Liver International
Volume 31, Issue 5, pages 676–684, May 2011
Abstract
Background: In the GLOBE trial, telbivudine demonstrated superior efficacy
to lamivudine at 2 years in patients with chronic hepatitis B (CHB).
Aims: To investigate the long-term efficacy and safety of telbivudine in
the telbivudine-treated cohort from the GLOBE trial.
Methods: Virological and biochemical responses were assessed in 213
HBeAg-positive and 186 HBeAg-negative CHB patients who continued
telbivudine treatment for 3 years.
Results: Undetectable hepatitis B virus DNA and HBeAg seroconversions were
achieved by 77 and 37% of HBeAg-positive patients respectively. Cumulative
HBeAg seroconversion rate was 46%. HBeAg seroconversion was sustained at 52
weeks off therapy in 84% of the patients enrolled in the off-treatment
follow-up arm of the study. Undetectable viraemia and normal alanine
aminotransferase (ALT) levels at 3 years were achieved by 85 and 83% of
HBeAg-negative patients respectively. Genotypic resistance rates for the
study population who continued therapy during the third year were 11.3 in
HBeAg-positive and 6.5% in HBeAg-negative patients. Patients with
undetectable viraemia at treatment week 24 had optimal outcomes at 3 years.
In the HBeAg-positive population, cumulative HBeAg seroconversion occurred
in 58%. Resistance rates for HBeAg-positive and HBeAg-negative patients
were 3.6 and 6.2% respectively. The telbivudine safety profile during
prolonged therapy was similar to that in the GLOBE trial.
Conclusions: Three years of telbivudine treatment yielded high rates of
viral suppression and ALT normalization with a favourable safety profile.
High rates of HBeAg seroconversion were achieved with prolonged telbivudine
therapy and were sustained in the majority of patients over 52 weeks off
therapy.作者: StephenW 时间: 2011-4-6 15:24