Drug Interaction Report

Coadministration of boceprevir and raltegravir may have modest effects on the pharmacokinetics of both drugs. The mechanism of interaction has not been established. When boceprevir 800 mg every 8 hours and raltegravir 400 mg every 12 hours were given together for 6 days, mean boceprevir peak plasma concentration (Cmax) and systemic exposure (AUC) were not significantly altered, but trough plasma concentration (Cmin) decreased by 26%. Likewise, boceprevir 800 mg three times a day for 10 days reduced the Cmin of a single 400 mg dose of raltegravir by 25%. These changes are not considered clinically significant. No dosage adjustment is required for boceprevir or raltegravir.

ADJUST DOSING INTERVAL: Food significantly enhances the oral bioavailability of boceprevir. When given at 800 mg three times daily with food, boceprevir exposure increased by up to 65% relative to administration in the fasting state. The bioavailability of boceprevir was similar regardless of meal type (e.g., high-fat versus low-fat) or whether taken 5 minutes prior to eating, during a meal, or immediately following completion of the meal. Therefore, boceprevir may be taken without regard to either meal type or timing of the meal.

MANAGEMENT: To ensure maximal oral absorption, boceprevir should be administered with a meal or light snack.