OBJECTIVE:To estimate the prevalence of liver injury among patients with acquired immunodeficiency syndrome (AIDS) who received highly active antiretroviral therapy (HAART) in rural Henan Province in China,and to explore whether Traditional Chinese Medicine (TCM) treatment based on HAART would increase this risk.METHODS:This was a retrospective cross-sectional study.We collected medical information on patients with AIDS from two treatment databases in 2014.Criteria established by the AIDS Clinical Trials Group in 1996 were used for grading liver injury,classified based on the limit of normal (ULN) for alanine transaminase and aspartate aminotransferase:grade 1 (1.25-2.5 × ULN);grade 2 (2.6-5 × ULN);grade 3 (5.1-10 × ULN);and grade 4 (＞ 10 × ULN).Factors associated with liver injury were evaluated using a logistic regression model.RESULTS:A total 6953 patients with AIDS (3324 male and 3629 female patients) were enrolled into this study.The prevalence of liver injury was 22.0％ (18.0％ grade 1,3.1％ grade 2,0.9％ grade 3).In multivariate analysis,patients aged 34-45 years were more likely to have liver injury than patients in other age groups [adjusted odds ratio (AOR),1.39;95％ CI,1.01-1.91)].Other factors associated with liver injury included male sex (AOR,1.64;95％ CI,1.46-1.85),HIV infection via blood (AOR,1.47;95％ CI,1.19-1.82),hepatitis B virus antibody positive (AOR,1.07;95％ CI,0.85-1.36),and hepatitis C virus (HCV) antibody positive (AOR,2.76;95％ CI,2.28-3.34).CONCLUSION:The prevalence of liver injury was relatively high among HAART-experienced patients.Several factors associated with liver injury included male sex,age 35-45 years old,HIV infection through blood,and concurrent HCV infection.TCM had no relationship with liver injury in patients receiving HAART.