无论基线病毒载量如何，长期使用替诺福韦治疗中国核苷（t

StephenW

Exp Ther Med. 2019 Jul;18(1):260-268. doi: 10.3892/etm.2019.7547. Epub 2019 May 6.
Efficacy of long-term treatment with tenofovir in Chinese nucleos(t)ide-naïve chronic hepatitis B patients regardless of baseline viral load.
Luo J1, You X2, Chong Y3, Wu Y3, Gong J4, Jie Y3, Li X3, Xi S3, Zhang Z3, Zhang Y3, Xie D3, Li Z3, Li X3.
Author information

1
    Department of Hepatology, The Third Affiliated Hospital of Shenzhen University, Shenzhen Luohu People's Hospital, Shenzhen, Guangdong 518000, P.R. China.
2
    Department of Clinical Laboratory, The Third Affiliated Hospital of Southern Medical University, Guangzhou, Guangdong 510630, P.R. China.
3
    Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.
4
    Department of Clinical Laboratory, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.

Abstract

The aim of the present study was to analyze the efficacy and safety of tenofovir (TDF) treatment for up to 5 years in nucleos(t)ide-naïve chronic hepatitis B (CHB) patients, particularly those with a high viral load, a in real-life scenario. A total of 144 nucleos(t)ide-naïve CHB patients who received TDF monotherapy for at least 3 months were retrospectively analyzed. The primary endpoint measure was the achievement of virological response (VR; undetectable serum HBV DNA, <100 IU/ml). The secondary endpoints were alanine aminotransferase (ALT) normalization (ALT < upper limit of normal), hepatitis B e antigen (HBeAg) seroconversion and safety. The median follow-up period was 120 weeks (range, 12-264 weeks). In total, 144, 130, 114, 78, 67, 40 and 13 patients were followed up for at least 12, 24, 48, 96, 144, 192 and 240 weeks, respectively. An incremental trend was observed in the rate of VR: 73.1, 91.3, 98.1, 100, 100 and 100% of the patients exhibited VR at 24, 48, 96, 144, 192 and 240 weeks, respectively. Furthermore, 29 patients with hepatitis B virus (HBV) DNA ≥8 log10 IU/ml at baseline achieved VR during the follow-up period. The proportions of patients achieving normal ALT levels were 72.1, 78.6, 91.2, 95, 96 and 100%, at 24, 48, 96, 144, 192 and 240 weeks, respectively. The rate of HBeAg loss reached 35.6% at week 240. Among the 130 patients, HBV DNA was detectable [partial VR (PVR)] in 35 patients at 24 weeks of follow-up, and 30 of those 35 patients (85.7%) required >24 weeks of further TDF therapy to achieve VR. No serious adverse events were reported. In conclusion, long-term TDF treatment of nucleos(t)ide-naïve chronic hepatitis B patients, regardless of high viral load at baseline, was effective and safe in a real-life scenario. Adjustment of TDF monotherapy may be unnecessary in nucleos(t)ide-naïve patients with PVR at 24 weeks.
KEYWORDS:

chronic; hepatitis B; nucleos(t)ide analogues; tenefovir

PMID:
    31258661
PMCID:
    PMC6566085
DOI:
    10.3892/etm.2019.7547

StephenW

Exp Ther Med。 2019年7月; 18（1）：260-268。 doi：10.3892 / etm.2019.7547。 Epub 2019年5月6日。
无论基线病毒载量如何，长期使用替诺福韦治疗中国核苷（t）未患慢性乙型肝炎患者的疗效。
罗J1，尤X2，庄Y3，吴Y3，龚J4，Jie Y3，李X3，席S3，张Z3，张Y3，谢D3，李Z3，李X3。
作者信息

1
深圳大学第三附属医院肝内科，深圳市罗湖区人民医院，广东深圳518000，中国。
2
南方医科大学附属第三医院检验科，广东广州510630，中国。
3
中山大学附属第三医院感染科，广东广州510630，中国。
4
中山大学附属第三医院临床实验室，广东广州510630，中国。

抽象

本研究的目的是分析替诺福韦（TDF）治疗核仁（t）初治慢性乙型肝炎（CHB）患者长达5年的疗效和安全性，特别是那些病毒载量高的患者，现实场景。共回顾性分析了接受TDF单药治疗至少3个月的144名核心（t）初始CHB患者。主要终点测量是病毒学应答的实现（VR;不可检测的血清HBV DNA，<100IU / ml）。次要终点是丙氨酸氨基转移酶（ALT）正常化（ALT <正常上限），乙型肝炎e抗原（HBeAg）血清转换和安全性。中位随访期为120周（范围12-264周）。总共有144,130,114,78,67,40和13名患者分别进行了至少12,24,48,96,144,192和240周的随访。在VR的速率中观察到增量趋势：73.1,91.3,98.1,100,100和100％的患者分别在24,48,96,144,192和240周时表现出VR。此外，29例基线时乙型肝炎病毒（HBV）DNA≥8log10 IU / ml的患者在随访期间达到VR。在24,48,96,144,192和240周时，达到正常ALT水平的患者比例分别为72.1％，78.6％，91.2％，95％，96％和100％。 240周时HBeAg丢失率达到35.6％。在130例患者中，随访24周时35例患者可检出HBV DNA [部分VR（PVR）]，35例患者中有30例（85.7％）需要> 24周的进一步TDF治疗以实现VR。未报告严重不良事件。总之，长期TDF治疗Nucles（t）ide-naïve慢性乙型肝炎患者，无论基线时的高病毒载量如何，在现实生活中都是有效和安全的。在24周时PVR患者的核心（t）初治患者可能不需要调整TDF单药治疗。
关键词：

慢性;乙型肝炎;核苷（酸）类似物; tenefovir

结论：
31258661
PMCID：
PMC6566085
DOI：
10.3892 / etm.2019.7547

StephenW

www.spandidos-publications.com/etm/18/1/260/download