A SONAR report on Nirmatrelvir/ritonavir-associated rebound COVID-19: Using new databases for evaluating new diseases.

Autor: Bennett CL; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.; Clinical Pharmacy and Outcomes Sciences, College of Pharmacy, University of South Carolina, Columbia, South Carolina, United States of America., Magagnoli J; Clinical Pharmacy and Outcomes Sciences, College of Pharmacy, University of South Carolina, Columbia, South Carolina, United States of America., Gundabolu K; Division of Hematology/Oncology, Department of Internal Medicine, Omaha School of Medicine University of Nebraska, Omaha, Nebraska, United States of America., Georgantopoulos P; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America., Lebby A; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America., Watson G; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America., Knopf K; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.; Hematology/Oncology, Highland Hospital, Alameda Health System, Oakland, California, United States of America., Martin L; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America., Carson KR; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.; Division of Hematology and Oncology, Department of Medicine, Feinberg School of Medicine Northwestern University, Chicago, Illinois, United States of America., Hrushesky WJ; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America., Nabhan C; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America., Zyszkowski E; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America., Smith EB; Department of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America., Gale RP; Centre for Haematology Research, Department of Immunology and Inflammation, Imperial College London, London, United Kingdom., Rosen ST; City of Hope Comprehensive Cancer Center and the Beckman Research Institute, Duarte, California, United States of America.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2024 Sep 25; Vol. 19 (9), pp. e0308205. Date of Electronic Publication: 2024 Sep 25 (Print Publication: 2024).
DOI: 10.1371/journal.pone.0308205
Abstrakt: Introduction: In May 2022, the Centers for Disease Control and Prevention disseminated an alert advising that "a few" persons with Nirmatrelvir/ritonavir (NM/R)-associated rebound of COVID-19 infection had been identified. Three case reports appearing as pre-print postings described the first cases. Analyses in March 2023 by NM/R's manufacturer and the Food and Drug Administration (FDA) reported no association between NM/R and COVID-19 rebound in a large phase 3 randomized clinical trial. Our study evaluated if social media databases or electronically disseminated new articles might provide insights related to the putative new toxicity, NM/R-associated COVID-19 rebound.
Methods: Information on NM/R-associated COVID-19 rebound cases was abstracted from preprint postings of non-peer-reviewed manuscripts, social media websites, electronically disseminated print and television media reports, a new FDA adverse event database for drugs that received Emergency Use Approval, and news articles in scientific journals.
Results: Thirty-five persons experienced presumed or documented NM/R-associated COVID-19 rebound, based on information described in preprint services (n = 27), Twitter postings and related news articles (n = 7), and news articles without related Twitter reports (n = 1). These reports included information on dates of initial COVID-19 illness and rebound onset, COVID-19 testing, vaccine status, presentation, and outcome. A new FDA safety database identified 12,500 possible cases of this toxicity, but the quality of these data was poor. Preprint postings preceded peer-reviewed publications describing the same cases by four months. Social media websites including Instagram, Reddit, YouTube, the Center for Disease Control and Prevention's (CDC) Health Alert Network, CDC Twitter, and Facebook did not provide clinically meaningful information on individual cases.
Conclusion: Preprint services and Twitter facilitated identification of the largest case series of NM/R-associated COVID-19 rebound. The cases were reported in non-peer-reviewed media several weeks prior to the first peer-reviewed electronically disseminated publication of one person with this diagnosis.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2024 Bennett et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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