{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T08:23:23Z","timestamp":1787732603360,"version":"build-2784847793"},"reference-count":36,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100004328","name":"Genentech","doi-asserted-by":"publisher","award":["ML43184"],"award-info":[{"award-number":["ML43184"]}],"id":[{"id":"10.13039\/100004328","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>COMBO 1 compared time to cessation of viral shedding (TCVS) among hospitalized influenza patients treated with oseltamivir plus a single dose of baloxavir vs. oseltamivir alone.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In a quadruple-blinded, placebo-controlled parallel group multicenter randomized controlled trial, hospitalized patients with laboratory-confirmed influenza were randomly enrolled in a 1:1 ratio to Group 1 (oseltamivir+placebo) or Group 2 (oseltamivir+baloxavir). All patients were treated with oseltamivir for 5 days; one dose of baloxavir or placebo was given in identical capsules. Primary efficacy and safety outcomes were TCVS by virus titer with qCulture TCID\n                      <jats:sub>50<\/jats:sub>\n                      agglutination and 30-day severe adverse event (SAE) rate, respectively. Secondary virology, clinical, and safety outcomes were assessed. Continuous and categorical data were analyzed with Wilcoxon Rank-Sum and Fisher\u2019s Exact Tests, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>14 participants were randomized and received study drug (Group 1: n=6, Group 2: n=8); the study was stopped early due to slow accrual. Baseline characteristics were balanced. Median TCVS with qCulture was 53.3 hours in Group 1 and 25.3 hours in Group 2 (p=0.13). 30-day overall SAE rates were 16.7% and 12.5%, respectively. All patients achieved negative qCulture. Median TCVS with quantitative PCR (RT-qPCR) was 115.6 and 34.4 hours (p=0.24); % achieving viral negative by RT-qPCR was 33.3% and 75.0% (p=0.28), respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Combination therapy with oseltamivir and a single dose of baloxavir was inconclusive with non-significant trends towards shorter median TCVS vs. monotherapy with oseltamivir in hospitalized patients with influenza. Interpretation is limited by small sample size and early termination.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13596535261479944","type":"journal-article","created":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T06:06:56Z","timestamp":1787551616000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["COMbination therapy with baloxavir and oseltamivir 1 for hospitalized patients with influenza: The pragmatic COMBO 1 randomized controlled trial"],"prefix":"10.1177","volume":"31","author":[{"given":"Jennifer","family":"Victory","sequence":"first","affiliation":[{"name":"Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2397-3337","authenticated-orcid":false,"given":"Melissa","family":"Scribani","sequence":"additional","affiliation":[{"name":"Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Hasuly","sequence":"additional","affiliation":[{"name":"Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Jenkins","sequence":"additional","affiliation":[{"name":"Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Krupa","sequence":"additional","affiliation":[{"name":"Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erik","family":"Riesenfeld","sequence":"additional","affiliation":[{"name":"Department of Medicine, Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dikshya","family":"Khatiwada","sequence":"additional","affiliation":[{"name":"Department of Medicine, Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmad","family":"Raja","sequence":"additional","affiliation":[{"name":"Department of Medicine, Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Summia","family":"Afridi","sequence":"additional","affiliation":[{"name":"Department of Medicine, Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Azkia","family":"Khan","sequence":"additional","affiliation":[{"name":"Department of Medicine, Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armando S.","family":"Paez","sequence":"additional","affiliation":[{"name":"Baystate Health"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3091-632X","authenticated-orcid":false,"given":"Akram","family":"Khan","sequence":"additional","affiliation":[{"name":"Oregon Health & Science University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2219-6900","authenticated-orcid":false,"given":"Daniel","family":"Freilich","sequence":"additional","affiliation":[{"name":"Bassett Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,8,23]]},"reference":[{"key":"e_1_3_9_2_2","unstructured":"Centers for Disease Control and Prevention. 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