A Study of Nevirapine Toxicity in HIV Infected Pregnant Women at the University Teaching Hospital in Lusaka, Zambia

Abstract

Objective: The general objective of the study was to determine incidence of nevirapine toxicity in pregnant HIV infected women commenced on nevirapine-based regimen in the current pregnancy with CD4 counts up to
350 cells/mm3 at the University Teaching Hospital, Lusaka, Zambia.

Design: Longitudinal observational study with 2 arms Group 1 (low CD4 count arm): HIV infected pregnant women with CD4 counts less than 250 cells/mm3 commenced on nevirapine based regimen in pregnancy. Group 2 (higher CD4 count arm): HIV infected pregnant women with CD4 counts between 250 and 350 cells/mm3 commenced on nevirapine based regimen in pregnancy.

Main outcome: Nevirapine toxicity (eithercutaneous and/or Hepatotoxicity)

Measures: Rash- at least grade 2 rash with or without mucous membrane involvement. Hepatic toxicity – at least grade 2 rise in aspartate aminotransferaseor alanine amino transferase The grading of toxicity was as per WHO toxicity estimates (2006 WHO ART guidelines)

Results: The incidence of nevirapine toxicity (at least grade 2 rash with or without mucous membrane involvement and/or at least grade 2 rise in Aspartate AminoTransferase) was found to be 0% in women with CD4 counts below 250cells/mm3; it was 13.5% (p=0.005) in women with CD4 counts between 250 to 350cell/mm3.

Conclusions: Though the study was powered to detect a15% difference, the results of the study show that women with CD4 counts of 250 to  350cells/mm3 are at substantial risk of nevirapine toxicity when  commenced on nevirapine based HAART regimen in pregnancy.