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Single-dose XOFLUZA had a similar adverse event (AE) rate as placebo—including in patients aged ≥12 years at high risk of developing complications from the flu.1
Adverse Event | XOFLUZA (n=1440) | Placebo (n=1136) |
---|---|---|
Diarrhea | 3% | 4% |
Bronchitis | 3% | 4% |
Nausea | 2% | 3% |
Sinusitis | 2% | 3% |
Headache | 1% | 1% |
*Based on combined data from 3 trials, a total of 1640 subjects received XOFLUZA: 1334 (81%) were adults (18-64 years of age), 209 (13%) were adults 65 years of age or older, and 97 (6%) were adolescents (12-17 years of age). Of these, 1440 subjects received XOFLUZA at the recommended dose.1
Adverse Event | XOFLUZA (n=79) |
---|---|
Vomiting | 5% |
Diarrhea | 5% |
Trial CP40563 was a randomized, double-blind, multicenter, active-controlled study designed to evaluate the safety, efficacy, and pharmacokinetics of a single oral dose of XOFLUZA compared with oseltamivir in otherwise healthy pediatric subjects (including subjects aged 5 to <12 years) with influenza-like symptoms. A total of 118 subjects aged 5 to <12 years were randomized 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 primary objective was to compare the safety of a single one-time dose of XOFLUZA with 5 days of oseltamivir administered twice daily. Of the 118 randomized subjects aged 5 to <12 years in Trial CP40563, 94 subjects had influenza confirmed by RT-PCR at baseline or during the trial. The median time to alleviation of influenza signs and symptoms was 138 hours in the XOFLUZA arm (95% CI: 117, 163) and 126 hours in the oseltamivir arm (95% CI: 96, 166).1
The safety profile of XOFLUZA was similar in patients aged 5 to <12 years and in patients aged 12 years and older.1
No serious treatment-related adverse events were reported.14
Trial T0834 was a phase 3, randomized, double-blind, multicenter, placebo-controlled study designed to evaluate the efficacy of a single oral dose of XOFLUZA compared with placebo in the prevention of influenza in subjects who were household contacts of influenza-infected patients in Japan. Influenza-infected index patients were required to have onset of symptoms for ≤48 hours, and subjects (household contacts) were required to have lived with the influenza-infected index patient for ≥48 hours. A total of 715 subjects (XOFLUZA n=360, placebo n=355) aged 5 years and older were randomized and received a single oral dose of XOFLUZA according to body weight and age, or placebo, on Day 1. Subjects received a single dose of 40 mg or 80 mg of XOFLUZA according to body weight (20 kg to <80 kg or ≥80 kg, respectively). The primary efficacy endpoint was the proportion of household subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from Day 1 to Day 10. Influenza infection was confirmed by RT-PCR, fever was defined as a body temperature (axillary) ≥37.5°C, and respiratory symptoms were defined as having a symptom of “cough” or “nasal discharge/nasal congestion” with a severity of moderate or severe as assessed by the subject. In subjects that were 5 years of age and older, there was a statistically significant reduction in the proportion of household contacts (subjects) with laboratory-confirmed clinical influenza from 13% in the placebo group to 2% in the XOFLUZA group.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.
Hayden FG, Sugaya N, Hirotsu N, et al; Baloxavir Marboxil Investigators Group. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N Engl J Med. 2018;379(10):913-923.
Hayden FG, Sugaya N, Hirotsu N, et al; Baloxavir Marboxil Investigators Group. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N Engl J Med. 2018;379(10):913-923.
People at higher risk of flu complications. Centers for Disease Control and Prevention (CDC). Accessed May 18, 2022. https://www.cdc.gov/flu/highrisk/index.htm
People at higher risk of flu complications. Centers for Disease Control and Prevention (CDC). Accessed May 18, 2022. https://www.cdc.gov/flu/highrisk/index.htm
National Diabetes Statistics Report. CDC. Accessed May 18, 2022. https://www.cdc.gov/diabetes/data/statistics-report/index.html
National Diabetes Statistics Report. CDC. Accessed May 18, 2022. https://www.cdc.gov/diabetes/data/statistics-report/index.html
Most recent national asthma data. CDC. Accessed May 18, 2022. https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm
Most recent national asthma data. CDC. Accessed May 18, 2022. https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm
Basics about COPD. CDC. Accessed May 18, 2022. https://www.cdc.gov/copd/basics-about.html
Basics about COPD. CDC. Accessed May 18, 2022. https://www.cdc.gov/copd/basics-about.html
Heart disease. CDC. Accessed May 18, 2022. https://www.cdc.gov/nchs/fastats/heart-disease.htm
Heart disease. CDC. Accessed May 18, 2022. https://www.cdc.gov/nchs/fastats/heart-disease.htm
Flu vaccination coverage, United States, 2021-22 influenza season. CDC. Accessed August 9, 2022. https://www.cdc.gov/flu/fluvaxview/coverage-2021estimates.htm
Flu vaccination coverage, United States, 2021-22 influenza season. CDC. Accessed August 9, 2022. https://www.cdc.gov/flu/fluvaxview/coverage-2021estimates.htm
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
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.
Clinical signs and symptoms of influenza. CDC. Accessed May 18, 2022. https://www.cdc.gov/flu/professionals/acip/clinical.htm
Clinical signs and symptoms of influenza. CDC. Accessed May 18, 2022. https://www.cdc.gov/flu/professionals/acip/clinical.htm
Ikematsu H, Hayden FG, Kawaguchi K, et al. Baloxavir marboxil for prophylaxis against influenza in household contacts. N Engl J Med. 2020;383(4):309-320. doi:10.1056/NEJMoa1915341
Ikematsu H, Hayden FG, Kawaguchi K, et al. Baloxavir marboxil for prophylaxis against influenza in household contacts. N Engl J Med. 2020;383(4):309-320. doi:10.1056/NEJMoa1915341
Estimated influenza illnesses, medical visits, hospitalizations, and deaths in the United States—2021-2022 influenza season. CDC. Accessed August 1, 2022. https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm
Estimated influenza illnesses, medical visits, hospitalizations, and deaths in the United States—2021-2022 influenza season. CDC. Accessed August 1, 2022. https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm
COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Updated May 13, 2022. Accessed May 18, 2022. https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf
COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Updated May 13, 2022. Accessed May 18, 2022. https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf
What is the difference between influenza (flu) and COVID-19? CDC. Accessed May 18, 2022. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm
What is the difference between influenza (flu) and COVID-19? CDC. Accessed May 18, 2022. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm
Cold versus flu. CDC. Accessed May 18, 2022. https://www.cdc.gov/flu/symptoms/coldflu.htm
Cold versus flu. CDC. Accessed May 18, 2022. https://www.cdc.gov/flu/symptoms/coldflu.htm
COVID data tracker. CDC. Accessed May 18, 2022. https://covid.cdc.gov/covid-data-tracker/#cases_ casesinlast7days
COVID data tracker. CDC. Accessed May 18, 2022. https://covid.cdc.gov/covid-data-tracker/#cases_ casesinlast7days
Common colds: protect yourself and others. CDC. Accessed May 18, 2022. https://www.cdc.gov/features/rhinoviruses/index.html
Common colds: protect yourself and others. CDC. Accessed May 18, 2022. https://www.cdc.gov/features/rhinoviruses/index.html
Lessler J, Reich NG, Brookmeyer R, Perl TM, Nelson KE, Cummings DAT. Incubation periods of acute respiratory viral infections: a systematic review. Lancet Infect Dis. 2009;9(5):291-300. doi:10.1016/s1473-3099(09)70069-6
Lessler J, Reich NG, Brookmeyer R, Perl TM, Nelson KE, Cummings DAT. Incubation periods of acute respiratory viral infections: a systematic review. Lancet Infect Dis. 2009;9(5):291-300. doi:10.1016/s1473-3099(09)70069-6
Symptoms of COVID-19. CDC. Updated March 22, 2022. Accessed May 18, 2022. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
Symptoms of COVID-19. CDC. Updated March 22, 2022. Accessed May 18, 2022. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
Key facts about influenza (flu). CDC. Accessed May 18, 2022. https://www.cdc.gov/flu/about/keyfacts.htm
Key facts about influenza (flu). CDC. Accessed May 18, 2022. https://www.cdc.gov/flu/about/keyfacts.htm
Influenza antiviral medications: summary for clinicians. CDC. Accessed May 18, 2022. https://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm#Table1
Influenza antiviral medications: summary for clinicians. CDC. Accessed May 18, 2022. https://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm#Table1
Samji T. Influenza A: understanding the viral life cycle. Yale J Biol Med. 2009;82(4):153-159.
Samji T. Influenza A: understanding the viral life cycle. Yale J Biol Med. 2009;82(4):153-159.
De Clercq E, Li G. Approved antiviral drugs over the past 50 years. Clin Microbiol Rev. 2016;29(3):695-747.
De Clercq E, Li G. Approved antiviral drugs over the past 50 years. Clin Microbiol Rev. 2016;29(3):695-747.
Fiore AE, Fry A, Shay D, et al. Antiviral agents for the treatment and chemoprophylaxis of influenza—recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011;60(1):1-24.
Fiore AE, Fry A, Shay D, et al. Antiviral agents for the treatment and chemoprophylaxis of influenza—recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011;60(1):1-24.
von Itzstein M. The war against influenza: discovery and development of sialidase inhibitors. Nat Rev Drug Discov. 2007;6(12):967-974. doi:10.1038/nrd2400
von Itzstein M. The war against influenza: discovery and development of sialidase inhibitors. Nat Rev Drug Discov. 2007;6(12):967-974. doi:10.1038/nrd2400
Data on File. Genentech. 2022.
Data on File. Genentech. 2022.
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