Publications

Pharmacokinetics

Protocol No.: A09-102

Huang YW, Qin A, Fang J, Wang TF, Tsai CW, Lin KC, et al. Novel Long-Acting Ropeginterferon Alfa-2b: Pharmacokinetics, Pharmacodynamics and Safety in a Phase I Clinical Trial. Br J Clin Pharmacol. 2022 May;88(5):2396-2407.

Protocol No.: A17-101

Huang YW, Tsai CY, Tsai CW, Wang W, Zhang J, Qin A, et al. Pharmacokinetics and Pharmacodynamics of Novel Long-Acting Ropeginterferon Alfa-2b in Healthy Chinese Subjects. Adv Ther. 2021 Sep;38(9):4756-4770.

Zhu M, Wang MX, Li ZR, Wang W, Su X, Jiao Z. Population Pharmacokinetics of Ropeginterferon Alfa-2b: A Comparison Between Healthy Caucasian and Chinese Subjects. Front Pharmacol. 2021 May 28;12:673492.

Protocol No.: A17-102

Miyachi N, Zagrijtschuk O, Kang L, Yonezu K, Qin A. Pharmacokinetics and Pharmacodynamics of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects After Single Subcutaneous Administration. Clin Drug Investig. 2021 Apr;41(4):391-404.

Chronic Hepatitis B

Protocol No.: A12-201

Huang YW, Hsu CW, Lu SN, Yu ML, Su CW, Su WW, et al. Ropeginterferon Alfa-2b Every 2 Weeks as a Novel Pegylated Interferon for Patients with Chronic Hepatitis B. Hepatol Int. 2020 Dec;14(6):997-1008.

Chronic Hepatitis C

Protocol No.: A11-201

Lin HH, Hsu SJ, Lu SN, Chuang WL, Hsu CW, Chien RN, et al. Ropeginterferon Alfa-2b in Patients with Genotype 1 Chronic Hepatitis C: Pharmacokinetics, Safety, and Preliminary Efficacy. JGH Open. 2021 Jul 10;5(8):929-940.

Protocol No.: A11-203

Hsu SJ, Yu ML, Su CW, Peng CY, Chien RN, Lin HH, et al. Ropeginterferon Alfa-2b Administered Every Two Weeks for Patients with Genotype 2 Chronic Hepatitis C. J Formos Med Assoc. 2021 Mar;120(3):956-964.

Protocol No.: A14-301

Chen CY, Chuang WL, Qin A, Zhang WH, Zhu LY, Zhang GQ, et al. A Phase 3 Clinical Trial Validating the Potency and Safety of An Innovative, Extra-Long-Acting Interferon in Chronic Hepatitis C. JGH Open. 2022 Oct 10;6(11):782-791.

Myeloproliferative Neoplasms

Protocol No.: P1101-ET

Verstovsek S, Komatsu N, Gill H, Jin J, Lee SE, Hou HA et al. SURPASS-ET: Phase III Study of Ropeginterferon Alfa-2b Versus Anagrelide as Second-Line Therapy in Essential Thrombocythemia. Future Oncol. 2022 Sep;18(27):2999-3009.

Protocol No.: A19-201

Edahiro Y, Ohishi K, Gotoh A, Takenaka K, Shibayama H, Shimizu T et al. Efficacy and Safety of Ropeginterferon Alfa-2b in Japanese Patients with Polycythemia Vera: An Open-label, Single-Arm, Phase 2 Study. Int J Hematol. 2022 Aug;116(2):215-227.

Compassionate Use Program

Huang CE, Wu YY, Hsu CC, Chen YJ, Tsou HY, Li CP, et al. Real-World Experience with Ropeginterferon-Alpha 2b (Besremi) in Philadelphia-Negative Myeloproliferative Neoplasms. J Formos Med Assoc. 2021 Feb;120(2):863-873.

Coronavirus Disease 2019

Off-Label Use

Chen KY, Lee KY, Qin A, Luo CS, Yeh YK, Zheng JQ, et al. Clinical Experience with Ropeginterferon Alfa-2b in the Off-Label Use for the Treatment of COVID-19 Patients in Taiwan. Adv Ther. 2022 Feb;39(2):910-922.

Special Issue

Treatment of Chronic Hepatitis C

Tsai D, Lai CY, Wang TF, Ma R, Kao J, Cheng CS, et al. An Alternative Treatment for Hepatitis C: Ropeginterferon alfa-2b (P1101). Formosan Journal of Medicine. 2017 Oct;21(6):603-13.

Review

Chronic Viral Hepatitis

Huang YW, Qin A, Tsai CY and Chen PJ. Novel Pegylated Interferon for the Treatment of Chronic Viral Hepatitis. Viruses. 2022 May 25;14(6):1128.

Chronic Hepatitis B/ Chronic Hepatitis D

Qin A, Huang YW and Chen PJ. A Validated, New-Generation Pegylated Interferon Therapy for Chronic Hepatitis B and Possibly D. Current Trends in Gastroenterology and Hepatology. 2022 Oct 4(1):343-5.