title: Comparison of lamivudine and alpha-interferon combination with alpha-interferon alone in the treatment of HBeAg-positive chronic hepatitis B.
abstract: OBJECTIVE
  To compare the efficacy of a combination of a-interferon (IFN-a) and lamivudine with IFN-a alone in the treatment of patients with HBeAg-positive chronic hepatitis B (CHB).
  
  
  METHODS
  Sixty-eight treatment-naove patients with HBeAg-positive CHB were randomized to receive either 9 MU of IFN-a2a three times a week and lamivudine 100 mg daily (Group 1), or IFN-a2a alone in the same dosage (Group 2), for 12 months. Serum ALT, HBeAg, anti-HBe and HBV DNA were tested at the end of treatment and 6 months later. Complete response was defined as normal ALT, negative HBeAg and negative HBV DNA, six months after stopping treatment.
  
  
  RESULTS
  Of the 68 patients, 64 completed the study. In Group 1 (n=31), mean (SD) ALT levels decreased from 124 (59) IU/L to 39 (18) IU/L at 12 months; corresponding values in Group 2 (n=33) were 128 (57) and 56 (11) IU/L (p< 0.05). Absence of HBV DNA at the end of treatment was more common in Group 1 (28/31) than in Group 2 (22/33; p< 0.022). The number of patients with seroconversion to anti-HBe (4/31 [13%] vs. 4/33 [12%], respectively; p>0.05), as also those with complete response (4/31 [13%] and 4/33 [12%], respectively; p>0.05) six months after completion of treatment was similar in Group 1 and Group 2.
  
  
  CONCLUSIONS
  Combination treatment with IFN-a and lamivudine was better than IFN-a monotherapy in normalization of ALT and clearance of HBV DNA; however, it did not have a better sustained response rate than IFN-a alone.
authors.affiliation: Department of Clinical Microbiology and Infection Diseases, Dicle University Medical School, Diyarbakir, Turkey.
authors.forename: Celal
authors.initials: C
authors.lastname: Ayaz
authors.forename: Mustafa Kemal
authors.initials: MK
authors.lastname: Celen
authors.forename: Habibe
authors.initials: H
authors.lastname: Colak
authors.forename: Salih
authors.initials: S
authors.lastname: Hosoglu
authors.forename: Mehmet Faruk
authors.initials: MF
authors.lastname: Geyik
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D019259:Lamivudine