Background Baloxavir marboxil (baloxavir), an anti-influenza drug with a novel mechanism of action, is expected to reduce influenza transmission by rapid reduction of viral load. The incidence of household transmission was compared between index patients (IPs) treated with baloxavir and those with neuraminidase inhibitors. Methods Using a Japanese claims database provided by JMDC Inc., the first family members with influenza diagnosis during 2018/2019 influenza season were identified as IPs, and the diagnosis date was designated Day 1. According to the anti-influenza drug dispensed to the IP, their families were classified into oral baloxavir group and three controls; oral oseltamivir group (a primary control), inhaled zanamivir group, and inhaled laninamivir group. A household transmission was defined as influenza diagnosed for any non-IP family members during Days 3−8. The incidence of household transmission was compared between groups using a logistic regression model adjusting backgrounds of IPs. Results The proportion of families with household transmission was 17.98% (15,226/84,672) in the baloxavir group and 24.16% (14,983/62,004) in the oseltamivir group. The covariate-adjusted odds ratio (oseltamivir/baloxavir) was 1.09 [95% confidence interval, 1.05–1.12], which indicated significantly lower incidence in the baloxavir group. Adjusted odds ratios (controls/baloxavir) against zanamivir and laninamivir were 0.93 [0.89–0.97] and 0.99 [0.96–1.02], respectively. Conclusions Baloxavir may contribute to reduce the incidence of household transmission compared with oseltamivir, which is widely used for oral influenza treatment. In comparison between baloxavir and inhalants, a similar reduction was not shown and it might be due to unmeasured confounding by administration route differences.

Purpose: Alerts for bleeding events are included in the Japanese package inserts of some anti-influenza drugs, including baloxavir marboxil and oseltamivir. However, there are few reports on the incidence of bleeding events during treatment with antiinfluenza drugs. This large-scale quantitative assessment compared the incidence of bleeding events in influenza patients treated with baloxavir and other anti-influenza drugs and in untreated patients.Methods: This retrospective cohort study used a large-scale Japanese employmentbased health insurance claims database provided by JMDC Inc. and included outpatients diagnosed with influenza between October 1, 2018 and April 11, 2019. Bleeding events were identified by International Classification of Diseases 10th revision codes. Incidences were compared between patients treated with baloxavir or neuraminidase inhibitors and untreated patients.Odds ratios were calculated after exact matching to adjust for potential confounders.

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Background Baloxavir marboxil (baloxavir) is a single-dose, oral anti-influenza drug with a novel mechanism of action. We compared the incidence of hospitalization in patients treated with baloxavir versus neuraminidase inhibitors. Methods This was a retrospective observational cohort study using real-world patient data extracted from a Japanese health insurance claims database. The enrollment period was October 1, 2018 to April 17, 2019. On day 1, eligible patients (N = 339 007) received baloxavir, oseltamivir, zanamivir, or laninamivir. Baseline characteristics were standardized using the inverse probability of treatment weighting method. Primary end point was the incidence of hospitalization (days 2–14). Secondary end points included antibacterial use, secondary pneumonia, and additional anti-influenza drug use. Results Compared with the baloxavir group, the incidence of hospitalization was greater in the oseltamivir group (risk ratio [RR] and 95% confidence interval [CI], 1.41 [1.00–2.00]; risk difference [RD] and 95% CI, 0.06 [0.01–0.12]) and zanamivir group (RR, 1.85 [1.23–2.78]; RD, 0.11 [0.02–0.20]). Oseltamivir-treated patients were less likely to require antibacterials than baloxavir-treated patients (RR, 0.87 [0.82–0.91]). However, oseltamivir-treated patients were more likely to be hospitalized with antibacterials (RR, 1.70 [1.21–2.38]) or antibacterial injection (RR, 1.67 [1.17–2.38]) than baloxavir-treated patients (post hoc analysis). Compared with baloxavir-treated patients, additional anti-influenza drug use was greater in oseltamivir-, zanamivir-, and laninamivir-treated patients (RR, 1.51 [1.05–2.18], 2.84 [2.04–3.96], and 1.68 [1.35–2.10], respectively). Conclusions Baloxavir is an efficacious anti-influenza treatment that may reduce hospitalization compared with oseltamivir and zanamivir.