I believe more than half a million people have already been treated with the new DAA's yet the knowledge of Best Practice tx is a hotchpot of trials where the number of participants in a particular
cohort is often so small that there is no statistical basis for any valid conclusion.They are almost always trials partially or fully sponsered by drug companies,who have no commercial interest in shortened tx times. It is not uncommon in trial data summaries to read something like
1a cirrohsis 12wk sof dac riba svr 12 96% (n=4) 24 wks sof dac riba svr 12 91% (n=6)
I have over the years seen so many similar examples.
Does this mean your chances of success are less at 24wks than 12wks.Of course not.It means the sample is so small the results have no statistical significance.It means at best at both 12 and 24 wks your chances are good,but there is the yet unproven possiblity you could be throwing money down the drain at 24wks.
We now have the emperical evidence the earth is not flat.
We now can calculate the statistical possiblity of an asteroid hitting the earth.
We have the statistical and empirical evidence that climate change is real.
We have no real knowledge of the best use of Ribavirin.Which is an absurdity given the data is out there waiting to be collected,given the length of time Ribavirin has been in use with the new DAA's
So often you see in tx recommendations you see +or- Ribavirin.I have never been able to work out what that exactly means.Does is really come down to the hunch of an individual Specialist.
It would be very useful to collect the data from every patient that is compelled to curtail the use of Riba in their tx and correlate it with tx outcomes against those who don't,and also correlate it according to time frames of use.Has it ever been done?
Has any statistics been done on the effect of erratic complience on tx outcomes?
Two of the bigger recent trials were the Compassionate youth Programs in France and Germany.
Yet when you look at the Gen1a/1b results they do not always concur with the latest AASLD guidelines.Could there possiblity be some commercial bias somewhere?
Many people on this forum (including myself) have been imbued with the idea that the longer and harder you hit the monster the better your chances of success are.I notice in Dr Freemans topic on gen3 he mentions 1+1 can in some circumstances mean less than 1.
It is frightening to consider the possiblity that to extend the use of Ribavirin or any DAAfor longer than a certain period one could actually be decreasing the chances of success and harming oneself physically and financially.On face value the idea would seen absurd,but there is no statistical evidence I know of that can definitively rule it out and cross it off the list.
If were able to be shown that 24wks of tx has no benefit over 22wks, or 11.4wks v 12wk you are looking at a cost saving (and loss to drug companies) of 5% approx .On a world wide scenario this amounts to many millions of dollars.In a 3rd world scenario it could mean the difference of cronies of the village chief being treated and everyone in the village being treated.
In any case it would far exceed the cost of setting up and maintaing a World Wide Tx outcomes database,and at least the numbers would be there to start plotting some really meaningful charts.
Given the urgency of the situation why isn't a body like the World Health Organisation looking into this.
Gen 1b 40yrs,tx naive, f3/f4.VL too high to quantify.
Started tx 12Oct.sof and riba India via greg.Dac from Mesochem.
4wk result virus not detected,all liver functions in normal ranges.
Only SE intermittent insomnia.Feel great and grateful otherwise
"In any case it would far exceed the cost of setting up and maintaing a World Wide Tx outcomes database,and at least the numbers would be there to start plotting some really meaningful charts."
This is actually happening at a local level in the UK with plans to join up the data country wide. My local hospital asks for voluntary, anonymous participation in the collection of hepC treatment data. The understanding is that this data will be used to inform treatment in the future. It is however still early days and data collection takes time. The need for comprehensive data somehow always exceeds the availability of it.
Data collection was also done during the time that ifn + riba was all that there was. Over those years a lot was learned about how to refine the treatment. The fact that ribvirin action is still not fully understood is not because of a lack of data or failure to study it.
Anyway, I do agree that data collection is very important. What concerns me more is who has access to it, and how is it used? Give a statistician a database and you can get almost any conclusion out of it that you want. There are powerful interests out there who like to start with a conclusion and work backwards to the data needed to prove it. So if you are looking for unbiased, meaningful charts then they could be hard to get, but we have to try. If you are looking to get over the "insufficient data" condition, I don't think that will happen any time soon.