@article{3d264b61fb684db19df4d52cee4d7acc,
title = "Ropeginterferon alfa-2b in patients with genotype 1 chronic hepatitis C: Pharmacokinetics, safety, and preliminary efficacy",
abstract = "Background and Aim: Ropeginterferon alfa-2b (P1101) is a novel long-acting mono-PEGylated recombinant proline interferon (IFN) conjugated to a 40 kDa branched polyethylene glycol (PEG) chain at its N-terminus, allowing every-two-week injection. It received European Medicines Agency and Taiwan marketing authorization for the treatment of polycythemia vera in 2019 and 2020, respectively. This phase 2 study aimed to evaluate the pharmacokinetics, safety, and preliminary efficacy of ropeginterferon alfa-2b as compared with PEG-IFN-α2a in patients with chronic hepatitis C virus genotype 1 infection. Methods: One hundred six treatment naive patients were enrolled in this phase 2 study and randomized to four treatment groups: subcutaneous weekly PEG-IFN-α2a 180 μg (group 1), weekly ropeginterferon alfa-2b 180 μg (group 2), weekly ropeginterferon alfa-2b 270 μg (group 3), or biweekly ropeginterferon alfa-2b 450 μg (group 4) plus ribavirin for 48 weeks. Results: After multiple weekly administration, serum exposure (AUC0-τ) in ropeginterferon alfa-2b 180 μg was approximately 41\% greater and the accumulation ratio of 2-fold greater than PEG-IFN-α2a 180 μg. The incidences of flu-like symptoms were 66.7\% (18/27), 53.3\% (16/30), 55.0\% (11/20), and 48.3\% (14/29), anxiety were 14.8\% (4/27), 6.7\% (2/30), 0\%, and 0\%, and depression were 25.9\% (7/27), 13.3\% (4/30), 0\%, and 3.4\% (1/29), for groups 1–4, respectively. Two grade 2 of 3 depression were noted in PEG-IFN-α2a arm, but none in ropeginterferon arms. The SVR24 rates were 77.8\% (21/27), 66.7\% (20/30), 80\% (16/20), and 69\% (20/29), respectively. Conclusions: Ropeginterferon alfa-2b showed longer effective half-life and superior safety profile than PEG-IFN-α2a. Biweekly injection of ropeginterferon alfa-2b will be studied in larger viral hepatitis patient population.",
keywords = "antiviral, chronic hepatitis C, clinical trial, genotype 1, interferon, ropeginterferon alfa-2b",
author = "Lin, \{Hsien Hong\} and Hsu, \{Shih Jer\} and Lu, \{Sheng Nan\} and Chuang, \{Wan Long\} and Hsu, \{Chao Wei\} and Chien, \{Rong Nan\} and Yang, \{Sien Sing\} and Su, \{Wei Wen\} and Wu, \{Jaw Ching\} and Lee, \{Tzong Hsi\} and Peng, \{Cheng Yuan\} and Tseng, \{Kuan Chiao\} and Albert Qin and Huang, \{Yi Wen\} and Chen, \{Pei Jer\}",
note = "Funding Information: The authors thank the patients, their families, and the study investigators who took part in this study. In addition to the authors, the following investigators participated in the study: Chuan-Mo Lee, Ding-Shinn Chen, Jia-Horng Kao, Chun-Jen Liu, Chen-Hua Liu, Hung-Chih Yang, Chia-Chi Wang, Ching-Sheng Hsu, Tai-Chung Tseng, Chieh-Chang Chen, Jing-Houng Wang, Chao-Hung Hung, Chien-Hung Chen, Kuo-Chin Chang, Kwong-Ming Kee, Yi-Hao Yen, Tsung-Hui Hu, Po-Lin Tseng, Chau-Ting Yeh, Yi-Cheng Chen, Chen-Chun Lin, Ming-Ling Chang, Jia-Jang Chang, Jui-Ting Hu, Pei-Yuan Su, Jia-Wei Yang, Shun-Sheng Wu, Syu-Heng Yan, You-Chun Syu, Chien-Wei Su, Hsueh-Chou Lai, Jung-Ta Kao, Sheng-Hung Chen, Cheng-Chao Liang, Cheng-Kuan Lin, Chien-Chu Lin, Chen-Shuan Chung, Sheng-Shun Yang, Hong-Zen Yeh, Chun Fang Tung, Teng-Yu Lee, I-Ta Lu, Chung -Hsin Chang, Ming-Lung Yu, Chia-Yen Dai, Jee- Fu Huang and Ming-Lun Yeh. The authors thank Chung-Wei (Darren) Tsai for assistance in preparing the manuscript. This study had been presented at the 25th Conference of the Asian Pacific Association for the Study of the Liver. 20 February?24 February, 2016, Tokyo, Japan. Abstract O-060. This study had also been presented at the 2016 APASL Single Topic Conference on Hepatitis C. 10 June?12 June, 2016, Kaohsiung, Taiwan. Abstract P-065. This study was funded by PharmaEssentia Corp. Funding Information: The authors thank the patients, their families, and the study investigators who took part in this study. In addition to the authors, the following investigators participated in the study: Chuan‐Mo Lee, Ding‐Shinn Chen, Jia‐Horng Kao, Chun‐Jen Liu, Chen‐Hua Liu, Hung‐Chih Yang, Chia‐Chi Wang, Ching‐Sheng Hsu, Tai‐Chung Tseng, Chieh‐Chang Chen, Jing‐Houng Wang, Chao‐Hung Hung, Chien‐Hung Chen, Kuo‐Chin Chang, Kwong‐Ming Kee, Yi‐Hao Yen, Tsung‐Hui Hu, Po‐Lin Tseng, Chau‐Ting Yeh, Yi‐Cheng Chen, Chen‐Chun Lin, Ming‐Ling Chang, Jia‐Jang Chang, Jui‐Ting Hu, Pei‐Yuan Su, Jia‐Wei Yang, Shun‐Sheng Wu, Syu‐Heng Yan, You‐Chun Syu, Chien‐Wei Su, Hsueh‐Chou Lai, Jung‐Ta Kao, Sheng‐Hung Chen, Cheng‐Chao Liang, Cheng‐Kuan Lin, Chien‐Chu Lin, Chen‐Shuan Chung, Sheng‐Shun Yang, Hong‐Zen Yeh, Chun Fang Tung, Teng‐Yu Lee, I‐Ta Lu, Chung ‐Hsin Chang, Ming‐Lung Yu, Chia‐Yen Dai, Jee‐ Fu Huang and Ming‐Lun Yeh. The authors thank Chung‐Wei (Darren) Tsai for assistance in preparing the manuscript. This study had been presented at the . 20 February–24 February, 2016, Tokyo, Japan. Abstract O‐060. This study had also been presented at the . 10 June–12 June, 2016, Kaohsiung, Taiwan. Abstract P‐065. This study was funded by PharmaEssentia Corp. 25th Conference of the Asian Pacific Association for the Study of the Liver 2016 APASL Single Topic Conference on Hepatitis C Publisher Copyright: {\textcopyright} 2021 The Authors. JGH Open published by Journal of Gastroenterology and Hepatology Foundation and John Wiley \& Sons Australia, Ltd.",
year = "2021",
month = aug,
doi = "10.1002/jgh3.12613",
language = "English",
volume = "5",
pages = "929--940",
journal = "JGH Open",
issn = "2397-9070",
publisher = "John Wiley \& Sons Inc.",
number = "8",
}
