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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

Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults

Not Applicable
Completed
Conditions
Influenza, Human
Interventions
Drug: Placebo
First Posted Date
2011-03-15
Last Posted Date
2019-02-05
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
716
Registration Number
NCT01314911
Locations
🇺🇸

East Valley Family Physicians, Chandler, Arizona, United States

🇺🇸

Horizon Research Group of Opelousas, LLC, Eunice, Louisiana, United States

🇺🇸

Michael Seep, MD; Centex Studies, Lake Charles, Louisiana, United States

and more 44 locations

Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

Not Applicable
Completed
Conditions
Influenza A
Interventions
Drug: H1N1 convalescent plasma and oseltamivir
First Posted Date
2011-03-02
Last Posted Date
2011-03-02
Lead Sponsor
The University of Hong Kong
Target Recruit Count
80
Registration Number
NCT01306773
Locations
🇨🇳

The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China

A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers

Phase 1
Completed
Conditions
Influenza, Human
Interventions
First Posted Date
2010-12-13
Last Posted Date
2017-06-07
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
28
Registration Number
NCT01258530
Locations
🇺🇸

GSK Investigational Site, Buffalo, New York, United States

Effect of Oseltamivir on Cognitive Function in Subjects With Influenza

Phase 4
Completed
Conditions
Influenza
Interventions
First Posted Date
2010-11-30
Last Posted Date
2017-03-09
Lead Sponsor
Trial Management Group Inc.
Target Recruit Count
122
Registration Number
NCT01249833
Locations
🇨🇦

Topsail Road Medical Clinic, St. John's, Newfoundland and Labrador, Canada

🇨🇦

Family First Medical Centre, Orleans, Ontario, Canada

🇨🇦

Moran Medical Centre, Collingwood, Ontario, Canada

and more 13 locations

Rapid Empiric Treatment With Oseltamivir Study (RETOS)

Phase 4
Completed
Conditions
Pneumonia
Influenza
Interventions
First Posted Date
2010-11-25
Last Posted Date
2023-06-15
Lead Sponsor
University of Louisville
Target Recruit Count
1107
Registration Number
NCT01248715
Locations
🇺🇸

Norton Hospital, Louisville, Kentucky, United States

🇺🇸

Rex Robley VA Medical Center, Louisville, Kentucky, United States

🇺🇸

Baptist Hospital East, Louisville, Kentucky, United States

and more 2 locations

A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza

Phase 3
Completed
Conditions
Influenza, Human
Interventions
Drug: Placebo to match zanamivir
Drug: Placebo to match oseltamivir
First Posted Date
2010-11-01
Last Posted Date
2018-10-15
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
626
Registration Number
NCT01231620
Locations
🇬🇧

GSK Investigational Site, Manchester, United Kingdom

Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications

Phase 2
Completed
Conditions
Influenza
Interventions
First Posted Date
2010-10-25
Last Posted Date
2019-02-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
881
Registration Number
NCT01227967
Locations
🇺🇸

Research Integrity, LLC, Owensboro, Kentucky, United States

🇺🇸

Boston Medical Center, Boston, Massachusetts, United States

🇦🇷

Hospital Rawson, Cordoba, Argentina

and more 88 locations

Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects

Phase 1
Completed
Conditions
Obesity
Interventions
First Posted Date
2010-08-11
Last Posted Date
2017-02-09
Lead Sponsor
Manjunath Prakash Pai
Target Recruit Count
21
Registration Number
NCT01179919
Locations
🇺🇸

TKL Research, Paramaus, New Jersey, United States

A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2010-07-30
Last Posted Date
2016-08-19
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
24
Registration Number
NCT01172847

Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Phase 2
Completed
Conditions
Influenza A Virus Infection
Interventions
First Posted Date
2010-06-17
Last Posted Date
2013-08-21
Lead Sponsor
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Target Recruit Count
40
Registration Number
NCT01146535
Locations
🇨🇳

Chang Gung Medical Foundation, LinKou Branch, Guishan, Taoyuan County, Taiwan

🇨🇳

Show-Chwan Memorial Hospital, Changhua, Taiwan

🇨🇳

Taiwan Municipal Hospital, Tainan, Taiwan

and more 1 locations
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