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

Abstract

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.

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

“…In addition, it was used as an off-label treatment for other indications. [22][23][24] The data from this Phase 3 study showed that in the clinical viral hepatitis C genotype 2 setting, ropeginterferon alfa-2b was efficacious, meeting the primary endpoint of non-inferiority to the weekly given, conventional pegylated IFN alfa-2b, previously approved for the CHC treatment. The ropeginterferon alfa-2b group also had numerically better virologic responses consistently in every time point of the measurements during the study.…”

“…It is the first approved IFN‐based therapy for an MPN by the US FDA. In addition, it was used as an off‐label treatment for other indications 22–24 …”

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

“…Type I interferons (IFN) was proposed to be a treatment option against SARS-CoV-2 infection by activating both cellular and humoral immunities. [5][6][7][8][9] In vitro and cohort clinical studies with small case numbers showed potential benefits with type I IFN treatment [6,[9][10][11]. Ropeginterferon alfa-2b is a site-selective PEGylated proline-IFN alfa-2b [12][13][14][15].…”

“…It was approved as the first IFN-based therapy for adult patients with polycythemia vera in Europe and the US, and is currently under clinical development for viral infection, including hepatitis B and C [16][17][18][19][20][21][22]. As for SARS-CoV-2 infection, a retrospective study by Chen et al demonstrated that ropeginterferon alfa-2b in combination with standard of care (SOC) was associated with a more rapid viral clearance than SOC alone in patients with moderate SARS-CoV-2 infection [7]. In this multi-centered, open-labeled, randomized, phase 3 study, we aimed to evaluate the efficacy and safety of ropeginterferon alfa-2b for the treatment of patients with moderate SARS-CoV-2 infection.…”

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

“…The safety of ropeginterferon alfa-2b was also evaluated in patients with chronic hepatitis B or hepatitis C (genotypes 1 and 2) at doses ranging from 270 to 450 mcg every 2 weeks as monotherapy or in combination with ribavirin (23)(24)(25)(26)(27), or in COVID-19 patients in combination with standard of care at 250 mcg (28). Most reported adverse events (AEs) during ropeginterferon alfa-2b treatment were mild or moderate and toxicities ≥grade 3 were uncommon.…”