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

{ 'indexed': {'date-parts': [[2024, 9, 25]], 'date-time': '2024-09-25T20:10:10Z', 'timestamp': 1727295010597}, 'reference-count': 53, 'publisher': 'Public Library of Science (PLoS)', 'issue': '9', 'license': [ { 'start': { 'date-parts': [[2024, 9, 25]], 'date-time': '2024-09-25T00:00:00Z', 'timestamp': 1727222400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'http://creativecommons.org/licenses/by/4.0/'}], 'funder': [ { 'DOI': '10.13039/100000054', 'name': 'National Cancer Institute', 'doi-asserted-by': 'publisher', 'award': ['1R01 CA102713'], 'id': [{'id': '10.13039/100000054', 'id-type': 'DOI', 'asserted-by': 'publisher'}]}, { 'name': 'Beckman Research Institute and the City of Hope Comprehensive Cancer Center, ' 'Duarte, California'}, { 'name': 'Beckman Research Institute and the City of Hope Comprehensive Cancer Center, ' 'Duarte, California'}], 'content-domain': {'domain': ['www.plosone.org'], 'crossmark-restriction': False}, 'abstract': '<jats:sec id="sec001">\n' '<jats:title>Introduction</jats:title>\n' '<jats:p>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.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec002">\n' '<jats:title>Methods</jats:title>\n' '<jats:p>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.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec003">\n' '<jats:title>Results</jats:title>\n' '<jats:p>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.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec004">\n' '<jats:title>Conclusion</jats:title>\n' '<jats:p>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.</jats:p>\n' '</jats:sec>', 'DOI': '10.1371/journal.pone.0308205', 'type': 'journal-article', 'created': {'date-parts': [[2024, 9, 25]], 'date-time': '2024-09-25T19:27:40Z', 'timestamp': 1727292460000}, 'page': 'e0308205', 'update-policy': 'http://dx.doi.org/10.1371/journal.pone.corrections_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'A SONAR report on Nirmatrelvir/ritonavir-associated rebound COVID-19: Using new databases for ' 'evaluating new diseases', 'prefix': '10.1371', 'volume': '19', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-8645-5705', 'authenticated-orcid': True, 'given': 'Charles L.', 'family': 'Bennett', 'sequence': 'first', 'affiliation': []}, {'given': 'Joseph', 'family': 'Magagnoli', 'sequence': 'additional', 'affiliation': []}, {'given': 'Krishna', 'family': 'Gundabolu', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-4113-6655', 'authenticated-orcid': True, 'given': 'Peter', 'family': 'Georgantopoulos', 'sequence': 'additional', 'affiliation': []}, {'given': 'Akida', 'family': 'Lebby', 'sequence': 'additional', 'affiliation': []}, {'given': 'Gretchen', 'family': 'Watson', 'sequence': 'additional', 'affiliation': []}, {'given': 'Kevin', 'family': 'Knopf', 'sequence': 'additional', 'affiliation': []}, {'given': 'Linda', 'family': 'Martin', 'sequence': 'additional', 'affiliation': []}, {'given': 'Kenneth R.', 'family': 'Carson', 'sequence': 'additional', 'affiliation': []}, {'given': 'William J.', 'family': 'Hrushesky', 'sequence': 'additional', 'affiliation': []}, {'given': 'Chadi', 'family': 'Nabhan', 'sequence': 'additional', 'affiliation': []}, {'given': 'Edward', 'family': 'Zyszkowski', 'sequence': 'additional', 'affiliation': []}, {'given': 'Edward B.', 'family': 'Smith', 'sequence': 'additional', 'affiliation': []}, {'given': 'Robert Peter', 'family': 'Gale', 'sequence': 'additional', 'affiliation': []}, {'given': 'Steven T.', 'family': 'Rosen', 'sequence': 'additional', 'affiliation': []}], 'member': '340', 'published-online': {'date-parts': [[2024, 9, 25]]}, 'reference': [ { 'issue': '2', 'key': 'pone.0308205.ref001', 'article-title': 'Systematic approach to pharmacovigilance beyond the limits: the ' 'southern network on adverse reactions (SONAR) projects', 'volume': '3', 'author': 'ZK Lu', 'year': '2014', 'journal-title': 'Adv Pharmacoepidemiol Drug Saf'}, { 'issue': '20', 'key': 'pone.0308205.ref002', 'doi-asserted-by': 'crossref', 'first-page': '1964', 'DOI': '10.1056/NEJMc2105869', 'article-title': 'Thrombotic Thrombocytopenia after Ad26.COV2.S Vaccination', 'volume': '384', 'author': 'KL Muir', 'year': '2021', 'journal-title': 'The New England journal of medicine'}, { 'key': 'pone.0308205.ref003', 'article-title': 'Viral Kinetics of Severe Acute Respiratory Syndrome Coronavirus 2 ' '(SARS-CoV-2) Omicron Infection in mRNA-Vaccinated Individuals Treated ' 'and Not Treated with Nirmatrelvir-Ritonavir', 'author': 'EY Dai', 'year': '2022', 'journal-title': 'medRxiv'}, { 'key': 'pone.0308205.ref004', 'article-title': 'The Paxlovid Rebound Study: A Prospective Cohort Study to Evaluate ' 'Viral and Symptom Rebound Differences Between Paxlovid and Untreated ' 'COVID-19 Participants', 'author': 'AP Jay', 'year': '2022', 'journal-title': 'medRxiv'}, { 'key': 'pone.0308205.ref005', 'article-title': 'COVID-19 rebound after Paxlovid and Molnupiravir during January-June ' '2022', 'author': 'L Wang', 'year': '2022', 'journal-title': 'medRxiv'}, { 'key': 'pone.0308205.ref006', 'unstructured': 'CDC Health Advisory. 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