Pharmacokinetic and pharmacogenomic modelling of the CYP3A activity marker 4β-hydroxycholesterol during efavirenz treatment and efavirenz/rifampicin co-treatment

J Antimicrob Chemother. 2014 Dec;69(12):3311-9. doi: 10.1093/jac/dku286. Epub 2014 Aug 4.

Abstract

Objectives: To assess the effect of the major efavirenz metabolizing enzyme (CYP2B6) genotype and the effects of rifampicin co-treatment on induction of CYP3A by efavirenz.

Patients and methods: Two study arms (arm 1, n = 41 and arm 2, n = 21) were recruited into this study. In arm 1, cholesterol and 4β-hydroxycholesterol were measured in HIV treatment-naive patients at baseline and then at 4 and 16 weeks after initiation of efavirenz-based antiretroviral therapy. In arm 2, cholesterol and 4β-hydroxycholesterol were measured among patients taking efavirenz during rifampicin-based tuberculosis (TB) treatment (efavirenz/rifampicin) just before completion of TB treatment and then serially following completion of TB treatment (efavirenz alone). Non-linear mixed-effect modelling was performed.

Results: A one-compartment, enzyme turnover model described 4β-hydroxycholesterol kinetics adequately. Efavirenz treatment in arm 1 resulted in 1.74 (relative standard error = 15%), 3.3 (relative standard error = 33.1%) and 4.0 (relative standard error = 37.1%) average fold induction of CYP3A for extensive (CYP2B6*1/*1), intermediate (CYP2B6*1/*6) and slow (CYP2B6*6/*6) efavirenz metabolizers, respectively. The rate constant of 4β-hydroxycholesterol formation [mean (95% CI)] just before completion of TB treatment [efavirenz/rifampicin co-treatment, 7.40 × 10(-7) h(-1) (5.5 × 10(-7)-1.0 × 10(-6))] was significantly higher than that calculated 8 weeks after completion [efavirenz alone, 4.50 × 10(-7) h(-1) (4.40 × 10(-7)-4.52 × 10(-7))]. The CYP3A induction dropped to 62% of its maximum by week 8 of completion.

Conclusions: Our results indicate that efavirenz induction of CYP3A is influenced by CYP2B6 genetic polymorphisms and that efavirenz/rifampicin co-treatment results in higher induction than efavirenz alone.

Keywords: HIV; induction; pharmacogenetics.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alkynes
  • Anti-HIV Agents / pharmacokinetics*
  • Anti-HIV Agents / therapeutic use
  • Antitubercular Agents / pharmacokinetics*
  • Antitubercular Agents / therapeutic use
  • Benzoxazines / pharmacokinetics*
  • Benzoxazines / therapeutic use
  • Cyclopropanes
  • Cytochrome P-450 CYP2B6 / genetics*
  • Cytochrome P-450 CYP3A / metabolism*
  • Female
  • Genotype
  • HIV Infections / drug therapy
  • Humans
  • Hydroxycholesterols / analysis*
  • Male
  • Middle Aged
  • Rifampin / pharmacokinetics*
  • Rifampin / therapeutic use
  • Tuberculosis / drug therapy

Substances

  • Alkynes
  • Anti-HIV Agents
  • Antitubercular Agents
  • Benzoxazines
  • Cyclopropanes
  • Hydroxycholesterols
  • cholest-5-ene-3,4-diol
  • CYP3A protein, human
  • Cytochrome P-450 CYP2B6
  • Cytochrome P-450 CYP3A
  • efavirenz
  • Rifampin