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.作者: StephenW 时间: 2021-1-13 18:45
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