Efficacy of 104-week Telbivudine-based optimization strategy in patients with HBeAg-negative chronic hepatitis B virus infections.

ABSTRACT: Background: Evaluate the safety and efficacy of 104-week regimen of Telbivudine(LdT)-based optimization strategy for Chinese patients who have chronic hepatits B(CHB) with HBeAg-negative.

Methods: This multi-center, open-label, prospective study enrolled 108 HBeAg-negative CHB patients who received LdT (600?mg/day) for 24?weeks, Adefovir (ADV) was added if HBV DNA remained detectable at week 24, otherwise LdT was maintained to use until 104?weeks. HBV DNA, alanine amino transferase (ALT), hepatitis B surface antigen(HBsAg), creatinine kinase(CK), and estimated glomerular filtration rate (eGFR) were measured, safety was assessed.

Results: Eighty-eight patients (81%) had HBV-DNA undetectable at 24?weeks and maintained to receive LdT monotherapy until 104?weeks, whereas the other 20 patients had HBV-DNA detectable and ADV was used in combination. For all patients, 72% of patients reached ALT normalization at 24?weeks, which increased to 80% at 52?weeks and 104?weeks, respectively.. 81% of total patients had undetectable HBV-DNA at 24?weeks, 92% at 52?weeks, and 94% at 104?weeks. The HBsAg titre declined steadily from baseline to 104?weeks (3.62 vs. 2.98 log10 IU/mL, p?2, p?
Conclusions: LdT was well tolerated and effective, and 94% of patients achieved virological suppression after 104?weeks.

Trial registration: This study was registered in clinicaltrials.gov on January 31, 2012 and the ID No. was NCT01521975 .

SUBMITTER: Gan W 

PROVIDER: S-EPMC7720458 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature