Boston—Taking daily statins was found to be so effective in reducing the increased risk of cardiovascular disease in HIV patients that a major clinical trial was stopped early.

The National Institutes of Health (NIH), which funded the study, said the large-scale trial was designed to test a primary cardiovascular prevention strategy in that population. A planned interim analysis of data from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) determined that participants who took pitavastatin calcium, a daily statin, drove down their risk of major adverse cardiovascular events by 35% compared with those receiving placebo. Adverse drug events were not any different from the general population on statin therapy, the study added.

Based on the interim analysis, the study’s independent Data Safety and Monitoring Board decided that evidence of efficacy was adequate and recommended the trial be stopped early, which 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. “These new data suggest that a common cholesterol-lowering medicine could substantially improve cardiovascular outcomes in people with HIV.”

Beginning in 2015, REPRIEVE enrolled 7,769 volunteers who were aged 40 to 75 years, with more than 30% women. The participants 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. The trial was conducted in 12 countries in Asia, Europe, North America, South America, and Africa.

The Massachusetts General Hospital-Harvard Medical School–led researchers said it was not clear if statins would have the same effect in those living with HIV; HIV-positive patients tend to have premature cardiovascular disease despite having low-to-moderate traditional risk.

For the REPRIEVE trial, participants were randomly assigned to receive a daily dose of 4 mg of pitavastatin or a placebo. The study team monitored them for major adverse cardiovascular events and adverse reactions to pitavastatin, which is considered safe for use with all prescribed antiretroviral therapy regimens.

Now that the trial has been halted for efficacy, study participants are being notified of the findings and will continue to be monitored for several months, according to the NIH, which added that full results are expected to be published in the coming weeks.

“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,” said National Heart, Lung and Blood Institute director Gary H. Gibbons, MD. “REPRIEVE is important because there are limited existing interventions to help prevent adverse cardiovascular outcomes in this population.”

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