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首页> 外文期刊>Digestive Diseases and Sciences >Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis
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Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis

机译:乙型肝炎表面抗原损失与替诺福韦解毒型富马酸盐加上Peginterferon Alfa-2a:第120周分析

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Background and AimsHepatitis B surface antigen (HBsAg) loss is the ideal clinical endpoint but is achieved rarely during oral antiviral treatment. A current unmet need in CHB management is achievement of HBsAg loss with a finite course of oral antiviral therapy, thereby allowing discontinuation of treatment. Significantly higher rates of HBsAg loss at 72weeks post-treatment have been demonstrated when tenofovir disoproxil fumarate (TDF) was combined with pegylated interferon (PEG-IFN) for 48weeks compared with either monotherapy. This analysis provides follow-up data at week 120.MethodsIn an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus PEG-IFN for 48weeks (group A), TDF plus PEG-IFN for 16weeks followed by TDF for 32weeks (group B), TDF for 120weeks (group C), or PEG-IFN for 48weeks (group D). Efficacy and safety at week 120 were assessed.ResultsRates of HBsAg loss at week 120 were significantly higher in group A (10.4%) than in group B (3.5%), group C (0%), and group D (3.5%). Rates of HBsAg loss and HBsAg seroconversion in group A were significantly higher than rates in group C (P0.001 for both) or group D (HBsAg loss: P=0.002; HBsAg seroconversion: P0.001).ConclusionsThe results of this analysis confirm the results from earlier time points which demonstrate the increased rate of HBsAg loss in patients treated with a finite course of PEG-IFN plus TDF compared with the rates in patients receiving either monotherapy.
机译:背景和AIMSHEPTETISB表面抗原(HBSAG)损失是理想的临床终点,但在口腔抗病毒治疗期间很少实现。 CHB管理中的目前未满足的需求是通过有限的口腔抗病毒治疗方法实现HBsAg损失,从而允许停止治疗。当与单一疗法相比,当替诺福韦毒性富马酸薄荷酸酯(TDF)与聚乙二醇化干扰素(PEG-IFN)结合48周时,已经证明了72周的HBsAg损失率显着提高了72周的损失。该分析在第120周提供后续数据。方法是一个开放标签,有效控制的研究,740例慢性乙型肝炎患者被随机分配到48周(A),TDF Plus PEG-IFN的TDF Plus PEG-IFN对于16周,其次是32周(B组),120周(C组)的TDF(C组),或48周的PEG-IFN(D组)。第120周的疗效和安全得到评估。第120周的HBsAg损失的培养物(10.4%)显着高于B(3.5%),C组(0%)和D组(3.5%)。 A组HBsAg损失和HBsAg血清转化率的速率显着高于C组(P <0.001)或群D的速率(HBsAg损失:P = 0.002; HBsAg Seroconversion:P <0.001)。该分析的结果确认该分析的结果确认早期时间点的结果证明了用PEG-IFN Plus TDF治疗的患者的HBsAg损失率增加,与接受单一疗法的患者的速率相比。

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