Baker Jeffery B, Block Stanley L, Cagas Steven E, Macutkiewicz Laura Burleigh, Collins Colleen, Sadeghi Mitra, Sarkar Sriparna, Williams Sarah
From the Clinical Research Prime, Idaho Falls, Idaho.
Kentucky Pediatric and Adult Research Inc, Bardstown, Kentucky.
Pediatr Infect Dis J. 2023 Nov 1;42(11):983-989. doi: 10.1097/INF.0000000000004062. Epub 2023 Aug 17.
miniSTONE-2 (NCT03629184) was a global, phase 3, randomized, controlled study that investigated the safety and efficacy of single-dose baloxavir marboxil in otherwise healthy children 1-<12 years of age and showed a positive risk-benefit profile. This post hoc analysis evaluated the safety and efficacy of baloxavir versus oseltamivir in children 5-11 years old with influenza.
Children received single-dose baloxavir or twice-daily oseltamivir for 5 days. Safety was the primary objective. Efficacy and virological outcomes included time to alleviation of symptoms, duration of fever and time to cessation of viral shedding by titer. Data were summarized descriptively.
Ninety-four children 5-11 years old were included (61 baloxavir and 33 oseltamivir). Baseline characteristics were similar between the groups. The incidence of adverse events was balanced and low in both treatment groups, with the most common being vomiting (baloxavir 5% vs. oseltamivir 18%), diarrhea (5% vs. 0%) and otitis media (0% vs. 5%). No serious adverse events or deaths occurred. Median (95% CI) time to alleviation of symptoms with baloxavir was 138.4 hours (116.7-163.4) versus 126.1 hours (95.9-165.7) for oseltamivir; duration of fever was comparable between groups [41.2 hours (23.5-51.4) vs. 51.3 hours (30.7-56.8), respectively]. Median time to cessation of viral shedding was shorter in the baloxavir group versus oseltamivir (1 vs. ≈3 days).
Safety, efficacy and virological results in children 5-11 years were similar to those from the overall study population 1-<12 years of age. Single-dose baloxavir provides an additional treatment option for pediatric patients 5-11 years old with influenza.
miniSTONE-2（NCT03629184）是一项全球性、3期、随机、对照研究，旨在调查单剂量巴洛沙韦酯在1至未满12岁健康儿童中的安全性和有效性，结果显示其风险效益比良好。这项事后分析评估了巴洛沙韦与奥司他韦在5至11岁流感儿童中的安全性和有效性。
儿童接受单剂量巴洛沙韦或每日两次奥司他韦治疗，持续5天。安全性是主要目标。疗效和病毒学结果包括症状缓解时间、发热持续时间以及病毒载量降至检测不到水平的时间。数据采用描述性总结。
纳入了94名5至11岁儿童（61名接受巴洛沙韦治疗，33名接受奥司他韦治疗）。两组的基线特征相似。两个治疗组不良事件发生率均衡且较低，最常见的是呕吐（巴洛沙韦组5%，奥司他韦组18%）、腹泻（5% vs. 0%）和中耳炎（0% vs. 5%）。未发生严重不良事件或死亡。巴洛沙韦组症状缓解时间的中位数（95%CI）为138.4小时（116.7至163.4）；奥司他韦组为126.1小时（95.9至165.7）；两组发热持续时间相当[分别为41.2小时（23.5至51.4）和51.3小时（30.7至56.8）]。巴洛沙韦组病毒载量降至检测不到水平的时间中位数短于奥司他韦组（1天对约3天）。
5至11岁儿童的安全性、疗效和病毒学结果与1至未满12岁的总体研究人群相似。单剂量巴洛沙韦为5至11岁流感儿童患者提供了另一种治疗选择。
