Abnormal Fat Distribution in AIDS Patients Following Protease Inhibitor Therapy: FDA Summary

M. Mann^{1}*, T. Piazza-Hepp^{1}, E. Koller^{1}, C. Gibert^{2} ^{1}FDA, Rockville, MD, ^{2}VAMC, Washington, DC

Anecdotal reports of peculiar changes in fat distribution have been reported in AIDS patients following protease inhibitors (PI) therapy. A retrospective review of adverse reactions reported to the US FDA was performed using the COSTART term for Cushing's syndrome as well as any term indicating a change in body habitus, weight, or composition. Nine cases were identified which either lacked complete data (n=5), in which concomitant corticosteroids were taken (n=2), or in which the event was not reasonably attributable to PI (n=2). We identified 9 additional cases in which concomitant glucocortoid use could be excluded: 7 males and 2 females, ages 4 to 58. Five patients were on indinavir (one later changing to nelfinavir), 2 on ritonavir, and 2 on invirase. All nine subjects experienced a redistribution of fat to either the central lower abdomen, neck, back, or retroperitoneal areas. "Buffalo hump," and "moon facies" were also described. Symptoms were apparent within one to six months of PI initiation. Two subjects underwent liposuction to remove fat, and one patient discontinued PI with resolution of symptoms. Changes in body habitus mimicking Cushing's syndrome appear to occur in some AIDS patients taking protease inhibitors and deserve further investigation.

Key words: Protease, Inhibitor, Fat