Comprehensive pharmacokinetic, pharmacodynamic and pharmacogenetic evaluation of once-daily Efavirenz 400 and 600 mg in treatment-naive HIV-infected patients at 96 Weeks: results of the ENCORE1 Study
- Dickinson, Laura
- Amin, Janaki
- Else, Laura
- Boffito, Marta
- Egan, Deirdre
- Owen, Andrew
- Khoo, Saye
- Back, David
- Orrell, Catherine
- Clarke, Amanda
- Losso, Marcelo
- Phanuphak, Praphan
- Carey, Dianne
- Cooper, David A.
- Emery, Sean
- Puls, Rebekah
Publication date
July 2016
DOI Publisher
Springer Science and Business Media LLCAbstract
Background: ENCORE1 demonstrated non-inferiority of daily efavirenz 400\ua0mg (EFV400) versus 600\ua0mg (EFV600) to 96\ua0weeks in treatment-naïve, HIV-infected adults but concerns regarding lower EFV400 concentrations remained. Therefore, relationships between EFV pharmacokinetics (PK) and key genetic polymorphisms with 96-week efficacy and safety were investigated. Methods: Relationships between EFV PK parameters and single nucleotide polymorphisms (SNP; CYP2B6,CYP2A6, CYP3A4, NR1I3, NR1I2, ABCB1) with plasma HIV-RNA (pVL
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