A network meta-analysis of the efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors for the treatment of influenza in otherwise healthy patients

Vanessa Taieb; Тайеб Ванесса; Hidetoshi Ikeoka; Икеока Хидэтоши; Fang-Fang Ma; Ма Фан-Фан; Katarzyna Borkowska; Борковска Катажина; Samuel Aballea; Абальеа Самюэль; Keiko Tone; Тон Кейко; Nobuo Hirotsu; Хироцу Нобуо

doi:10.26442/00403660.2020.11.000870

A network meta-analysis of the efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors for the treatment of influenza in otherwise healthy patients

Authors: Taieb V.¹, Ikeoka H.², Ma F.¹, Borkowska K.¹, Aballea S.³, Tone K.⁴, Hirotsu N.⁵
Affiliations:
1. Creativ-Ceutical
2. Shionogi & Co. Ltd.
3. 3Creativ-Ceutical
4. Shionogi Limited
5. Hirotsu Clinic
Issue: Vol 92, No 11 (2020)
Pages: 122-131
Section: Meta-analysis
URL: https://journals.rcsi.science/0040-3660/article/view/56950
DOI: https://doi.org/10.26442/00403660.2020.11.000870
ID: 56950

Cite item

Full Text

Abstract
Full Text
About the authors
References
Supplementary files
Statistics

Abstract

Aim. Baloxavir marboxil (baloxavir) is the first cap-dependent endonuclease inhibitor being studied for the treatment of influenza in single oral dosing regimen. This network meta-analysis (NMA) evaluated the efficacy and safety of baloxavir compared to other antivirals for influenza in otherwise healthy patients.

Methods. A systematic literature review was performed on 14 November 2016 in Medline, Embase, CENTRAL, and ICHUSHI to identify randomized controlled trials assessing antivirals for influenza. A NMA including 22 trials was performed to compare the efficacy and safety of baloxavir with other antivirals.

Results. The time to alleviation of all symptoms was significantly shorter for baloxavir compared to zanamivir (difference in median time 19.96 h; 95% CrI [3.23, 39.07]). The time to cessation of viral shedding was significantly shorter for baloxavir than zanamivir and oseltamivir (47.00 h; 95% CrI [28.18, 73.86] and 56.03 h [33.74, 87.86], respectively). The mean decline in virus titer from baseline to 24 h was significantly greater for baloxavir than for the other drugs. Other differences in efficacy outcomes were not significant. No significant differences were found between baloxavir and the other antivirals for safety, except total drug-related adverse events where baloxavir demonstrated a decrease compared to oseltamivir and laninamivir.

Conclusion. The NMA suggests that baloxavir demonstrated better or similar efficacy results compared to other antivirals with a comparable safety profile. Baloxavir led to a significant decrease in viral titer versus zanamivir, oseltamivir and peramivir and decreased viral shedding versus zanamivir and oseltamivir.

Keywords

baloxavir, influenza, network meta-analysis, otherwise healthy patients

Full Text

##article.viewOnOriginalSite##

References

Nabeshima S, Kashiwagi K, Ajisaka K, et al. A randomized, controlled trial comparing traditional herbal medicine and neuraminidase inhibitors in the treatment of seasonal influenza. J Infect Chemoth. 2012;18:534-43.
Kelly H, Birch C. The causes and diagnosis of influenza-like illness. Aust Fam Physician. 2004;33:305-9.
National Institute of Infectious Diseases. IASR 36(11), Influenza 2014/15 season/Japan [Internet; cited 2016 Nov 7]. Available from: https://www.niid.go.jp/niid/en/iasr-e/865-iasr/6096-tpc429.html.
Centers for Disease Control and Prevention. Estimated Influenza Illnesses, Medical Visits, Hospitalizations, and Deaths Averted by Vaccination in the United States [Internet]. 2016 [updated 2016 Dec 13; cited 2017 Jan 18]. Available from: https://www.cdc.gov/flu/about/disease/2015-16.htm
Molinari NA, Ortega-Sanchez IR, Messonnier ML, et al. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007;25:5086-96.
National institute of infectious diseases. Influenza 2014/15 season, Japan [Internet]. 2015 [cited 2016 Nov 7]. Available from: http://www.nih.go.jp/niid/en/component/content/article/865-iasr/6096-tpc429.html
Takaku F. Manual of therapeutic agents 2018. Igaku Syoin. 2018:1576-81.
Moscona A. Neuraminidase inhibitors for influenza. N Engl J Med. 2005;353:1363-73.
Osaka JaFP, NJ – Shionogi & Co., Ltd. Shionogi to present S-033188 phase 3 CAPSTONE-1 study results for treatment of influenza at IDWEEK 2017 [Internet]. 2017 [cited 2018 Mar 7]. Available from: https://www.prnewswire.com/news-releases/shionogi-to-present-s-033188-phase-3-capstone-1-study-results-fortreatment-of-influenza-at-idweek-2017-300531077.html
Portsmouth S, Kawaguchi K, Arai M, et al. Cap-dependent endonuclease inhibitor S-033188 for the treatment of influenza: results from a phase 3, randomized, double-blind, placeboand active-controlled study in otherwise healthy adolescents and adults with seasonal influenza. Open Forum Infectious Dis. 2017;4:S734.
Centre for Reviews and Dissemination, U.o.Y. Systematic Reviews – CRD’s guidance for undertaking reviews in health care. York: University of York; 2008.
Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0 [Internet]. 2011 [cited 2016 Nov 7]. Available from: http://handbook-5-1.cochrane.org/[13] Lumley T. Network meta-analysis for indirect treatment comparisons. Stat Med. 2002;21:2313-24.
Centers for Disease Control and Prevention. People at High Risk of Developing Flu-Related Complications [Internet] [cited 2017 March 6]. Available from: https://www.cdc.gov/flu/about/disease/high_risk.htm
Spiegelhalter D, Best N, Carlin B, et al. Bayesian measures of model complexity and fit. Quality Control Appl Statistics. 2003;48:431-2.
Dias S, Sutton AJ, Ades AE, et al. Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials. Med Decis Making. 2013;33:607-17.
Kohno S, Kida H, Mizuguchi M, et al. Efficacy and safety of intravenous peramivir for treatment of seasonal influenza virus infection. Antimicrob Agents Chemother. 2010;54:4568-74.
Treanor JJ, Hayden FG, Vrooman PS, et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. US Oral Neuraminidase Study Group. JAMA. 2000;283:1016-24.
Nicholson KG, Aoki FY, Osterhaus AD, et al. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet. 2000;355:1845-50.
Matsumoto K, Ogawa N, Nerome K, et al. Safety and efficacy of the neuraminidase inhibitor zanamivir in treating influenza virus infection in adults: results from Japan. GG167 Group. Antivir Ther. 1999;4:61-8.
Li L, Cai B, Wang M, et al. A double-blind, randomized, placebocontrolled multicenter study of oseltamivir phosphate for treatment of influenza infection in China. Chin Med J (Engl). 2003;116:44-8.
Puhakka T, Lehti H, Vainionpaa R, et al. Zanamivir: a significant reduction in viral load during treatment in military conscripts with influenza. Scand J Infect Dis. 2003;35:52-8.
Kohno S, Yen MY, Cheong HJ, et al. Phase III randomized, double-blind study comparing single-dose intravenous peramivir with oral oseltamivir in patients with seasonal influenza virus infection. Antimicrob Agents Chemother. 2011;55:5267-76.
Duval X, van der Werf S, Blanchon T, et al. Efficacy of oseltamivir-zanamivir combination compared to each monotherapy for seasonal influenza: a randomized placebo-controlled trial. PLoS Med. 2010;7:e1000362.
Watanabe A, Chang SC, Kim MJ, et al. Long-acting neuraminidase inhibitor laninamivir octanoate versus oseltamivir for treatment of influenza: a double-blind, randomized, noninferiority clinical trial. Clin Infect Dis. 2010;51:1167-75.
Boivin G, Goyette N, Hardy I, et al. Rapid antiviral effect of inhaled zanamivir in the treatment of naturally occurring influenza in otherwise healthy adults. J Infect Dis. 2000;181:1471-4.
Makela MJ, Pauksens K, Rostila T, et al. Clinical efficacy and safety of the orally inhaled neuraminidase inhibitor zanamivir in the treatment of influenza: a randomized, double-blind, placebocontrolled European study. J Infect. 2000;40:42-8.
Monto AS, Fleming DM, Henry D, et al. Efficacy and safety of the neuraminidase inhibitor zanamivirin the treatment of influenza A and B virus infections. J Infect Dis. 1999;180:254-61.
Hayden FG, Osterhaus AD, Treanor JJ, et al. Efficacy and safety of the neuraminidase inhibitor zanamivir in the treatment of influenzavirus infections. GG167 Influenza Study Group. N Engl J Med. 1997;337:874-80.
Randomised trial of efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections. The MIST (Management of Influenza in the Southern Hemisphere Trialists) Study Group. Lancet. 1998;352:1877-81.
Management of Influenza in the Southern Hemisphere Trialists (MIST). BioCryst Pharmaceuticals. Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza [Internet]. 2007 [cited 2016 Nov 25]. Available from: https://clinicaltrials.gov/ct2/show/results/NCT00419263?term¼NCT00419263&rank¼1
Ikematsu. Clinical efficacy at the early stage of inhaled anti-influenza drug zanamivir after inhalation randomized open label test. J Japan Clin Inter Med Assoc. 2011;26(2):215-9.
Kashiwagi S, Kudoh S, Watanabe A, et al. Clinical efficacy and safety of the selective oral neuraminidase inhibitor oseltamivir in treating acute influenza – placebo-controlled double-blind multicenter phase III trial. kansenshogakuzasshi. 2000;74:1044-61.
Pharmaceuticals and Medical Devices Agency. Relenza (Zanamivir) package insert. 2017.
Pharmaceuticals and Medical Devices Agency. Report on the Deliberation Results (Laninamivir). 2010.
Food and Drug Administration. Center for drug evaluation and research (Application number: 021246Orig1s045 and 021087Orig1s062) Labeling. 2012.
Suess T, Remschmidt C, Schink SB, et al. Comparison of shedding characteristics of seasonal influenza virus (sub)types and influenza A(H1N1)pdm09; Germany, 2007–2011. PLoS One. 2012;7:e51653.
Lau LL, Ip DK, Nishiura H, et al. Heterogeneity in viral shedding among individuals with medically attended influenza A virus infection. J Infect Dis. 2013;207:1281-5.
Fielding JE, Kelly HA, Mercer GN, et al. Systematic review of influenza A(H1N1)pdm09 virus shedding: duration is affected by severity, but not age. Influenza Other Resp. 2014;8:142-50.
Tsang TK, Cowling BJ, Fang VJ, et al. Influenza A virus shedding and infectivity in households. J Infect Dis. 2015;212:1420.
Gubareva LV, Novikov DV, Hayden FG. Assessment of hemagglutinin sequence heterogeneity during influenza virus transmission in families. J Infect Dis. 2002;186:1575.
Poon LL, Chan KH, Chu DK, et al. Viral genetic sequence variations in pandemic H1N1/2009 and seasonal H3N2 influenza viruses within an individual, a household and a community. J Clin Virol. 2011;52:146-50.
Papenburg J, Baz M, Hamelin ME, et al. Household transmission of the 2009 pandemic A/H1N1 influenza virus: elevated laboratory-confirmed secondary attack rates and evidence of asymptomatic infections. Clin Infect Dis. 2010;51:1033.
Wang K, Shun-Shin M, Gill P, et al. Neuraminidase inhibitors for preventing and treating influenza in children (published trials only). Cochrane Database Syst Rev. 2012;18:CD002744.
Burch J, Paulden M, Conti S, et al. Antiviral drugs for the treatment of influenza: a systematic review and economic evaluation. Health Technol Assess. 2009;13:1-265,III-IV.
Turner D, Wailoo A, Nicholson K, et al. Systematic review and economic decision modelling for the prevention and treatment of influenza A and B. Health Technol Assess. 2003;7:III-IV, XI-XIII, 1-170.
Gums JG, Pelletier Em, Blumentals WA. Oseltamivir and influenzarelated complications, hospitalization and healthcare expenditure in healthy adults and children. Expert Opin Pharmacother. 2008;9:151-61.
Chow MY, Morrow AM, Booy R, et al. Impact of children’s influenza-like illnesses on parental quality of life: a qualitative study. J Paediatr Child Health. 2013;49(8):664-70.
Jefferson T, Jones MA, Doshi P, et al. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database Syst Rev. 2012;1:CD008965.
To MJ, Jones J, Emara M, et al. Are reports of randomized controlled trials improving over time? A systematic review of 284 articles published in high-impact general and specialized medical journals. PLoS One. 2013;8:e84779.