NEWS HIGHLIGHTSMedia Articles Related to Tamiflu (Oseltamivir)
Review Questions Tamiflu's Effectiveness
Source: MedicineNet Pneumonia Specialty [2009.12.09]
Title: Review Questions Tamiflu's Effectiveness
Category: Health News
Created: 12/8/2009 4:10:00 PM
Last Editorial Review: 12/9/2009
Tamiflu-Resistant Swine Flu Found in Canadian Father
Source: MedicineNet oseltamivir Specialty [2009.11.12]
Title: Tamiflu-Resistant Swine Flu Found in Canadian Father
Category: Health News
Created: 11/11/2009 4:10:00 PM
Last Editorial Review: 11/12/2009
Tamiflu-Resistant Swine Flu Passed Person-to-Person in U.S.
Source: MedicineNet amantadine Specialty [2009.10.30]
Title: Tamiflu-Resistant Swine Flu Passed Person-to-Person in U.S.
Category: Health News
Created: 10/29/2009 2:10:00 PM
Last Editorial Review: 10/30/2009
Targeted Prevention Measures Stopped Spread Of H1N1 Flu At Alabama Boys Camp, Doctor Says
Source: Flu / Cold / SARS News From Medical News Today [2010.02.04]
Providing preventive Tamiflu and educating and emphasizing the need for repeated hand sanitizer use and disinfectant spray helped stop the spread of H1N1 influenza at a boys' summer camp in northern Alabama, according the co-director of the University of Alabama at Birmingham (UAB) Division of Pediatric Infectious Diseases. David Kimberlin, M.D...
Preventive Steps Helped Summer Campers Avoid Swine Flu (HealthDay)
Source: Y! Health Cold & Flu News [2010.02.01]
HealthDay - MONDAY, Feb. 1 (HealthDay News) -- An Alabama summer camp managed
to contain the spread of swine flu by giving preventive Tamiflu to kids at
risk and encouraging the use of sanitizers for hands and surfaces, a new
report says.
Published Studies Related to Tamiflu (Oseltamivir)
Oseltamivir oral suspension and capsules are bioequivalent for the active metabolite in healthy adult volunteers. [2009.08]
Aims: The objective of this study was to assess the relative bioavailability of oseltamivir carboxylate (active metabolite) following oral administration of the market suspension, the clinical trial suspension and the market capsule formulations of oseltamivir (prodrug) in healthy subjects...
Pharmacokinetics and tolerability of oseltamivir combined with probenecid. [2008.09]
Oseltamivir is an inhibitor of influenza virus neuraminidase, which is approved for use for the treatment and prophylaxis of influenza A and B virus infections.Alternate-day dosing of oseltamivir plus dosing with probenecid four times daily achieved trough oseltamivir carboxylate concentrations adequate for neuraminidase inhibition in vitro, and this combination should be studied further.
A comparison of the effectiveness of zanamivir and oseltamivir for the treatment of influenza A and B. [2008.01]
OBJECTIVE: To compare the effectiveness of zanamivir with oseltamivir for influenza A and B... CONCLUSION: Zanamivir therapy is more effective than oseltamivir for the treatment of influenza B infection.
Active metabolite from Tamiflu solution is bioequivalent to that from capsule delivery in healthy volunteers: a cross-over, randomised, open-label study. [2006.11.10]
The bioavailability of oseltamivir phosphate and oseltamivir carboxylate were assessed in healthy volunteers when delivered as a solution of the active pharmaceutical ingredient (API) compared with the commercial capsule formulation. The 90% confidence intervals (CIs) for the ratios of the two treatments (capsule versus solution) were within the reference region [0.80-1.25] for area under the curve (AUC(0-infinity): [0.94-0.99]) and maximum observed plasma concentrations (C(max): [0.93-1.08])...
Efficacy of oseltamivir phosphate to horses inoculated with equine influenza A virus. [2006.09]
We investigated the efficacy of the oral administration of oseltamivir phosphate (OP) in horses experimentally infected with equine influenza A virus (H3N8). Nine horses were divided into three horses each of control, treatment and prophylaxis groups... The results indicated that the oral administration of OP to horses affected with equine influenza would contribute to reduce the magnitude of virus excretion, pyrexia and consequent secondary bacterial pneumonia.
Clinical Trials Related to Tamiflu (Oseltamivir)
Evaluation of Alternative Oseltamivir (Tamiflu) Dosing Strategies. [Completed]
Objective 1: Determine the safety and toxicity profile of Tamiflu administered in
combination with probenecid in healthy adults. Objective 2: Determine the pharmacokinetic
profile of Tamiflu and probenecid in healthy adults.
Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine [Completed]
This study is designed to assess the safety and pharmacokinetic effects of oseltamivir
administration alone or in combination with amantadine in healthy volunteers.
Efficacy Study of Early vs. Late Oseltamivir Administration for Treating and Preventing Influenza [Active, not recruiting]
This study is a randomized, blinded, placebo-controlled clinical efficacy trial to assess the
duration and severity of influenza symptoms, duration of viral shedding, and household
transmission in influenza patients receiving oseltamivir early and late relative to placebo.
There are four main hypotheses:
1. The duration of influenza symptoms, severity, and duration of viral shedding are reduced
in patients who start oseltamivir treatment late (48 to 119 hours after illness onset)
compared to those receiving no antiviral therapy;
2. Antiviral effectiveness for reducing infectiousness to household contacts is at least
80% for index cases starting therapy early (<48 hours) compared to those receiving no
antiviral therapy;
3. Antiviral effectiveness for reducing infectiousness to household contacts is at least
60% when patients initiate treatment late (48 to 119 hours) compared to those receiving
no antiviral therapy;
4. Prior influenza vaccination during the same season reduces the duration of influenza
symptoms and symptom severity in patients receiving oseltamivir after adjusting for age
and timing of antiviral therapy (early vs. late).
There are two secondary hypotheses:
1. The duration of influenza symptoms, severity, and duration of viral shedding are reduced
in patients with influenza who start oseltamivir treatment early (within 48 hours) vs.
late (48 to 119 hours);
2. The incidence of secondary complications is lower in patients starting oseltamivir
therapy late relative to those receiving no antiviral therapy.
A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza. [Terminated]
This study will evaluate the efficacy and safety of Tamiflu in patients with
clinically-diagnosed influenza occurring during an influenza outbreak within the community.
Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs
and antibiotics) or support therapy alone. The anticipated time on study treatment is <3
months, and the target sample size is <100 individuals.
Alternative Oseltamivir Dosing Strategies [Active, not recruiting]
This study will determine if oseltamivir (Tamiflu® (Registered Trademark)) is safe and
effective given less frequently than the currently prescribed dose of twice a day for 5 days
to people who have the flu, and once a day for up to 6 weeks in people who have been exposed
to someone else with flu and want to prevent getting it themselves. This study will see if
the drug can be given once every other day instead of daily if given with another medication
called probenecid (Benemid® (Registered Trademark) or Probalan® (Registered Trademark)).
Healthy people 18 years of age and older may be eligible for this study. Candidates are
screened with a medical history, physical examination, and blood and urine tests.
Participants are randomly assigned to one of the following regimens for 2 weeks: 1) 75
milligrams (mg) of oseltamivir once a day; 2) 75 mg of oseltamivir once every other day plus
500 mg probenecid four times a day; or 3) 75 mg of oseltamivir once every other day plus 500
mg probenecid twice a day. All medications are taken by mouth. On study day 0, subjects have
the following baseline procedures: measurement of vital signs, review of medical and
medication history, physical examination, blood draw and urine test. They also receive the
first dose of oseltamivir or oseltamivir and probenecid. In addition, they undergo the
following procedures as follows:
- Days 1 and 4: Vital signs; review of clinical symptoms, side effects and medications
taken; urine testing and blood draw.
- Day 8: Same as day 1 plus count of study medication.
- Day 14: Same as day 8 plus pharmacokinetic study to measure the amount of oseltamivir
and probenecid in the blood. For this test, a catheter is inserted into an arm vein and
blood samples are collected through the catheter before taking the study medications, at
the time the medications are taken, and again at 15 minutes, 30 minutes, 45 minutes and
1, 1. 5, 2, 4, 8 and 12 hours after the medication is taken. The catheter is then
removed. This is the last day to take the study medication.
- Day 15: Blood draw for 24-hour (post medication) blood sample.
- Day 16: Blood draw for 48-hour (post medication) blood sample.
- Days 21 and 28: Same as day 1.
|
