title: Lamivudine treatment for acute severe hepatitis B: a pilot study.
abstract: BACKGROUND
  Experience with lamivudine treatment of immunocompetent patients with acute hepatitis B is limited.
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of lamivudine for the treatment of acute severe hepatitis B virus (HBV) infection in immunocompetent adults.
  
  
  METHODS
  Fifteen patients (10 men, 5 women, mean age 34.3+/-7.3 years) with severe acute HBV infection were treated with lamivudine 100 mg daily for 3-6 months, starting 3-12 weeks after onset of infection. Prior to treatment, 5 patients had grade 1-4 encephalopathy; all patients had severe coagulopathy (mean INR was 4.5+/-6.4), and all patients had evidence of severe hepatocyte lysis (mean alanine aminotransferase 3738+/-1659 U/L, and mean total serum bilirubin 18+/-6.8 mg/dl). All patients had evidence of highly replicative HBV (mean HBV DNA 13.5 x 10(6)+/-11 x 10(6) copies/ml).
  
  
  RESULTS
  Thirteen patients (86.6%) responded to treatment. Encephalopathy disappeared within 3 days of treatment and coagulopathy improved within 1 week. Serum HBV DNA was undetectable (by polymerase chain reaction) within 4 weeks, and serum liver enzyme levels normalized within 8 weeks. Two patients in whom lamivudine therapy was delayed developed fulminant hepatitis and underwent urgent liver transplantation. (One died of vascular complications 1 month later). The 11 patients who were serum HBeAg-positive before treatment seroconverted, and HBeAb developed within 12 weeks in 9 of them; HBsAg was undetectable in all 11 tested patients, and protective titer of HBsAb developed within 12-16 weeks in 9 of them. Therapy was well tolerated in all cases.
  
  
  CONCLUSIONS
  These data indicate that lamivudine induces a prompt clinical, biochemical, serological and virological response in immunocompetent patients with de novo HBV infection. Lamivudine may prevent the progression of severe acute disease to fulminant or chronic hepatitis and should be considered for use in selected patients. A large randomized controlled, double-blind prospective study is needed.
authors.affiliation: Gastroenterology Unit, Rabin Medical Center, Golda Campus, Israel.
authors.forename: H
authors.initials: H
authors.lastname: Schmilovitz-Weiss
authors.forename: Z
authors.initials: Z
authors.lastname: Ben-Ari
authors.forename: E
authors.initials: E
authors.lastname: Sikuler
authors.forename: E
authors.initials: E
authors.lastname: Zuckerman
authors.forename: W
authors.initials: W
authors.lastname: Sbeit
authors.forename: Z
authors.initials: Z
authors.lastname: Ackerman
authors.forename: R
authors.initials: R
authors.lastname: Safadi
authors.forename: Y
authors.initials: Y
authors.lastname: Lurie
authors.forename: G
authors.initials: G
authors.lastname: Rosner
authors.forename: R
authors.initials: R
authors.lastname: Tur-Kaspa
authors.forename: R
authors.initials: R
authors.lastname: Reshef
mesh_terms: D000208:Acute Disease; D000328:Adult; D004279:DNA, Viral / Q000032:analysis; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D016867:Immunocompromised Host; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D010865:Pilot Projects; D016133:Polymerase Chain Reaction / Q000379:methods; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D004279:DNA, Viral; D019259:Lamivudine