A Phase 3, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Ropeginterferon Alfa-2b in Patients with Moderate COVID-19

Moghadasi SA, Heilmann E, Khalil AM, Nnabuife C, Kearns FL, Ye C, et al. Transmissible SARS-CoV-2 variants with resistance to clinical protease inhibitors. Sci Adv 2023;9:eade8778.

Vitiello A. Sars-Cov-2 and risk of antiviral drug resistance. Ir J Med Sci. 2022;191:2367–8.

Article  CAS  PubMed  Google Scholar 

Rahmah L, Abarikwu SO, Arero AG, Essouma M, Jibril AT, Fal A, et al. Oral antiviral treatments for COVID-19: opportunities and challenges. Pharmacol Rep. 2022;74:1255–78.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Hoffmann M, Hofmann-Winkler H, Krüger N, Kempf A, Nehlmeier I, Graichen L, et al. SARS-CoV-2 variant B.1.617 is resistant to bamlanivimab and evades antibodies induced by infection and vaccination. Cell Rep 2021;36:109415.

King C, Sprent J. Dual Nature of Type I Interferons in SARS-CoV-2-Induced Inflammation. Trends Immunol. 2021;42:312–22.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bhushan BLS, Wanve S, Koradia P, Bhomia V, Soni P, Chakraborty S, et al. Efficacy and safety of pegylated interferon-α2b in moderate COVID-19: a phase 3, randomized, comparator-controlled, open-label study. Int J Infect Dis. 2021;111:281–7.

Article  Google Scholar 

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;39:910–22.

Article  CAS  PubMed  Google Scholar 

National Institutes of Health. COVID-19 treatment guidelines. Last Updated: March 6, 2023. Available on: https://www.covid19treatmentguidelines.nih.gov/overview/clinical-spectrum/

Reis G, Moreira Silva EAS, Medeiros Silva DC, Thabane L, Campos VHS, Ferreira TS, et al. Early treatment with pegylated interferon lambda for COVID-19. N Engl J Med. 2023;388:518–28.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lokugamage KG, Hage A, deVries M, Valero-Jimenez AM, Schindewolf C, Dittmann M, et al. Type I interferon susceptibility distinguishes SARS-CoV-2 from SARS-CoV. J Virol. 2020;94:e01410-e1420.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Mantlo E, Bukreyeva N, Maruyama J, Paessler S, Huang C. Antiviral activities of type I interferons to SARS-CoV-2 infection. Antiviral Res. 2020;179: 104811.

Article  CAS  PubMed  PubMed Central  Google Scholar 

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;41:391–404.

Article  CAS  PubMed  Google Scholar 

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;88:2396–407.

Article  CAS  PubMed  Google Scholar 

Huang YW, Tsai CY, Tsai CW, Wang W, Zhang JJ, Qin A, et al. Pharmacokinetics and pharmacodynamics of novel long-acting ropeginterferon alpha-2b in healthy Chinese subjects. Adv Ther. 2021;38:4756–70.

Article  CAS  PubMed  Google Scholar 

Huang YW, Qin A, Tsai CY, Chen PJ. Novel pegylated interferon for the treatment of chronic viral hepatitis. Viruses. 2022;14:1128.

Article  CAS  PubMed  PubMed Central  Google Scholar 

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;6:782–91.

Article  PubMed  PubMed Central  Google Scholar 

Qin A, Urbansky RW, Yu L, Ahmed T, Mascrenhas J. An alternative dosing strategy for ropeginterferon alfa-2b may help improve outcomes in myeloproliferative neoplasms: an overview of previous and ongoing studies with perspectives on the future. Front Oncol. 2023;13:1109866.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jin J, Qin A, Zhang L, Shen WH, Wang W, Zhang JJ, et al. A phase 2 trial to assess the efficacy and safety of ropeginterferon alfa-2b in Chinese patients with polycythemia vera. Future Oncol 2023;Online ahead of print.

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;18:2999–3009.

Article  CAS  PubMed  Google Scholar 

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;5:929–40.

Article  PubMed  PubMed Central  Google Scholar 

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;120:956–64.

Article  CAS  PubMed  Google Scholar 

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;14:997–1008.

Article  PubMed  Google Scholar 

WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197.

Martínez Chamorro E, Díez Tascón A, Ibáñez Sanz L, Ossaba Vélez S, Borruel Nacenta S. Radiologic diagnosis of patients with COVID-19. Radiologia (Engl Ed). 2021 Jan-Feb;63(1):56–73.

Abd-Elsalam S, Salama M, Soliman S, Naguib AM, Ibrahim IS, Torky M, et al. Remdesivir efficacy in COVID-19 treatment: a randomized controlled trial. Am J Trop Med Hyg. 2021;106:886–90. https://doi.org/10.4269/ajtmh.21-0606.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Shih W, Aisner J. Statistical design and analysis of clinical trials: principles and methods. 1st ed. Chapman & Hall/CRC Biostatistics Series; 2015.

Chow SC, Shao J, Wang HS, Lokhnygina Y. Sample Size calculations in clinical research 3rd ed. Chapman & Hall/CRC Biostatistics Series; 2017.

Liu WD, Wang JT, Shih MC, Chen KH, Huang ST, Huang CF, et al. Effect of early dexamethasone on outcomes of COVID-19: A quasi-experimental study using propensity score matching. J Microbiol Immunol Infect. 2024;S1684–1182(24):00039–42.

Google Scholar 

Bojkova D, Widera M, Ciesek S, Wass MN, Michaelis M, Cinatl J Jr. Reduced interferon antagonism but similar drug sensitivity in omicron variant compared to delta variant of SARS-CoV-2 isolates. Cell Res. 2022;32:319–21.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bojkova D, Rothenburger T, Ciesek S, Wass MN, Michaelis M, Cinatl J Jr. SARS-CoV-2 omicron variant virus isolates are highly sensitive to interferon treatment. Cell Discov. 2022;8:42.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Vitiello A, Zovi A, Rezza G. New emerging SARS-CoV-2 variants and antiviral agents. Drug Resist Updat. 2023;70: 100986.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lazear HM, Schoggins JW, Diamond MS. Shared and distinct functions of type I and type III interferons. Immunity. 2019;50:907–23.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Park A, Iwasaki A. Type I and type III interferons- induction, signaling, evasion, and application to combat COVID-19. Cell Host Microbe. 2020;27:870–8.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Contoli M, Papi A, Tomassetti L, Rizzo P, Vieceli Dalla Sega F, Fortini F, et al. Blood interferon-α levels and severity, outcomes, and inflammatory profiles in hospitalized COVID-19 patients. Front Immunol 2021;12:648004.

Hadjadj J, Yatim N, Barnabei L, Corneau A, Boussier J, Smith N, et al. Impaired type I interferon activity and inflammatory responses in severe COVID-19 patients. Science. 2020;369:718–24.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Feld JJ, Kandel C, Biondi MJ, Kozak RA, Zahoor MA, Lemieux C, et al. Peginterferon lambda for the treatment of outpatients with COVID-19: a phase 2, placebo-controlled randomised trial. Lancet Respir Med. 2021;9:498–510.

Article  CAS  PubMed  PubMed Central  Google Scholar 

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