Background:  Nevirapine (NVP) -based regimens are recommended for first-line therapy by the World Health Organization (WHO) for HIV-infected children in resource-limited settings. An analysis was conducted to assess the response to treatment to a NVP-based regimen in 2 cohorts of HIV-infected Ugandan children, who were exposed or not exposed to single-dose NVP at birth.

Methods:  HIV-infected children were initiated on stavudine (d4T)/lamivudine (3TC)/NVP. A t-test was performed to compare immunologic and virologic responses at baseline versus 12, 24, 36, and 48 weeks post-therapy.

Results:  We enrolled 92 children and started them on HAART. The single-dose NVP cohort was significantly younger than the NVP-unexposed cohort:  median age at enrollment was 1.7 years (range 0.6 to 6.3) for the NVP-exposed group compared to 7.8 years (range 2.9 to 12.4) in NVP-unexposed cohort (p <0.001). Both groups showed sharp increases in CD4 percentage; the younger single-dose NVP-exposed group had a significantly better response at 48 weeks (p <0.0001) than the NVP-unexposed group. Median viral load at baseline was 650,568 copies/mL in the NVP-exposed cohort and 239,027 copies/mL in the NVP-unexposed cohort. Both cohorts (80% of the NVP-unexposed and 76% of the single-dose NVP-exposed group) had a median viral load that was non-detectable (<400copies/mL) after 48 weeks of therapy (p = 0.74). 

*ND = Non-detectable <400 copies/mL

Conclusions:  A NVP-based regimen led to a significant increase in CD4 percentage and decrease in viral load in both single-dose NVP-exposed and NVP-unexposed cohorts after 48 weeks of therapy. These data suggest that prior single-dose NVP exposure did not have a negative effect on treatment success for children placed on a NVP-based HAART at a median age of 1.7 years.