Pharmacokinetic Interaction between amprenavir and rifabutin or rifampin in healthy males

Antimicrob Agents Chemother. 2001 Feb;45(2):502-8. doi: 10.1128/AAC.45.2.502-508.2001.

Abstract

The objective of this study was to determine if there is a pharmacokinetic interaction when amprenavir is given with rifabutin or rifampin and to determine the effects of these drugs on the erythromycin breath test (ERMBT). Twenty-four healthy male subjects were randomized to one of two cohorts. All subjects received amprenavir (1,200 mg twice a day) for 4 days, followed by a 7-day washout period, followed by either rifabutin (300 mg once a day [QD]) (cohort 1) or rifampin (600 mg QD) (cohort 2) for 14 days. Cohort 1 then received amprenavir plus rifabutin for 10 days, and cohort 2 received amprenavir plus rifampin for 4 days. Serial plasma and urine samples for measurement of amprenavir, rifabutin, and rifampin and their 25-O-desacetyl metabolites, were measured by high-performance liquid chromatography. Rifabutin did not significantly affect amprenavir's pharmacokinetics. Amprenavir significantly increased the area under the curve at steady state (AUC(ss)) of rifabutin by 2.93-fold and the AUC(ss) of 25-O-desacetylrifabutin by 13.3-fold. Rifampin significantly decreased the AUC(ss) of amprenavir by 82%, but amprenavir had no effect on rifampin pharmacokinetics. Amprenavir decreased the results of the ERMBT by 83%. The results of the ERMBT after 2 weeks of rifabutin and rifampin therapy were increased 187 and 156%, respectively. Amprenavir plus rifampin was well tolerated. Amprenavir plus rifabutin was poorly tolerated, and 5 of 11 subjects discontinued therapy. Rifampin markedly increases the metabolic clearance of amprenavir, and coadministration is contraindicated. Amprenavir significantly decreases clearance of rifabutin and 25-O-desacetylrifabutin, and the combination is poorly tolerated. Amprenavir inhibits the ERMBT, and rifampin and rifabutin are equipotent inducers of the ERMBT.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Anti-Bacterial Agents
  • Antibiotics, Antitubercular / pharmacokinetics*
  • Biotransformation
  • Breath Tests
  • Carbamates
  • Cytochrome P-450 CYP3A
  • Cytochrome P-450 Enzyme Inhibitors
  • Cytochrome P-450 Enzyme System / genetics
  • Cytochrome P-450 Enzyme System / metabolism
  • Dealkylation
  • Drug Interactions
  • Erythromycin
  • Furans
  • Humans
  • Male
  • Middle Aged
  • Mixed Function Oxygenases / antagonists & inhibitors
  • Mixed Function Oxygenases / genetics
  • Mixed Function Oxygenases / metabolism
  • Rifabutin / pharmacokinetics*
  • Rifampin / pharmacokinetics*
  • Sulfonamides / blood
  • Sulfonamides / pharmacokinetics*
  • Sulfonamides / urine

Substances

  • Anti-Bacterial Agents
  • Antibiotics, Antitubercular
  • Carbamates
  • Cytochrome P-450 Enzyme Inhibitors
  • Furans
  • Sulfonamides
  • Rifabutin
  • amprenavir
  • Erythromycin
  • Cytochrome P-450 Enzyme System
  • Mixed Function Oxygenases
  • CYP3A protein, human
  • Cytochrome P-450 CYP3A
  • Rifampin