761. Clinical and Virologic Outcomes with Peramivir Therapy in Hospitalized Adults with Influenza B: Sub-Group Analysis of a Phase 2 Trial
Session: Abstracts: Virology: Influenza
Friday, October 22, 2010
Background:

The investigational neuraminidase inhibitor (NAI) peramivir is more potent in vitro against influenza B than oseltamivir. Possible clinical correlates were analyzed in a completed, multinational study comparing both NAIs (BCX1812-201).  

Methods:

Subjects received 5 days therapy with IV peramivir QD, (400 mg or 200 mg), or PO oseltamivir 75 mg BID.   An exploratory primary endpoint (time to clinical stability, TTCS) was based on normalization of vital signs and O2 saturation.  Nasal swabs were collected twice daily, while hospitalized and cultured on MDCK cells with susceptibility by MUNANA..  A post-hoc analysis for influenza B combined subjects randomized to peramivir vs. oseltamivir.

Results:

Influenza B was confirmed by PCR in 32 subjects among  a total study population of 137 subjects

                       Endpoint

Peramivir

n=21

Oseltamivir

n=11

P value

 

[median (95% CI)]

 

TTCS (hr)

31.0 (21.2, 48.4)*

41.8 (28.1, 68.0)*

0.38

Time to Normal Temperature (hr)

24.3 (13.1, 47.7)

35.5 (12.1, 48.5)

0.78

Time to Return to Usual Activities (TTRUA; days)

6.4 (3.5, NA)

10.0 (2.7, NA)

0.95

All AEs

14 (67%)

4 (36%)

 

Grade 3/4 AEs

3 (14%)

1 (9%)

 

SAEs

2 (10%)

(unrelated to treatment)

0

 

Deaths

0

0

 

*Data on TTCS are based on 17 peramivir- and 10 oseltamivir-treated subjects clinically unstable at baseline.

Change from baseline in viral titers (log10 TCID50/mL ):

Hours after initiation of treatment

Peramivir

n=21

Mean (SD)

Oseltamivir

n=11

Mean (SD)

Difference between Peramivir and Oseltamivir

P value

12

-1.3 (1.35)

-0.9 (1.24)

0.4

0.49

24

-2.1 (0.99)

-1.6 (1.11)

0.5

0.36

36

-2.8 (1.07)

-1.7 (1.38)

1.1

0.03

48

-2.9 (0.76)

-2.2 (2.05)

0.7

0.14

Conclusion:

In a sub-group analysis, peramivir appeared clinically and virologically better than oseltamivir in treatment of adults hospitalized with influenza B.  These preliminary findings may reflect superior in vitro antiviral activity of peramivir against influenza B.


Subject Category: V. Virology including clinical and basic studies of viral infections, including hepatitis

Speakers:
Michael G. Ison, MD, MS , Medicine, Northwestern University, Chicago, IL
David SC Hui , Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong
Peter J. Sebastian, MD , PJ Sebastian, Durban, South Africa
Amy Flynt, PhD , PharPoint Research, Apex, NC
Phil Collis, PhD , BioCryst Pharmaceuticals, Durham, NC
William J. Alexander, MD , BioCryst Pharmaceuticals, Durham, NC
Jaime Hernandez, MD , BioCryst Pharmaceuticals, Durham, NC

Disclosures:

M. G. Ison, None

D. S. Hui, Yes
BioCryst Pharmaceuticals: Grant Investigator,

P. J. Sebastian, Yes
BioCryst Pharmaceuticals: Grant Investigator,

A. Flynt, Yes
BioCryst Pharmaceuticals: Consultant,

P. Collis, Yes
BioCryst Pharmaceuticals: Employee,

W. J. Alexander, Yes
BioCryst Pharmaceuticals: Consultant,

J. Hernandez, Yes
BioCryst Pharmaceuticals: Employee and Shareholder, Salary

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