104周基于替比夫定的优化策略对HBeAg阴性慢性乙型肝炎病毒感

StephenW

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 .

Keywords: Chronic hepatitis B; HBeAg; Telbivudine; eGFR.

StephenW

104周基于替比夫定的优化策略对HBeAg阴性慢性乙型肝炎病毒感染患者的疗效
甘为强1，李建国1，张春兰2，陈学福3，林朝双4，高志良5
隶属关系
隶属关系

    1个
    广东省广州市天河区天河路600号中山大学附属第三医院感染科
    2
    广州市第八人民医院肝病科，广东省广州市510000。
    3
    广东省总医院传染病科，广东省广州市510000。
    4
    广东省广州市天河区天河路600号中山大学附属第三医院感染科[email protected]。
    5
    广东省广州市天河区天河路600号中山大学附属第三医院感染科[email protected]。

    PMID：33287722 DOI：10.1186 / s12879-020-05642-y

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抽象

背景：评估基于Telbivudine（LdT）的104周方案对HBeAg阴性的慢性乙型肝炎（CHB）中国患者的安全性和有效性。

方法：这项多中心，开放性，前瞻性研究招募了108名接受LdT（600毫克/天）治疗24周的HBeAg阴性CHB患者，如果在第24周仍可检测到HBV DNA，则添加阿德福韦（ADV），否则维持使用至104周。测量HBV DNA，丙氨酸氨基转移酶（ALT），乙型肝炎表面抗原（HBsAg），肌酐激酶（CK）和估计的肾小球滤过率（eGFR），评估安全性。

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。

结论：LdT具有良好的耐受性和有效性，并且104周后94％的患者获得了病毒学抑制。

试验注册：该研究于2012年1月31日在Clinicaltrials.gov上注册，ID号为NCT01521975。

关键字：慢性乙型肝炎；乙肝抗原替比夫定; eGFR。

StephenW

https://bmcinfectdis.biomedcentr ... 879-020-05642-y.pdf

lancas

。。。替比夫定。。。。