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Journal Article Epublish 3 citations

PubMed: 39552926 DOI: 10.1016/j.nmni.2024.101522

Real world effectiveness of early ensitrelvir treatment in patients with SARS-CoV-2, a retrospective case series.

New Microbes New Infect 62:101522

Authors: Shuichi Abe, Dhammika Leshan Wannigama, Yu Suzuki, Daisuke Akaneya, Junko Igarashi, Mayu Suto, Kazunori Moriya, Daisuke Ishizawa, Yoshikazu Okuma, Parichart Hongsing, Cameron Hurst, Thammakorn Saethang, Paul G Higgins, Stephen M Stick, Anthony Kicic

Affiliations

  • Department of Infectious Diseases and Infection Control, Yamagata Prefectural Central Hospital, Yamagata, Japan.
  • Pathogen Hunter's Research Team, Department of Infectious Diseases and Infection Control, Yamagata Prefectural Central Hospital, Yamagata, Japan.
  • Department of Infectious Diseases and Infection Control, Yamagata Prefectural Central Hospital, Yamagata, Japan. Pathogen Hunter's Research Team, Department of Infectious Diseases and Infection Control, Yamagata Prefectural Central Hospital, Yamagata, Japan. Department of Infectious Diseases, Faculty of Medicine Yamagata University, Yamagata, Japan. School of Medicine, Faculty of Health and Medical Sciences, The University of Western Australia, Nedlands, Western Australia, Australia. Biofilms and Antimicrobial Resistance Consortium of ODA Receiving Countries, The University of Sheffield, Sheffield, United Kingdom.
  • Department of Clinical Laboratory, Yamagata Prefectural Central Hospital, Yamagata, Japan.
  • Department of Pharmacy, Yamagata Prefectural Central Hospital, Yamagata, Japan.
  • Mae Fah Luang University Hospital, Chiang Rai, Thailand.
  • School of Integrative Medicine, Mae Fah Luang University, Chiang Rai, Thailand.
  • Molly Wardaguga Research Centre, Charles Darwin University, Queensland, Australia.
  • Department of Clinical Epidemiology, Faculty of Medicine, Thammasat University, Rangsit, Thailand, 10120.
  • Center of Excellence in Applied Epidemiology, Thammasat University, Rangsit, Thailand, 10120.
  • Department of Computer Science, Faculty of Science, Kasetsart University, Bangkok, Thailand.
  • Institute for Medical Microbiology, Immunology and Hygiene, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
  • German Centre for Infection Research, Partner Site Bonn-Cologne, Cologne, Germany.
  • Wal-yan Respiratory Centre, Telethon Kids Institute, University of Western Australia, Nedlands, 6009, Western Australia, Australia.
  • Department of Respiratory and Sleep Medicine, Perth Children's Hospital, Nedlands, 6009, Western Australia, Australia.
  • Centre for Cell Therapy and Regenerative Medicine, Medical School, The University of Western Australia, Nedlands, 6009, Western Australia, Australia.
  • School of Population Health, Curtin University, Bentley, 6102, Western Australia, Australia.

Abstract

Background

Ensitrelvir, a 3C-like protease inhibitor, received emergency approval in Japan in November 2022 for treating non-hospitalized patients with mild-to-moderate COVID-19. However, confirmation of its real-world clinical effectiveness is limited.

Methods

This retrospective study evaluated 18 vaccinated outpatients (15 men; median age, 39.5 years; range, 26-56), treated with a 5-day oral ensitrelvir regimen (375 mg loading dose, followed by 125 mg daily) between December 1, 2022, and January 31, 2023. Nasal swabs were collected on days 0, 3, 6, and 9 for RT-qPCR to assess viral load. Variants were identified by Sanger sequencing, and outcomes were compared to historical controls. Patients were followed for 60 days to monitor for post-acute sequelae of COVID-19 (PASC).

Results

Symptoms such as mild fever and sore throat improved rapidly after one day of ensitrelvir treatment, with 66 % of patients recovering within six days. All individuals were infected with the BA.5 Omicron variant. Viral loads, as measured by Ct values, increased significantly from 21.82 at symptom onset to 37.65 b y day 6, with SARS-CoV-2 RNA undetectable in most patients by day 9. Those treated within 48 h of symptom onset showed the viral load reduction. Compared to historical controls, where symptom resolution took 8.5 days, ensitrelvir shortened recovery time to as little as 1.4 days for over 66 % of patients.

Conclusion

Ensitrelvir treatment resulted in rapid symptom relief and significant viral load reduction, with no adverse events, viral rebound, or PASC symptoms, demonstrating its potential efficacy and safety. Larger studies are needed for further confirmation.

MeSH

Sars-Cov-2, Viral Load, Therapeutics, Severe Acute Respiratory Syndrome-Related Coronavirus

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