Background/aims: Current international guidelines indicate that finite therapy with nucleos(t)ide analogues (NAs) is possible in chronic hepatitis B (CHB) patients. Here we evaluate the durability of efficacy after telbivudine (LdT) off-treatment.
Methods: 39 CHB patients with normalized ALT, undetectable HBV-DNA and HBeAg seroconversion for at least 48 weeks were observed after telbivudine discontinuation. We analyzed the follow-up clinical condition of off-treatment, calculated the cumulative clinical relapse rate, and explored the predictive factors for clinical relapse.
Results: Totally 8 patients encountered clinical relapse in the first 60 weeks after telbivudine discontinuation. The cumulative clinical relapse rates at week 24, 48, 60 and 204 were respectively 2.6%, 7.7%, 16.3% and 23.3%. No significant difference was found between cumulative clinical relapse rates of HBeAg(+) and HBeAg(-). No significant baseline or on-treatment factors for clinical relapse were found.
Conclusion: The present study demonstrated that most CHB patients maintained sustained response and HBeAg seroconversion following telbivudine off-treatment. Clinical relapses may often occur in the early period, with low clinical relapse rate. More follow-up data will be on-going and complemented in the further studies.
Keywords: CHB; Durability; Relapse; Telbivudine; Withdraw.
Copyright © 2013. Published by Elsevier B.V.