2025-04-23 ミシガン大学
<関連情報>
- https://news.umich.edu/drug-that-treats-flu-shows-additional-benefit-of-protecting-close-contacts-from-infection/
- https://www.nejm.org/doi/full/10.1056/NEJMoa2413156
インフルエンザ感染予防におけるバロキサビル治療の有効性 Efficacy of Baloxavir Treatment in Preventing Transmission of Influenza
Arnold S. Monto, M.D., Klaus Kuhlbusch, M.D., Corrado Bernasconi, M.D., Ph.D., Bin Cao, M.D., Herman Avner Cohen, M.D., Emily Graham, Ph.D., Aeron C. Hurt, Ph.D., +7 , and Benjamin J. Cowling, Ph.D.
The New England Journal of Medicine Published: April 23, 2025
DOI: 10.1056/NEJMoa2413156
Abstract
Background
Baloxavir marboxil (baloxavir) rapidly reduces influenza virus shedding, which suggests that it may reduce transmission. Studies of treatment with neuraminidase inhibitors have not shown sufficient evidence that they prevent transmission to contacts.
Methods
We conducted a multicountry, phase 3b trial to assess the efficacy of single-dose baloxavir treatment to reduce influenza transmission from index patients to household contacts. Influenza-positive index patients 5 to 64 years of age were randomly assigned in a 1:1 ratio to receive baloxavir or placebo within 48 hours after symptom onset. The primary end point was transmission of influenza virus from an index patient to a household contact by day 5. The first secondary end point was transmission of influenza virus by day 5 that resulted in symptoms.
Results
Overall, 1457 index patients and 2681 household contacts were enrolled across the 2019–2024 influenza seasons; 726 index patients were assigned to the baloxavir group, and 731 to the placebo group. By day 5, transmission of laboratory-confirmed influenza was significantly lower with baloxavir than with placebo (adjusted incidence, 9.5% vs. 13.4%; adjusted odds ratio, 0.68; 95.38% confidence interval [CI], 0.50 to 0.93; P=0.01), with an adjusted relative risk reduction of 29% (95.38% CI, 12 to 45). The adjusted incidence of transmission of influenza virus by day 5 that resulted in symptoms was 5.8% with baloxavir and 7.6% with placebo; however, the difference was not significant (adjusted odds ratio, 0.75; 95.38% CI, 0.50 to 1.12; P=0.16). Emergence of drug-resistant viruses during the follow-up period occurred in 7.2% (95% CI, 4.1 to 11.6) of the index patients in the baloxavir group; no resistant viruses were detected in household contacts. No new safety signals were identified.
Conclusions
Treatment with a single oral dose of baloxavir led to a lower incidence of transmission of influenza virus to close contacts than placebo. (Funded by F. Hoffmann–La Roche and others; CENTERSTONE ClinicalTrials.gov number, NCT03969212.)
