Livry Claire, Binquet Christine, Sgro Catherine, Froidure Marie, Duong Michel, Buisson Marielle, Grappin Michèle, Quantin Catherine, Portier Henri, Chavanet Pascal, Piroth Lionel
Centre Régional de Pharmacovigilance de Bourgogne, Hôpital Général, CHU Dijon, France.
HIV Clin Trials. 2003 Nov-Dec;4(6):400-10. doi: 10.1310/2L6M-EE7G-5PGN-FJYP.
Acute liver enzyme elevations (ALEE) have been associated with a first-line highly active antiretroviral therapy (HAART) and/or viral hepatitis coinfections in HIV-infected patients. By comparison, the frequency and the risk factors of ALEE in untreated patients and in patients treated with several antiretroviral regimens need to be assessed.
To describe the long-term frequency and the characteristics of ALEE in antiretroviral treated and untreated patients and to define risk factors for ALEE in a retrospective cohort of HIV-1-infected patients.
An HIV-infected cohort was retrospectively examined. ALEE was defined as levels of alanine amino transferase and/or alkaline phosphatase rising to at least 2.5 times above baseline values. Hazard ratios (HR) for ALEE were estimated using an extension of the Cox proportional model taking into account recurrent events.
Out of 239 assessable patients, 12 (5%) were coinfected with hepatitis B virus (HBV) and 34 (14.2%) with hepatitis C virus (HCV). The incidence rate of ALEE was 9.9/100 patients-year and the cumulative incidence was 20.9%. HCV genotype 3 tended to give a higher risk of ALEE. Independent factors for developing ALEE in multivariate logistic regression were HBV (HR = 4.0) and HCV (HR = 3.4) coinfections, antiretroviral therapy (HR = 2.6), CDC stage C (HR = 2.5), and high alkaline phosphatase baseline values (HR = 1.7).
The occurrence of ALEE is influenced more by the past medical history and the clinical background of the patients than by antiretroviral therapy. These patient-linked variables must be taken into account to avoid unwarranted treatment withdrawal.
急性肝酶升高（ALEE）与HIV感染患者的一线高效抗逆转录病毒治疗（HAART）和/或病毒性肝炎合并感染有关。相比之下，需要评估未治疗患者和接受多种抗逆转录病毒方案治疗患者中ALEE的发生率及危险因素。
描述接受抗逆转录病毒治疗和未治疗患者中ALEE的长期发生率及特征，并确定HIV-1感染患者回顾性队列中ALEE的危险因素。
对一个HIV感染队列进行回顾性研究。ALEE定义为丙氨酸氨基转移酶和/或碱性磷酸酶水平升至基线值以上至少2.5倍。考虑到复发事件，使用Cox比例模型的扩展方法估计ALEE的风险比（HR）。
在239例可评估患者中，12例（5%）合并乙型肝炎病毒（HBV）感染，34例（14.2%）合并丙型肝炎病毒（HCV）感染。ALEE的发病率为9.9/100患者年，累积发病率为20.9%。HCV基因3型往往使ALEE风险更高。多因素逻辑回归中发生ALEE的独立因素为HBV（HR = 4.0）和HCV（HR = 3.4）合并感染、抗逆转录病毒治疗（HR = 2.6）、美国疾病控制与预防中心（CDC）C期（HR = 2.5）以及碱性磷酸酶基线值高（HR = 1.7）。
ALEE的发生更多地受患者既往病史和临床背景影响，而非抗逆转录病毒治疗。必须考虑这些与患者相关的变量，以避免不必要的治疗中断。
