The Body Covers: The 37th Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy
Safety of Saquinavir Soft Gelatin Capsule (SQV-SGC) with Other Antiviral Agents
September 28 - October 1, 1997
Abstract I -90A larger trial of the safety and tolerability of the soft gel saquinavir involving 442 patients in an open label study. The patients added SQV-SGC to any pre-existing medications, or preferably, could change the other medications at the same time. After 48 weeks, 70% were still on the study.
Diarrhea occurred in 20% (not much detail on severity), nausea in 11%, heartburn in 8% and flatulence in 8%. Mild to moderate increases in liver enzymes were seen in about 1%.
Taken together with other studies, these two studies suggest that saquinavir in the new formulation is a highly active protease inhibitor. With the increased blood levels and efficacy seem to come some more side effects, but these seem to be mild, manageable (so far) and on a par with other protease inhibitors. It is important to realize that, like the other PI's, using the new saquinavir formulation carelessly will lead to resistance and a once resistance develops to one PI, there is broad cross resistance.
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