UNMC’s Specialty Care Clinic part of ‘landmark’ HIV study

UNMC served as a site for a recent national trial to explore the use of a drug to prevent cardiovascular disease in people with HIV, resulting in what researcher Sara Bares, MD, calls “a landmark study.” The study explored the role of statin therapy in the prevention of cardiovascular disease, which occurs more commonly in people with HIV than it does in the general population.

UNMC does not have an author on the New England Journal of Medicine publication – Pitavastatin to Prevent Cardiovascular Disease in HIV Infection – but Dr. Bares said she was proud of UNMC’s role in what she calls “the largest-ever randomized trial on HIV,” with nearly 8,000 participants.

The study, originally slated to run for up to seven years, stopped early because the study drug had such a significant impact in reducing the risk of cardiovascular disease, Dr. Bares said.

UNMC was one of 145 sites across 12 countries in the study and the only Nebraska location.

UNMC’s point of pride was not only in enrolling 50 participants to the study, but also in maintaining the enrollment through the long study period. Dr. Bares credited the staff of the Specialty Care Clinic, including research nurses Jennifer O’Neill and Maureen Kubat, in working with the patients to maintain study protocols throughout the five-year study period.

“People with HIV have twice the risk of cardiovascular disease as people without HIV, and it’s not explained by typical risk factors for cardiovascular disease like high blood pressure and age,” Dr. Bares said. “Nor is it eliminated by successful treatment of HIV.”

The study assigned participants with HIV and a low-to-moderate risk of cardiovascular disease who were receiving antiretroviral therapy to receive a daily dose of pitavastatin or a placebo.

The study’s authors report the incidence of a major adverse cardiovascular event was 4.81 per 1,000 person-years in the pitavastatin group, compared to 7.32 per 1,000 person-years in the placebo group – a difference so startling that the trial was stopped early.

“This is already changing the way we’re practicing medicine,” Dr. Bares said. “And it’s been really rewarding for the patients who participated to know that their efforts are making a difference for patients around the world.”

The team met with patients every four months in clinic.

“Our study team worked hard to recruit the patients and keep them in the study through many years of waiting,” she said. “They got to know the patients well. The patients really value that relationship with the study nurses and the other providers and members of our care team.”

The study showed the drug works to prevent cardiovascular disease, but it opens the door to additional questions, Dr. Bares said. “What was the mechanism? Why in particular did this drug work so well? We know that the drug works to lower cholesterol, but there’s probably another effect at work. One of the hypotheses is that it may also work by reducing inflammation. People with HIV have elevated levels of inflammation even after their HIV is well-controlled on treatment, and this is one of the things that leads to the higher risk of cardiovascular disease and other complications of aging. Additional analyses will help answer this and other questions.”

As antiretroviral therapies have become more effective, clinic work now can focus not only on controlling HIV, but also helping patients live long and healthy lives, Dr. Bares said.

“People with HIV still experience a higher risk for other diseases, specifically diseases related to aging, like cardiovascular disease, and so that’s a big area of focus,” she said. “How do we optimize the quality of that life for patients with HIV?

“This study is going to generate more data, I think, than any other study in HIV care to date. We’ll have data to answer questions related to the effect of pitavastatin on systemic inflammation in people with HIV and many other questions related to HIV care.”