As cardiovascular disease is becoming one of the most significant comorbidities of people with HIV, the National Institutes of Health continues to enroll people in its landmark study, Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE).
February is American Heart Month, and traditionally a time when organizations such as the American Heart Association ramp up initiatives to promote awareness of heart disease. Because cardiovascular disease (CVD) is the leading cause of death worldwide, one major step in shifting its paradigm lies in the medical community’s efforts to improve the public’s knowledge of its underlying risk factors.
However, in addition to traditional risk factors for CVD, such as smoking, high blood pressure, obesity, and diabetes, clinicians and researchers also want to raise awareness of other risk factors—including HIV infection.
In an interview with Contagion®, Anthony S. Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, acknowledged that major advances in HIV research, especially in treatment, have provided lifesaving therapy for HIV patients who have advanced disease.
However, although these drugs have prolonged the meaningful lifespans of affected patients, he highlighted the emergence of a concerning new trend. “We have started to see disturbing increases in cardiovascular events, and in markers of CVD, among people who are otherwise doing really quite well with their HIV infection,” he said.
The underlying mechanisms of this increased CVD risk in people with HIV relates to various factors. These factors include aberrant immune activation associated with HIV infection, as well as effects such as increased cholesterol levels that are associated with the drugs used to treat the infection. Indeed, CVD risk can be about 50% greater for people living with HIV.
“So, is there anything we can do to ameliorate this risk?” Dr. Fauci asks.
To help answer this question, the National Institutes of Health launched the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) in 2015.
According to Dr. Fauci, this large study aims to determine whether statins can reduce the elevated CVD risk for people with HIV. While the study has continued to enroll participants at multiple sites in the United States since its launch, he added that international REPRIEVE sites are now also opening in countries such as Canada, South Africa, Brazil, Peru, and Thailand.
The REPRIEVE trial will recruit more than 6,000 participants across about 100 sites, said Dr. Fauci, randomizing them to receive a daily dose of either pitavastatin or placebo. Although statin drugs are known to interact with antiretroviral agents, Dr. Fauci noted that pitavastatin was chosen because it interacts minimally with these HIV drugs.
As its primary endpoint, the trial will determine whether statin treatment reduces the incidence of clinically relevant cardiovascular events such as heart attack or stroke, said Dr. Fauci. A secondary endpoint is lowering of plasma cholesterol levels.
He stressed that the trial also aims to recruit as many women as possible, so that a sub-study can focus on differences in CVD risk between women and men. “Women often have heart disease that goes unnoticed,” said Dr. Fauci. “It’s an underappreciated source of morbidity and mortality in women.”
In summarizing, Dr. Fauci emphasized that REPRIEVE is a very important study because heart disease is becoming one of the most significant comorbidities of people with HIV infection. “So, that’s the reason why we are pushing this study. We want to make people aware of it so they can continue to enroll,” he concluded.
Dr. Parry graduated from the University of Liverpool, England in 1997 and is a board-certified veterinary pathologist. After 13 years working in academia, she founded Midwest Veterinary Pathology, LLC where she now works as a private consultant. She is passionate about veterinary education and serves on the Indiana Veterinary Medical Association’s Continuing Education Committee. She regularly writes continuing education articles for veterinary organizations and journals, and has also served on the American College of Veterinary Pathologists’ Examination Committee and Education Committee.