By Megan Brooks
An international clinical trial evaluating the use of statins for primary cardiovascular prevention in people with human immunodeficiency virus (HIV) was 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 reduced the risk of major adverse cardiovascular events by 35%, compared to placebo.
The 35% reduction in major adverse cardiovascular events in the trial was "more than we had anticipated," lead investigator Dr. Steven Grinspoon, of Harvard University and Massachusetts General Hospital in Boston, USA, told Medscape Medical News .
The preliminary efficacy data were "sufficiently compelling" for the study's independent Data Safety and Monitoring Committee to recommend early termination of the trial, the National Institutes of Health said in a press release .
Clear benefit for the high-risk population
Patients living with human immunodeficiency virus have "a higher-than-expected risk of cardiovascular disease, and this often occurs in younger patients whose usual cardiovascular risk is relatively low or moderate. In other words, they don't typically have high cholesterol or other risk factors, and statin therapy wouldn't normally be recommended for them," explained Dr. Grinspoon.
"Our hypothesis was that a statin treatment that simultaneously lowered low-density lipoprotein cholesterol, but also had anti-inflammatory effects, would be a two-for-one treatment that would help prevent heart disease in this population," he shared.
The REPRIEVE study began in 2015 and included 7,769 adults aged 40 to 75 living with human immunodeficiency virus, from 12 countries in Asia, Europe, North America, South America and Africa.
All participants were on antiretroviral therapy, had CD4+ cell counts > 100 cells/ mm3 of blood at enrollment, and had a low or moderate risk of cardiovascular disease.
"We demonstrated that over an average duration of a little over 5 years, statin therapy is clearly beneficial in reducing heart attacks and strokes, and that there are no problems with unforeseen adverse effects in this population," Dr. Grinspoon told Medscape Medical News .
In light of the data, at its most recent meeting, the Data Safety and Monitoring Committee determined that the benefits of daily pitavastatin administration outweighed any risks and suggested that the study be terminated early, a recommendation that the National Institutes of Health accepted.
Dr. Grinspoon noted that starting statins on a patient with human immunodeficiency virus remains "an individualized decision, but the data certainly indicate that there is a clear benefit for this population."
Evolution of science on the human immunodeficiency virus
"These latest findings represent the culmination of an unprecedented 8-year effort to generate evidence that can help physicians better address the unique cardiovascular health needs of people living with human immunodeficiency virus," said Dr. Gary H. Gibbons, director of the National Heart, Lung, and Blood Institute , in the statement.
"REPRIEVE is an important trial because existing interventions to help prevent adverse cardiovascular outcomes in this population are scarce," added Dr. Gibbons.
Dr. Hugh Auchincloss, acting director of the National Institute of Allergy and Infectious Diseases , stated that REPRIEVE "reflects the evolution of the science on the virus and the progress from focusing primarily on treating and controlling the virus to finding ways to improve the overall health of people living with human immunodeficiency virus."
"This new data suggests that a common cholesterol-lowering drug could substantially improve cardiovascular outcomes for people with human immunodeficiency virus," added Dr. Auchincloss.
The results of the REPRIEVE study are expected to be published in the coming weeks, the statement said.