Efficacy of 104-week Telbivudine-based optimization strategy in patients with HBeAg-negative chronic hepatitis B virus infections
Weiqiang Gan 1 , Jianguo Li 1 , Chunlan Zhang 2 , Xuefu Chen 3 , Chaoshuang Lin 4 , Zhiliang Gao 5
Affiliations
Affiliations
1
Department of Infectious Disease, The Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe District, Guangzhou, 510630, Guangdong Province, China.
2
First Department of Liver Disease, Guangzhou Eighth People's Hospital, Guangzhou, 510000, Guangdong Province, China.
3
Department of Infectious Disease, Guangdong General Hospital, Guangzhou, 510000, Guangdong Province, China.
4
Department of Infectious Disease, The Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe District, Guangzhou, 510630, Guangdong Province, China. [email protected].
5
Department of Infectious Disease, The Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe District, Guangzhou, 510630, Guangdong Province, China. [email protected].
PMID: 33287722 DOI: 10.1186/s12879-020-05642-y
Free article
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 < 0.05), and the eGFR increased steadily from baseline to 104 weeks (92.9 vs. 104.4 mL/min/1.73 m2, p < 0.05). Although 79 patients (73%) had at least one time of elevated CK, most of these patients had CK elevated in Grade 1/2.
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 .
结果：88例患者（81％）在24周时未检测到HBV-DNA，并维持接受LdT单药治疗直至104周，而其他20例患者可检测到HBV-DNA，并联合使用ADV。所有患者中，有72％的患者在24周时达到ALT正常化水平，分别在52周和104周时达到ALT正常化。总患者中有81％在24周时检测不到HBV-DNA，在52周时有92％， 104周时为94％。 HBsAg滴度从基线下降至104周（3.62比2.98 log10 IU / mL，p <0.05），eGFR从基线稳定上升至104周（92.9 vs. 104.4 mL / min / 1.73 m2，p <0.05 ）。尽管79例患者（73％）的CK升高至少达到了1倍，但这些患者大多数都具有1/2级的CK升高。