Department of Internal Medicine, National Taiwan University Hospital Yunlin Branch, Yunlin, Taiwan; Hepatology Medical Center, National Taiwan University Hospital Yunlin Branch, Yunlin, Taiwan.
Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; School of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
J Formos Med Assoc. 2021 Mar;120(3):956-964. doi: 10.1016/j.jfma.2020.09.018. Epub 2020 Oct 16.
Ropeginterferon alfa-2b is a novel mono-pegylated interferon that has only one major form as opposed to the 8 to 14 isomers of other on-market pegylated interferon products, allowing every-two-week injection with high tolerability. It received European Medicines Agency marketing authorization in 2019 and Taiwan Biologics License Applications Approval in 2020 for the treatment of polycythemia vera. This study aimed to evaluate the safety and efficacy of Ropeginterferon alfa-2b plus ribavirin in genotype 2 chronic hepatitis C (CHC) patients.
Eighty-six treatment naive patients with genotype 2 CHC were randomized to weekly peginterferon alfa-2a (Peg-IFN-α2a) at 180 μg (n = 22), or every-two-week Ropeginterferon alfa-2b at 270 μg (n = 23), 360 μg (n = 21), 450 μg (n = 20), plus daily oral ribavirin 1000 mg (≤75 kg) or 1200 mg (>75 kg). Patients with rapid virologic response received 16-week regimen while those without RVR received 24-week regimen. The primary endpoint was sustained virologic response at 24 weeks post-treatment (SVR24).
SVR24 was achieved by 95.5%, 78.3%, 85.7%, and 60% of subjects in Peg-IFN-α2a 180 μg, Ropeginterferon alfa-2b 270 μg, 360 μg, and 450 μg groups, respectively. The safety profile was similar across 4 groups. The incidence rate of adverse event during the treatment period was 0.407, 0.252, 0.395, and 0.347 per patient-week, respectively.
Ropeginterferon alfa-2b, although at only half the number of injections, is as safe and effective as Peg-IFN-α2a for genotype 2 CHC. A phase 3 study to confirm safety and efficacy of Ropeginterferon alfa-2b in genotype 2 CHC is ongoing.
罗匹尼罗干扰素阿尔法-2b 是一种新型单聚乙二醇干扰素，与其他市售聚乙二醇干扰素产品的 8 到 14 个异构体不同，它只有一种主要形式，允许每两周注射一次，具有较高的耐受性。它于 2019 年获得欧洲药品管理局的营销授权，并于 2020 年获得台湾生技药品许可证申请批准，用于治疗真性红细胞增多症。本研究旨在评估罗匹尼罗干扰素阿尔法-2b 联合利巴韦林在基因型 2 慢性丙型肝炎（CHC）患者中的安全性和疗效。
86 例初治基因型 2 CHC 患者被随机分为每周聚乙二醇干扰素阿尔法-2a（Peg-IFN-α2a）180μg（n=22）组，或每两周罗匹尼罗干扰素阿尔法-2b 270μg（n=23）、360μg（n=21）、450μg（n=20）组，联合每日口服利巴韦林 1000mg（≤75kg）或 1200mg（>75kg）。快速病毒学应答的患者接受 16 周治疗方案，而无快速病毒学应答的患者接受 24 周治疗方案。主要终点是治疗后 24 周时持续病毒学应答（SVR24）。
Peg-IFN-α2a 180μg、罗匹尼罗干扰素阿尔法-2b 270μg、360μg 和 450μg 组分别有 95.5%、78.3%、85.7%和 60%的患者达到 SVR24。4 组的安全性特征相似。治疗期间不良事件的发生率分别为每患者-周 0.407、0.252、0.395 和 0.347。
罗匹尼罗干扰素阿尔法-2b 虽然注射次数减半，但与 Peg-IFN-α2a 相比，治疗基因型 2 CHC 的安全性和疗效相当。一项罗匹尼罗干扰素阿尔法-2b 治疗基因型 2 CHC 的安全性和疗效的 3 期研究正在进行中。
