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Indinavir concentrations and antiviral effect.

E P Acosta¹, K Henry, L Baken

¹College of Pharmacy, Department of Clinical Pharmacology, University of Minnesota Academic Health Sciences Center, Minneapolis 55455, USA.

Pharmacotherapy

|July 3, 1999

Summary

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Indinavir drug concentrations varied significantly between patients, impacting antiviral effectiveness. Higher indinavir levels were linked to undetectable HIV RNA in treatment-naive individuals, suggesting a dose-response relationship.

Area of Science:

Pharmacology
Infectious Diseases
Clinical Pharmacy

Background:

Indinavir is a protease inhibitor used to treat Human Immunodeficiency Virus (HIV) infection.
Understanding drug concentration variability is crucial for optimizing therapeutic outcomes.

Purpose of the Study:

To assess indinavir pharmacokinetic variability in HIV-infected patients.
To investigate the relationship between indinavir exposure and its antiviral effect.

Main Methods:

Formal pharmacokinetic evaluation of 43 HIV-infected adults on indinavir therapy.
Measurement of indinavir concentrations and determination of pharmacokinetic parameters.
Comparison of virologic and pharmacologic characteristics in 23 protease inhibitor-naive patients.

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Main Results:

Significant inter-patient variability in indinavir systemic exposure was observed.
Indinavir exposure (AUC8) was higher in protease inhibitor-naive patients with undetectable HIV RNA compared to those with detectable HIV RNA.
Higher indinavir concentrations at 5 and 8 hours post-dose correlated with undetectable HIV RNA.

Conclusions:

Indinavir plasma concentrations exhibit high variability among patients on the same dosage.
Higher indinavir concentrations and slower oral clearance were associated with undetectable HIV RNA in naive patients.
Quantifying indinavir concentration-effect relationships can explain therapeutic response heterogeneity.