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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
Associated Therapies
-

Treatment of Severe Influenza A Infection

Phase 3
Completed
Conditions
Influenza, Human
Interventions
First Posted Date
2014-04-09
Last Posted Date
2019-10-21
Lead Sponsor
The University of Hong Kong
Target Recruit Count
107
Registration Number
NCT02108366
Locations
🇭🇰

Ivan Hung, Hong Kong, Hong Kong

A Multicenter Randomized Open-label Study of Oseltamivir Combined With HD-DEX Versus HD-DEX in the Management of ITP

Phase 2
Completed
Conditions
Thrombocytopenia
Interventions
First Posted Date
2013-10-18
Last Posted Date
2020-08-25
Lead Sponsor
Shandong University
Target Recruit Count
96
Registration Number
NCT01965626
Locations
🇨🇳

Qilu hospital, Shandong University, Jinan, Shandong, China

Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza

Phase 4
Completed
Conditions
Influenza
Interventions
Drug: Ergoferon
Drug: Oseltamivir
First Posted Date
2013-05-09
Last Posted Date
2020-04-16
Lead Sponsor
Materia Medica Holding
Target Recruit Count
184
Registration Number
NCT01850446
Locations
🇷🇺

Regional State Budgetary Healthcare Institution "Clinical Hospital №1", Smolensk, Russian Federation

🇷🇺

Pirogov Russian National Research Medical University, Moscow, Russian Federation

🇷🇺

St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117", St. Petersburg, Russian Federation

and more 4 locations

Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

Phase 4
Completed
Conditions
Influenza
Interventions
Drug: Ergoferon
Drug: Oseltamivir
First Posted Date
2013-03-05
Last Posted Date
2015-06-23
Lead Sponsor
Materia Medica Holding
Target Recruit Count
161
Registration Number
NCT01804946
Locations
🇷🇺

St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117", St. Petersburg, Russian Federation

🇷🇺

State Budgetary Educational Institution of Higher Professional Education "Smolensk State Medical Academy" of Ministry of Health and Social Development of Russian Federation, Smolensk, Russian Federation

🇷🇺

St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106", St. Petersburg, Russian Federation

and more 5 locations

A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection

Phase 1
Completed
Conditions
Influenza
Interventions
First Posted Date
2012-10-29
Last Posted Date
2018-10-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
20
Registration Number
NCT01715909
Locations
🇺🇸

Lucile Packard Child Hosp; Pediatric Pulmonary Division, Palo Alto, California, United States

🇧🇪

Cliniques Universitaires St-Luc, Bruxelles, Belgium

🇧🇷

Hospital São Lucas da PUCRS, Porto Alegre, RS, Brazil

and more 47 locations

Alcohol Inhibits Drug Metabolism by Carboxylesterases

Phase 1
Completed
Conditions
Drug Interactions
Interventions
First Posted Date
2012-10-16
Last Posted Date
2012-10-16
Lead Sponsor
University of Tennessee
Target Recruit Count
19
Registration Number
NCT01708369
Locations
🇺🇸

University of Tennessee Health Science Center, Memphis, Tennessee, United States

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

Phase 3
Completed
Conditions
Influenza
Interventions
Drug: Nitazoxanide
Drug: Oseltamivir
Drug: Placebo Oral Tablet
Drug: Placebo Oral Capsule
First Posted Date
2012-06-01
Last Posted Date
2018-03-29
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
1941
Registration Number
NCT01610245
Locations
🇦🇺

Influence Study SIte, Nedlands, Western Australia, Australia

🇳🇿

Influence Study Site, Christchurch Central, Christchurch, New Zealand

Oseltamivir for Influenza Lower Respiratory Tract Infection in Children Under One

Phase 2
Withdrawn
Conditions
Influenza
Interventions
First Posted Date
2012-03-07
Last Posted Date
2013-07-29
Lead Sponsor
University of Oxford
Registration Number
NCT01546935
Locations
🇹🇭

Queen Sirikit National Institute of Child Health, Bangkok, Thailand

🇹🇭

Faculty of Medicine Siriraj Hospital, Bangkok, Thailand

Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)

Phase 4
Terminated
Conditions
Influenza
Interventions
First Posted Date
2011-10-20
Last Posted Date
2013-08-09
Lead Sponsor
Trial Management Group Inc.
Target Recruit Count
48
Registration Number
NCT01456234
Locations
🇨🇦

Springbank Medical Centre, London, Ontario, Canada

🇨🇦

London Road Diagnostic Clinic and Medical Centre, Sarnia, Ontario, Canada

🇨🇦

Dr. Anil Gupta, Toronto, Ontario, Canada

and more 12 locations

Characterisation of the Human Carboxylesterase 1 (CES1) Mutations in Thailand

Phase 4
Completed
Conditions
Metabolic Disease
Interventions
First Posted Date
2011-09-30
Last Posted Date
2018-06-27
Lead Sponsor
University of Oxford
Target Recruit Count
1
Registration Number
NCT01443806
Locations
🇹🇭

The Faculty of Tropical medicine,Mahidol University, Bangkok, Thailand

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