We recently reanalyzed the peramivir data in DynaMed and found what looks like substantial subgroup differences in the trial of 300 previously healthy adults (158 treated within 24 hours of symptom onset, 138 treated 24-48 hours of symptom onset) and revised our conclusion to:
peramivir IV may reduce symptom duration by about 1 day in previously healthy adults treated within 24 hours of influenza symptom onset, but may not be effective if used > 24 hours after symptom onset (level 2 [mid-level] evidence)
So if you were going to use it this way, perhaps only when someone presents in the first 24 hours.
The recent trial done in hospitalized patients also had many "subgroup challenges" (including use of oseltamivir in most patients), so we ended up with a conclusion of:
addition of IV peramivir does not appear to reduce symptom duration in hospitalized patients with influenza treated with oseltamivir (level 2 [mid-level] evidence); efficacy of peramivir in hospitalized patients not treated with oseltamivir is uncertain
The details should get published by the end of the day.
Brian S. Alper, MD, MSPH, FAAFP
Founder of DynaMed
Vice President of EBM Research and Development, Quality & Standards
dynamed.ebscohost.com
-----Original Message-----
From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Brian Alper MD
Sent: Tuesday, December 23, 2014 2:03 PM
To: [log in to unmask]
Subject: Re: FDA approves Rapivab to treat flu infection
So peramivir (Rapivab) is like Tamiflu, just given as a single IV dose. The FDA approval sounds like it may be based primarily on 1 trial with nearly 300 people showing 21-22 hours different in time to alleviation of symptoms. This trial may be Antimicrob Agents Chemother. 2010 Nov;54(11):4568-74. (PMID 20713668) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2976170/ --- this was a trial in "previously healthy adults aged 20 to 64 years reporting onset of influenza-like illness within the previous 48 h"
If giving an antiviral IV is really the value of this drug, then use in hospitalized patients and can this help for the sickest patients would be the most relevant clinical question.
Well....
Clin Infect Dis. 2014 Dec 15;59(12):e172-85. doi: 10.1093/cid/ciu632. Epub 2014 Aug 12.
Evaluation of intravenous peramivir for treatment of influenza in hospitalized patients.
http://www.ncbi.nlm.nih.gov/pubmed/25115871
400 patients hospitalized with influenza - randomized to peramivir IV or placebo IV for 5 days and.....
THE STUDY WAS TERMINATED FOR FUTITLITY AFTER A PREPLANNED INTERIM ANALYSIS.
Brian S. Alper, MD, MSPH, FAAFP
Founder of DynaMed
Vice President of EBM Research and Development, Quality & Standards dynamed.ebscohost.com
-----Original Message-----
From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Ted Harding
Sent: Tuesday, December 23, 2014 1:22 PM
To: [log in to unmask]
Subject: Re: FDA approves Rapivab to treat flu infection
Tom Jefferson has nicely widened the efficacity of a well-established folk medicine, already renowned for its beneficial effects on mental and emotional function, namely: Salisternuvir.
Etymology (from Latin)
"Salis": salt
"Ternum": pinch
"vir": Obligatory suffix required by Regulatory Authorities
Well done, Tom.
And Season's Greetings to all!
Ted.
On 23-Dec-2014 07:40:23 Tom Jefferson wrote:
> The label says:
>
> "Overall, subjects receiving RAPIVAB 600 mg experienced alleviation of
> their combined influenza symptoms a median of 21 hours sooner than
> those receiving placebo. The median time to recovery to normal
> temperature (less than 37°C) in the 600 mg group was approximately
> 12 hours sooner compared to placebo."
>
> "There is no evidence for efficacy of RAPIVAB in any illness caused by
> agents other than influenza viruses. Serious bacterial infections may
> begin with influenza-like symptoms or may coexist with or occur as
> complications during the course of influenza. RAPIVAB has not been
> shown to prevent such complications."
>
> It is also worth having a look at the press release.
>
> http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427755.ht
> m
>
> noting the irrelevance of the opening CDC-like statement about
> hospitalisations for a drug which does not have evidence of affecting
> hospitalizations, complications etc.
>
> The harms bit is generic with gastrointestinal harms (like the other
> two
> NIs) and the mystification of psychiatric effects (which could be be
> confused with influenza symptoms and viceversa). We labelled these
> "compliharms" in our review.
>
> We have shown that in prophylaxis (where there is no influenza
> interference) there is increased risk of neuropsychiatric harms.
>
> All in all this means that the FDA press releases are to be taken with
> many pinches of salt.
>
>
> Tom.
>
> On 23 December 2014 at 08:29, Tom Jefferson <[log in to unmask]> wrote:
>
>> No, the same as Tamiflu and Zanamvir.
>>
>> The drugs have a central action probably acting on the hypothalamus
>> and bringing fever down. Their in vitro effect on influenza viruses
>> does not appear to have a practical impact in vivo.
>>
>> There is no other credible evidence of any other effect on any other
>> outcomes.
>>
>> I notice that there is nothing on harms.
>>
>> Happy Xmas to you all,
>>
>> Tom.
>>
>> On 22 December 2014 at 22:48, write words <[log in to unmask]> wrote:
>>
>>> Is this clinically relevant?
>>>
>>> From the press release
>>> <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427755
>>> .htm>
>>> :
>>>
>>> Rapivab's efficacy was established in 297 participants with
>>> confirmed influenza who were randomly assigned to receive Rapivab
>>> 300 milligrams (mg), Rapivab 600 mg or placebo. Overall,
>>> participants receiving Rapivab
>>> 600 mg had their combined influenza symptoms alleviated 21 hours
>>> sooner, on average, than those receiving placebo, which is
>>> consistent with other drugs in the same class. Those receiving
>>> Rapivab 600 mg also recovered to normal temperature approximately 12
>>> hours sooner compared to placebo. Supportive trials confirmed these
>>> findings. However, efficacy could not be established in patients with serious influenza requiring hospitalization.
>>>
>>>
>>>
>>> -Christie
>>>
>>>
>>
>>
>> --
>> Dr Tom Jefferson
>> Medico Chirurgo
>> GMC # 2527527
>>
>
>
>
> --
> Dr Tom Jefferson
> Medico Chirurgo
> GMC # 2527527
-------------------------------------------------
E-Mail: (Ted Harding) <[log in to unmask]>
Date: 23-Dec-2014 Time: 18:21:40
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