Statin Primary Prevention Trial in HIV Halted for Efficacy

Megan Brooks

April 12, 2023

An international clinical trial testing statin therapy for primary cardiovascular prevention in people living with HIV has been stopped early due to strong evidence of efficacy and safety in this population.

A planned interim analysis of data from the REPRIEVE study showed that a daily dose of pitavastatin lowered the risk for major adverse cardiovascular events (MACEs) by 35% compared with placebo.

The 35% reduction in MACEs in the trial was "more than we hypothesized," principal investigator Steven Grinspoon, MD, with Harvard University and Massachusetts General Hospital, Boston, told | Medscape Cardiology.

The interim efficacy data were "sufficiently compelling" that the study's independent Data Safety and Monitoring Board (DSMB) recommended the trial be stopped early, the National Institutes of Health (NIH) said in a press statement.

Clear Benefit in High-Risk Population

Patients with HIV have "higher than expected risk of cardiovascular disease and this is occurring often in younger patients who have relatively low to only moderate traditional cardiovascular risk. In other words, they don't typically have high cholesterol and other risk factors and typically they wouldn't be recommended for statin therapy," Grinspoon explained.

"We hypothesized that statin treatment that would simultaneously lower LDL [low-density lipoprotein] cholesterol but also have anti-inflammatory effects would be a two for one therapy which would help prevent heart disease in this population," he noted.

The REPRIEVE study began in 2015 and enrolled 7769 adults aged 40-75 years with HIV from 12 countries in Asia, Europe, North America, South America, and Africa.

All participants were taking antiretroviral therapy, had CD4+ cell counts > 100 cells/mm3 of blood at enrollment, and were at low to moderate risk for cardiovascular disease.

"We showed over an average duration of just over 5 years that there was a clear benefit of statin therapy to reduce heart attacks and strokes and no unanticipated safety concerns in this population," Grinspoon told | Medscape Cardiology.

Given the data, at its most recent meeting, the DSMB determined that the benefits of daily pitavastatin outweighed any risks and recommended that the study terminate early, a recommendation that the NIH accepted.

Grinspoon noted that starting a patient with HIV on a statin remains "an individualized decision but the data certainly suggests that there's a clear benefit in this population."

Evolution of HIV Science

"These latest findings represent the culmination of an unprecedented 8-year effort to generate evidence that can help clinicians better support the unique cardiovascular health needs of people living with HIV," Gary H. Gibbons, MD, director of the National Heart, Lung, and Blood Institute (NHLBI), said in the release.

"REPRIEVE is important because there are limited existing interventions to help prevent adverse cardiovascular outcomes in this population," Gibbons added.

Hugh Auchincloss, MD, acting director of the National Institute of Allergy and Infectious Diseases (NIAID), said REPRIEVE "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.

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

Results of the REPRIEVE study are expected to be published in the coming weeks, the release notes.

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

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