Baltic Post-marketing Study of Pegilated Interferon α-2a 40 KD Efficacy and Safety in Patients with HBeAg-Positive and HBeAg- Negative Chronic Hepatitis B

Introduction: Pegilated interferon alpha-2a 40KD (Pegasys®) is registered in European Union, and is indicated for the treatment of HBeAg positive or HBeAg negative chronic hepatitis B in adult patients with compensated liver disease, evidence of viral replication and increased ALT. The aim of this study was to evaluate efficacy and safety of Pegasys® for Pegasys® treatment naive patients with HBeAg positive and HBeAg negative chronic hepatitis B. Materials and methods: Multicenter trial design (8 centers in the Baltic States), prospective, non-randomized, open label study. In total, 39 patients with chronic active hepatitis B were enrolled in the study. Study drug – Pegasys® 180 mcg, once per week. After completion of the treatment, patients were followed up for additional 24 weeks. Neutrophils, platelets, ALT, HBV DNA, HBeAg, HBsAg, HBeAb, and HBsAb were controlled. Results: For efficacy assessment, 36 patients were analyzed. Safety analysis was performed for 39 patients. No serious adverse events and laboratory abnormalities were observed for 37 patients. Adverse events were self limited without drug ordination after stopping the study medication. Conclusions: Peg-interferon α-2a 40 KD–Pegasys® therapy for chronic hepatitis B patients is efficient and demonstrates good tolerability, minimal number of self limited side effects–only neutropenia, thrombocytopenia.