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Oseltamivir

Generic Name
Oseltamivir
Brand Names
Ebilfumin, Tamiflu
Drug Type
Small Molecule
Chemical Formula
C16H28N2O4
CAS Number
196618-13-0
Unique Ingredient Identifier
20O93L6F9H
Background

Oseltamivir (marketed as the product TamifluⓇ), is an antiviral neuraminidase inhibitor used for the treatment and prophylaxis of infection with influenza viruses A (including pandemic H1N1) and B. Oseltamivir exerts its antiviral activity by inhibiting the activity of the viral neuraminidase enzyme found on the surface of the virus, which prevents budding from the host cell, viral replication, and infectivity.

The clinical benefit of use of oseltamivir is greatest when administered within 48 hours of the onset of influenza symptoms since effectiveness decreases significantly after that point in time; there is generally no benefit in use beyond 48 hours for healthy, low-risk individuals as influenza is a self-limiting illness. However, antiviral treatment might be beneficial when initiated after 48 hours for patients with severe, complicated or progressive illness or for hospitalized patients. According to the CDC, data from clinical trials and observational studies have demonstrated that early antiviral treatment can shorten the duration of fever and illness symptoms, and may reduce the risk of some complications (including pneumonia and respiratory failure). They recommend the use of oseltamivir in people with a higher risk of developing complications including children younger than 2 years, people over 65 years, people with some chronic conditions or immunosuppression, pregnant women, residents of long term care facilities, and indigenous communities for example.

The benefits of oseltamivir use are controversial; a 2014 Cochrane Review of the evidence found that oseltamivir treatment had limited benefit. The authors concluded that oseltamivir use in healthy adults had small, non-specific effects on symptoms (where the time to first alleviation of symptoms was only reduced from 7 to 6.3 days), it had no effect on hospitalizations, and that there was no evidence for any reductions in complications of influenza such as pneumonia. Due to the risk of adverse effects such as nausea, vomiting, psychiatric effects and renal adverse events in adults and vomiting in children, the harms are generally considered to outweigh the small clinical benefit of use of oseltamivir.

Notably, in 2017, the World Health Organization downgraded oseltamivir from its essential medicines list from a "core" drug to a "complementary" drug, due to limited cost-effectiveness. Yearly vaccination with the influenza vaccine is still considered the best preventative measure.

Indication

According to FDA prescribing information, oseltamivir is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours . In particular, this agent is indicated in adults and children including full-term neonates who present with symptoms typical of influenza when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of the first onset of symptoms.

Oseltamivir is also indicated for the prophylaxis of influenza in patients one year and older . Specifically, post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community qualifies for such prophylactic therapy. Oseltamivir would only be indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak.

Associated Conditions
Flu caused by Influenza, Influenza A Virus Infection, Influenza A, Influenza B, Influenza Type B

Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During Lactation

Phase 4
Completed
Conditions
Influenza
Interventions
First Posted Date
2010-05-26
Last Posted Date
2012-10-08
Lead Sponsor
Pharmahungary Group
Target Recruit Count
6
Registration Number
NCT01130636
Locations
🇭🇺

DEOEC University of Debrecen, Clinic of Obstetrics and Gynecology, Debrecen, Hungary

🇭🇺

Selye János Hospital, Department of Obstetrics and Gynecology, Komárom, Hungary

A Study on Higher-dose Oseltamivir Treatment's Impact on Viral Clearance and Clinical Recovery in Adults Hospitalized With Influenza

Phase 4
Completed
Conditions
Influenza
Respiratory Tract Infections
Interventions
First Posted Date
2010-01-21
Last Posted Date
2012-07-20
Lead Sponsor
Chinese University of Hong Kong
Target Recruit Count
157
Registration Number
NCT01052961
Locations
🇭🇰

The Chinese University of Hong Kong, Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital, Hong Kong, Hksar, Hong Kong

A Randomised Controlled Trial on the Effect of Post-exposure Oseltamivir Prophylaxis on Influenza Transmission in Nursing Homes

Phase 4
Conditions
Influenza
Interventions
First Posted Date
2010-01-21
Last Posted Date
2010-01-21
Lead Sponsor
National Institute for Public Health and the Environment (RIVM)
Target Recruit Count
900
Registration Number
NCT01053377
Locations
🇳🇱

Institute of Public Health and the Environment, Bilthoven, Utrecht, Netherlands

A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza

Phase 1
Terminated
Conditions
Influenza
Interventions
First Posted Date
2010-01-21
Last Posted Date
2016-07-27
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
9
Registration Number
NCT01053663

A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza

Phase 3
Completed
Conditions
Influenza
Interventions
First Posted Date
2010-01-15
Last Posted Date
2013-11-01
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
118
Registration Number
NCT01050257

Open-Label Pharmacokinetic of Oseltamivir in Healthy Obese Thai Adult Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-01-14
Last Posted Date
2010-10-08
Lead Sponsor
South East Asia Infectious Disease Clinical Research Network
Target Recruit Count
24
Registration Number
NCT01049763
Locations
🇹🇭

Mahidol-Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Bangkok, Bangkok,, Thailand

Safety and Efficacy of Oseltamivir in Children Younger Than One Year of Age

Phase 2
Withdrawn
Conditions
Influenza
Interventions
First Posted Date
2009-12-23
Last Posted Date
2014-08-06
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Registration Number
NCT01037634

A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain

Phase 4
Terminated
Conditions
Influenza
Interventions
Drug: Placebo
First Posted Date
2009-12-16
Last Posted Date
2012-10-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
102
Registration Number
NCT01032837

A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

Phase 1
Completed
Conditions
Influenza
Interventions
First Posted Date
2009-12-16
Last Posted Date
2016-08-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
8
Registration Number
NCT01033734

Trial Comparing High Versus Standard Dose Oseltamivir in Severe Influenza Infection in ICU

Phase 2
Terminated
Conditions
Influenza A Virus
Interventions
First Posted Date
2009-11-09
Last Posted Date
2011-06-10
Lead Sponsor
University of Manitoba
Target Recruit Count
59
Registration Number
NCT01010087
Locations
🇨🇦

Winnipeg Regional Health Authority; Health Sciences Centre, Winnipeg, Manitoba, Canada

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