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

Abstract

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-naïve 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 (ΔCD4) from therapy initiation: groups A (<emph type="2">n</emph>=37, ΔCD4<0.052×10⁹/l) and B (<emph type="2">n</emph>=111, ΔCD4≥0.052×10⁹/l). Patients were also stratified according to achievement of HIV RNA<400 copies/ml (<emph type="2">n</emph>=122) or ≥400 copies/ml (<emph type="2">n</emph>=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≥copies/ml versus reaching viral suppression<400 copies/ml was associated with an increased risk of HIV-related disease only in patients with ΔCD4<0.052×10⁹/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.