Because the CDC is still pounding the pavement hawking neuraminidase inhibitors, the market is ripe for profit. Not content to allow Roche all the fun, BioCryst Pharmaceuticals is trying to edge its way into the game.
BioCryst, as you now know, is the manufacturer of peramivir, a neuraminidase inhibotir whose initial claim to fame was emergency approval for intravenous use during the initial H1N1 pandemic. They were in the news a few months back when they presented results for combined trials highlighting its use as a single intramuscular dose in the outpatient setting. Now, the results of said trial are fully published, comprising combined populations of a phase 2 and under-enrolled phase 3 trial.
What net benefit, in these sponsored trials, in the lab-confirmed influenza population?
About an 18-hour reduction in symptoms, from a mean of 148 hours down to a mean of 130 hours with the 300mg IM injection. The number of days until resumption of usual activities was nearly identical, from a mean of 9.4 in the 300mg cohort to 10.2 days in the placebo cohort.
And, what’s interesting, if you go back to some of the earlier studies, you might find nearly all the observed benefit associated with antiviral treatment was observed in the cohort treated within 24-hours, with no clinically relevant benefit between 24-48 hours. However, you’ll only rarely see such detail presented, as it diminishes the viability of the product.
And, finally, just to add to your peramivir update – a clinical trial regarding the value of intravenous peramivir in hospitalized patients with influenza. In a rather complicated and confounded design with only a few hundred patients, no benefit was demonstrated by use of peramivir whether as NAI monotherapy or adjunctive therapy to other neuraminidase inhibitors. In the 121 patients who received peramivir monotherapy as part of the standard of care, there was no difference in any secondary infection or mortality.
But, I’m sure peramivir will rapidly be added to our antiviral armamentarium as a lovely money-wasting enterprise, regardless.
“Single dose peramivir for the treatment of acute seasonal influenza: integrated analysis of efficacy and safety from two placebo-controlled trials.”
http://www.ncbi.nlm.nih.gov/pubmed/25318121
“Efficacy and Safety of Intravenous Peramivir for Treatment of Seasonal Influenza Virus Infection”
http://www.ncbi.nlm.nih.gov/pubmed/20713668
“Evaluation of Intravenous Peramivir for Treatment of Influenza in Hospitalized Patients”
http://www.ncbi.nlm.nih.gov/pubmed/25115871