title: A randomized controlled trial of lamivudine to treat acute hepatitis B.
abstract: The role of antivirals in patients with acute viral hepatitis B (AVH-B) has not been evaluated in controlled trials. The aim of this study was to evaluate the efficacy of lamivudine in patients with AVH-B. AVH-B patients with serum bilirubin of more than 5 mg/dL were randomized to receive either 100 mg of lamivudine daily for 3 months (group 1, n = 31) or placebo (group 2, n = 40). Patients were considered to have severe AVH-B if they fulfilled 2 of 3 criteria: (1) hepatic encephalopathy; (2) serum bilirubin > or = 10.0 mg/dL; and (3) international normalized ratio (INR) > or = 1.6. At week 4, HBV DNA levels were significantly lower (P = 0.037) in group 1 (median: 3.6721 log copies/mL) than group 2 (median: 4.2721 log copies/mL). Thereafter, HBV DNA levels were comparable in the 2 groups. The improvement in serum bilirubin, ALT, and INR values was similar in the 2 groups. Twenty-two patients (71%) in group 1 and 25 patients (62.5%) in group 2 had severe AVH-B. Results were similar when patients with severe AVH-B were analyzed separately. After 12 and 18 months, 93.5% and 92.5%, respectively, of patients in the lamivudine group and 96.7% and 97.5%, respectively, of patients in the placebo group lost HBsAg. There were no deaths in either group. After 1 year, 21 patients (67.7%) in group 1 and 34 patients (85%) in group 2 developed protective anti-HBs titers (P = 0.096). All HBeAg-positive patients in both groups lost e antigen and anti-HBe developed in 71% and 87.5% of patients in groups 1 and 2, respectively (P = 0.132).
  
  
  CONCLUSIONS
  Though lamivudine causes a greater decrease in levels of HBV DNA, it does not cause significantly greater biochemical and clinical improvement as compared to placebo in patients with acute hepatitis B.
authors.affiliation: Department of Gastroenterology, GB Pant Hospital, New Delhi, India.
authors.forename: M
authors.initials: M
authors.lastname: Kumar
authors.forename: S
authors.initials: S
authors.lastname: Satapathy
authors.forename: R
authors.initials: R
authors.lastname: Monga
authors.forename: K
authors.initials: K
authors.lastname: Das
authors.forename: S
authors.initials: S
authors.lastname: Hissar
authors.forename: C
authors.initials: C
authors.lastname: Pande
authors.forename: B C
authors.initials: BC
authors.lastname: Sharma
authors.forename: S K
authors.initials: SK
authors.lastname: Sarin
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D001663:Bilirubin / Q000097:blood; D002648:Child; D004279:DNA, Viral / Q000378:metabolism; D005260:Female; D006509:Hepatitis B / Q000188:drug therapy* / Q000276:immunology* / Q000378:metabolism; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D006801:Humans; D007121:Immunocompetence / Q000276:immunology*; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D001663:Bilirubin