Evidence map›Paper›PMID 39552926›Full record

ArticleNew microbes and new infections2024

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

Shuichi Abe, Dhammika Leshan Wannigama, Yu Suzuki, Daisuke Akaneya, Junko Igarashi, Mayu Suto, Kazunori Moriya, Daisuke Ishizawa, Yoshikazu Okuma, Parichart Hongsing and 5 more

Abstract read
In one paragraph

Article in New microbes and new infections, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Shuichi AbeDepartment of Infectious Diseases and Infection Control, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Dhammika Leshan WannigamaDepartment of Infectious Diseases and Infection Control, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Yu SuzukiDepartment of Clinical Laboratory, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Daisuke AkaneyaDepartment of Clinical Laboratory, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Junko IgarashiDepartment of Clinical Laboratory, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Mayu SutoDepartment of Clinical Laboratory, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Kazunori MoriyaDepartment of Infectious Diseases and Infection Control, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Daisuke IshizawaDepartment of Pharmacy, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Yoshikazu OkumaDepartment of Pharmacy, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Parichart HongsingMae Fah Luang University Hospital, Chiang Rai, Thailand.
Cameron HurstMolly Wardaguga Research Centre, Charles Darwin University, Queensland, Australia.
Thammakorn SaethangDepartment of Computer Science, Faculty of Science, Kasetsart University, Bangkok, Thailand.
Paul G HigginsInstitute for Medical Microbiology, Immunology and Hygiene, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
Stephen M StickWal-yan Respiratory Centre, Telethon Kids Institute, University of Western Australia, Nedlands, 6009, Western Australia, Australia.
Anthony KicicWal-yan Respiratory Centre, Telethon Kids Institute, University of Western Australia, Nedlands, 6009, Western Australia, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Identifiers

PMID39552926
PMCPMC11567130

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.