Efficacy and Safety of Telbivudine as First-Line Therapy in Patients With Compensated Chronic Hepatitis B

Introduction: Chronic hepatitis B (CHB) is a global health problem, with more than 350 million people worldwide infected with hepatitis B virus. Telbivudine, a synthetic thymidine nucleoside analogue, is effective for the treatment of patients with CHB. Methods: This was a non-interventional, observational study conducted in Austria. Treatment of patients with telbivudine (Sebivo^®) was in accordance with the actual approved label. Patients were recruited and observed between 28 June 2007 and 22 September 2013. The recommended dose of telbivudine was 600 mg daily. The visits and assessments were performed within the 1-year period. During the observation time, visits took place every 3 months. Results: A total of 80 patients with CHB were enrolled from nine centres. Fifty four patients were males and 26 were females who received first-line telbivudine. Efficacy: Patients received telbivudine at a dose of 600 mg/day. The median viral load was reduced from 1410692 to 19 copies/mL during the observation period (median: 392 days, range: 76 – 829 days). HbeAg seroconversion was documented in 9 patients. The visual analogue scale (VAS) was used to evaluate the quality of life of patients. The subjective well-being was stable during the observational period. The rates of HBeAg seroconversion increased over time from 5% at visit 2 to 12.5% at visit 5. Higher rates of negative HBV DNA levels were observed during the course of the study. Safety: In total, 32 adverse events (AEs) were reported in this study. Out of the 80 patients, 19 (23.7%) patients experienced at least one AE. In total, nine AEs in 8 patients: abdominal pain (1), increased CK (3), myalgia/myopathy (4) and neuropathy (1), which were deemed related to the study drug. Conclusions: Results showed that treatment with telbivudine as first-line therapy was effective and well tolerated in patients with CHB in real-world clinical practice.