György Miklós Keserű Gyógyszerkémiai Kutatócsoport, Természettudományi Kutatóközpont, Budapest Magyarország; Medicinal Chemistry Research Group, Research Centre for Natural Sciences, Budapest, Hungary
Magyar Koronavírus-kutatási Akciócsoport, Budapest, Magyarország; Hungarian Coronavirus Research Task Force, Budapest, Hungary

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Összefoglaló. A COVID–19-járvány egyre növekvő számú fertőzött betegének ellátása érdekében rövid időn belül szükség mutatkozott vírusellenes terápiás lehetőségekre. A gyors reagálás szempontját figyelembe véve erre a célra elsősorban más vírusok ellen már kifejlesztett vírusellenes szerek jöhetnek szóba. A magyar betegek ellátásbiztonsága szempontjából különösen fontos a hatóanyagok és gyógyszerkészítmények hazai gyártása. Ezt a cél tűzte ki a favipiravir, egy széles spektrumú antivirális hatóanyag hazai fejlesztése, amely sikeresen befejeződött, a gyógyszerkészítmény klinikai vizsgálata folyamatban van.

Summary. Increasing impact of COVID-19 on the healthcare system prompted the identification of potential antiviral therapies. Due to the immediate demand, known drugs were subjected to repositioning attempts. These drugs include agents inhibiting the viral entry into the host cells, drugs potentially blocking the release of the viral RNA from the endosomes, antivirals inhibiting the replication of the viral RNA and finally compounds that might prevent the assembly of the new virion. Since there is less experience with camostat and nafamostat, the entry inhibitors tested in Japan, and due to the ambiguous data collected with the endosome blocking chloroquine and hydroxyl-chloroquine, we focused on the actual antiviral treatment options for COVID-19 infections. In addition to favipiravir and remdesivir that were used early, at the onset of the pandemic, we discuss novel candidates including molnupiravir, a promising antiviral actually investigated in clinical trials. Considering the needs of Hungarian COVID patients and the security of supply as first priority, we selected favipiravir and developed a convenient process for the industry-scale production of the active pharmaceutical ingredient (API). At the end of this review we summarize the development and clinical investigation of favipiravir, a wide spectrum antiviral drug used for the treatment of mild and moderate COVID patients in Hungary in both ambulant and clinical settings. The Hungarian COVID Task Force set up two consortia, one for the development and the other for the clinical investigations of favipiravir. The objective of the favipiravir development consortium was to develop processes for the production of Favipiravir API and dosage forms. The consortium completed the pilot plant scale industrial production of the API and produced clinical samples for the upcoming trials. The selection and laboratory scale optimization of the synthesis route was performed at the Medicinal Chemistry Research Group of the Research Center for Natural Sciences. The laboratory scale synthesis was scaled up for pilot plant production at EVI plc and Gedeon Richter plc. GMP production was realized at the facilities of Gedeon Richter plc. Finished dosage forms were developed at Meditop Ltd who produced the clinical samples under GMP conditions. The clinical consortium is headed by the Hungarian section of the European Clinical Research Infrastructure Network (ECRIN) and organized two trials. One of these trials investigates favipiravir produced in Hungary while the other trial is performed with favipiravir produced in Japan. Both studies were approved by the Hungarian regulatory agency (OGYÉI) and are ongoing.

  • 1

    Furuta, Y., Komeno, T., & Nakamura, T. (2017) Favipiravir (T-705), a broad spectrum inhibitor of viral RNA polymerase. Proceedings of the Japan Academy. Series B, Physical and biological Sciences, Vol. 93. No. 7. pp. 449–463.

  • 2

    Gottlieb, R. L. et al. (2021) Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA, Vol. 325. No. 7. pp. 632–644.

  • 3

    Guy, R. K. et al. (2020) Rapid repurposing of drugs for COVID-19. Science (New York, N.Y.) Vol. 368. No. 6493. pp. 829–830.

  • 4

    He, X. et al. (2021) Clinical Symptom Differences Between Mild and Severe COVID-19 Patients in China: A Meta-Analysis. Frontiers in Public Health, Vol. 8. 561264.

  • 5

    Hoffmann, M. et al. (2020) SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell, Vol. 181. No. 2. pp. 271–280.e8.

  • 6

    Jorgensen, S., Kebriaei, R., & Dresser, L. D. (2020) Remdesivir: Review of Pharmacology, Pre-clinical Data, and Emerging Clinical Experience for COVID-19. Pharmacotherapy, Vol. 40. No. 7. pp. 659–671.

  • 7

    Lan, J. et al. (2020) Structure of the SARS-CoV-2 spike receptor-binding domain bound to the ACE2 receptor. Nature, Vol. 581. No. 7807. pp. 215–220.

  • 8

    Li, G., & De Clercq, E. (2020) Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nature reviews. Drug Discovery, Vol. 19. No. 3. pp. 149–150.

  • 9

    Martinez, M. A. (2020) Clinical Trials of Repurposed Antivirals for SARS-CoV-2. Antimicrobial Agents and Chemotherapy, Vol. 64. No. 9. e01101–20.

  • 10

    Painter, W. P. et al. (2021) Human Safety, Tolerability, and Pharmacokinetics of Molnupiravir, a Novel Broad-Spectrum Oral Antiviral Agent with Activity Against SARS-CoV-2. Antimicrobial Agents and Chemotherapy, AAC.02428-20.

  • 11

    Titova, Y. A. & Fedorova, O. V. (2020) Favipiravir – a Modern Antiviral Drug: Synthesis and Modifications. Chemistry of Heterocyclic Compounds, Vol. 56. pp. 659–662.

  • 12

    Tobaiqy, M. et al. (2020) Therapeutic management of patients with COVID-19: a systematic review. Infection Prevention in Practice, Vol. 2. No. 3. 100061.

  • 13

    Wang, M. et al. (2020). Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Research, Vol. 30. No. 3. pp. 269–271.

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  • Tamás NÉMETH

Managing Editor:

  • István SABJANICS (Ministry of Interior, Budapest, Hungary)

Editorial Board:

  • Attila ASZÓDI (Budapest University of Technology and Economics)
  • Zoltán BIRKNER (National Research, Development and Innovation Office)
  • Valéria CSÉPE (Research Centre for Natural Sciences, Brain Imaging Centre)
  • Gergely DELI (University of Public Service)
  • Tamás DEZSŐ (Migration Research Institute)
  • Imre DOBÁK (University of Public Service)
  • Marcell Gyula GÁSPÁR (University of Miskolc)
  • József HALLER (University of Public Service)
  • Charaf HASSAN (Budapest University of Technology and Economics)
  • Zoltán GYŐRI (Hungaricum Committee)
  • János JÓZSA (Budapest University of Technology and Economics)
  • András KOLTAY (National Media and Infocommunications Authority)
  • Gábor KOVÁCS (University of Public Service)
  • Levente KOVÁCS buda University)
  • Melinda KOVÁCS (Hungarian University of Agriculture and Life Sciences (MATE))
  • Miklós MARÓTH (Avicenna Institue of Middle Eastern Studies )
  • Judit MÓGOR (Ministry of Interior National Directorate General for Disaster Management)
  • József PALLO (University of Public Service)
  • István SABJANICS (Ministry of Interior)
  • Péter SZABÓ (Hungarian University of Agriculture and Life Sciences (MATE))
  • Miklós SZÓCSKA (Semmelweis University)

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