Bevirimat - Toxicity and Side Effects

Toxicity and Side Effects

Preclinical studies have not presented any sign that bevirimat might be associated with any specific safety concerns that would limit its clinical use. In vitro preclinical studies in human cells propose that bevirimat should have low potential for cytotoxicity. There is no evidence of any reproductive or developmental toxicity and it is not immunotoxic. Bevirimat was initially evaluated for safety and pharmacokinetics in a single-dose, randomized, double-blind, placebo-controlled phase clinical study in healthy volunteers. It was administered as an oral solution in doses of 25, 50, 100, and 250 mg. The plasma concentrations were dose-proportional, and the compound was seen to be safe and well tolerated with no dose-limiting toxicities and no serious adverse effects. In one clinical trial, headaches was the most commonly reported side effect of bevirimat, reported by four participants on bevirimat and one on the placebo. The second most common reported side effect was throat discomfort by two participants on bevirimat. No serious adverse effects were reported, all adverse effects reported were mild, and no participants discontinued use of bevirimat because of the adverse effects.