Switching From Stavudine to Efavirenz Maintains Long-Term Control of HIV, Improves Metabolic Profile: Presented at AIDS 2008

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Title: Switching From Stavudine to Efavirenz Maintains Long-Term Control of HIV, Improves Metabolic Profile: Presented at AIDS 2008
URL: http://www.pslgroup.com/dg/22769A.htm
Doctor's Guide
August 7, 2008

By Ed Susman

MEXICO CITY -- August 7, 2008 -- Switching patients with human immunodeficiency virus (HIV) from a backbone regimen that includes stavudine to one containing tenofovir maintains suppression of the virus and improves the patients' metabolic profile, according to researchers presenting here at the 17th International AIDS Conference (AIDS 2008).

"We saw significant decreases in serum triglycerides and cholesterol and significant increases in limb fat," said Jose Valdez-Madruga, MD, Sao Paulo AIDS Program, Brazil. "We also demonstrated that, through 4 years, there was maintenance of virological suppression and continued immunologic improvement."

Dr. Valdez-Madruga and colleagues recruited 85 patients from a completed clinical trial (Study 903) that compared stavudine with tenofovir. Following completion of the trial, patients on stavudine were switched over to a 4-year, open-label extension study of tenofovir. All patients were on background combination therapy with lamivudine and efavirenz. The switch resulted in patients taking a once-daily regimen; stavudine is dosed twice a day.

In a poster presentation here on August 7, the researchers demonstrated that over the 4-year extension, 84% of patients were able to maintain viral suppression of <50 copies/mL. At the same time, CD-positive cell counts increased by about 136 cells above baseline measurements, Dr. Valdez-Madruga noted.

The mean decrease in fasting cholesterol levels from baseline at the time of the switch through 4 years was about 22 mg/dL from a mean starting point of 210 mg/dL; the change did reach statistical significance (P < .001). A similar scenario was observed with triglycerides, with a mean fall of 89 mg/dL from a mean baseline measurement of 263 mg/dL.

"We did not observe changes in spine bone mineral density, but there was a small but statistically significant decrease in hip bone mineral density," Dr. Valdez-Madruga added. He said that the 1 fracture reported in the study was the result of trauma.

The average age of patients in this study was 37 years at the time of the switch. About 64% of subjects were white, 14% were black, and 22% comprised other ethnicities; 60% of the group was male.

The patients had been treated with stavudine for an average of 152 weeks before the switch.

Funding for this study was provided by Gilead Sciences, Inc.

[Presentation title: The Safety and Efficacy of Switching Stavudine to Tenofovir DF in Combination with Lamivudine and Efavirenz in HIV-1 Infected Patients: A Four-Year Follow-Up. Abstract TUPE0054]

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