Drug Interactions between bictegravir / emtricitabine / tenofovir alafenamide and Di-Gel Lemon

ADJUST DOSING INTERVAL: Concurrent administration of medications or oral supplements containing polyvalent cations such as aluminum, calcium, iron, or magnesium may decrease the oral bioavailability of bictegravir. The mechanism of interaction has not been described.

Antacids - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 20 mL dose of maximum strength antacid (aluminum hydroxide-magnesium hydroxide-simethicone 80 mg-80 mg-8 mg/mL) under fasted conditions decreased mean bictegravir peak plasma concentration (Cmax) and systemic exposure (AUC) by approximately 80%, whereas simultaneous administration under fed conditions decreased mean bictegravir Cmax and AUC by approximately 50%. When the antacid was administered 2 hours before bictegravir under fasted conditions, mean Cmax and AUC of bictegravir decreased by 58% and 52%, respectively. However, when the antacid was administered 2 hours after bictegravir under fasted conditions, mean Cmax and AUC of bictegravir decreased by just 7% and 13%, respectively.

Calcium - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 1200 mg dose of calcium carbonate under fasted conditions decreased mean Cmax and AUC of bictegravir by 42% and 33%, respectively, while simultaneous administration under fed conditions had no significant effects on the Cmax and AUC of bictegravir.

Iron - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 324 mg dose of ferrous fumarate under fasted conditions decreased mean Cmax and AUC of bictegravir by 71% and 63%, respectively, while simultaneous administration under fed conditions decreased mean bictegravir Cmax and AUC by just 25% and 16%, respectively.

Sucralfate - Sucralfate contains the polyvalent cation aluminum. Concomitant administration with bictegravir is expected to lead to reduced plasma concentrations of bictegravir similar to that observed with antacids. However, data are not available.

MANAGEMENT: When used with antacids containing aluminum, magnesium or calcium, bictegravir may be taken under fasting conditions 2 hours before the antacids. Routine administration of bictegravir simultaneously with, or 2 hours after, antacids containing aluminum, magnesium or calcium is not recommended. When used with supplements containing calcium or iron, bictegravir and the supplements may be taken together with food. Routine administration of bictegravir under fasting conditions simultaneously with, or 2 hours after, supplements containing calcium or iron is not recommended.

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ADJUST DOSING INTERVAL: Concurrent administration of medications or oral supplements containing polyvalent cations such as aluminum, calcium, iron, or magnesium may decrease the oral bioavailability of bictegravir. The mechanism of interaction has not been described.

Antacids - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 20 mL dose of maximum strength antacid (aluminum hydroxide-magnesium hydroxide-simethicone 80 mg-80 mg-8 mg/mL) under fasted conditions decreased mean bictegravir peak plasma concentration (Cmax) and systemic exposure (AUC) by approximately 80%, whereas simultaneous administration under fed conditions decreased mean bictegravir Cmax and AUC by approximately 50%. When the antacid was administered 2 hours before bictegravir under fasted conditions, mean Cmax and AUC of bictegravir decreased by 58% and 52%, respectively. However, when the antacid was administered 2 hours after bictegravir under fasted conditions, mean Cmax and AUC of bictegravir decreased by just 7% and 13%, respectively.

Calcium - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 1200 mg dose of calcium carbonate under fasted conditions decreased mean Cmax and AUC of bictegravir by 42% and 33%, respectively, while simultaneous administration under fed conditions had no significant effects on the Cmax and AUC of bictegravir.

Iron - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 324 mg dose of ferrous fumarate under fasted conditions decreased mean Cmax and AUC of bictegravir by 71% and 63%, respectively, while simultaneous administration under fed conditions decreased mean bictegravir Cmax and AUC by just 25% and 16%, respectively.

Sucralfate - Sucralfate contains the polyvalent cation aluminum. Concomitant administration with bictegravir is expected to lead to reduced plasma concentrations of bictegravir similar to that observed with antacids. However, data are not available.

MANAGEMENT: When used with antacids containing aluminum, magnesium or calcium, bictegravir may be taken under fasting conditions 2 hours before the antacids. Routine administration of bictegravir simultaneously with, or 2 hours after, antacids containing aluminum, magnesium or calcium is not recommended. When used with supplements containing calcium or iron, bictegravir and the supplements may be taken together with food. Routine administration of bictegravir under fasting conditions simultaneously with, or 2 hours after, supplements containing calcium or iron is not recommended.

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