Researchers have begun enrolling South African participants in a first of its kind international clinical trial to test whether a statin drug can reduce the risk of major adverse cardiovascular events, such as heart attacks, strokes and heart disease, in people with HIV infection. The Randomized Trial to Prevent Vascular Events in HIV, or REPRIEVE, is the largest randomized clinical trial to date to address the elevated risk of heart disease in people living with HIV.
The need for strategies to prevent adverse cardiovascular events in people living with HIV is great and growing:
- Previous studies indicate that people living with HIV are up to twice as likely as people without HIV to experience a heart attack or develop another form of heart disease.
- This 50 to 100 percent increased risk remains even after controlling for traditional risk factors for heart disease, such as high cholesterol, high blood pressure and smoking.
- Elevated heart disease risk persists even in those with access to effective HIV treatment with combination antiretroviral therapy.
- There are currently no evidence-based therapies to prevent cardiovascular disease in people living with HIV.
REPRIEVE will test whether this risk can be reduced when people living with HIV and taking antiretroviral therapy also take a statin drug called pitavastatin. Statins are a class of drugs that have been previously demonstrated to be effective in lowering cholesterol levels and reducing the risk of major adverse cardiovascular events in non-HIV populations. Statins have also been shown to reduce inflammation in people with HIV.
A number of factors combine to put people with HIV at increased risk for cardiovascular disease:
- HIV causes inflammation in the body that results in activated immune cells. Both inflammation and activated immune cells contribute to plaque buildup in the arteries. These arteries can become blocked, leading to life-threatening heart disease.
- The use of some antiretroviral therapies result in higher cholesterol levels, which may contribute to cardiovascular disease risk.
- The rates of some conventional risk factors for cardiovascular disease, such as smoking, are also higher in HIV-infected populations.
Clinical sites for REPRIEVE have previously opened in the United States, Canada, Thailand and Brazil. REPRIEVE is expected to enroll 6,500 participants across approximately 100 international sites. Participants must be living with HIV, between the ages of 40 to 75 years, and at low to moderate risk for heart disease. Investigators will randomize volunteers to receive either a daily dose of pitavastatin or a placebo while continuing with antiretroviral therapy.
Investigators will follow the participants for up to six years, assessing them for the development of major adverse cardiovascular events, such as heart attacks and strokes. The researchers will also continue to evaluate the safety of statin therapy; the effects of statins on cholesterol levels, immunologic parameters, and serious non-cardiovascular disease events, such as new-onset diabetes; and gender differences in the effects of statins on people with HIV. The trial is supported by the United States National Institutes of Health.
For more information on the REPRIEVE trial
Media Coverage Report: REPRIEVE South Africa Launch
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