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 language||English (US)|
|Number of pages||6|
|Journal||Journal of Acquired Immune Deficiency Syndromes|
|State||Published - Feb 2006|
- Generic antiretrovirals