title: [Meglumine acridonacetate in combined antiviral treatment of HBeAg-positive chronic hepatitis B].
abstract: 647 patients with HBeAg positive chronic hepatitis B who have not previously received antiviral therapy were participated in randomized, post-marketing, double-blinded, placebo-controlled clinical trial. Interferon inducer cycloferon was presented as study drug. 323 patients with chronic hepatitis B (HBV) with "wild" HBeAg(+) strain of HBV were treated with cycloferon and Lamivudin for 48 weeks. Control group included 324 patients with similar pathology, treated with Lamivudin and placebo for 48 weeks. The study has shown the benefit of cycloferon+lamivudin treatment in comparison with lamivudin monotherapy. Improving of liver histology in 48 weeks of the therapy was observed in 71% of patients in Study group in comparison with 57% in control group (p<0.01). Combined therapy has resulted in decrease of relapse by 24 week of the follow-up period (13% vs. 86%, p<0.001). The higher efficacy of cycloferon+lamivudin in patients with HBeAg positive chronic hepatitis B has proven the role of own antiviral effect of interferon inducer cycloferon, interferon effect of cycloferon in the elimination of virus-infected hepatocytes, as well as the presence of an immunomodulatory effect of the preparation, aimed at the elimination of HBeAg and HBsAg with the following seroconversion. 48-week course of combined antiviral therapy of HBeAg-positive patients with chronic hepatitis B is recommended as first-line therapy for patients with HBeAg-positive chronic hepatitis B, who have not previously received nucleoside analogues, as well as alternative therapy of Lamivudin-refractory patients.
authors.forename: V V
authors.initials: VV
authors.lastname: Stel'makh
authors.forename: S V
authors.initials: SV
authors.lastname: Okovityĭ
authors.forename: M G
authors.initials: MG
authors.lastname: Romantsov
authors.forename: N Kh
authors.initials: NKh
authors.lastname: Tuan
authors.forename: M
authors.initials: M
authors.lastname: Oiungerel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006513:Hepatitis B e Antigens / Q000276:immunology*; D006515:Hepatitis B virus / Q000276:immunology*; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008536:Meglumine / Q000627:therapeutic use*; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D008536:Meglumine