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Background:  Efavirenz (EFV)-based HAART is more expensive than nevirapine (NVP). Our objective was to compare the immunologic effectiveness of both these regimens in antiretroviral naïve HIV-1 infected Indian patients in an observational, non-randomized, longitudinal, cohort study conducted in tertiary care infectious diseases clinics in Ahmedabad, and Pune, India.

Methods:  Antiretroviral-naïve HIV-1 patients receiving EFV- and NVP-based ART from June 2001 to December 2002 were followed. Clinical evaluations were performed monthly and CD4/CD8 counts quarterly. Patients with at least 3 months’ follow-up were included in analysis. Baseline characteristics between the groups were analyzed by Fischer’s exact test (binary) and Mann Whitney test (continuous). Median CD4 counts were determined at each time points. We fitted a random effects model to assess the differences in the improvement in CD4 counts over time between the 2 treatment arms.

Results:  We studied 857 and 254 patients in the NVP and EFV arms, respectively. Baseline characteristics, including CD4 counts (p = 0.17) were similar between the 2 groups. Baseline and median improvement in CD4 counts at each time point has been shown below:

In the random effects model, there was an increase of 40.97 (p <0.05) units of CD4 cell counts with an unit increase in time in the NVP arm as against a 44.75 (p< 0.05) units of increase in CD4 cell counts in the EFV group with an unit increase in time, which is significant for both groups. However, at any point there was no difference in the rate of increase of CD4 count between the two treatment arms (p = 0.58).

Conclusions:  Though observational and non-randomized this study shows equivalent immunological effectiveness of NVP and EFV based regimen in a developing country scenario, which is in line with the results of the 2NN study.

Keywords: Nevirapine; Efavirenz; Generic drugs