大连联合使用替诺福韦和聚乙二醇干扰素α-2a增加慢性乙型肝炎患者表面抗原清除-大连春柳胃肠医院

大连联合使用替诺福韦和聚乙二醇干扰素α-2a增加慢性乙型肝炎患者表面抗原清除

来源:大连春柳胃肠医院时间：2021-08-28 02:30

联合使用替诺福韦和聚乙二醇干扰素α-2a增加慢性乙型肝炎患者表面抗原清除

翻译：赵广西董玲

复旦大学附属中山医院消化内科

摘自：Gastroenterology, 2016 Jan;150(1):134-144.e10.

背景与目的

慢性乙型肝炎患者很少能够通过标准治疗获得乙型肝炎病毒表面抗原（HBsAg）清除。该研究旨在评价联合使用替诺福韦（TDF）和聚乙二醇干扰素α-2a对慢性乙型肝炎患者HBsAg的清除效率。

方法

740例慢性乙型肝炎患者随机分为TDF+聚乙二醇干扰素α-2a 48周组（A组）；TDF+聚乙二醇干扰素α-2a 16周继而TDF 32周组（B组）；TDF 120周组（C组）以及聚乙二醇干扰素α-2a 48周组（D组），主要终点为72周时HBsAg血清学清除的患者的比例。

结果

72周时，9.1%的 A组患者发生了HBsAg血清学清除，B组和D组均有2.8%的患者发生了HBsAg血清学清除，C组患者无HBsAg血清学清除。A组患者HBsAg血清学清除率显著高于C组（P < 0.001）和D组（P =0.003），而B组患者与C组（P=0.466）和D组（P=0.883）均无显著差异。各组患者的常见不良反应（包括头痛、脱发和发热）以及由此而导致的停药的发生率无明显差异。

结论

联合使用TDF+聚乙二醇干扰素α-2a 治疗48周的HBsAg血清学清除率显著高于TDF或聚乙二醇干扰素α-2a单独治疗。

英文原文：

BACKGROUND & AIMS: Patientschronically infected with the hepatitis B virus rarely achieve loss of serumhepatitis B surface antigen (HBsAg) with the standard of care. We evaluatedHBsAg loss in patients receiving the combination of tenofovir disoproxil fumarate(TDF) and peginterferon α-2a (peginterferon) for a finite duration in arandomized trial.

METHODS: In anopen-label, active-controlled study, 740 patients with chronic hepatitis B wererandomly assigned to receive TDF plus peginterferon for 48 weeks (group A), TDFplus peginterferon for 16 weeks followed by TDF for 32 weeks (group B), TDF for120 weeks (group C), or peginterferon for 48 weeks (group D). The primary endpoint was the proportion of patients with serum HBsAg loss at week 72.

RESULTS: At weekseventy-two, 9.1% of subjects in group A had HBsAg loss compared with 2.8% ofsubjects in group B, none of the subjects in group C, and 2.8% of subjects ingroup D. A significantly higher proportion of subjects in group A had HBsAgloss than in group C (P < 0.001) or group D (P = 0.003). However, theproportions of subjects with HBsAg loss did not differ significantly betweengroup B and group C (P = 0.466) or group D (P = 0.883). HBsAg loss ingroup A occurred in hepatitis B e antigen-positive and hepatitis B eantigen-negative patients with all major viral genotypes. The incidence ofcommon adverse events (including headache, alopecia, and pyrexia) and treatmentdiscontinuation due to adverse events was similar among groups.

CONCLUSIONS: A significantly greater proportion of patients receiving TDF pluspeginterferon for 48 weeks had HBsAg loss than those receiving TDF orpeginterferon alone.