Abstract
Aim:
A population pharmacokinetic analysis was performed using plasma concentration data (n = 7025) from 380 patients to examine the relationship between ribavirin dose and its pharmacokinetics.
Methods:
Ribavirin pharmacokinetics were described by a three-compartment model with sequential zero-order and a first-order absorption processes. Interoccasion variability and food effects were included.
Results:
Lean body weight (range 41-91 kg) was the only covariate with a clinically significant influence on ribavirin pharmacokinetics, affecting clearance (15.3-23.9 l h(-1)) and the volume of the larger peripheral compartment.
Conclusion:
The model provided a good description of the available data, confirmed by accurate estimates of parameter values and low residual variability (17%).
MeSH terms
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Adolescent
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Adult
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Aged
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Antiviral Agents / administration & dosage
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Antiviral Agents / blood
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Antiviral Agents / pharmacokinetics*
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Clinical Trials, Phase I as Topic
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Clinical Trials, Phase III as Topic
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Cross-Over Studies
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Drug Combinations
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Female
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Hepatitis C, Chronic / blood
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Hepatitis C, Chronic / drug therapy*
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Humans
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Interferon alpha-2
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Interferon-alpha / administration & dosage
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Interferon-alpha / blood
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Interferon-alpha / pharmacokinetics
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Male
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Middle Aged
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Models, Biological
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Polyethylene Glycols / administration & dosage
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Polyethylene Glycols / pharmacokinetics
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Recombinant Proteins
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Ribavirin / administration & dosage
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Ribavirin / blood
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Ribavirin / pharmacokinetics*
Substances
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Antiviral Agents
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Drug Combinations
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Interferon alpha-2
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Interferon-alpha
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Recombinant Proteins
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Polyethylene Glycols
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Ribavirin
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peginterferon alfa-2a