A randomized crossover study to determine bioequivalence of generic and brand name nevirapine, zidovudine, and lamivudine in HIV-negative women in India

Heather E. Vezina, William K Henry, G. D. Ravindran, Anura V. Kurpad, Tony D.S. Raj, Kathy Fox, Dennis Weller, Richard Brundage, Winston Cavert, Henry H Balfour

Research output: Contribution to journalArticle

19 Scopus citations

Abstract

Low-cost generic antiretroviral drugs are available in resource-limited settings for treatment of HIV infections. However, few bioequivalence data in specific populations in which these generics are likely to be used are available. We conducted a randomized crossover bioequivalence study of generic and brand name formulations of nevirapine, zidovudine, and lamivudine in HIV-negative Indian women using US Food and Drug Administration (FDA) criteria. Subjects took single doses of all formulations separated by a 14-day washout period. Plasma concentrations were measured over 96 hours during each study period. Average bioequivalence was determined using natural log-transformed maximum concentration (C max) and area-under-the-concentration-time curve (AUC) mean ratio data. Fifteen Indian women were enrolled. The 90% confidence intervals for nevirapine (14 subjects) and lamivudine (15 subjects) C max, AUC from 0 to the last measurable time point (AUC 0-t), and AUC from 0 to infinity (AUC 0-∞) mean ratios and zidovudine (15 subjects) AUC 0-t and AUC 0-∞ mean ratios were all within 0.80 to 1.25. However, the 90% confidence interval for zidovudine C max mean ratio was 0.70 to 1.46. Generic and brand name nevirapine and lamivudine met FDA average bioequivalence criteria. Lack of average bioequivalence for zidovudine was found for C max but is not expected to be clinically significant, because the total AUC values were similar between formulations.

Original languageEnglish (US)
Pages (from-to)131-136
Number of pages6
JournalJournal of Acquired Immune Deficiency Syndromes
Volume41
Issue number2
DOIs
StatePublished - Feb 1 2006

Keywords

  • Bioequivalence
  • Generic antiretrovirals
  • Lamivudine
  • Nevirapine
  • Pharmacokinetics
  • Zidovudine

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