New studies are evaluating how well cholesterol-lowering statin drugs ward off heart disease in people with HIV.
In this day and age, Americans with HIV seldom progress to AIDS and die of an opportunistic infection.
Instead, like many older Americans, people with HIV tend to die from heart disease. In fact, due to HIV-related factors like chronic inflammation, the chances of developing heart disease are up to twice as great for HIV-infected people as they are for the general population.
And it’s made worse by a monkey wrench in the gears. Doctors have long believed that cholesterol-lowering statin drugs, which reduce a person’s risk of heart disease, negatively interact with modern antiretroviral therapy (ART) drugs used to control HIV.
Research published earlier this year showed that people with HIV may be at greater risk of having a heart attack due to the buildup of non-calcified, or “soft,” plaque in their arteries. Yet little research has been done on whether the statin medications that help protect the heart are safe and effective in people with HIV.
“With the remarkable success of antiretroviral therapy, people living with HIV have a near-normal life expectancy,” Dr. Anthony Fauci, head of the National Institute of Allergies and Infectious Diseases, said in a news release. “We need to study the effects on the immune system of drugs normally prescribed for these conditions to ensure they are beneficial for HIV-infected individuals.”
Now, a pair of studies is being conducted to find out whether statins really do conflict with ART and what can be done to prevent it.
The first is a large multi-center clinical trial based at Massachusetts General Hospital in Boston. It will include at least 6,500 volunteers over the course of six years. Participants in the randomized trial will receive either pitavastatin (Livalo) or a placebo.
The second study is an 80-person, intramural trial conducted by the National Institutes of Health (NIH). Not only will the study compare people with HIV on ART who are taking the popular statin atorvastatin (Lipitor) to those taking aspirin, but researchers will also compare subjects who have HIV but who are not on ART.
People in the latter group, made up of rare individuals called “elite controllers,” have HIV but do not progress even without taking ART. Doctors will monitor all the patients for blood clotting and signs of inflammation by looking at blood samples and MRI scans of the neck.
The NIH study, which is currently enrolling patients, is small, but it may help researchers determine the effects of the statins and HIV on heart function.
Dr. Merle Myerson, director of the Mount Sinai Roosevelt and St. Luke’s Cardiovascular Disease Prevention Program and director of the cardiac section of the Institute for Advanced Medicine at Mount Sinai, told Healthline, “It has really become apparent that we need to be aware of the cardiovascular risks that people living with HIV have.”
The American Heart Association brought the issue of HIV and heart disease into the spotlight in 2007. “People have been relatively slow to realize [the connection], until now, and it’s just really exploding. People aren’t dying of HIV anymore. They’re getting cancers, heart disease, and having strokes,” she said.
Myerson stressed the importance of primary care physicians staying up-to-date on treating people with HIV for cardiovascular disease.
Dr. Judith Aberg, one of her colleagues at Mount Sinai, is chairing a National Lipid Association committee writing new guidelines for treating HIV-infected people who have lipidemia. Lipidemia is an excess of fat, or cholesterol, in the blood.
Aberg, well-known for her HIV research, is serving as a site investigator for the large Massachusetts General study, called the REPRIEVE study.
According to lead investigator Dr. Udo Hoffmann of Massachusetts General, the study aims to improve on previous trials that showed pitavastatin can reduce cholesterol in people with HIV who take ART.
“Understanding the structural changes that statins induce in the … plaques of HIV-infected patients and confirming the role of increased inflammation in triggering plaque rupture would add important justification for preventive statin therapy,” Hoffmann said.