Background: Early antiretroviral therapy (ART) is recommended as an intervention for HIV by the World Health Organization. However, the association between the CD4 count at ART initiation and the risk of adverse drug reactions (ADRs) remains unclear. Purpose: This study aimed to describe the trends related to symptom number and intensity among patients newly diagnosed with HIV in three different CD4-count-based groups and then to investigate the ADR trends for these three groups at different points in time. Methods: This multi-center cohort study recruited newly diagnosed HIV/AIDS patients who had not previously used ART from AIDS-designated hospitals in Taiwan from March 2015 to December 2016. Study measures were assessed at the time of case enrollment (T0) and during the 1st month (T1), 4–6th month (T2), and 7–9th month (T3) of ART treatment. Patients were stratified into three groups according to initial CD4 count: ≤ 350 cells/mm3, > 350-500 cells/ mm3 and >500 cells/mm3. Repeated measures ANOVA and generalized estimating equations were used to estimate the relationships between the level of initial CD4 count and ADRs. Results: A total of 207 patients completed the study. Mean symptom numbers and symptom intensities decreased significantly over time in all three groups (p <.01). The largest mean reduction in both symptom number and intensity was achieved by the CD4 count > 500 cells/mm3 group. Overall, at least one ADR was reported by 85.7% of the participants at the first month of ART use, and the incidence of ADR had decreased by an average of 22% at the 7–9th month assessment (p <.001). ARDs decreased significantly over time in the CD4 count > 500 cells/mm3 group, with the degrees of ADRs in systematic side effect most significantly decreased in this group (p =.03). Conclusions/ Implications for Practice: Number and intensity of symptoms significantly improved over time in all three CD4 count groups. The percentage of systematic side effects was most reduced in the CD4 count >500 cells/mm3 group. The results of this study may be referenced by HIV care providers when discussing with patients the initiation of ART and the potential risks of experiencing ADRs.
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