| dc.description.abstract | Background: The toxicity of nevirapine based regimen in pregnant women with CD4 counts greater than 250 cells/mm3 is well documented. WHO as well as the United States Food and Drug Agency (US FDA) cautions use of nevirapine in pregnant women with CD4 counts greater than 250 cells/mm3. The Zambian guidelines recommend initiating HAART for all HIV positive pregnant women with CD4 counts less than 350 cells/mm3. Nevirapine based regimen is the recommended first line, even for CD4 counts between 250 to 350cell/mm3. We compared incidence of nevirapine toxicity in pregnant HIV infected women commenced on a nevirapine based regimen in pregnancy with CD4 counts less than 250 cells/mm3 to that of women with CD4 counts between 250 and 350 cells/mm3. Methods: Longitudinal observational study with 2 arms; CD4 count below 250 cells/ mm3, and CD4 count of 250-350 cells/ mm3. Convenience sampling was used to enroll 146 patients. All HIV infected pregnant women with CD4 counts less than or equal to 350cells/mm3 commenced on nevirapine based regimen in the current pregnancy were enrolled if they consented and they fulfilled the eligibility criteria. Women were allocated to the 2 arms based on their CD4 count. An interviewer administered questionnaire was used to collect demographic details at the recruitment stage. On subsequent visits, a check list was used to collect data.SAS statistical package was used to analyze the data. Results: The incidence of nevirapine toxicity Rash (at least grade 2 rash with or without mucous membrane involvement and/or at least grade 2 rise in Aspartate Amino Transferase)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 a 15% 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 | en_US |
