初診斷愛滋感染者接受抗病毒藥物治療之免疫力與副作用趨勢變化

Trends in Immunity and Adverse Drug Reactions Among People Newly Diagnosed With HIV

背景：世界衛生組織（World Health Organization）於2016年更新愛滋病治療指引，呼籲一旦確立診斷後，不論CD4數值，即可進行治療。然而HIV感染者在初服藥時的免疫力與副作用之變化尚未清楚。目的：初診斷愛滋感染者依據其初服藥CD4數值分為三組：CD4 ? 350 cells／mm3、＞350－500cell／mm3及CD4＞500 cells／mm3，探討(1)三組受試者其症狀數／強度在四個量測時間點之趨勢變化；(2)三組受試者其副作用在四個量測時間點之趨勢變化。方法：採多中心世代研究法，於2015年3月至2016年12月間，針對初次服藥的愛滋感染者，於基準值（T0）、服藥後1個月（T1）、4－6個月（T2）及7－9個月（T3）四個時間點，進行症狀評估，並依據其初服藥CD4數值分為三組，以重複測量單因子變異數分析以及廣義估計式進行結果分析。結果：共207位感染者完整追蹤至T3，隨時間變化三組之平均症狀數及平均症狀強度總分均顯著下降，且皆以CD4數值＞500 cells／mm3下降幅度為最高。85.7％感染者服藥後至少出現一個副作用，追蹤至T3其服藥副作用會顯著降低22％。僅CD4＞500 cells／mm3其服藥副作用會隨著時間大幅降低，尤其以全身性副作用最為顯著（p＝.03）。結論／實務應用：無論初服藥時CD4數值，其症狀數與症狀強度總分均隨著時間有明顯改善，其中以CD4＞500 cells／mm3病人其全身副作用隨著時間達到顯著下降。此實證性結果可作為鼓勵感染者及早服藥的參考，並降低感染者擔心產生服藥副作用之疑慮。

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.