Hi Vororo,

Looking at the report in a bit more detail, it has the following statement:

“Objectives: To assess the benefits and harms of DAAs in people with chronic HCV.”

They then go on to state that they investigated all the clinical trials of DAAs they could discover irrespective of type including “unpublished” and “grey” trials. It appears they also included unsuccessful trials in their investigation of the 51 DAAs they state are involved. So even something that was determined in trial to be unsafe or ineffective against HCV is included in the data?

Reading through the abstract it appears that the investigations actually looked at whether the trials conformed to ideal best practices including allocation of participants by such means as random computer assignment using a “locked” computer and other similar type criteria. i.e. It was a retrospective study (audit) of the methodology of the clinical trials using strict criteria as to what complied with their definition of best practice. This is good! I’ve conducted many similar “Quality Audits” in my industry, they are an excellent means of keeping the participants honest and driving continuous improvement in standards. We can always do better and this review seems to have highlighted quite a few areas where clinical trials can be improved based on their findings of “the quality of evidence is very low” for compliance with their criteria.

However…..we need to remember that the clinical trials under review were to determine the efficacy and safety of the DAA involved against HCV as measured by plasma RNA levels and adverse events at predetermined points during and post treatment. They were not and were never intended to be whole of life studies of the participants health. Out of the 51 DAAs trialled, something like 25-33% have been approved for use with the rest presumably being determined insufficiently effective or safe although it seems the results from these are included in the data used in conclusions of the authors.

Now go back and read the quoted Objective at the start of my post. As far as I can determine these researchers have audited a large number of clinical trials for compliance with what they consider best practice in a clinical trial and found many areas for procedural improvement due to what they claim is “very low quality evidence”. But they have then used that same allegedly poor evidence (including that from all the unsuccessful trials) to extrapolate about the long term prognosis for those taking approved DAAs.

From my perspective, their study approach of investigating procedural elements/reporting of clinical trials does not constitute a meaningful analysis of their stated objective of “assessing the the benefits and harm of DAAs” and thus their conclusions regarding that aspect look to be flawed.

Please see my blog post about it here: http://fixhepc.com/blog/item/81-bad-science.html

Yesterday the Guardian published and article called ‘Miracle’ hepatitis C drugs costing £30k per patient ‘may have no clinical effect’

https://www.theguardian.com/society/2017/jun/08/miracle-hepatitis-c-drugs-costing-30k-per-patient-may-have-no-clinical-effect

The problem with this sensationalist headline is that while it is reporting what was said by the Cochrane Collaboration what they looked at was trial specifically designed to test SVR rates, and not specifically designed to look at long-term outcomes.

Here is a commentary from Dr Andrew Hill and the study to which he refers which was presented at AASLD in 2015 and published in Clinical Infectious Diseases.

Total rubbish! Here is our paper showing a really strong correlation between curing HCV and improved survival.

Please see the attached paper where we had much longer follow up and showed a strong effect of SVR on improved survival. Our analysis included 2210 deaths – slightly more than the Cochrane study!

Here is Dr Hill’s AASLD presentation:

AASLD_Outcomes_Oct30x_SLIDES.pdf

And here is the full journal article from Clinical Infectious Diseases:

HepatitisCureSurvival.pdf

And an after thought, what are DAA’s supposed to do other then clear the virus, guarantee a lottery win as well??

Yes, a proper title for this study would have been DAA therapy is no more dangerous than placebo.

Congratulations Sabrecat!

I think it is technical speak for “you win”.

Yay
That’s fantastic Sabrecat (the UND that is…not your lack of luck with Lady Lottery)! Some mates you don’t need anymore.

Hi Hazel, I noticed from your signature:

“Fibroscan 40 down to 22 by 29/3/16- 10/16 dropped to 9.5, no cirrhosis. Started Buyers Club Sof/Dac 14 Nov 15. SVR 12 29/0716”

that getting rid of our unwanted friend may be the beginning of more good news liver health wise. I always wondered if what they say about the liver repairing itself is entirely true …….

A big reason for me undertaking therapy was to reduce the morbidity associated with the liver being beaten around by the bug.

I thought was was SVR at 12 weeks just before the blood test. After the Ribavirin wore off I was energy +.

If this gets even more better, then I may well assume he old boot is repairing itself. I can only assume as my liver was chopped up a bit so fibroscans do not really work with me (at least this is what I was told at one liver clinic).

Yours

Jeff

P.S. all the best on your own stunning result.

Ha ha, it was a good run while it lasted! But if Bristol Myers Squibb and Gilead are denouncing their conclusions, their “stature” may now be permanently diminished. Talk about shooting yourself in the foot I’m cured and I know it for damn sure, I feel terrific!