title: The efficacy and safety of entecavir in patients with advanced schistosomiasis co-infected with hepatitis B virus.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of entecavir (ETV) in patients with advanced schistosomiasis and hepatitis B virus (HBV) co-infection.
  
  
  METHODS
  Sixty-seven patients with advanced schistosomiasis and HBV co-infection were enrolled in this study. The patients were randomly divided into the ETV treatment group (n=35) and the control group (n=32). The patients in the control group adopted routine supportive therapy for 52 weeks, and those in the ETV treatment group received ETV at a dose of 0.5mg once daily on the basis of routine supportive therapy for 52 weeks. Hepatic fibrosis markers (hyaluronic acid, type III procollagen, type IV collagen, laminin, and fibronectin), Ishak fibrosis score, alanine transaminase (ALT), HBV DNA, and Child-Pugh score were compared between the two groups. The intention to treat (ITT) population was used for the analysis. The measurement data and count data were analyzed by t-test and Chi-square test, respectively.
  
  
  RESULTS
  After 52 weeks of treatment, the hepatic fibrosis markers (hyaluronic acid, type III procollagen, type IV collagen, laminin, and fibronectin) were significantly improved in the ETV treatment group compared to the control group (all p<0.05). A ≥1-point improvement in the Ishak fibrosis score was found in 25.7% (9/35) of the ETV group, and the mean change from the baseline in the Ishak fibrosis score was a 0.3-point reduction. The control group showed disease progression in the Ishak fibrosis score. More patients in the ETV group than in the control group had undetectable serum HBV DNA levels (82.9% vs. 3.1%, p<0.05) and ALT normalization (68.6% vs. 18.3%, p<0.05). The ETV treatment group demonstrated an improvement in Child-Pugh score at week 52 (-3.7 vs. 0.3, p<0.05). In addition, no obvious adverse reactions were observed during ETV treatment.
  
  
  CONCLUSIONS
  ETV is safe and effective in patients with advanced schistosomiasis and HBV co-infection.
authors.affiliation: Institute of Liver Diseases in Wuxi City, The Fifth People's Hospital of Wuxi, Wuxi, China.
authors.forename: Li-Hua
authors.initials: LH
authors.lastname: Huang
authors.forename: Yuan-Wang
authors.initials: YW
authors.lastname: Qiu
authors.forename: Hai-Yong
authors.initials: HY
authors.lastname: Hua
authors.forename: Xue-Hua
authors.initials: XH
authors.lastname: Niu
authors.forename: Peng-Fei
authors.initials: PF
authors.lastname: Wu
authors.forename: Hang-Yuan
authors.initials: HY
authors.lastname: Wu
authors.forename: Hong-Ying
authors.initials: HY
authors.lastname: Zhu
authors.forename: Xiao-Juan
authors.initials: XJ
authors.lastname: Yang
authors.forename: Shang-Zhi
authors.initials: SZ
authors.lastname: Yao
authors.forename: Yi-Guang
authors.initials: YG
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000378:metabolism; D060085:Coinfection; D005260:Female; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006509:Hepatitis B / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology / Q000821:virology; D006801:Humans; D008103:Liver Cirrhosis / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012549:Schistosoma japonicum; D012552:Schistosomiasis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; C413685:entecavir; D006147:Guanine