Data_Sheet_1_Prospective observational study of baloxavir marboxil in adults and adolescents with uncomplicated influenza from China.pdf

IntroductionThere are limited data on the efficacy of baloxavir marboxil (baloxavir) versus oseltamivir in Chinese patients with influenza A.
MethodsThis study is an observational real-world investigation encompassing 246 patients (baloxavir, n = 147; oseltamivir, n = 99) confirmed positive for influenza A. The choice between baloxavir and oseltamivir antiviral treatments was determined collaboratively by the clinician and the patient. A thorough comparative analysis was undertaken between the two groups, examining parameters such as the duration of fever and symptoms, viral load dynamics, lymphocyte changes, and enhancements in health-related quality of life (QoL).
ResultsNo significant differences were observed in demographic data between the two groups. The duration of fever was significantly shorter in the baloxavir group (P < 0.001). However, the duration of symptoms was not significant different (P = 0.167). Multivariable Cox analysis showed the independent factors affecting duration of fever were baloxavir treatment (HR = 2.033, P < 0.001), fever on day 1 (HR = 0.741, P = 0.010) and CRP level (HR = 1.009, P = 0.039). Moreover, sex (HR= 0.660, P = 0.019) and monocyte count (HR = 1.355, P = 0.018) were independent factors affecting the duration of symptoms. No significant difference in change of health-related quality of life (P > 0.05), positive rate of viral antigen on day 3 (P = 0.477) between the two groups. Remarkably, a mutation was observed in one case on the third-day after baloxavir treatment compared with first-day, from cysteine to serine at position 384 of the PA subunit.
ConclusionIn the clinical setting, baloxavir demonstrated comparable clinical benefits to oseltamivir, establishing its efficacy as an effective antiviral therapy for Chinese patients with influenza.

引言 目前针对中国甲型流感患者使用玛巴洛沙韦（baloxavir marboxil，以下简称baloxavir）对比奥司他韦（oseltamivir）的疗效数据仍较为有限。
方法 本研究为一项观察性真实世界研究，共纳入246例甲型流感病毒检测阳性患者（玛巴洛沙韦组n=147；奥司他韦组n=99）。抗病毒治疗方案的选择（玛巴洛沙韦或奥司他韦）由临床医师与患者共同协商确定。研究对两组患者开展了全面的对比分析，考察指标涵盖发热时长、症状持续时间、病毒载量动态变化、淋巴细胞变化以及健康相关生活质量（health-related quality of life，以下简称QoL）的改善情况。
结果 两组患者的人口学资料无显著差异。玛巴洛沙韦组的发热时长显著短于奥司他韦组（P<0.001），但两组症状持续时间无显著差异（P=0.167）。多变量Cox比例风险回归分析显示，影响发热时长的独立危险因素包括玛巴洛沙韦治疗（风险比HR=2.033，P<0.001）、入院首日发热（HR=0.741，P=0.010）以及C反应蛋白（CRP）水平（HR=1.009，P=0.039）。此外，性别（HR=0.660，P=0.019）与单核细胞计数（HR=1.355，P=0.018）是影响症状持续时间的独立危险因素。两组患者的健康相关生活质量变化（P>0.05）及第3日病毒抗原阳性率（P=0.477）均无显著差异。值得注意的是，1例接受玛巴洛沙韦治疗的患者在治疗第3日与首日相比，其PA亚基384位氨基酸发生了从半胱氨酸到丝氨酸的突变。
结论 临床实践中，玛巴洛沙韦与奥司他韦的临床获益相当，证实其可作为中国甲型流感患者的有效抗病毒治疗方案。