Pharmacokinetics of new 625mg nelfinavir formulation during pregnancy and postpartum

Jennifer S. Read, B. M. Best, A. M. Stek, C. Hu, E. V. Capparelli, D. T. Holland, S. K. Burchett, M. E. Smith, E. C. Sheeran, W. T. Shearer, I. Febo, M. Mirochnick

Research output: Contribution to journalArticlepeer-review

26 Scopus citations


Objectives: Our objective was to evaluate the pharmacokinetics of nelfinavir (NFV) (625 mg tablets) 1250 mg twice daily during pregnancy and postpartum. Methods: The participants were HIV-1-infected pregnant women enrolled in P1026s and receiving NFV (625 mg tablets) 1250 mg twice daily as part of routine clinical care. Intensive steady-state 12-h NFV pharmacokinetic profiles were performed during pregnancy and postpartum. The target NFV area under the plasma concentration-time curve (AUC0-12) was ≥ 10th percentile NFV AUC0-12 in non-pregnant historical controls (18.5 μgh/mL). Results: Of 27 patients receiving NFV, pharmacokinetic data were available for four (second trimester), 27 (third trimester) and 22 (postpartum) patients. The NFV maximum concentration (Cmax), 12-h post-dose concentration (C12) and AUC0-12 were significantly lower during the third trimester compared to postpartum (P ≤ 0.03). The metabolite hydroxyl-tert-butylamide (M8) AUC0-12 and the M8/NFV AUC ratio were lower during the third trimester compared to postpartum (P < 0.01). The NFV AUC0-12 exceeded the AUC0-12 target for 15/27 (56%) and 21/22 (95%) of third trimester and postpartum patients, respectively. The minimum concentration (Cmin) was above the suggested minimum trough concentration (0.8 μg/mL) in 15% (third trimester) and 18% (postpartum). The plasma viral load was < 400HIV-1 RNAcopies/mL in 81% of patients at delivery. Conclusions: These results suggest that higher doses of NFV should be considered during pregnancy.

Original languageEnglish (US)
Pages (from-to)875-882
Number of pages8
JournalHIV Medicine
Issue number10
StatePublished - Nov 2008


  • HIV
  • Nelfinavir
  • Pharmacokinetics
  • Pregnancy

ASJC Scopus subject areas

  • Health Policy
  • Infectious Diseases
  • Pharmacology (medical)


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