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A5207 Study Design

A5207 Study Design. Randomized to intrapartum sd-NVP + 7 or 21 days of selected ARV regimens. 416 pregnant women in Haiti, India, Malawi, South Africa, Tanzania, Uganda received sd-NVP in A5207. 301 in pharmacogenetic analyses.

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A5207 Study Design

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  1. A5207 Study Design Randomized to intrapartum sd-NVP + 7 or 21 days of selected ARV regimens • 416 pregnant women in Haiti, India, Malawi, South Africa, Tanzania, Uganda received sd-NVP in A5207. • 301 in pharmacogenetic analyses. • 214 polymorphisms assayed ABCB1, CYP2B6, CYP2C19, CYP3A4, CYP3A5, NR1I2.

  2. Plasma Concentrations over 5 weeksafter single-dose Nevirapine for PMTCT

  3. Nevirapine Measured & Modeled Profiles Approx. 14 days Approx. 14 days

  4. Plasma Nevirapine Decay by CYP2B6 516G→T and 983T→C African descent Indian 516G→T 983T→C

  5. Conclusions • With sd-NVP, CYP2B6 516G→T has little or no effect on NVP plasma decay. • CYP2B6 983T→C may have a greater effect size (esp. C/C). • Mechanisms by which 516G→T and 983T→C affect CYP2B6 may differ. • Analysis of associations with emergent drug-resistant HIV-1 are pending.

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