Committee studies long-term effects of HIV drugs
Committee studies long-term effects of HIV drugs
Studies will examine cardiovascular disease
Clinicians should have some comprehensive data about the effects of antiretroviral drugs on patients’ cardiovascular and metabolic systems within the next few years.
An international committee consisting of pharmaceutical companies and their researchers, HIV specialists, and consultants has begun a prospective cohort study of the risk of cardiovascular events in HIV patients on highly active antiretroviral therapy (HAART).
The committee also will study short-term problems, such as lipodystrophy and glucose changes.
"Our major objective is to come up with appropriate ways to evaluate some of the longer- and shorter-term consequences of highly active antiretroviral therapy," says David Pizzuti, MD, chairman of the oversight committee of the Steering Committee for the Evaluation of Metabolic Complications of HAART. Pizzuti also is vice president of medical affairs for the pharmaceutical products division of Abbott Laboratory in Abbott Park, IL.
Nine pharmaceutical companies are funding the research.
The committee will look at the effect of HAART from a safety point of view, Pizzuti says. "It’s to try to get a handle on the occurrence rate of some of these adverse events across a very large population and whether or not they are any worse in people who have been on therapy for a very long time."
Larger databases are needed
So far, the research into long-term complications has not studied large enough populations of HIV patients, Pizzuti says.
"The main reason people are concerned about it is that because there are elevations in lipids for people who take HAART, people don’t know whether or not that really means anything from a cardiovascular point of view," he explains. "Usually, you need a database of 15,000 to 20,000 people to find a difference."
The committee has agreed to assemble a group of cohorts with a minimum of 15,000 HIV patients. Investigators will follow the patients for two years and look at their rates of cardiovascular adverse events.
"We’ll look at people who have been on therapy for a long time vs. ones who haven’t and see whether or not you can tell a difference," Pizzuti says.
"One of the other things that we’re going to do in this group is to look at a meta-analysis of prospective trials for short-term complications, such as body composition changes, so we can see whether fat distribution occurs more or less in certain subgroups of patients," he adds.
The committee also is involved in a case-control analysis of 800 patients from 20 sites across the world. This analysis will serve as the foundation for the development of a case definition of lipodystrophy and metabolic complications.
"One of the biggest problems we’ve seen in this field is that people refer to things in various ways, and a lot of times people are not speaking the same language," Pizzuti says. "So what we’ve done is to fund an international study that looks at approximately 800 patients, divided into cases and controls." The study will look at diagnostic criteria relating to patients’ symptoms.
It is also possible that the committee will take a retrospective look at U.S. Veterans Affairs data on HIV patients. This type of study is appealing because the VA has comprehensive hospital records and other data, and this also could provide information about long-term event rates, Pizzuti says.
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