Switch to atazanavir associated with cholesterol and triglyceride reductions

This article is more than 22 years old.

Atazanavir is an investigational protease inhibitor being developed by Bristol-Myers Squibb company. It is currently in phase III clinical trials.

Data presented today at the 14th International AIDS conference in Barcelona demonstrated that a switch to atazanavir from the licensed protease inhibitor nelfinavir was associated with significant reductions in blood levels of total cholesterol, low density lipoprotein (LDL) or “bad” cholesterol and triglycerides.

The study (AI424-044) included 346 people (217 men, 129 women) who had previously completed on average 76 weeks of treatment in a prior atazanavir study which had compared 400mg and 600mg atazanavir once daily to nelfinavir alongside d4T and 3TC.

Glossary

cholesterol

A waxy substance, mostly made by the body and used to produce steroid hormones. High levels can be associated with atherosclerosis. There are two main types of cholesterol: low-density lipoprotein (LDL) or ‘bad’ cholesterol (which may put people at risk for heart disease and other serious conditions), and high-density lipoprotein (HDL) or ‘good’ cholesterol (which helps get rid of LDL).

triglycerides

A blood fat (lipid). High levels are associated with atherosclerosis and are a risk factor for heart disease.

 

lipoprotein

Any member of a group of substances containing both lipid (fat) and protein. Lipoproteins are found in both blood plasma and cell membranes. They are the mode of transport for cholesterol through the bloodstream and lymphatic fluid. 

investigational

In medicine, a drug that is approved by the regulatory authorities (Food and Drug Administration, European Medicines Agency) for testing in clinical trials, but not yet approved for commercial marketing and sale. Also called experimental drug, investigational agent, and investigational new drug (IND).

phase III

The third and most definitive stage in the clinical evaluation of a new drug or intervention, typically a randomised control trial with the new intervention compared to an existing therapy or a placebo, in large numbers of participants (typically hundreds or thousands). Trial results are used to evaluate the overall risks and benefits of the drug and provide the information needed for regulatory approval.

In total 63 patients were switched from nelfinavir to 400mg atazanavir with d4T and 3TC. At 12 weeks, the switch was associated with significant reductions in total cholesterol (16%), LDL cholesterol (21%) and triglycerides (28%) and a significant increase in high density lipoprotein (HDL) “good” cholesterol (5%). The switch was associated with a decrease in the proportion of patients with undesirable levels of triglycerides (>240 milligrams per deciliter (mg/dl) of blood) from 32% to 10% and LDL cholesterol (>130mg/dl) from 55% to 22%.

Minimal changes in cholesterol and triglyceride levels were seen in patients who remained on the 400mg or 600mg dose of atazanavir.

Presenting the data Dr Rob Murphy, Director of HIV clinical research at Northwestern University said these data “demonstrate a potentially significant reduction in cardiovascular risk factors, when switching from nelfinavir to atazanavir".

These encouraging results follows data presented yesterday by Dr Guiseppe Barbero and reported on aidsmap implicating the metabolic disorders associated with use of protease inhibitors in the development of angina and heart attack.

References

Murphy R. Switch to atazanavir from nelfinavir associated with cholesterol and triglyceride improvement:12 week results from BMS AI424-044.Abstract LbPeB9013