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 Acute Uncomplicated Seasonal Influenza A in Adult Subjects

Phase 2
Completed
Conditions
Influenza A
Interventions
Drug: Placebo
Drug: VX-787 300 mg
Drug: VX-787 600 mg
First Posted Date
2015-01-19
Last Posted Date
2025-02-04
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
292
Registration Number
NCT02342249

A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection

Phase 2
Completed
Conditions
Influenza
Interventions
First Posted Date
2014-11-18
Last Posted Date
2018-06-18
Lead Sponsor
Genentech, Inc.
Target Recruit Count
168
Registration Number
NCT02293863
Locations
🇲🇽

CEPREP; Hospital Universitario, Monterrey, Mexico

🇵🇱

Oddział Anestezjologii i Intensywnej Terapii Wojewódzki Specjalistyczny Szpital im dr Wł Biegańsk, Łódź, Poland

🇧🇬

MHAT "Dr. Tota Venkova"- Gabrovo, Gabrovo, Bulgaria

and more 168 locations

An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.

Phase 4
Withdrawn
Conditions
Pulmonary Disease
Influenza
Interventions
Other: Placebo
First Posted Date
2014-11-04
Last Posted Date
2018-10-26
Lead Sponsor
McMaster University
Registration Number
NCT02282384

A Study to Assess the Drug-Drug Interaction Between VX-787 and Oseltamivir

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-10-13
Last Posted Date
2014-11-04
Lead Sponsor
Janssen Infectious Diseases BVBA
Target Recruit Count
38
Registration Number
NCT02262715

Banlangen Granules Anti-seasonal Influenza Study

Phase 4
Conditions
Influenza
Interventions
Drug: placebo of Banlangen(Radix Isatidis) granules
Drug: Banlangen (Radix Isatidis) granules
First Posted Date
2014-09-05
Last Posted Date
2016-03-04
Lead Sponsor
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
Target Recruit Count
177
Registration Number
NCT02232945
Locations
🇨🇳

Guangzhou Institute of Respiratory Disease, Guangzhou, Guangdong, China

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 Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model

Phase 2
Completed
Conditions
Healthy Volunteer
Interventions
Drug: MHAA549A
Drug: Placebo
First Posted Date
2013-11-11
Last Posted Date
2017-03-09
Lead Sponsor
Genentech, Inc.
Target Recruit Count
101
Registration Number
NCT01980966
Locations
🇬🇧

Retroscreen Ltd, London, United Kingdom

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

A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2013-07-18
Last Posted Date
2014-05-19
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
20
Registration Number
NCT01902342
Locations
🇰🇷

Seoul National University Hospital Clinical Trial Center, Seoul, Korea, Republic of

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

Phase 4
Completed
Conditions
Influenza
Interventions
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
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