Dataset Information

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.

SUBMITTER: van Seyen M

PROVIDER: S-EPMC6851656 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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

van Seyen Minou M Colbers Angela A Abbink Evertine J EJ Drenth Joost P H JPH Burger David M DM

Clinical pharmacology and therapeutics 20190818 5

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 ...[more]

PMID: 31313296

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Project description:Policy Points There is growing understanding of how manufacturers of harmful products influence health policy. The strategies, approaches, and influences from such manufacturers that are detrimental to health have been termed the "corporate" or "commercial" determinants of health. However, while partnerships with the tobacco industry are clearly unacceptable for public health organizations, ties to other industries continue to be pursued. Such partnerships may influence health organizations in a number of ways detrimental to population health. However, with the exception of tobacco industry tactics as revealed by internal documents, we know relatively little about how this influence operates. This article uses emails between the Coca-Cola Company and the Centers for Disease Control and Prevention, which we obtained through Freedom of Information Act requests, to explore the nature of corporate influence, conflicts of interest, and lobbying "in their own words," and highlights the need for greater transparency and clearer policies on engaging with such industries. CONTEXT:There is a continuing debate about the appropriateness of contacts between manufacturers of some harmful products and health researchers, as well as practitioners and policymakers. Some argue that such contacts may be a means of exerting undue influence, while others present them as an opportunity to pursue shared health goals. This article examines interactions between the Centers for Disease Control and Prevention (CDC) and the Coca-Cola Company (Coca-Cola) as revealed by communications obtained through Freedom of Information Act (FOIA) requests. METHODS:We sent 10 US FOIA requests in 2016/2017 for communications between employees at the CDC and Coca-Cola. We then performed a thematic content analysis of the documents provided. FINDINGS:Of our 10 FOIA requests, 3 requests are still pending (at the time of this publication); 5 were rejected as too broad or because no records were found; and 3 returned 295 pages from 86 emails. The CDC withheld 102 pages to "protect commercial or financial information which is privileged or confidential." The returned emails demonstrate three main themes in Coca-Cola's contact with CDC employees: to gain and expand access, to lobby, and to shift attention and blame away from sugar-sweetened beverages. CONCLUSIONS:The emails we obtained using FOIA requests reveal efforts by Coca-Cola to lobby the CDC to advance corporate objectives rather than health, including to influence the World Health Organization. Our findings provide a rare example of the ways in which corporate interests attempt to influence public health practitioners "in their own words," and they demonstrate a need for clearer policies on avoiding partnerships with manufacturers of harmful products.

Dataset Information

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

Publications

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

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