Concomitant Intake of Coca-Cola to Manage the Drug-Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers.

Abstract

We aimed to evaluate the effect of the acid beverage Coca‐Cola on the pharmacokinetics of velpatasvir (VEL) when given with omeprazole. This was an open‐label, randomized, crossover trial in 11 healthy adults. A single dose of sofosbuvir/velpatasvir (SOF/VEL) 400/100 mg was administered alone (reference) or with omeprazole 40 mg once daily with water (intervention I); in the intervention II arm, omeprazole 40 mg was combined with 250 mL of Coca‐Cola. Geometric mean ratios (GMRs) were calculated for VEL area under the concentration‐time curve from zero to infinity (AUC 0−inf) and maximum plasma concentration (Cmax). VEL exposure was reduced by 26.7% when SOF/VEL was coadministered with omeprazole vs. reference: GMRs (90% confidence interval (CI)) were 73.3% (55.6–96.8) and 69.1% (52.3–91.2) for AUC 0‐inf and Cmax, respectively. Intake of SOF/VEL with Coca‐Cola compensated for the interaction with omeprazole and resulted in a higher VEL exposure. GMRs (90% CI) were 161.6% (122.4–213.3) for AUC 0‐inf and 143.9% (109.0–190.0) for Cmax. Therefore, Coca‐Cola can be used to overcome the drug–drug interaction between VEL and omeprazole.