Effectiveness of a new bioequivalent formulation of oseltamivir (Enfluvir®) on 2010–2011 seasonal influenza viruses: an open phase IV study

Ceyhan, Mehmet; Karadag Oncel, Eda; Badur, Selim; Ciblak, Meral Akcay; Alhan, Emre; Celik, Umit Sızmaz; Kurugol, Zafer; Saz, Eylem Ulas; Ozsurekci, Yasemin; Celik, Melda; Parlakay, Aslınur Ozkaya

doi:10.1016/j.ijid.2011.12.008

« Previous Next »International Journal of Infectious Diseases
Volume 16, Issue 4 , Pages e273-e278, April 2012

Effectiveness of a new bioequivalent formulation of oseltamivir (Enfluvir^®) on 2010–2011 seasonal influenza viruses: an open phase IV study

Mehmet Ceyhan
- Department of Pediatrics, Pediatric Infectious Disease Unit, Faculty of Medicine, Hacettepe University, Ankara, Turkey
Eda Karadag Oncel
- Department of Pediatrics, Pediatric Infectious Disease Unit, Faculty of Medicine, Hacettepe University, Ankara, Turkey
- Corresponding author. Tel.: +90 312 3051166; fax: +90 312 3108241.
Selim Badur
- Department of Clinical Microbiology and Microbiology, National Influenza Reference Laboratory, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey
Meral Akcay Ciblak
- Department of Clinical Microbiology and Microbiology, National Influenza Reference Laboratory, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey
Emre Alhan
- Department of Pediatrics, Pediatric Infectious Disease Unit, Faculty of Medicine, Çukurova University, Adana, Turkey
Umit Sızmaz Celik
- Department of Pediatrics, Pediatric Infectious Disease Unit, Faculty of Medicine, Çukurova University, Adana, Turkey
Zafer Kurugol
- Department of Pediatrics, Pediatric Infectious Disease Unit, Faculty of Medicine, Ege University, Izmir, Turkey
Eylem Ulas Saz
- Department of Pediatrics, Pediatric Emergency Unit, Faculty of Medicine, Ege University, Izmir, Turkey
Yasemin Ozsurekci
- Department of Pediatrics, Pediatric Infectious Disease Unit, Faculty of Medicine, Hacettepe University, Ankara, Turkey
Melda Celik
- Department of Pediatrics, Pediatric Infectious Disease Unit, Faculty of Medicine, Hacettepe University, Ankara, Turkey
Aslınur Ozkaya Parlakay
- Department of Pediatrics, Pediatric Infectious Disease Unit, Faculty of Medicine, Hacettepe University, Ankara, Turkey

Received 6 August 2011; received in revised form 11 December 2011; accepted 13 December 2011. published online 10 February 2012.

Corresponding Editor: William Cameron, Ottawa, Canada

Summary

Objective

The aim of this multicenter prospective study was to evaluate the efficacy of a new bioequivalent formulation of oseltamivir for the treatment of influenza A, influenza B, and H1N1 during the 2010–2011 influenza season.

Methods

We compared the symptoms and signs of 300 pediatric patients presenting to three university hospitals with an influenza-like illness between January and March 2011. Nasal swab specimens were collected from all children and tested by reverse-transcription polymerase chain reaction (RT-PCR) for influenza viruses. After randomization, half of the participants were prescribed oseltamivir, while the other half were observed conservatively. Forty patients who were followed-up for influenza prior to the study were also included in the evaluation.

Results

Influenza was confirmed by RT-PCR in 129 children, 71 of whom were prescribed oseltamivir. The durations of the symptoms fever, cough, nasal congestion, and rhinorrhea were significantly shorter for patients who were treated with oseltamivir compared with untreated patients (p<0.002 for all symptoms). Early initiation of oseltamivir therapy (within 48h of the onset of symptoms) was associated with more favorable outcomes and an earlier recovery than in patients for whom treatment was delayed (beyond 48h). Thirty-seven patients (28.7%) had H1N1, 44 (34.1%) had influenza A, 46 (35.7%) had influenza B, one (0.8%) had H1N1 plus influenza A, and one (0.8%) had influenza A plus influenza B viruses. In the comparison of the duration of symptoms according to the different virus types, a statistically significant difference was only observed in patients with influenza B who had a longer duration of cough (p<0.001), nasal congestion (p<0.001), and rhinorrhea (p<0.001).

Conclusions

Oseltamivir is an effective treatment for the management of seasonal influenza and H1N1, and should be initiated immediately without waiting for laboratory confirmation of diagnosis.

Keywords: Influenza, Children, Symptom duration, Oseltamivir