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Background:  Efavirenz (EFV)-based HAART is the current standard of care in HIV-1-infected patients. Few clinical data on effectiveness of generic EFV-based HAART is available.

Methods:  We conducted an observational, non-randomized, longitudinal, cohort study in which HIV-1-infected patients who had initiated an EFV-based regimen were followed-up clinically monthly (to assess adverse drug reactions, progression of disease) and CD4 cell counts every 3 months. Data were analyzed to study effectiveness (immunologic) and adverse drug reactions to regimen. Adherence was assessed by self-reporting. Age and sex distribution between 2 groups was analyzed by using t-test and χ² analysis, respectively. Improvement in CD4 cell count was assessed by using Kaplan-Meier product-limit survival estimation for all the patients and then stratified by treatment groups. All the results were adjusted for age and sex by using multivariate analysis techniques.

Results:  Since August 2001, 447 patients were initiated with EFV-based HAART; 385 patients were antiretroviral-naοve (group A) and 62 were treatment-experienced (protease inhibitor) (group B). The 2 groups were age- and sex-matched (p = 0.62 and 0.42, respectively). Median CD4 levels at various time points are given in the table below:  7.01% and 22.58% patients had immunologic failure in group A and B, respectively (p = 0.0002). Two patients in group A developed intolerance to EFV. Number of patients lost to follow-up in both groups was comparable (p = 0.52). Various adverse drug reactions were comparable. Median rise in CD4 cells from baseline was higher at each estimation point in group A than in group B (286 cells and 150 cells, respectively, at 24 months).

Log Rank Test χ² =34.13 p = 0.028, * Wilcoxon Test χ² = 5.11 p = 0.023

Conclusions: Generic efavirenz based HAART is effective and also well tolerated during two years of follow-up period. Antiretroviral naοve patients have better CD4 cells improvement compared to treatment-experienced patients.

Keywords: Generic antiretrovirals; Efavirenz; HAART