Luo Jie, You Xu, Chong Yutian, Wu Yuankai, Gong Jiao, Jie Yusheng, Li Xinhua, Xi Sujuan, Zhang Zhiwei, Zhang Yufeng, Xie Dongying, Li Zhanyi, Li Xiangyong
Department of Hepatology, The Third Affiliated Hospital of Shenzhen University, Shenzhen Luohu People's Hospital, Shenzhen, Guangdong 518000, P.R. China.
Department of Clinical Laboratory, The Third Affiliated Hospital of Southern Medical University, Guangzhou, Guangdong 510630, P.R. China.
Exp Ther Med. 2019 Jul;18(1):260-268. doi: 10.3892/etm.2019.7547. Epub 2019 May 6.
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 log 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.
本研究的目的是分析在真实临床环境中，初治慢性乙型肝炎（CHB）患者接受替诺福韦（TDF）治疗长达5年的疗效和安全性，尤其是那些高病毒载量的患者。对总共144例接受TDF单药治疗至少3个月的初治CHB患者进行了回顾性分析。主要终点指标是实现病毒学应答（VR；血清HBV DNA检测不到，<100 IU/ml）。次要终点包括丙氨酸氨基转移酶（ALT）正常化（ALT<正常上限）、乙肝e抗原（HBeAg）血清学转换和安全性。中位随访期为120周（范围12 - 264周）。分别有144例、130例、114例、78例、67例、40例和13例患者至少随访了12周、24周、48周、96周、144周、192周和240周。观察到VR率呈递增趋势：分别有73.1%、91.3%、98.1%、100%、100%和100%的患者在24周、48周、96周、144周、192周和240周时实现VR。此外，29例基线时乙肝病毒（HBV）DNA≥8 log IU/ml的患者在随访期间实现了VR。实现ALT正常水平的患者比例在24周、48周、96周、144周、192周和240周时分别为72.1%、78.6%、91.2%、95%、96%和10
