Virological and immunological responses of efavirenz-based HAART regimen initiated in HIV-infected patients at CD4 < 100 versus CD4 ≥ 100 cells/mm ³

Objective: To compare virological and immunological responsiveness of efavirenz (EFV)-based highly active anti retroviral therapy (HAART) between patients with baseline CD4 < 100 and CD4 ≥ 100 cells/mm ³. Material and Method: A prospective cohort study in antiretroviral-naive HIV-infected patients was conducted between February and April 2002. Donated HAART regimen, consisting of stavudine, didanosine, and EFV was initiated. The primary outcome was time to undetectable HIV RNA, < 50 copies/mL. Patients were followed up every 12 weeks until 48 weeks (the end of the study). Results: Forty-six patients were included, 21 patients for CD4 < 100 cells/mm ³ and 25 patients for CD4 ≥100 cells/mm ³. Median CD4 cell counts of these corresponding groups were 26.5 and 177 cells/mm ³. Patients' characteristics were similar between the two groups except CD4. The probability of undetectable HIV RNA at 12, 24, 36, and 48 weeks were 57.1% (95%CI, 37.7-78.1%), 76.2% (95%CI, 56.9-91.3%), 80.9% (95%CI, 62.3-94.0%), and 90.5% (95%CI, 68.9-99.1%) for the former group; and 64.0% (95%CI, 45.8-81.8%), 92.0% (95%CI, 77.5-98.6%), 96.0% (95%CI, 83.0-99.7%), and 96.0% (95%CI, 83.0-99.7%) for the latter group. Median time to undetectable HIV RNA was 12 weeks for both groups. Median CD4 change at 48 weeks was 171 and 132 cells/mm ³, respectively (p = 0.232). The adverse events were similar between the two groups. Conclusion: Initiation of EFV-based HAART regimen in HIV-infected patients at CD4 < 100 and ≥ 100 cells/mm ³ gains similar immunological and virological response.