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
Associated Therapies
-

IMU-838 and Oseltamivir in the Treatment of COVID-19

Phase 2
Completed
Conditions
Covid 19
Interventions
Drug: IMU-838
Drug: Oseltamivir
First Posted Date
2020-08-18
Last Posted Date
2023-08-22
Lead Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Target Recruit Count
38
Registration Number
NCT04516915
Locations
🇬🇧

University Hospital Coventry and Warwickshire NHS Trust, Coventry, West Midlands, United Kingdom

Administration of Allogenic UC-MSCs as Adjuvant Therapy for Critically-Ill COVID-19 Patients

Phase 1
Conditions
Pulmonary Infection
Sars-CoV2
COVID
Interventions
Drug: Oseltamivir
Drug: Azithromycin
Biological: Umbilical Cord Mesenchymal Stem Cells
First Posted Date
2020-07-07
Last Posted Date
2020-07-07
Lead Sponsor
Indonesia University
Target Recruit Count
40
Registration Number
NCT04457609
Locations
🇮🇩

Sulianti Saroso Center for Infectious Disease, Jakarta, DKI Jakarta, Indonesia

🇮🇩

Universitas Indonesia Hospital, Depok, West Java, Indonesia

🇮🇩

Persahabatan General Hospital, Jakarta, DKI Jakarta, Indonesia

and more 1 locations

Randomised Evaluation of COVID-19 Therapy

Phase 3
Recruiting
Conditions
Severe Acute Respiratory Syndrome
Interventions
Drug: Lopinavir-Ritonavir
Biological: Convalescent plasma
Biological: Immunoglobulin
Drug: Corticosteroid
Drug: Synthetic neutralising antibodies
Drug: Empagliflozin
Drug: Anakinra
Drug: High Dose Corticosteroid
Drug: Sotrovimab
Drug: Paxlovid
Drug: Baloxavir Marboxil
Drug: Hydroxychloroquine
Drug: Azithromycin
Drug: Tocilizumab
Drug: Aspirin
Drug: Dimethyl fumarate
Drug: Colchicine
Drug: Baricitinib
Drug: Oseltamivir
Drug: Molnupiravir
First Posted Date
2020-05-11
Last Posted Date
2024-01-05
Lead Sponsor
University of Oxford
Target Recruit Count
70000
Registration Number
NCT04381936
Locations
🇻🇳

Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam

🇬🇭

Kumasi Center for Collaborative Research in Tropical Medicine KNUST, Kumasi, Ghana

🇮🇳

Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases, New Delhi, India

and more 4 locations

Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019

Early Phase 1
Conditions
COVID-19 Pneumonia
Interventions
Drug: Oseltamivir
Drug: hormones
Device: oxygen therapy
Procedure: mesenchymal stem cells
First Posted Date
2020-05-01
Last Posted Date
2020-05-01
Lead Sponsor
Fuzhou General Hospital
Target Recruit Count
60
Registration Number
NCT04371601
Locations
🇨🇳

Fuzhou General Hospital, Fuzhou, Fujian, China

Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT

Phase 3
Completed
Conditions
COVID 19
Interventions
First Posted Date
2020-04-08
Last Posted Date
2022-02-10
Lead Sponsor
Shehnoor Azhar
Target Recruit Count
550
Registration Number
NCT04338698
Locations
🇵🇰

Gujranwala Medical College, Gujrānwāla, Pakistan

🇵🇰

Khyber Teaching Hospital, Peshawar, Pakistan

🇵🇰

Akram Medical Complex, Lahore, Pakistan

and more 8 locations

A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia

Phase 3
Conditions
2019-nCoV Pneumonia
Interventions
Drug: ASC09F+Oseltamivir
Drug: Ritonavir+Oseltamivir
Drug: Oseltamivir
First Posted Date
2020-02-07
Last Posted Date
2020-03-17
Lead Sponsor
Tongji Hospital
Target Recruit Count
60
Registration Number
NCT04261270
Locations
🇨🇳

Department and Institute of Infectious Disease, Wuhan, Hubei, China

A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia

Phase 4
Conditions
2019-nCoV
Interventions
Drug: Lopinavir/ritonavir
Drug: Abidol hydrochloride
Drug: Oseltamivir
First Posted Date
2020-02-05
Last Posted Date
2020-03-17
Lead Sponsor
Tongji Hospital
Target Recruit Count
400
Registration Number
NCT04255017
Locations
🇨🇳

Department and Institute of Infectious Disease, Wuhan, Hubei, China

Evaluation of the Safety and Efficacy of a Monoclonal Antibody to Treat Influenza

Phase 2
Withdrawn
Conditions
Influenza
Interventions
Biological: MEDI8852
Drug: Placebo
Drug: Oseltamivir
First Posted Date
2019-04-04
Last Posted Date
2020-01-18
Lead Sponsor
MedImmune LLC
Registration Number
NCT03903718

Adjunctive Sirolimus and Oseltamivir Versus Oseltamivir Alone for Treatment of Influenza

Phase 3
Recruiting
Conditions
Influenza
Interventions
First Posted Date
2019-04-03
Last Posted Date
2023-11-27
Lead Sponsor
Chinese University of Hong Kong
Target Recruit Count
160
Registration Number
NCT03901001
Locations
🇭🇰

Prince of Wales Hospital, Hong Kong, Hong Kong

Oseltamivir Versus Paracetamol for Influenza-like Illness During the Influenza Season

Phase 4
Conditions
Influenza
Interventions
First Posted Date
2018-11-27
Last Posted Date
2019-01-30
Lead Sponsor
Rambam Health Care Campus
Target Recruit Count
436
Registration Number
NCT03754686
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