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. 2024 Sep;30(9):946-950.
doi: 10.1016/j.jiac.2024.02.015. Epub 2024 Feb 15.

Ensitrelvir in patients with SARS-CoV-2: A retrospective chart review

Masaya Yamato  1 , Masahiro Kinoshita  2 , Shogo Miyazawa  3 , Masayuki Seki  1 , Tomoki Mizuno  1 , Takuhiro Sonoyama  4
Affiliations
Free article

Ensitrelvir in patients with SARS-CoV-2: A retrospective chart review

Masaya Yamato et al. J Infect Chemother. 2024 Sep.
Free article

Abstract

Antivirals with proven effectiveness against the Omicron SARS-CoV-2 variant are required for COVID-19 treatment in hospitalized patients, particularly those with severe underlying conditions. Ensitrelvir, a 3C-like protease inhibitor, received emergency approval in Japan in November 2022, based on evidence of rapid symptom resolution in non-hospitalized patients, but confirmation of its effectiveness in hospitalized patients is lacking. This retrospective chart review reports outcomes for all patients who received ensitrelvir whilst hospitalized with SARS-CoV-2 infection at Rinku General Medical Center, Japan (November 2022-April 2023). Thirty-two hospitalized patients received 5 days of ensitrelvir treatment (375 mg loading dose, 125 mg as maintenance dose). Patients' mean age was 73.5 years and most had mild COVID-19. Patients exhibited various underlying diseases, most commonly hypertension (78.1%) and chronic kidney disease (25.0%). Seven (21.9%) patients were on hemodialysis. The most common concomitant medications were antihypertensives (59.4%) and corticosteroids (31.3%); 2 (6.3%) patients were being treated with rituximab; 28 (87.5%) patients had viral persistence following pre-treatment by remdesivir. Following ensitrelvir treatment, viral clearance was recorded in 18 (56.3%) patients by Day 6 and 25 (78.1%) patients at final measurement. All patients experienced clinical improvement as assessed by the investigator at Day 5. No intensive care unit admissions or deaths due to COVID-19 occurred. No new safety signals were observed. In conclusion, positive virological outcomes were observed following ensitrelvir treatment, in hospitalized patients with SARS-CoV-2 in a real-world setting, including high-risk patients, who failed previous antiviral therapy. These results require confirmation in more extensive studies. TRIAL REGISTRATION: UMIN000051300.

Keywords: COVID-19; Ensitrelvir; Remdesivir-failure; SARS-CoV-2; Viral load; Viral persistence.

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Conflict of interest statement

Declaration of competing interest M. Yamato has received lecture fees from, and serves as an advisor for, Shionogi & Co., Ltd. M. Kinoshita, S. Miyazawa, T. Sonoyama, T. Horiyama and T. Tsushima are employees of Shionogi & Co., Ltd. Masayuki Seki and T. Mizuno have nothing to disclose. This study was supported by Shionogi & Co., Ltd. in terms of costs associated with the development and publication of this manuscript.

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