Prognostic value of changes in CD4 count and HIV RNA during the first six months on highly active antiretroviral therapy in chronic human immunodeficiency virus infection.

The aim of this study was to evaluate the prognostic value of changes in CD4 counts and human immunodeficiency virus (HIV) RNA following 6 months of highly active antiretroviral therapy (HAART) in chronic HIV-1 infection. 148 treatment-naive patients treated with 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) + at least 1 protease inhibitor or non-NRTI for at least 180 d were included. Mean follow-up time after 6 months on HAART was 758 d. The patients were divided into 2 groups based on the increase in CD4 count (deltaCD4) from therapy initiation: groups A (n = 37, deltaCD4 < 0.052 x 10(9)/l) and B (n = 111, deltaCD4 > or = 0.052 x 10(9)/l). Patients were also stratified according to achievement of HIV RNA < 400 copies/ml (n = 122) or > or = 400 copies/ml (n = 26). Endpoints were the occurrence of subsequent HIV-related disease (CDC category B or C) or death after 6 months on HAART. Subjects in group A had an increased risk of HIV-related disease compared with group B when adjusted for CD4 count at initiation of therapy [adjusted risk ratio (RR) 2.62, 95% confidence interval (95% CI) 1.07-6.40]. Viral load > or = copies/ml versus reaching viral suppression < 400 copies/ml was associated with an increased risk of HIV-related disease only in patients with deltaCD4 < 0.052 x 10(9)/l (RR 4.20, 95% CI 1.05-16.9). Thus, this study indicates that patients with no or a small increase in CD4 counts after 6 months of HAART and low CD4 levels at initiation of therapy have an increased risk of HIV-related disease.