Tier 2 — strong

Meal Effects Confound Attempts to Counteract Rabeprazole-Induced Hypochlorhydria Decreases in Atazanavir Absorption

Kathleen Panter Faber, Hsin-Fang Wu, Marc R Yago, Xiaohui Xu, Pathanjali Kadiyala, Lynda A Frassetto, Leslie Z Benet
Pharmaceutical research 2017 34(3):619-628

Bibliography

PubMed
PMID 28028768
PubMed Central
PMC7179955
DOI
10.1007/s11095-016-2090-2
Funding
Indexed grant support: UL1 TR000004 — NCATS NIH HHS — United States. The indexed list may not contain the complete funding declaration.
Competing interests
A competing-interest declaration was not available in the indexed record or accessible disclosure metadata.

Study snapshot

DesignRandomized crossover controlled trial
ModelHuman participants
SampleHealthy volunteers in a three-period pharmacokinetic study
InterventionAtazanavir/ritonavir with rabeprazole, with or without betaine HCl 1.5 g
DurationSingle-dose fed-state experiments
EndpointsAtazanavir exposure; Food effects; Gastric pH

What the study showed, in plain terms

Published in 2017, this source examined betaine hcl and topical formulations. Design: Randomized crossover controlled trial. Sample/model: Healthy volunteers in a three-period pharmacokinetic study. The exposure or intervention was Atazanavir/ritonavir with rabeprazole, with or without betaine HCl 1.5 g. Follow-up or treatment period: Single-dose fed-state experiments.

Betaine HCl did not adequately restore atazanavir exposure during rabeprazole treatment with food.

Food and drug-specific effects prevent generalization from the earlier dasatinib experiment.

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Key findings

  • Betaine HCl did not adequately restore atazanavir exposure during rabeprazole treatment with food.
  • The recorded outcome domains were Atazanavir exposure; Food effects; Gastric pH.
  • The result applies to the tested exposure: Atazanavir/ritonavir with rabeprazole, with or without betaine HCl 1.5 g; Single-dose fed-state experiments.

What this study can and cannot tell us

  • Food and drug-specific effects prevent generalization from the earlier dasatinib experiment.
  • An individual controlled trial must be interpreted alongside its comparator, sample size, endpoint selection and independent replication. It does not validate a different commercial formulation or a general longevity claim.
  • Source basis: Accessible full-text extract plus indexed bibliographic data. Missing method details, funding information or participant denominators are not inferred.

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Gastric reacidification with betaine HCl in healthy volunteers with rabeprazole-induced hypochlorhydria
Marc R Yago et al. · Molecular pharmaceutics · 2013
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The use of betaine HCl to enhance dasatinib absorption in healthy volunteers with rabeprazole-induced hypochlorhydria
Marc R Yago et al. · The AAPS journal · 2014
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Food, Acid Supplementation and Drug Absorption - a Complicated Gastric Mix: a Randomized Control Trial
Dalga D Surofchy et al. · Pharmaceutical research · 2019

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology