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

A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)

Phase 1
Completed
Conditions
End Stage Renal Disease
Interventions
First Posted Date
2015-12-01
Last Posted Date
2016-02-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
24
Registration Number
NCT02617784

ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir

Phase 4
Completed
Conditions
Influenza
Interventions
First Posted Date
2015-11-20
Last Posted Date
2019-10-04
Lead Sponsor
Johns Hopkins University
Target Recruit Count
180
Registration Number
NCT02609399
Locations
🇺🇸

Maricopa Integrated Health System, Phoenix, Arizona, United States

🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza

Phase 1
Completed
Conditions
Influenza
Interventions
First Posted Date
2015-11-13
Last Posted Date
2018-06-08
Lead Sponsor
MedImmune LLC
Target Recruit Count
126
Registration Number
NCT02603952
Locations
🇿🇦

Research Site, Welkom, South Africa

A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

Phase 1
Conditions
Influenza
Interventions
First Posted Date
2015-10-09
Last Posted Date
2015-10-09
Lead Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Target Recruit Count
300
Registration Number
NCT02572583
Locations
🇨🇳

Dongfang Hospital affiliated to Beijing University of Chinese Medicine, Beijing, China

A Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza

Phase 4
Terminated
Conditions
Influenza
Interventions
Other: Placebo
First Posted Date
2015-09-25
Last Posted Date
2017-08-04
Lead Sponsor
McMaster University
Target Recruit Count
1
Registration Number
NCT02561169
Locations
🇨🇦

Foothills Medical Centre Emergency Department, Calgary, Alberta, Canada

A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection

Phase 2
Completed
Conditions
Influenza A Virus
Interventions
First Posted Date
2015-08-25
Last Posted Date
2020-03-27
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
102
Registration Number
NCT02532283

A Bioequivalence Study of Oseltamivir From Oseltamivir 75 mg Caps (Pharmacare PLC, Palestine) and Tamiflu® 75 mg Caps (Hoffmann-La Roche, Switzerland)

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2015-07-24
Last Posted Date
2015-07-24
Lead Sponsor
Genuine Research Center, Egypt
Target Recruit Count
24
Registration Number
NCT02507648
Locations
🇪🇬

Genuine Research Center GRC, Cairo, Egypt

Evaluating the Bioequivalence of HIP1403, HGP0919

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: HGP0919
First Posted Date
2015-06-17
Last Posted Date
2016-10-13
Lead Sponsor
Hanmi Pharmaceutical Company Limited
Target Recruit Count
32
Registration Number
NCT02473900
Locations
🇰🇷

Korea University Anam Hospital, Seoul, Korea, Republic of

Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza

Phase 2
Completed
Conditions
Virus Diseases
Interventions
Drug: GSK1325756 (Danirixin)
Drug: Placebo To Match GSK1325756
First Posted Date
2015-06-11
Last Posted Date
2019-07-23
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
45
Registration Number
NCT02469298
Locations
🇿🇦

GSK Investigational Site, Reiger Park, South Africa

Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza

Phase 3
Completed
Conditions
Influenza
Interventions
First Posted Date
2015-02-23
Last Posted Date
2021-03-23
Lead Sponsor
BioCryst Pharmaceuticals
Target Recruit Count
137
Registration Number
NCT02369159
Locations
🇿🇦

Peramivir Investigative Site, Pretoria, South Africa

🇺🇸

Peramivir investigative site, South Jordan, Utah, United States

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