Hep C Discussion Forum

Hi Isiscat,

Like you, I was surprised by the IL28B references. I'm sure this hasn't previously been mentioned for non-Interferon treatments.

The report is comprehensive, but there is obviously an agenda to discredit the Sovaldi trials and the AASLD guidelines. It's probably to save Oregon some money in limiting the approval of the Sovaldi regimes.

Another report is needed after Ledipasvir and the AbbVie trio are approved.

Tig56 wrote:

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Gator Man,

 "If I grow a third eye in the future as some Sx from Sovaldi, maybe I will change my opinion. Until that point, probably not. "

I see a new avatar in your future, lol!

Tig

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 Hmm ...

This report highlights the need for evidence based treatment as well as the need for neutrality and transparency in clinical trials.  Further, it demonstrates the necessity for individualized treatment plans.  

I find it astonishing that pharma is permitted to pick and choose which trial results it will publish while many if not most trial results are never known to physicians or the patients.  Patient populations for clinical trials are cherry picked.  Statistical data is carefully manipulated.  The numerous biases that are built in to the existing system are mind boggling. 

In the COSMOS trial, in which the Sovaldi/Olysio combo was tested, the test results failed to include the patients who were withdrawn for virological failure or for whom treatment was discontinued.  Including those numbers would have seriously impacted the SVR rates.  Moreover, had the virological failures been openly discussed, perhaps "stopping rules" would be implemented.  Neither patients nor the public is well served by this lack of transparency. 

Some of the data was surprising.  For example the IL28B will probably continue to play a role in tx success (although it will continue to not be widely tested for).

Some of the relapse rates were surprising as well (90% relapse for Genotype 1 with 12 week S/R protocol).  And, the FDA essentially allowed Gilead to move the SVR date from 24 weeks to 12.  Follow-up reports to determine relapse rates, long term effects, etc, are virtually non existent post FDA approval.  Another interesting fact is that FDA approval is made before much of the evidence is even in.  Pharma can file evidence in support of approval a year after approval is given.

That some people would choose to treat no matter what the evidence reveals is not a legitimate argument for withholding evidence from physicians, patients, and the public, IMHO.  

All and all Sovaldi still looks pretty good; better than what came before it.  But, the lack of neutrality or transparency serves only to increase sales and diminish positive results by encouraging the one size fits all; treat now and retreat later mentality.   

Good stuff. This is the least biased report of this sort I've seen thus far. Most seem skewed towards either the drug manufacturers (Buy Now!!) or the insurance industry (We Won't Pay!!).