tetano
Editor, Senior Moderator
Clin Infect Dis. 2019 Jul 27. pii: ciz634. doi: 10.1093/cid/ciz634. [Epub ahead of print]
[h=1]Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults With Influenza: A Randomized Clinical Trial.[/h] Beigel JH[SUP]1[/SUP], Manosuthi W[SUP]2[/SUP], Beeler J[SUP]3[/SUP], Bao Y[SUP]4[/SUP], Hoppers M[SUP]5[/SUP], Ruxrungtham K[SUP]6[/SUP], Beasley RL[SUP]7[/SUP], Ison M[SUP]8[/SUP], Avihingsanon A[SUP]6[/SUP], Losso MH[SUP]9[/SUP], Langlois N[SUP]10[/SUP], Hoopes J[SUP]11[/SUP], Lane HC[SUP]1[/SUP], Holley HP[SUP]3[/SUP], Myers CA[SUP]12[/SUP], Hughes MD[SUP]4[/SUP], Davey RT[SUP]4[/SUP].
[h=3]Author information[/h] 1 National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland. 2 Bamrasnaradura Infectious Diseases Institute, Department of Disease Control, Nonthaburi, Thailand. 3 Leidos Biomedical Research, Inc, Frederick, Maryland. 4 Harvard T.H. Chan School of Public Health, Boston, Massachusetts. 5 Clinical Research Solutions, Jackson, Tennessee. 6 Department of Medicine, Faculty of Medicine, Chulalongkorn University, and Center for Biostatistics in AIDS Research, Human Immunodeficiency Virus Netherlands Australia Thailand Research Collaboration, Thai Red Cross AIDS Research Center, Bangkok, Thailand. 7 Health Concepts, Rapid City, South Dakota. 8 Department of Medicine, Northwestern University, Chicago, Illinois. 9 Immunocompromised Service, Hospital General De Agudos J. M. Ramos Mej?a, Buenos Aires, Argentina. 10 Social & Scientific Systems, Inc, Silver Spring, Maryland. 11 AVR Laboratories LLC, Logan, Utah; and. 12 Operational Infectious Diseases, Naval Health Research Center, San Diego, California.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Duration of viral shedding is a determinant of infectivity and transmissibility, but few data exist about oseltamivir's ability to alter viral shedding.
[h=4]METHODS:[/h] From January 2012 through October 2017, a randomized, double-blinded multicenter clinical trial was conducted in adults aged 18-64 years at 42 sites in Thailand, the United States, and Argentina. Participants with influenza A or B and without risk factors for complications of influenza were screened for the study. Eligible participants were randomized to receive oseltamivir 75 mg or placebo twice daily for 5 days. The primary endpoint was the percentage of participants with virus detectable by polymerase chain reaction in nasopharyngeal swab at day 3.
[h=4]RESULTS:[/h] Of 716 adults screened for the study, 558 were randomized, and 501 were confirmed to have influenza. Forty-six participants in the pilot study were excluded, and 449 of the 455 participants in the population for the primary analysis had day 3 viral shedding results. Ninety-nine (45.0%) of 220 participants in the oseltamivir arm had virus detected at day 3 compared with 131 (57.2%) of 229 participants in the placebo arm (absolute difference of -12.2% [-21.4%, -3.0%], P =; .010). The median time to alleviation of symptoms was 79.0 hours for the oseltamivir arm and 84.0 hours for the placebo arm (P =; .34) in those with confirmed influenza infection.
[h=4]CONCLUSIONS:[/h] Oseltamivir decreased viral shedding in this low-risk population. However, in the population enrolled in this study, it did not significantly decrease the time to resolution of clinical symptoms.
[h=4]CLINICAL TRIALS REGISTRATION:[/h] NCT01314911.
Published by Oxford University Press for the Infectious Diseases Society of America 2019. This work is written by (a) US Government employee(s) and is in the public domain in the US.
[h=4]KEYWORDS:[/h] influenza-like illness; respiratory virus; viral shedding
PMID: 31541242 DOI: 10.1093/cid/ciz634
[h=1]Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults With Influenza: A Randomized Clinical Trial.[/h] Beigel JH[SUP]1[/SUP], Manosuthi W[SUP]2[/SUP], Beeler J[SUP]3[/SUP], Bao Y[SUP]4[/SUP], Hoppers M[SUP]5[/SUP], Ruxrungtham K[SUP]6[/SUP], Beasley RL[SUP]7[/SUP], Ison M[SUP]8[/SUP], Avihingsanon A[SUP]6[/SUP], Losso MH[SUP]9[/SUP], Langlois N[SUP]10[/SUP], Hoopes J[SUP]11[/SUP], Lane HC[SUP]1[/SUP], Holley HP[SUP]3[/SUP], Myers CA[SUP]12[/SUP], Hughes MD[SUP]4[/SUP], Davey RT[SUP]4[/SUP].
[h=3]Author information[/h] 1 National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland. 2 Bamrasnaradura Infectious Diseases Institute, Department of Disease Control, Nonthaburi, Thailand. 3 Leidos Biomedical Research, Inc, Frederick, Maryland. 4 Harvard T.H. Chan School of Public Health, Boston, Massachusetts. 5 Clinical Research Solutions, Jackson, Tennessee. 6 Department of Medicine, Faculty of Medicine, Chulalongkorn University, and Center for Biostatistics in AIDS Research, Human Immunodeficiency Virus Netherlands Australia Thailand Research Collaboration, Thai Red Cross AIDS Research Center, Bangkok, Thailand. 7 Health Concepts, Rapid City, South Dakota. 8 Department of Medicine, Northwestern University, Chicago, Illinois. 9 Immunocompromised Service, Hospital General De Agudos J. M. Ramos Mej?a, Buenos Aires, Argentina. 10 Social & Scientific Systems, Inc, Silver Spring, Maryland. 11 AVR Laboratories LLC, Logan, Utah; and. 12 Operational Infectious Diseases, Naval Health Research Center, San Diego, California.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Duration of viral shedding is a determinant of infectivity and transmissibility, but few data exist about oseltamivir's ability to alter viral shedding.
[h=4]METHODS:[/h] From January 2012 through October 2017, a randomized, double-blinded multicenter clinical trial was conducted in adults aged 18-64 years at 42 sites in Thailand, the United States, and Argentina. Participants with influenza A or B and without risk factors for complications of influenza were screened for the study. Eligible participants were randomized to receive oseltamivir 75 mg or placebo twice daily for 5 days. The primary endpoint was the percentage of participants with virus detectable by polymerase chain reaction in nasopharyngeal swab at day 3.
[h=4]RESULTS:[/h] Of 716 adults screened for the study, 558 were randomized, and 501 were confirmed to have influenza. Forty-six participants in the pilot study were excluded, and 449 of the 455 participants in the population for the primary analysis had day 3 viral shedding results. Ninety-nine (45.0%) of 220 participants in the oseltamivir arm had virus detected at day 3 compared with 131 (57.2%) of 229 participants in the placebo arm (absolute difference of -12.2% [-21.4%, -3.0%], P =; .010). The median time to alleviation of symptoms was 79.0 hours for the oseltamivir arm and 84.0 hours for the placebo arm (P =; .34) in those with confirmed influenza infection.
[h=4]CONCLUSIONS:[/h] Oseltamivir decreased viral shedding in this low-risk population. However, in the population enrolled in this study, it did not significantly decrease the time to resolution of clinical symptoms.
[h=4]CLINICAL TRIALS REGISTRATION:[/h] NCT01314911.
Published by Oxford University Press for the Infectious Diseases Society of America 2019. This work is written by (a) US Government employee(s) and is in the public domain in the US.
[h=4]KEYWORDS:[/h] influenza-like illness; respiratory virus; viral shedding
PMID: 31541242 DOI: 10.1093/cid/ciz634