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In Trial T0831 (conducted in the United States and Japan), subjects aged 20 to 64 years received either XOFLUZA (n=612), oseltamivir (n=514), or placebo (n=310). Adolescent subjects 12 to less than 20 years of age received weight-based XOFLUZA or placebo as a single oral dose. For subjects aged 12 to 64 years, the median value of the primary endpoint of time to alleviation of symptoms (TTAS) with XOFLUZA was 54 hours (95% CI: 50, 59) vs 80 hours (95% CI: 73, 87) with placebo.1
TTAS was defined as the time when all 7 symptoms (cough, sore throat, nasal congestion, headache, feverishness, myalgia, and fatigue) had been assessed by the subject as none or mild for a duration of at least 21.5 hours.1,4
For subjects aged 12 to 17 years in Trial T0831, TTAS was achieved 39 hours (1.6 days) faster with XOFLUZA (n=63) when compared with placebo (n=27; median time of 54 hours [95% CI: 43, 81] vs 93 hours [95% CI: 64, 118]).1
Trial CP40563 was not powered to detect statistically significant differences in this secondary endpoint.
In Trial CP40563, otherwise healthy pediatric subjects aged 5 to <12 years (n=118) were randomized (2:1) and received a single one-time oral dose of XOFLUZA (n=79) based on body weight (2 mg/kg for subjects weighing <20 kg or 40 mg for subjects weighing ≥20 kg) or oseltamivir (n=39) for 5 days (dose based on body weight). The secondary efficacy endpoint included time to alleviation of influenza signs and symptoms (TTASS) of a single one-time dose of XOFLUZA with 5 days of oseltamivir administered twice daily. TTAS was defined as the time when all of the following were met for at least 21.5 hours: cough and nasal symptoms were assessed by the caregiver as no problem or minor problem, subject was able to return to normal daily activity, and subject was afebrile (temperature ≤37.2°C). TTASS was comparable between XOFLUZA (138 hours [95% CI: 117, 163]) and olseltamivir (126 hours [95% CI: 96, 156]).1
Sample a full course of flu treatment with single-dose XOFLUZA.1
XOFLUZA. Prescribing information. Genentech USA, Inc.
XOFLUZA. Prescribing information. Genentech USA, Inc.
Baker J, Block SL, Matharu B, et al. Baloxavir marboxil single-dose treatment in influenza-infected children: a randomized, double-blind, active controlled phase 3 safety and efficacy trial (miniSTONE-2). Pediatr Infect Dis J. 2020;39(8):700-705. doi:10.1097/INF.0000000000002747
Baker J, Block SL, Matharu B, et al. Baloxavir marboxil single-dose treatment in influenza-infected children: a randomized, double-blind, active controlled phase 3 safety and efficacy trial (miniSTONE-2). Pediatr Infect Dis J. 2020;39(8):700-705. doi:10.1097/INF.0000000000002747
TAMIFLU. Prescribing information. Genentech USA, Inc.; 2019.
TAMIFLU. Prescribing information. Genentech USA, Inc.; 2019.
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Ison MG. Portsmouth high-risk adolescent and adult outpatients with uncomplicated influenza (CAPTONSE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. Published online June 8, 2020. doi:10.1016/S1473-3099(20)30004-9
Supplement to: Ison MG, Portsmouth S, Yoshida Y, et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020;20(10)suppl:S8-S10.
Supplement to: Ison MG, Portsmouth S, Yoshida Y, et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020;20(10)suppl:S8-S10.
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Data on File. Genentech. 2022.
Data on File. Genentech. 2022.
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