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Lancet Gastroen Hepatol:替诺福韦艾拉酚胺治疗HBV感染

2020-02-24 MedSci MedSci原创

与替诺福韦二吡呋酯相比,替诺福韦艾拉酚胺的疗效相当,且更为安全

替诺福韦二吡呋酯治疗慢性乙型肝炎病毒(HBV)感染会导致部分患者出现肾毒性或骨密度降低。替诺福韦艾拉酚胺具有较高的肝内活性药物浓度可减少全身替诺福韦暴露,可改善肾脏和骨安全性。近日研究人员比较二者治疗慢性乙型肝炎的疗效和安全性。

已接受替诺福韦二吡呋酯治疗至少48周的患者参与研究,其HBV DNA低于定量下限(LLOQ)至少12周,随机接受替诺福韦艾拉酚胺25 mg、每天一次或继续服用替诺福韦二吡呋酯300 mg ,每天一次。研究的主要疗效终点是病毒控制失败,定义为在48周HBV DNA含量超过20 IU/mL。安全终点是髋关节和脊柱骨密度的变化、肌酐清除率、骨转换和肾小管功能。

替诺福韦艾拉酚胺组243名患者和替诺福韦二吡呋酯组245名患者完成研究。在第48周,每个治疗组(均<1%)中有1名患者的HBV DNA至少为20 IU/mL(比例差异为0.0%),达到疗效非劣性终点。接受替诺福韦艾拉酚胺治疗的患者在48周时,与替诺福韦二吡呋酯相比,髋部(平均变化率为0.66% vs-0.51%;最小二乘法的差异率为1.17%)和脊柱(平均变化率为1.74% vs-0.11%;最小二乘法的差异意味着1.85%)骨密度显著增加,肌酐清除率(中位数变化0.94 mL/min vs-2.74 mL/min)显著增加,骨转换和肾小管功能指标也有所改善。最常见的治疗相关不良事件是上呼吸道感染和鼻咽炎,组间三级及以上不良事件和严重不良事件发生率相似,且较低,未观察到病毒耐药性。

研究认为,与替诺福韦二吡呋酯相比,替诺福韦艾拉酚胺的疗效相当,且更为安全。

原始出处:


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    2020-06-29 klivis
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    2020-06-17 许安
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    2020-11-22 howi
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    2020-02-26 gwc384
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