[Efficacy and safety of tenofovir amibufenamide in the treatment of patients over 65 years of age with chronic hepatitis B]

Zhonghua Gan Zang Bing Za Zhi. 2024 Oct 20;32(10):904-909. doi: 10.3760/cma.j.cn501113-20240829-00402.
[Article in Chinese]

Abstract

Objective: To investigate the efficacy and safety of tenofovir amibufenamide in patients over 65 years old with chronic hepatitis B and liver cirrhosis. Methods: We recruited 45 patients in Linyi People's Hospital with chronic hepatitis B and liver cirrhosis who were treated with TMF antiviral therapy for 48 weeks, compared the virologic response rate and HBV DNA decrease level at 12, 24 and 48 weeks, and the changes in hepatitis B surface antigen, alanine aminotransferase, glomerular filtration rate, creatinine, triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, serum phosphorus and blood lipids, and the changes in ALT normalization rate at 48 weeks. P<0.05 was statistically significant. Results: The age of the enrolled patients was 69.0 (67.0, 72.5) years. At 12, 24, and 48 weeks of treatment, the complete virological response rates were 32.4% (12/37), 70.0% (28/40), and 84.6% (33/39) respectively, and the level of HBV DNA decreased from baseline (P<0.05). After 48 weeks of treatment, the level of HBsAg decreased (P<0.05), and there was no negative HBsAg conversion and seroconversion. After 48 weeks of treatment, the level of ALT decreased (P<0.05). At 48 weeks of treatment, the rates of ALT reverted to normality were 88.9% (16/18) and 70.4% (19/27), respectively. There was no significant difference in the levels of glomerular filtration rate, creatinine, phosphorus, triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol estimated at baseline before and after treatment (P>0.05), and no serious adverse events were observed. Conclusions: For patients over 65 years old with chronic hepatitis B and liver cirrhosis, TMF can significantly inhibit HBV DNA replication, and the ALT normalization rate is high and well tolerated.

目的: 探讨艾米替诺福韦(TMF)在治疗65岁以上慢性乙型肝炎及肝硬化患者中的有效性及安全性。 方法: 纳入临沂市人民医院45例慢性乙型肝炎及肝硬化患者,TMF治疗48周比较治疗第12、24、48周时病毒学应答率、HBV DNA较基线下降水平,治疗前后乙型肝炎表面抗原(HBsAg)、丙氨酸转氨酶(ALT)、肾小球滤过率(eGFR)、肌酐、甘油三酯(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)及血磷、血脂的变化及48周时ALT复常率变化。以P<0.05表示差异具有统计学意义。 结果: 入组患者年龄为69.0(67.0,72.5)岁。TMF治疗12、24、48周的完全病毒学应答率为32.4%(12/37)、70.0%(28/40)、84.6%(33/39),HBV DNA较基线有明显下降(P值均<0.05)。治疗48周后HBsAg水平下降(P<0.05),未出现HBsAg转阴及血清转换患者。治疗48周后ALT水平下降(P<0.05)。治疗48周时ALT复常率分别为88.9%(16/18)、70.4%(19/27)。基线与治疗48周后的eGFR、肌酐、磷、TG、TC、HDL-C、LDL-C水平差异无统计学意义(P值均>0.05),暂未观察到严重不良反应事件发生。 结论: 对于65岁以上慢性乙型肝炎及肝硬化患者,TMF可显著抑制HBV DNA复制,且ALT复常率高、耐受性好。.

Publication types

  • English Abstract

MeSH terms

  • Aged
  • Alanine Transaminase / blood
  • Antiviral Agents* / therapeutic use
  • DNA, Viral / blood
  • Female
  • Hepatitis B Surface Antigens / blood
  • Hepatitis B virus / drug effects
  • Hepatitis B, Chronic* / drug therapy
  • Humans
  • Liver Cirrhosis / drug therapy
  • Male
  • Tenofovir* / therapeutic use
  • Treatment Outcome

Substances

  • Tenofovir
  • Antiviral Agents
  • DNA, Viral
  • Hepatitis B Surface Antigens
  • Alanine Transaminase