title: Treatment with lamivudine and entecavir in severe acute hepatitis B.
abstract: BACKGROUND
  Severe acute hepatitis B (SAHB) is an insufficiently described clinical entity, with relatively scarce data on anti-viral therapy available in field literature.
  
  
  METHODS
  We performed an open-label study to evaluate specific anti-viral therapy in SAHB in Bucharest, Romania, during 2005-2009. Patients were allocated to two treatment groups and one control group: Group 1 - lamivudine 100 mg/day, Group 2 - entecavir 0.5 mg/day and Group 3 - standard of care, without anti-viral therapy. The primary endpoint was hepatitis B surface antigen (HBsAg) to hepatitis B surface antibody (anti-HBs) seroconversion by 24 weeks. Additional analyses included assessment of HBsAg clearance and hepatitis B e antigen (HBeAg) to hepatitis B e antibody (anti-HBe) seroconversion.
  
  
  RESULTS
  In Group 1, 7/69 patients (10.14%, P = 0.032) reached HBsAg/Ab seroconversion by 24 weeks, compared with 9/21 (42.85%, P = 0.053) in Group 2 and 25/110 (22.72%) in Group 3. HBsAg clearance by 24 weeks: 16/69 patients (23.18%, P = 0.027) in Group 1, 11/21 (52.38%, P = 0.256) in Group 2 and 43/110 (39.09%) in Group 3. HBeAg/Ab seroconversion: 46/61 (75.40%, P = 0.399) in Group 1, 9/19 (47.36%, P = 0.001) in Group 2 and 74/100 (74.00%) in Group 3.
  
  
  CONCLUSIONS
  Anti-viral therapy can be considered for managing selected cases of SAHB. Biochemical as well as virological parameters need to orient the choice of the anti-viral agent. Lamivudine displayed a greater decrease in viral load compared to controls, but it was associated with lower levels of HBsAg to anti-HBs seroconversion. Patients treated with entecavir showed a better response in terms of HBs seroconversion by 24 weeks.
authors.forename: A
authors.initials: A
authors.lastname: Streinu-Cercel
authors.affiliation: Department of Infectious Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest 050474,; Department of Adults II, National Institute for Infectious Diseases, Bucharest 021105, Romania.
authors.forename: O
authors.initials: O
authors.lastname: Sandulescu
authors.forename: M
authors.initials: M
authors.lastname: Stefan
authors.forename: A
authors.initials: A
authors.lastname: Streinu-Cercel
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D005260:Female; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006509:Hepatitis B / Q000188:drug therapy*; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012383:Romania; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D019259:Lamivudine; C413685:entecavir; D006147:Guanine