Serious Liver and Metabolism Problems Associated with Use of the Anti-HIV Drug Stavudine

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The summary below is from the full report titled "Lactic Acidosis and Hepatic Steatosis Associated with Use of Stavudine: Report of Four Cases." It is in the 1 August 2000 issue of Annals of Internal Medicine (volume 133, pages 192-196). The authors are K.D. Miller, M. Cameron, L.V. Wood, M.C. Dalakas, and J.A. Kovacs.

What is the problem and what is known about it so far?

Fatty infiltration of the liver (hepatic steatosis) combined with high levels of a certain type of acid (lactic acidosis) is an uncommon but potentially fatal combination of complications that has been reported with use of the anti-HIV drugs didanosine and zidovudine. Stavudine, one of the most commonly used anti-HIV medicines, has rarely been associated with these complications.

Why did the researchers do this particular study?

To describe the medical history of four patients who developed hepatic steatosis and lactic acidosis while taking stavudine.

Who was studied?

Four patients with HIV infection who had been taking stavudine for 3 to 15 months in combination with other anti-HIV drugs.

How was the study done?

The authors reported the clinical findings and laboratory tests of the four patients and described the time course of the illness that developed in each patient.

What did the researchers find?

All of the patients developed lactic acidosis and abnormal blood levels of liver enzymes. Computed tomographic (CAT) scans showed fatty deposits in their livers. Two of the patients had elevated blood levels of muscle enzymes, and two also had inflammation of the pancreas. Small samples of liver tissue (liver biopsies) were obtained from two patients during their illness; these samples showed hepatic steatosis. Small pieces of muscle tissue (muscle biopsies) were also taken from two patients; these samples showed the same type of muscle damage that has been associated with use of didanosine and zidovudine in other studies. All four patients had long, complicated hospital stays, but they recovered after stavudine therapy was stopped. Once they had recovered, all patients began taking other anti-HIV drugs without a problem.

What were the limitations of the study?

This report describes only four patients who developed these complications while taking stavudine. The report suggests but does not prove that stavudine caused the hepatic steatosis and lactic acidosis. In addition, the report does not provide any information about how often stavudine might cause these complications.

What are the implications of the study?

Patients taking stavudine should be aware that these rare but serious complications can occur. Doctors should consider the possibility of these complications in patients who become ill while taking stavudine.