EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF ORAL GANCICLOVIR

The steady-state pharmacokinetics of oral ganciclovir in the fasting v ersus fed state were studied in 20 patients infected with human immuno deficiency virus and with a seropositive test result for cytomegalovir us in a two-way crossover study. Patients received oral ganciclovir at a dose of 1000 mg every 8 hours for 8 days. On days 4 and 8, subjects were randomly assigned to receive the morning dose either after an ov ernight fast or after a standardized 602-calorie, high-fat (46.5%) bre akfast. Serial blood samples were obtained over the 8-hour morning dos e interval. The mean time to maximum concentration (t(max)) was increa sed from 1.8 hours in the fasting state to 3.0 hours in the fed state. Mean maximum serum concentration (C-max) and area under the concentra tion-time curve from time 0 to 8 hours (AUC(0-8)) of ganciclovir were significantly higher in the fed state than after an overnight fast. Be cause food could potentially increase the bioavailability of oral ganc iclovir, patients should be instructed to take each dose of oral ganci clovir with food.