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

摘要: Evaluate the safety and efficacy of 104-week regimen Telbivudine(LdT)-based optimization strategy for Chinese patients who have chronic hepatits B(CHB) with HBeAg-negative. This multi-center, open-label, prospective study enrolled 108 HBeAg-negative CHB received LdT (600 mg/day) 24 weeks, Adefovir (ADV) was added if HBV DNA remained detectable at week 24, otherwise maintained to use until 104 weeks. DNA, alanine amino transferase (ALT), hepatitis B surface antigen(HBsAg), creatinine kinase(CK), estimated glomerular filtration rate (eGFR) were measured, assessed. Eighty-eight (81%) had HBV-DNA undetectable 24 weeks receive monotherapy 104 weeks, whereas other 20 ADV used in combination. For all patients, 72% reached ALT normalization which increased 80% 52 weeks respectively.. 81% total 92% 52 weeks, 94% The HBsAg titre declined steadily from baseline 104 weeks (3.62 vs. 2.98 log10 IU/mL, p < 0.05), eGFR (92.9 104.4 mL/min/1.73 m2, p < 0.05). Although 79 (73%) least one time elevated CK, most these CK Grade 1/2. well tolerated effective, achieved virological suppression after registered clinicaltrials.gov on January 31, 2012 ID No. NCT01521975 .