每2周一次Ropeginterferon alfa-2b作为一种新型聚乙二醇化干扰素

StephenW

Ropeginterferon alfa-2b every 2 weeks as a novel pegylated interferon for patients with chronic hepatitis B

    Yi-Wen Huang, Chao-Wei Hsu, Sheng-Nan Lu, Ming-Lung Yu, Chien-Wei Su, Wei-Wen Su, Rong-Nan Chien, Ching-Sheng Hsu, Shih-Jer Hsu, Hsueh-Chou Lai, Albert Qin, Kuan-Chiao Tseng & Pei-Jer Chen

Hepatology International volume 14, pages997–1008(2020)Cite this article

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Abstract
Background

Ropeginterferon alfa-2b is a novel mono-pegylated interferon that has only one major form as opposed to 8–14 isomers of other on-market pegylated interferon, allowing injection every two or more weeks with higher tolerability. It received European Medicines Agency and Taiwan marketing authorization in 2019 and 2020, for treatment of polycythemia vera. This phase I/II study aimed to have preliminary evaluation of safety and efficacy in chronic hepatitis B.
Methods

Thirty-one HBeAg-positive and 31 HBeAg-negative were stratified by HBeAg status and randomized at 1:1:1 ratio to q2w ropeginterferon alfa-2b 350 μg (group 1), q2w 450 μg (group 2) or q1w PEG-IFN alfa-2a 180 μg (group 3). Each patient received 48-week treatment (TW48) and 24-week post-treatment follow-up (FW24).
Results

The baseline demographics were comparable among the three groups, except for mean HBeAg in HBeAg-positive patients (2.90, 2.23, 2.99 log10 S/CO, respectively). Cumulative HBeAg seroconversion rate at follow-up period was 27.3% (3/11), 36.4% (4/11), and 11.1% (1/9) with time to HBeAg seroconversion starting from TW24, TW16, and TW48 in group 1, 2, and 3, respectively. The rate of HBV DNA < 2000 IU/mL and HBsAg levels < 1500 IU/mL at FW24 were comparable in all groups. Ropeginterferon alfa-2b (group 1 & 2) had numerically lower incidence of rash (9.5% and 4.5%) as compared to PEG-IFN alfa-2a (36.8%). Ropeginterferon alfa-2b 350 μg (group 1) had more ALT elevation (38.1%), however the rate was comparable in group 2 (9.1%) and group 3 (10.5%).
Conclusion

In this preliminary study, ropeginterferon alfa-2b, although in only half the number of injections, is as safe and effective as pegylated interferon alfa-2a for chronic hepatitis B.

StephenW

每2周一次Ropeginterferon alfa-2b作为一种新型聚乙二醇化干扰素，用于慢性乙型肝炎患者

    黄以文，徐朝伟，陆胜男，于明龙，苏建伟，苏卫文，钱荣南，徐静生，徐世杰，赖学周，秦伟杰，曾宽乔，陈培杰

《国际肝病学》第14卷，第997–1008页（2020年）

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抽象
背景

Ropeginterferon alfa-2b是一种新颖的单聚乙二醇化干扰素，与其他市售聚乙二醇化干扰素的8–14个异构体相比，只有一种主要形式，允许每两周或更多周注射一次，具有更高的耐受性。它在2019年和2020年获得了欧洲药品管理局和台湾的市场授权，用于治疗真性红细胞增多症。这项I / II期研究旨在对慢性乙型肝炎的安全性和有效性进行初步评估。
方法

根据HBeAg状态对31例HBeAg阳性和31例HBeAg阴性进行分层，并以1：1：1的比例随机分配给q2wropginterferon alfa-2b 350μg（组1），q2w 450μg（组2）或q1w PEG-IFN α-2a180μg（第3组）。每位患者接受48周治疗（TW48）和治疗后24周随访（FW24）。
结果

除了HBeAg阳性患者的平均HBeAg（分别为2.90、2.23、2.99 log10 S / CO）外，三组患者的基线人口统计学相当。从第1组的TW24，TW16和TW48开始，随访期间的累积HBeAg血清转化率分别为27.3％（3/11），36.4％（4/11）和11.1％（1/9）。 ，2和3。在所有组中，HBV DNA <2000 IU / mL和HBsAg水平<1500 IU / mL的比率在所有组中均相当。与PEG-IFN alfa-2a（36.8％）相比，Ropeginterferon alfa-2b（组1和2）的皮疹发生率在数值上较低（9.5％和4.5％）。 Ropeginterferon alfa-2b 350μg（第1组）的ALT升高更高（38.1％），但是在第2组（9.1％）和第3组（10.5％）的比率相当。
结论

在这项初步研究中，ropeginterferon alfa-2b虽然只注射一半，但与聚乙二醇化干扰素alfa-2a一样安全有效。

StephenW

https://link.springer.com/articl ... c_springer_20210113