Department of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.
Radboudumc Technology Center Clinical Studies, Radboud University Medical Center, Nijmegen, The Netherlands.
Clin Pharmacol Ther. 2019 Nov;106(5):1093-1098. doi: 10.1002/cpt.1569. Epub 2019 Aug 18.
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 ) and maximum plasma concentration (C ). 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 and C , 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 and 143.9% (109.0-190.0) for C . Therefore, Coca-Cola can be used to overcome the drug-drug interaction between VEL and omeprazole.
我们旨在评估酸性饮料可口可乐对给予奥美拉唑时伏帕他韦（VEL）药代动力学的影响。这是一项在 11 名健康成年人中进行的开放标签、随机、交叉试验。单剂量索非布韦/伏帕他韦（SOF/VEL）400/100mg 单独给药（参比）或与奥美拉唑 40mg 每日一次用清水给药（干预 I）；在干预 II 臂中，奥美拉唑 40mg 与 250mL 可口可乐合用。计算了 VEL 从零到无穷大的浓度-时间曲线下面积（AUC）和最大血浆浓度（C）的几何均数比值（GMR）。与参比相比，SOF/VEL 与奥美拉唑合用使 VEL 暴露减少了 26.7%：AUC 和 C 的 GMR（90%置信区间（CI））分别为 73.3%（55.6-96.8）和 69.1%（52.3-91.2）。与可口可乐合用 SOF/VEL 可补偿与奥美拉唑的相互作用，从而提高 VEL 暴露。AUC 和 C 的 GMR（90%CI）分别为 161.6%（122.4-213.3）和 143.9%（109.0-190.0）。因此，可口可乐可用于克服 VEL 和奥美拉唑之间的药物相互作用。
