[Compare the effect of combined therapy between telbivudine plus adefovir dipivoxil and lamivudine plus adefovir dipivoxil corresponding to renal function in patients with hepatitis B virus infection]

Zhonghua Gan Zang Bing Za Zhi. 2018 Apr 20;26(4):288-293. doi: 10.3760/cma.j.issn.1007-3418.2018.04.011.
[Article in Chinese]

Abstract

Objective: To compare the effect of combined therapy using lamivudine (LAM) plus adefovir (ADV) versus telbivudine (LdT) plus adefovir corresponding to the renal function of CHB patients. Methods: A total of 120 patients with chronic hepatitis B were enrolled. According to single daily dosing, they were divided into 4 groups: LdT + ADV group (n = 32), ADV+LdT group (n = 28), LAM + ADV group (n = 38) and ADV + LAM group (n = 22). Hepatorenal function, HBV serological markers, HBV DNA quantification, creatine kinase (CK) and other parameters were examined every 3 months. Serum alanine aminotransferase (ALT) normalization rate, undetectable HBV DNA rate, hepatitis B e antigen (HBeAg) seroconversion rate, level of serum creatinine (CR) and estimated glomerular filtration rate (eGFR) were analyzed at baseline time, and at weeks 24 and 52.Stastical data were analyzed by t- test and analysis of variance, count data using χ (2) test. Results: There was no statistically significant difference between the four groups in terms of ALT normalization rate, HBeAg seroconversion rate, undetectable HBV DNA rate at 24 and 52 weeks. Compared with baseline, at 24 weeks of treatment, there was no significant change in serum creatinine and eGFR in the 4 groups, but after 52 weeks of treatment, serum creatinine decreased in LdT + ADV and ADV + LdT groups and eGFR increased (P < 0.05); Serum creatinine in ADV and ADV + LAM increased, and eGFR was decreased than before (P < 0.05). After treatment, there was no significant difference in renal function between the four groups at 24 weeks, but at week 52, eGFR increased and serum creatinine decreased in LdT + ADV group compared with LAM + ADV group (P < 0.05); ADV + LdT Compared with ADV + LAM group, eGFR increased and serum creatinine decreased (P < 0.05). At 52 weeks of treatment, 5 patients with mildly impaired renal function in the ADV + LdT group [n = 10, eGFR 60-90 ml·min(-1) ·(1.73 m(2))(-1)] returned to normal, and none of the ADV + LAM group (n = 9) returned to normal. Conclusion: For patients with mild impaired renal function, adding LdT combined with ADV can improve renal function compared to that of LAM plus ADV.

目的: 比较替比夫定(LdT)联合阿德福韦酯(ADV)与拉米夫定(LAM)联合ADV治疗慢性乙型肝炎对肾功能的影响,为临床核苷(酸)类联合治疗方案选择提供依据。 方法: 共纳入120例慢性乙型肝炎患者,根据服用单药时间先后顺序分为4组:LdT + ADV组(n = 32)、ADV + LdT组(n = 28)、LAM + ADV组(n = 38)、ADV + LAM组(n = 22)。每3个月检测肝肾功能、HBV血清学标志物、HBV DNA定量、肌酸激酶(CK)等指标,比较基线、治疗24周、治疗52周时患者丙氨酸氨基转移酶(ALT)复常率、HBV DNA未检出率、HBeAg血清转换率、血清肌酐(CR)和估算肾小球滤过率(eGFR)的变化,计量资料用t检验和方差分析,计数资料用χ(2)检验。 结果: 治疗24周、52周时,4组之间ALT复常率、HBeAg血清转换率、HBV DNA未检出率的差异无统计学意义。与基线比较,治疗24周时,4组患者血CR和eGFR无明显变化;但52周治疗后,LdT + ADV、ADV + LdT两组CR降低,eGFR升高(P<0.05);而LAM + ADV、ADV + LAM两组CR升高,eGFR较前下降(P<0.05)。治疗后肾功能比较,24周时4组间差异无统计学意义,但52周时LdT + ADV组与LAM + ADV组相比,eGFR升高、CR值下降(P<0.05);ADV + LdT组与ADV + LAM组相比,eGFR升高、CR值下降(P<0.05)。治疗52周时ADV + LdT组基线时肾功能轻度受损者[n = 10,eGFR 60~90 ml·min(-1)·(1.73 m(2))(-1)]有5例恢复正常,而ADV + LAM组(n = 9)无一例恢复正常。 结论: 与LAM联合ADV治疗相比,LdT联合ADV治疗可改善肾功能,尤其是对于肾功能轻度受损的患者,其肾功能改善作用更明显。.

Keywords: Adefovir dipivoxil; Glomerular filtration rate; Hepatitis B, chronic; Lamivudine; Renal function; Telbivudine.

MeSH terms

  • Adenine / administration & dosage
  • Adenine / analogs & derivatives*
  • Adenine / therapeutic use
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / therapeutic use*
  • Creatinine / blood
  • DNA, Viral
  • Drug Therapy, Combination
  • Glomerular Filtration Rate / drug effects*
  • Hepatitis B virus / drug effects*
  • Hepatitis B, Chronic / drug therapy*
  • Humans
  • Kidney Function Tests
  • Lamivudine / administration & dosage
  • Lamivudine / therapeutic use*
  • Organophosphonates / administration & dosage
  • Organophosphonates / therapeutic use*
  • Telbivudine / administration & dosage
  • Telbivudine / therapeutic use*
  • Treatment Outcome

Substances

  • Antiviral Agents
  • DNA, Viral
  • Organophosphonates
  • Telbivudine
  • Lamivudine
  • Creatinine
  • Adenine
  • adefovir dipivoxil