The trial is being launched in South Africa but will span four continents and involve 6,500 participants. The Conversation Africa’s health and medicine editor Candice Bailey asked Carl Dieffenbach and Gita Ramjee to explain the significance of the trial.
How common is it for people living with HIV to suffer from strokes, heart attacks and heart disease? Why is this?
Carl Dieffenbach: Research suggests that people living with HIV are up to twice as likely to experience cardiovascular disease as those who do not have the virus. Several factors combine to elevate one’s risk of these life-threatening complications.
First and chiefly, even HIV that has been well controlled with effective antiretroviral therapy can cause chronic inflammation throughout the body. In the arteries, this inflammation can lead to plaque build up that – if left unchecked – can cause serious vascular events such as heart attacks and strokes.
Additionally, some anti-HIV medications are associated with side effects that put people at a higher risk of developing heart disease.
As science continues to improve and refine HIV treatment, newer generations of anti-HIV drugs leave users with a smaller chance of developing these side effects.
Studies show that certain conventional risk factors for heart disease, like smoking cigarettes, tend to be more common in people living with HIV.
What will this clinical trial entail?
Gita Ramjee: The trial aims to enrol 6,500 participants between the ages of 40 and 75 and is open in South Africa, the US, Canada, Thailand and Brazil. In South Africa clinics have been opened in Johannesburg, Cape Town, and Durban.
The trial is called REPRIEVE, which stands for the Randomised Trial to Prevent Vascular Events in HIV. It will test whether a daily dose of a cholesterol-lowering statin medication can lower the risk of heart disease in people living with HIV.
Participants who are already taking antiretroviral therapy will either receive a statin drug called pitavastatin or a placebo. Regardless of which group they are in they will receive guidance on what steps they need to follow to achieve a heart-healthy lifestyle. This includes eating well, getting enough exercise and not smoking.
The study team will then monitor participants’ cardiovascular and overall health in a variety of ways, including checking vital signs like blood pressure and heart rate, as well as chemical indicators of heart disease that appear in blood tests.
To volunteer for the study, participants must have been on antiretroviral therapy for at least six months, have no history of heart disease, including a heart attack or stroke, and not be using a statin drug. The average REPRIEVE volunteer can expect to participate in the trial for about 48 months and will visit the study staff at a clinic near them about three times a year.
What makes this clinical trial unique and important? And why is it being launched in South Africa?
Carl Dieffenbach: As HIV treatment continues to improve, many people living with HIV are living longer and more healthy lives than ever before. While the world celebrates this success, scientists must focus on ailments that affect people living with HIV as they grow older – especially ailments that appear to occur more than in the uninfected population.
Heart disease, in particular, has emerged as a leading cause of death in people living with HIV – and yet no specifically tailored treatments exist to prevent heart disease in this population.
Gita Ramjee: The REPRIEVE study has been designed to rectify this by exploring how to prevent heart disease in people living with HIV in the long-term while it gathers heart health information from men and women of diverse racial and ethnic backgrounds.
South Africa was chosen to be a part of the study partly because of its high prevalence of HIV. About one in five South Africans is living with the virus. In 2015 about 380,000 South Africans acquired HIV.
Cardiovascular diseases account for almost a fifth of non-communicable disease deaths in South Africa.
After the clinical trial is complete, what are the next steps?
Carl Dieffenbach: REPRIEVE will principally answer whether statins should be prescribed to people living with HIV to prevent heart disease and its life-threatening consequences. The findings will inform clinical standards of care for people living with HIV around the world and help address complications that may accompany ageing with HIV.
Researchers will also have the opportunity to use data collected during the REPRIEVE trial to illuminate further the connection between HIV and heart health, such as how HIV may have different effects on the hearts of men and women or people of different races.
Carl W. Dieffenbach, Director of the Division of AIDS , National Institute of Allergy and Infectious Diseases and Gita Ramjee, Director of HIV Prevention Research Unit,, South African Medical Research Council