title: Antiretroviral therapy hepatotoxicity: Prevalence, risk factors, and clinical characteristics in a cohort of Han Chinese.
abstract: OBJECTIVE
  To investigate the incidence and risk factors of hepatotoxicity in Han Chinese patients with acquired immunodeficiency syndrome on combined anti-retroviral therapy (cART).
  
  
  METHODS
  A retrospective study was conducted.
  
  
  RESULTS
  Among 330 subjects on cART in the cohort, 75.2% infected HIV due to improper plasma donations, 67.3% was either hepatitis C virus (HCV) or hepatitis B virus (HBV) co-infected and 46.4% had at least one episode of ALT elevation during a median 23 months follow-up time. Baseline alanine aminotransferase (ALT) elevation (P = 0.004, OR = 9.560), receiving nevirapine (NVP) based cART regimen (P = 0.007, OR = 2.470), HCV co-infection (P = 0.000, OR = 3.433) were risk factors for cART related hepatotoxicity, while greater increased CD4(+) T(CD4) cell count was protective against hepatotoxicity development (P = 0.000, OR = 0.996). Patients co-infected with HCV who received NVP based cART had the greatest probability of hepatotoxicity (Log rank: x(2) = 27.193, P = 0.000). Twenty-five of the 153 subjects (16.3%) with cART related hepatotoxicity discontinued cART temporarily or shifted NVP to efavirenz (EFV). There was no difference in CD4 cell count (t = 0.526, P = 0.599), CD4 cell count change from baseline (t = 0.442, P = 0.659) and all-cause mortality (x(2) = 0.259, P = 0.611) between subjects with and without hepatotoxicity during a median 38 months of follow-up time.
  
  
  CONCLUSIONS
  cART induced hepatotoxicity was common among subjects in this cohort. Baseline ALT elevation, HCV co-infection and the use of NVP based cART regimens were associated statistically with the development of hepatotoxicity. Hepatotoxicity, led to some of the subjects discontinuing cART temporarily or switching to other regimens, had no impact on immune restore and survival in this cohort of patients during a median 38 months of follow-up time.
authors.affiliation: Department of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.
authors.forename: Shicheng
authors.initials: S
authors.lastname: Gao
authors.forename: Xi-En
authors.initials: XE
authors.lastname: Gui
authors.forename: Lipin
authors.initials: L
authors.lastname: Deng
authors.forename: Yongxi
authors.initials: Y
authors.lastname: Zhang
authors.forename: Ke
authors.initials: K
authors.lastname: Liang
authors.forename: Rongrong
authors.initials: R
authors.lastname: Yang
authors.forename: Yajun
authors.initials: Y
authors.lastname: Yan
authors.forename: Yupin
authors.initials: Y
authors.lastname: Rong