ABSTRACT
Comparative placebo-controlled study entrolled 647 patients with verified diagnosis of chronic virus hepatitis B (HBeAg+), not previously subjected to antiviral therapy (with nucleotide analogues or interferons). The drug under the investigation was cycloferon, an earlier interferon inductor. The antiviral combination therapy of the main group patients (323 subjects) included the use of cycloferon + lamivudine for 48 weeks and the therapy of the control group patients (324 subjects) included the use of lamivudine + placebo for 48 weeks. The cycloferon and lamividine combination antiviral therapy was shown preferable vs. the lamivudine + placebo therapy by biochemical remission, virusological response, seroconversion by HBeAg by the 48th week of the treatment and HBsAg clearance. The conbination therapy provided lower frequency of the relapses within 24 weeks of the observation. The higher efficacy of the antiviral combination therapy was evident of the impact of the antiviral activity of cycloferon itself and its immunomodulating and interferon-inducing activity on elimination of the virus-infected hepatocytes. The use of the 48-week course of the antiviral combination therapy is advisable as the prime treatment in the management of patients with HBeAg-positive chronic hepatitis not previously treated with nucleoside analogues and as a variant of therapy for lamivudine-refractory patients.
