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 (AUC0-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 AUC0-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 AUC0-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.