Ropeginterferon Alfa-2b administered every two weeks for patients with genotype 2 chronic hepatitis C

Hsu, Shih‐Jer; Yu, Ming; Su, Chien Wei; Peng, Cheng Yuan; Chien, Rong Nan; Lin, Hsien Hong; Lo, Gin Ho; Su, Wei; Kuo, Hsing Tao; Hsu, Chao‐Wei; Yang, Shwu Huey; Yang, Shih-Chieh; Tseng, Kuan Chiao; Qin, Albert; Huang, Yi Wen; Chuang, Wan‐Long

doi:10.1016/j.jfma.2020.09.018

Cited by 16 publications

(19 citation statements)

References 15 publications

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“…However, increased pulmonary AEs were reported in the phase 3 trial and the project was discontinued in 2010 22 . In contrast, no lung toxicities was observed in ropeginterferon alfa‐2b use, up to totally 629 patients, including 102 healthy subjects, 313 patients with CHB or C, and 214 PV patients 1–3 …”

Section: Discussionmentioning

confidence: 99%

“… 22 In contrast, no lung toxicities was observed in ropeginterferon alfa‐2b use, up to totally 629 patients, including 102 healthy subjects, 313 patients with CHB or C, and 214 PV patients. 1 , 2 , 3 …”

Section: Discussionmentioning

confidence: 99%

“…The superior pharmacokinetics (PK) profile and longer half‐life of ropeginterferon alfa‐2b allow less frequent injections of once every 2 weeks. Moreover, ropeginterferon alfa‐2b dose up to 450 μg was safe and well‐tolerated in patients with genotype 2 chronic hepatitis C (CHC), PV, and chronic hepatitis B (CHB) 1–3 …”

Section: Introductionmentioning

confidence: 99%

“…Moreover, ropeginterferon alfa‐2b dose up to 450 μg was safe and well‐tolerated in patients with genotype 2 chronic hepatitis C (CHC), PV, and chronic hepatitis B (CHB). 1 , 2 , 3 …”

Section: Introductionmentioning

confidence: 99%

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Ropeginterferon alfa‐2b in patients with genotype 1 chronic hepatitis C: Pharmacokinetics, safety, and preliminary efficacy

Lin

Hsu

et al. 2021

JGH Open

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Moreover, ropeginterferon alfa‐2b dose up to 450 μg was safe and well‐tolerated in patients with genotype 2 chronic hepatitis C (CHC), PV, and chronic hepatitis B (CHB). 1 , 2 , 3 …”

Section: Introductionmentioning

confidence: 99%

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Ropeginterferon alfa‐2b in patients with genotype 1 chronic hepatitis C: Pharmacokinetics, safety, and preliminary efficacy

Lin

Hsu

et al. 2021

JGH Open

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“…Previously, the safety of ropeginterferon alfa-2b has been well studied in multiple studies in patients with polycythemia vera , chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, and healthy subjects. Ropeginterferon alfa-2b was found to be generally well tolerated in these studies [ 15 – 17 , 19 , 20 ]. In this study, adverse events (AEs) were also examined.…”

Section: Methodsmentioning

confidence: 99%

Clinical Experience with Ropeginterferon Alfa-2b in the Off-Label Use for the Treatment of COVID-19 Patients in Taiwan

Chen

Lee

Qin³

et al. 2021

Adv Ther

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Introduction This study, for the first time to our knowledge, evaluated the efficacy of ropeginterferon alfa-2b, a long-acting pegylated interferon (IFN)-alfa, in the treatment of COVID-19. Methods We retrospectively evaluated ropeginterferon alfa-2b administered subcutaneously at a single dose of 250 µg for the treatment of mild and moderate COVID-19. Primary outcome was to compare the overall negative conversion time from the confirmed, last positive SARS-CoV-2 RT-PCR to the first RT-PCR negative conversion between patients receiving ropeginterferon alfa-2b plus standard of care (SOC) and those receiving SOC alone. Results Thirty-five patients with mild COVID-19 and 37 patients with moderate disease were included. Of them, 19 patients received SOC plus ropeginterferon alfa-2b and 53 patients received SOC alone. All patients with moderate disease in the ropeginterferon alfa-2b group showed RT-PCR negative conversion within 8 days, while a significant portion of patients in the SOC alone group failed to do so. For patients with moderate disease and age ≤ 65 years old, the ropeginterferon alfa-2b group had statistically significant shorter median RT-PCR conversion time than the SOC alone group (7 vs. 11.5 days, p < 0.05). Conclusions Ropeginterferon alfa-2b showed the potential for the treatment of moderate COVID-19 patients. A randomized, controlled Phase III study is planned to further assess the effectiveness of ropeginterferon alfa-2b in COVID-19 patients. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01998-y.

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A Phase 3 clinical trial validating the potency and safety of an innovative, extra‐long‐acting interferon in chronic hepatitis C

Chen

Chuang

Qin³

et al. 2022

JGH Open

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Background and Aim Ropeginterferon alfa‐2b is a novel mono‐pegylated, extra‐long‐acting interferon. It is administered infrequently and showed good tolerability and clinical activity for the chronic hepatitis B or C treatment in our previous Phase 2 clinical trials. This study aims to validate the potency and safety of this novel agent in a Phase 3 chronic viral hepatitis setting. Methods Patients with chronic hepatitis C genotype 2 were randomized to receive subcutaneous injections of ropeginterferon alfa‐2b biweekly or the conventional pegylated interferon alfa‐2b weekly for 24 weeks, combined with ribavirin. The primary endpoint was to assess the safety and antiviral potency of ropeginterferon alfa‐2b by the non‐inferiority in sustained virologic response at 12 weeks after treatment. Results A total of 222 patients were enrolled. Ropeginterferon alfa‐2b group showed a favorable safety profile. Side effects that were generally associated with prior interferon therapies, including neutropenia, asthenia, fatigue, alopecia, dizziness, decreased appetite, nausea, flu‐like symptoms including myalgia, pyrexia, and headache, and administration site reactions, were notably less in the ropeginterferon alfa‐2b group. The cumulative incidence of adverse events of special interest was also notably higher in the control group. The primary endpoint was met and ropeginterferon alfa‐2b showed a better SVR12 rate of 79.8% than 71.9% of the control group. Conclusion Ropeginterferon alfa‐2b is efficacious and has a favorable safety profile as compared with the conventional pegylated interferon alfa‐2b. This study together with previous Phase 2 data validated ropeginterferon alfa‐2b to be a new treatment option for chronic hepatitis C genotype 2.

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Ropeginterferon Alfa-2b administered every two weeks for patients with genotype 2 chronic hepatitis C

Cited by 16 publications

References 15 publications

Ropeginterferon alfa‐2b in patients with genotype 1 chronic hepatitis C: Pharmacokinetics, safety, and preliminary efficacy

Ropeginterferon alfa‐2b in patients with genotype 1 chronic hepatitis C: Pharmacokinetics, safety, and preliminary efficacy

Clinical Experience with Ropeginterferon Alfa-2b in the Off-Label Use for the Treatment of COVID-19 Patients in Taiwan

A Phase 3 clinical trial validating the potency and safety of an innovative, extra‐long‐acting interferon in chronic hepatitis C

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