A pilot study to assess the immunologic and virologic efficacy of generic nevirapine, zidovudine and lamivudine in the treatment of HIV-1 infected women with pre-exposure to single dose nevirapine or short course zidovudine and their spouses in Chitungwiza, Zimbabwe

Abstract

Objective: A pilot study to assess effectiveness of generic Nevirapine (NVP)+Zidovudine(AZT)+Lamivudine (3TC) as potent antiretroviral therapy (ART) in women exposed to either SD NVP or short course (SC) AZT through participation in prevention of mother-to-child transmission of HIV-1 (pMTCT) interventions, and their spouses. Design: A pilot study of antiretroviral treatment of adults with AIDS. Setting: Primary health care clinics; Seke North and St Mary’s in Chitungwiza, Zimbabwe. Subjects: Women with pre-exposure to SD NVP or SC AZT and their spouses with CD4 count <200 cells/ pL. Interventions: Generic AZT/3TC twice daily plus NVP daily for the first 14 days and then twice a day thereafter, administered to the cohort. Main Outcome Measures: The baseline median CD4 count for women and men was 128.5 and 119.0 cells/ pL respectively. The geomean virus load was similar for the women and men. At weeks 16,24 and 48,82.8%, 85.1% and 73.8% had < 400 copies/ml of HIV RNA respectively. Only at 16 weeks, was the proportion of women (75.9%) with undetectable virus significantly lower than that for men (93.9%). p=0.031. Median CD4 count for both men and women increased significantly, p<0.001. There were no significant differences in virologic responses between the women with pre-exposure to SD NVP and SC AZT. The mean adherence for women and men was similar, >98%.