Nevirapine- versus efavirenz-based highly active antiretroviral therapy regimens in antiretroviral-naïve patients with advanced HIV infection.

Abstract

To compare virological and immunological responses to nevirapine (NVP)-based and efavirenz (EFV)-based highly active antiretroviral therapy (HAART) regimens in antiretroviral-naïve patients with advanced HIV infection. A retrospective observational cohort study was conducted on antiretroviral-naïve HIV-infected patients whose pretreatment CD4 cell counts were less than 100 cells/microL or whose viral loads were greater than 100,000 HIV-1 RNA copies/mL. Baseline characteristics of patients in the NVP (n=24) and EFV (n=29) groups were not different. The proportion of patients with viral loads >100,000 copies/mL was higher in the EFV group. The probability of virological success estimated by the Kaplan-Meier method showed that 3- and 6-month success rates were 30.8% [95% confidence interval (CI): 16.7-52.2%] and 63.1% (95% CI: 44.7-81.3%) for the NVP group. The corresponding values were 41.2% (95% CI: 25.8-61.0%) and 62.9% (95% CI: 45.7-80.1%) for the EFV-based group. The median success times of the two groups were about 4 and 3 months (P=0.678), respectively, for NVP and EFV. Cox's proportional hazard was used after adjusting for age, previous opportunistic infections (OIs), and viral load at baseline, and showed that patients who received the NVP-based regimen had about 25% [hazard ratio (HR)=0.75, 95% CI: 0.37-1.51] less chance of virological success than patients who received the EFV-based regimen (P=0.415). The median times to CD4 > or =100 cells/microL were 5.6 and 4.4 months for the NVP- and EFV-based regimens, respectively (log-rank test, P=0.144). NVP- and EFV-based HAART regimens as initial regimens in patients with advanced HIV infection are effective and comparable, in term of virological and immunological responses. However, further large-scale randomized controlled clinical trials in this group of patients with advanced HIV infection are needed.