MedPath

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

Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit

Not Applicable
Withdrawn
Conditions
Influenza A Virus Infection
Influenza B Virus Infection
Interventions
First Posted Date
2009-02-16
Last Posted Date
2019-09-17
Lead Sponsor
University of Manitoba
Registration Number
NCT00844155
Locations
🇨🇦

Health Sciences Centre, Winnipeg, Manitoba, Canada

Efficacy and Safety of Combination Therapies With Oseltamivir & Zanamivir or Oseltamivir & Amantadine Versus Oseltamivir Monotherapy in the Treatment of Seasonal Influenza A Infection

Phase 2
Terminated
Conditions
Influenza A Infection
Interventions
First Posted Date
2009-01-27
Last Posted Date
2010-09-30
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
60
Registration Number
NCT00830323
Locations
🇫🇷

Hospices civils de Lyon, Lyon, France

A Multinational Phase III Study of CS-8958 (MARVEL)

Phase 3
Completed
Conditions
Influenza, Human
Interventions
First Posted Date
2008-12-05
Last Posted Date
2019-01-09
Lead Sponsor
Daiichi Sankyo Co., Ltd.
Target Recruit Count
1002
Registration Number
NCT00803595

Evaluation of Efficacity and Safety of Oseltamivir and Zanamivir

Phase 3
Terminated
Conditions
Gastric Influenza
Interventions
First Posted Date
2008-12-01
Last Posted Date
2012-03-19
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
541
Registration Number
NCT00799760
Locations
🇫🇷

Centre Investigateur 155, Deulemont, France

Oseltamivir Randomised Controlled Efficacy Trial

Phase 3
Completed
Conditions
Viral Shedding
Influenza
Pneumonia
Lower Respiratory Tract Infection
Upper Respiratory Tract Infection
Interventions
Drug: Placebo
First Posted Date
2008-07-01
Last Posted Date
2018-06-06
Lead Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Target Recruit Count
1190
Registration Number
NCT00707941
Locations
🇧🇩

Kamalapur Urban Site, ICDDR,B, Dhaka, Bangladesh

Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

Phase 4
Completed
Conditions
Influenza
Interventions
Drug: placebo
First Posted Date
2008-01-15
Last Posted Date
2009-06-19
Lead Sponsor
Hospital District of Southwestern Finland
Target Recruit Count
409
Registration Number
NCT00593502
Locations
🇫🇮

Turku University Hospital, Turku, Finland

Efficacy Study of Early Versus Late Oseltamivir Administration for Treating and Preventing Influenza

Not Applicable
Completed
Conditions
Influenza
Interventions
Drug: Placebo
First Posted Date
2007-11-09
Last Posted Date
2018-10-16
Lead Sponsor
Marshfield Clinic Research Foundation
Target Recruit Count
194
Registration Number
NCT00555893
Locations
🇺🇸

Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States

A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

Phase 3
Completed
Conditions
Influenza, Human
Interventions
Other: placebo
First Posted Date
2007-10-17
Last Posted Date
2018-07-12
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
228
Registration Number
NCT00545532
Locations
🇺🇸

Baylor University Medical Center Transplant Administration, Dallas, Texas, United States

🇺🇸

Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation, Dallas, Texas, United States

🇺🇸

UCLA Medical center Medicine/Nephrology, Los Angeles, California, United States

and more 205 locations

A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects

Phase 1
Withdrawn
Conditions
Healthy Subjects
Interventions
First Posted Date
2007-10-08
Last Posted Date
2010-05-31
Lead Sponsor
GlaxoSmithKline
Registration Number
NCT00540501

Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza

Phase 2
Completed
Conditions
Influenza
Interventions
First Posted Date
2007-03-29
Last Posted Date
2015-02-12
Lead Sponsor
BioCryst Pharmaceuticals
Target Recruit Count
137
Registration Number
NCT00453999
Locations
🇺🇸

Pulmonary Associates of Mobile, P.C., Mobile, Alabama, United States

🇺🇸

Washington University School of Medicine, St. Louis, Missouri, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 80 locations
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