Baloxavir marboxil for uncomplicated influenza in adults and adolescents

New England Journal of Medicine

Volumn 379, Issue 10, 2018, Pages 913-923

  Hayden, Frederick G ^a,l   Sugaya, Norio ^b   Hirotsu, Nobuo ^c   Lee, Nelson ⁱ   De Jong, Menno D ^j   Hurt, Aeron C ^k   Ishida, Tadashi ^d   Sekino, Hisakuni ^e   Yamada, Kota ^f   Portsmouth, Simon ^g   Kawaguchi, Keiko ^g   Shishido, Takao ^g   Arai, Masatsugu ^g   Tsuchiya, Kenji ^g   Uehara, Takeki ^g   Watanabe, Akira ^h  

^a UNIVERSITY OF VIRGINIA   (United States)

^b Keiyu Hospital   (Japan)

^c Hirotsu Clinic   (Japan)

^d KURASHIKI CENTRAL HOSPITAL   (Japan)

^e Sekino Hospital   (Japan)

^f Tsuchiura Beryl Clinic   (Japan)

^g SHIONOGI AND CO LTD   (Japan)

^h TOHOKU UNIVERSITY   (Japan)

ⁱ UNIVERSITY OF ALBERTA   (Canada)

^j UNIVERSITY OF AMSTERDAM   (Netherlands)

^k UNIVERSITY OF MELBOURNE   (Australia)

^l UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; BALOXAVIR; BALOXAVIR MARBOXIL; OSELTAMIVIR; PLACEBO; ANTIVIRUS AGENT; ENDONUCLEASE;

2009 H1N1 INFLUENZA; ADOLESCENT; ADULT; AGE DISTRIBUTION; AMINO ACID SUBSTITUTION; ANTIVIRAL ACTIVITY; ANTIVIRAL SUSCEPTIBILITY; ARTICLE; BRONCHITIS; CHILD; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEVER; HEADACHE; HUMAN; INFLUENZA A (H3N2); INTENTION TO TREAT ANALYSIS; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; NAUSEA; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; SINUSITIS; TIME TO TREATMENT; TREATMENT RESPONSE TIME; VIRUS LOAD; VOMITING; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; DRUG EFFECT; INFLUENZA; KAPLAN MEIER METHOD; MIDDLE AGED; MULTICENTER STUDY; VIROLOGY; VIRUS REPLICATION; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIVIRAL AGENTS; CHILD; DOUBLE-BLIND METHOD; ENDONUCLEASES; FEMALE; HUMANS; INFLUENZA, HUMAN; INTENTION TO TREAT ANALYSIS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; OSELTAMIVIR; VIRAL LOAD; VIRUS REPLICATION; YOUNG ADULT;

EID: 85053212099     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1716197     Document Type: Article

References (34)

1. Hurt AC, Chotpitayasunondh T, Cox NJ, et al. Antiviral resistance during the 2009 influenza A H1N1 pandemic: public health, laboratory, and clinical perspectives. Lancet Infect Dis 2012; 12: 240-8.
2. Li TC, Chan MC, Lee N. Clinical implications of antiviral resistance in influenza. Viruses 2015; 7: 4929-44.
3. Shi F, Xie Y, Shi L, Xu W. Viral RNA polymerase: a promising antiviral target for influenza A virus. Curr Med Chem 2013; 20: 3923-34.
4. Stevaert A, Naesens L. The influenza virus polymerase complex: an update on its structure, functions, and significance for antiviral drug design. Med Res Rev 2016; 36: 1127-73.
5. Pflug A, Guilligay D, Reich S, Cusack S. Structure of influenza A polymerase bound to the viral RNA promoter. Nature 2014; 516: 355-60.
6. Reich S, Guilligay D, Pflug A, et al. Structural insight into cap-snatching and RNA synthesis by influenza polymerase. Nature 2014; 516: 361-6.
7. Yuan P, Bartlam M, Lou Z, et al. Crystal structure of an avian influenza polymerase PA(N) reveals an endonuclease active site. Nature 2009; 458: 909-13.
8. The new drug application approval of "AVIGANR tablet 200mg" in Japan for the anti-influenza virus drug. Press release of Toyama Chemical, March 24, 2014 (https://www .toyama -chemical .co .jp/ eng/ news/ news140324e .html).
9. Epstein C. Experience with favipiravir in phase 3 and implications for future studies. Presented at the 5th ISIRV-AVG Conference on Prevention and Treatment of RVIs: Antivirals, Traditional Therapies and Host-Directed Interventions, Shanghai, China, June 14-16, 2017. abstract.
10. Clark MP, Ledeboer MW, Davies I, et al. Discovery of a novel, first-in-class, orally bioavailable azaindole inhibitor (VX-787) of influenza PB2. J Med Chem 2014; 57: 6668-78.
11. Finberg R, Lanno R, Anderson D, et al. The Topaz trial: a phase 2B study of pimodivir (JNJ-63623872 or JNJ-872; formerly VX-787) as monotherapy or in combination with oseltamivir in the treatment of acute uncomplicated seasonal influenza. Presented at the 5th ISIRV-AVG Conference on Prevention and Treatment of RVIs: Antivirals, Traditional Therapies and Host-Directed Interventions, Shanghai, China, June 14-16, 2017. abstract.
12. O'Neil B, Ison M, Hallouin-Bernard M, et al. The Opal Trial: a placebo-controlled phase 2b trial studying pimodivir plus oseltamivir vs. placebo plus oseltamivir in adult and elderly hospitalized patients with influenza A infection. Presented as a late-breaking abstract at the 6th ESWI Conference, Riga, Latvia, September 10-13, 2017.
13. Uehara T, Shishido T, Ishibashi T, et al. S-033188, a small molecule inhibitor of Cap-dependent endonuclease of influenza A and B virus, leads to rapid and profound viral load reduction. Presented at Options IX for the Control of Influenza, Chicago, August 24-28, 2016. abstract.
14. Kawasaki A, Sato C, Ishibashi T, et al. A phase 1 study of safety, tolerability and pharmacokinetics of oral single dose S-033188, a novel anti-influenza agent, in healthy adult male participants. Presented at IDWeek, New Orleans, October 26-30, 2016. abstract.
15. Aoki FY, Macleod MD, Paggiaro P, et al. Early administration of oral oseltamivir increases the benefits of influenza treatment. J Antimicrob Chemother 2003; 51: 123-9.
16. 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. JAMA 2000; 283: 1016-24.
17. Nicholson KG, Aoki FY, Osterhaus AD, et al. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Lancet 2000; 355: 1845-50.
18. Kohno S, Kida H, Mizuguchi M, Shimada J. Efficacy and safety of intravenous peramivir for treatment of seasonal influenza virus infection. Antimicrob Agents Chemother 2010; 54: 4568-74.
19. Leekha S, Zitterkopf NL, Espy MJ, Smith TF, Thompson RL, Sampathkumar P. Duration of influenza A virus shedding in hospitalized patients and implications for infection control. Infect Control Hosp Epidemiol 2007; 28: 1071-6.
20. Lee N, Chan PK, Hui DS, et al. Viral loads and duration of viral shedding in adult patients hospitalized with influenza. J Infect Dis 2009; 200: 492-500.
21. Fielding JE, Kelly HA, Mercer GN, Glass K. Systematic review of influenza A(H1N1)pdm09 virus shedding: duration is affected by severity, but not age. Influenza Other Respir Viruses 2014; 8: 142-50.
22. Reddy KP, Bajwa EK, Parker RA, Onderdonk AB, Walensky RP. Relationship between upper respiratory tract influenza test result and clinical outcomes among critically ill influenza patients. Open Forum Infect Dis 2016; 3: ofw023.
23. de Jong MD, Simmons CP, Thanh TT, et al. Fatal outcome of human influenza A (H5N1) is associated with high viral load and hypercytokinemia. Nat Med 2006; 12: 1203-7.
24. Hu Y, Lu S, Song Z, et al. Association between adverse clinical outcome in human disease caused by novel influenza A H7N9 virus and sustained viral shedding and emergence of antiviral resistance. Lancet 2013; 381: 2273-9.
25. Choi SM, Boudreault AA, Xie H, Englund JA, Corey L, Boeckh M. Differences in clinical outcomes after 2009 influenza A/H1N1 and seasonal influenza among hematopoietic cell transplant recipients. Blood 2011; 117: 5050-6.
26. Memoli MJ, Athota R, Reed S, et al. The natural history of influenza infection in the severely immunocompromised vs nonimmunocompromised hosts. Clin Infect Dis 2014; 58: 214-24.
27. Lee N, Chan PK, Wong CK, et al. Viral clearance and inflammatory response patterns in adults hospitalized for pandemic 2009 influenza A(H1N1) virus pneumonia. Antivir Ther 2011; 16: 237-47.
28. South East Asia Infectious Disease Clinical Research Network. Effect of double dose oseltamivir on clinical and virological outcomes in children and adults admitted to hospital with severe influenza: double blind randomised controlled trial. BMJ 2013; 346: f3039.
29. de Jong MD, Ison MG, Monto AS, et al. Evaluation of intravenous peramivir for treatment of influenza in hospitalized patients. Clin Infect Dis 2014; 59(12): e172-e185.
30. Marty FM, Vidal-Puigserver J, Clark C, et al. Intravenous zanamivir or oral oseltamivir for hospitalised patients with influenza: an international, randomised, double-blind, double-dummy, phase 3 trial. Lancet Respir Med 2017; 5: 135-46.
31. Kitano M, Yamamoto A, Noshi T, et al. Synergistic antiviral activity of S-033188/S-033447, a novel inhibitor of influenza virus cap-dependent endonuclease, in combination with neuraminidase inhibitors in vitro. Presented at IDWeek, San Diego, CA, October 4-8, 2017. abstract.
32. Shishido T, Kurihara N, Rokushima M, et al. Genotypic and phenotypic monitoring of treatment-emergent resistance to S-033188, an influenza cap-dependent endonuclease inhibitor, in a phase 2, randomized, double-blind, placebo-controlled study in otherwise healthy adults with seasonal influenza. Presented at the 5th ISIRV-AVG Conference on Prevention and Treatment of RVIs: Antivirals, Traditional Therapies and Host-Directed Interventions, Shanghai, China, June 4-16, 2017. abstract.
33. Noshi T, Miki S, Omoto S, et al. Isolation and characterization of influenza A/ H1N1 virus resistant to S-033188/S-033447, a novel inhibitor of influenza virus capdependent endonuclease. Presented at ASM Microbe, New Orleans, June 1-5, 2017. abstract.
34. Stevaert A, Dallocchio R, Dessi A, et al. Mutational analysis of the binding pockets of the diketo acid inhibitor L-742,001 in the influenza virus PA endonuclease. J Virol 2013; 87: 10524-38.