Switching PI Therapy to Amprenavir & The Affect on Lipodystrophy & Lipids
Reduction in lipid abnormalities during
treatment with amprenavir in subjects experiencing hyperlipidemia on a PI containing regimen
L. Pedneault, C. Garris, S. Castillo, M. Rogers, N. Graham, L. Garrett, B. Akil, T. Scott, Glaxo Wellcome, and Beverly Hills, Calif.
Previous reports suggested in vitro and in vivo that amprenavir may have less adverse affect on metabolic changes (lipoatrophy and elevated lipids) than other protease inhibitors. This Glaxo Wellcome study aimed to assess the safety & tolerability of amprenavir on lipid metabolism in subjects experiencing hyperlipidemia with or without lipodystrophy. Patients were given open-label amprenavir with at least 2 other ART drugs. Concomitant use of other PI was not allowed. Subjects were required to have at least 4 weeks prior PI use. Subjects had to have grade 1-4 hyperlipidemia. Fasting blood samples, anthropometric measures & lipodystrophy signs & symptoms were collected at 12 week intervals.
As you may know a new version of amprenavir is in phase 3 clinical study. The pill burden is greatly reduced. The antiviral efficacy and side effect profile results from this study will be important in assessing the usefulness of the new amprenavir.