艾米替诺福韦治疗慢性乙型肝炎患者的早期疗效:一项真实世界多中心临床研究

肝脏 ›› 2023, Vol. 28 ›› Issue (1): 100-104.

艾米替诺福韦治疗慢性乙型肝炎患者的早期疗效:一项真实世界多中心临床研究

李亚萍, 崔丹丹, 苟国娥, 蔺咏梅, 祖红梅, 徐光华, 高晓红, 党双锁

710004 陕西西安交通大学第二附属医院(李亚萍,崔丹丹,苟国娥,党双锁);西安交通大学附属三二〇一医院(蔺咏梅);青海省第四人民医院(祖红梅);延安大学附属医院(徐光华,高晓红)

收稿日期:2022-10-30 出版日期:2023-01-31 发布日期:2023-02-21
通讯作者: 党双锁,Email:dang212@126.com

Early efficacy of tenofovir amibufenamide (TMF) in the treatment of patients with chronic hepatitis B: a real-word multicenter clinical study

LI Ya-ping¹, CUI Dan-dan¹, GOU Guo-e¹, LIN Yong-mei², ZU Hong-mei³, XU Guang-hua⁴, GAO Xiao-hong⁴, DANG Shuang-suo¹

1. The Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi 710004, China;
2. 3201 Hospital Affiliated to Xi'an Jiaotong University, Hanzhong 723000, China;
3. The Fourth People's Hospital of Qinghai Province, Xining 810000, China;
4. Affiliated Hospital of Yan'an University, Shaanxi 716000, China

Received:2022-10-30 Online:2023-01-31 Published:2023-02-21
Contact: DANG Shuang-suo,Email:dang212@126.com

摘要/Abstract

摘要： 目的探讨艾米替诺福韦(tenofovir amibufenamide, TMF)治疗慢性乙型肝炎(chronic hepatitis B, CHB)患者的早期疗效。方法该项多中心、前瞻性、真实世界研究纳入2021年8月—2022年8月就诊于4所研究中心感染科门诊使用TMF抗病毒治疗的91例CHB患者,收集其临床资料,比较12周、24周时患者HBV DNA的变化、丙氨酸氨基转移酶(alanine transaminase, ALT)复常率、乙型肝炎e抗原 (hepatitis B e antigen, HBeAg)和乙型肝炎表面抗原(hepatitis B surface antigen, HBsAg)血清学转换情况及肾功能、血脂代谢情况。结果 24周时共入组91例患者,初治28例,经治63例。在抗病毒治疗12周、24周时实现完全病毒学应答初治患者分别有17.4%、47.9%,经治患者分别有48.4%、58.1%。基线与12周、24周初治患者HBV DNA [(4.88±0.54) lg IU/mL vs (2.69±0.35) lg IU/mL vs (2.40±0.39) lg IU/mL]显著降低(F=24.51,P<0.001);经治患者HBV DNA[(2.67±0.31) lg IU/mL vs (1.70±0.24) lg IU/mL vs (1.49±0.09) lg IU/mL]较前下降(F=5.83, P=0.009)。基于实验室标准12周及24周的ALT复常率分别为64%和92%,AASLD 2018标准12周及24周的复常率分别为38.4%和73.9%。治疗24周后4.53%的患者HBeAg转阴,2.17%出现HBeAg血清转换,1.09%的患者HBsAg转阴,暂未出现HBsAg血清学转换患者。安全性方面,与基线相比CHB患者治疗24周时血Cr、eGFR、CysC无显著变化,对已有早期肾损伤的33例经治患者换用TMF继续抗病毒治疗24周后尿α1-MG和尿NAG、尿β2-MG较基线明显下降(P值均<0.05)。与基线相比,TG有下降趋势,TC有升高趋势,但差异无统计学意义。结论 TMF治疗CHB患者早期疗效显著,总体安全性相对良好。

关键词: 慢性乙型肝炎, 艾米替诺福韦, 抗病毒, 疗效, 真实世界

Abstract: Objective To evaluate the efficacy and safety of tenofovir amibufenamide (TMF) in the treatment of patients with chronic hepatitis B (CHB). Methods In this multicenter, prospective, real-world cohort study, we recruited 91 patients with CHB who attended the outpatient clinic of the Department of Infection of the 4 sites from August 2021 to August 2022 and were treated with TMF antiviral therapy. We collected clinical data, and compared the changes of HBV DNA, alanine transaminase (ALT), hepatitis B virus e antigen (HBeAg) and hepatitis B virus surface antigen (HBsAg) conversion, renal function and lipid metabolism at 12W and 24W. Results A total of 91 CHB patients were enrolled at 24W, 28 patients in treatment-naïve and 63 patients in previously treated. Complete virological response was achieved in 17.4% and 47.9% of treatment-naïve patients at 12W and 24W. The proportion of treated patients achieving complete virological response at 12W and 24W was 48.4% and 58.1%, respectively. HBV DNA [(4.88±0.54) lg IU/mL vs (2.69±0.35) lg IU/mL vs (2.40±0.39 lg IU/mL)] was significantly lower compared to baseline and 12W primary patients (F=24.51, P=0.000); HBV DNA in previously treated patients[(2.67±0.31) lg IU/mL vs (1.70±0.24) lg IU/mL vs (1.49±0.09) lg IU/mL decreased from before (F=5.83, P=0.009). The ALT recurrence rates based on laboratory criteria were 64% and 92% for 12W and 24W, respectively. And the ALT recurrence rates were 38.4% and 78.9% for 12W and 24W using AASLD 2018 criteria. After 24W of antiviral therapy 4.53% of patients had HBeAg conversion, 2.17% of patients had HBeAg seroconversion, 1.09% of patients had HBsAg conversion, no patients have yet had HBsAg seroconversion. In terms of safety, there was no significant change in blood Cr, eGFR and CysC at 24 weeks of antiviral therapy in CHB patients compared with baseline. 33 treated patients who had early kidney injury switched to TMF and continued antiviral therapy for 24W had a significant decrease in urinary α1-MG and urinary NAG and urinary β2-MG compared with baseline, with P values <0.05, which were statistically significant. Compared with baseline, there was a trend of decreasing TG and increasing TC, but the difference was not statistically significant.Conclusion TMF is effective and safe in the treatment of patients with CHB.

Key words: Chronic Hepatitis B, Tenofovir amibufenamide, Antiviral, Efficacy, Real world

李亚萍, 崔丹丹, 苟国娥, 蔺咏梅, 祖红梅, 徐光华, 高晓红, 党双锁. 艾米替诺福韦治疗慢性乙型肝炎患者的早期疗效:一项真实世界多中心临床研究[J]. 肝脏, 2023, 28(1): 100-104.

LI Ya-ping, CUI Dan-dan, GOU Guo-e, LIN Yong-mei, ZU Hong-mei, XU Guang-hua, GAO Xiao-hong, DANG Shuang-suo. Early efficacy of tenofovir amibufenamide (TMF) in the treatment of patients with chronic hepatitis B: a real-word multicenter clinical study[J]. Chinese Hepatolgy, 2023, 28(1): 100-104.

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