the coming weeks.

“These latest findings represent the culmination of an unprecedented eight-year effort to generate evidence that can help clinicians better meet 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 few existing interventions to help prevent cardiovascular adverse events in this population.”

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