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The Body Covers: The 39th Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy
Poster Session 127.I: Toxicity of Antiretroviral Therapy

September 27, 1999

These researchers have identified a group of patients with lipodystrophy (N=35) who were being treated with d4T + ddI + a protease inhibitor (PI) for at least 6 months. Patients with lipodystrophy must have had a loss of at least 5% body fat in face and upper and lower limbs; abdominal girth increase of greater than 5cm (confirmed by X-ray and CAT scan); and triglycerides greater than 400 mg/dl. The objective of this study was to determine if these symptoms could be reversed by switching d4T + ddI to AZT + 3TC, while keeping the protease inhibitor, which in most cases was indinavir. Results were only reported for 10 patients. The researchers stated that triglycerides and body measures (anthropometrics) improved significantly as early as 12 weeks after switching, and continued to improve for at least 24 weeks. They also reported improved CD4 counts and reduced viral load. However, when questioned during their poster session, Drs. Polo and Verdejo admitted that there were 25 other patients who also switched to AZT + 3TC and did not benefit from the switch and were not included in their report.

There were a total of 35 patients evaluated but they only included the 10 who benefited from the switch. Another significant limitation of this study is the fact that these researchers did not provide the drug histories of these patients. While they may have been on d4T + ddI at the time they had lipodystrophy, they may have been on other antiretrovirals in the past, which may have had an overall impact on the development of lipodystrophy in these patients. Also, no other information was provided in terms of other measures that were taken to help reduce the symptoms of lipodystrophy in these patients. These data do not substantiate reports by this group and others that patients on d4T + ddI are at an increased risk of lipodystrophy. While switching patients to AZT + 3TC may have helped a small minority of patients, it is hard to determine how beneficial this switch truly was since there was so little information provided regarding their treatment history and other interventions that may have been utilized (i.e., diet, exercise, etc.).

Abstract: Switch to AZT + 3TC Improves Lipodystrophy Signs in the Presence of PIs (Paper 1306)
Authored by: R. Polo, J. Verdejo, M. Gomez-Cano, et al.

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