美国密歇根州大学公共卫生学院Arnold S. Monto团队研究了巴洛沙韦治疗预防流感传播的疗效。相关论文于2025年4月24日发表在《新英格兰医学杂志》上。

巴洛沙韦（Baloxavir）可迅速减少流感病毒的传播，这表明它可能会减少传播。对神经氨酸酶抑制剂治疗的研究没有显示出足够的证据表明它们可以防止传播给接触者。

研究组进行了一项多国3b期试验，以评估单剂量巴洛沙韦治疗减少流感从指标患者向家密歇根州大学公共卫生学院庭接触者传播的疗效。将5至64岁的流感阳性指数患者以1:1的比例随机分配，在症状发作后48小时内接受巴洛沙韦或安慰剂治疗。主要终点是第5天流感病毒从一名指标患者传播给一名家庭接触者。第一个次要终点是第5天流感病毒的传播，导致症状。

总体而言，在2019-2024年流感季节，共有1457名指标患者和2681名家庭接触者参与；726名指标患者被分配到巴洛韦组，731名被分配到安慰剂组。到第5天，巴洛昔韦的实验室确诊流感传播明显低于安慰剂（调整后的发病率为9.5%对13.4%；调整后的比值比为0.68；95.38%置信区间[CI]为0.50至0.93；P=0.01），调整后的相对风险降低了29%（95.38%CI为12至45）。在第5天，巴洛沙韦组和安慰剂组导致症状的流感病毒传播调整后发生率分别为5.8%和7.6%；然而，差异并不显著（调整后的比值比为0.75；95.38%置信区间为0.50至1.12；P=0.16）。在随访期间，巴洛沙韦组中7.2%（95%CI，4.1至11.6）的指标患者出现了耐药病毒；在家庭接触者中未检测到耐药病毒。没有发现新的安全信号。

研究结果表明，与安慰剂相比，单剂量口服巴洛沙韦治疗导致流感病毒向密切接触者传播的发生率较低。

附：英文原文

Title: Efficacy of Baloxavir Treatment in Preventing Transmission of Influenza

Author: Arnold S. Monto, Klaus Kuhlbusch, Corrado Bernasconi, Bin Cao, Herman Avner Cohen, Emily Graham, Aeron C. Hurt, Laurie Katugampola, Takashi Kamezawa, Adam S. Lauring, Barry McLean, Takahiro Takazono, Andreas Widmer, Steffen Wildum, Benjamin J. Cowling

Issue&Volume: 2025-04-24

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.

DOI: NJ202504243921606

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2413156