I am concerned about the total effectiveness with generics, as the relapse news is now seemingly hitting full stride with people testing SVR 1-16-24.
Hi Sven, the SVR12 rates overall are > 90% which is as good as could be hoped for.
Amongst the dozens of reasons NOT to be involved (and there are lots) one of the major ones was the 100% certain knowledge that an SVR rate of 95% is also a 5% failure rate which means that I knew at least 5 out of every 100 patients would fail to SVR, even if we got real world results as good as the clinical trials, which once again, we (as in doctors) know is never the case. I resolved that if we were not seeing 90% I would reassess things. We are, which is one reason we continue.
There are literally thousands of patients taking generics so there are hundreds of people expected to fail to SVR - any one of whom might choose to sue me or others involved in their treatment. REDEMPTION is as much about
CYA
as it is about proving generic copies are effective, because it is only in the context of a group that an individual relapse has any context. So if a lawyer comes along an says we are starting a class action because patient's A B and C have relapsed I'll go good for you, but guess what, patients D E F G H I J K L M N O P Q R S T U V W X Y and Z did not, and I have the evidence, so perhaps you'd like to re-consider your case because you're going to lose so kindly
FOAD
.
So is it that the voices we hear are those whom have failed SVR and the ones that are 100% done never post any further?
Yes, if you look at the forum and do a search like this (from the search tab)
fixhepc.com/forum/search.html?query=trea...c&childforums=1&ids=
Which is for posts more than 6 months ago, searched for the word "treatment", sorted by earliest first you will see hundreds of names of people you've probably never heard of. They came, they treated, and they've moved on. Treatment gives people back their lives and while I miss their company, humour and insights, it's the way it should be.
A big reason this forum exists is also CYA in the context of informed consent. Anyone who wanted to say I had no idea that there are side effects, that patient's relapse, etc, etc would be hard pressed to prove that was because they were not informed. This forum is far more transparent then any drug company trial and carries far more real world information about DAA treatment than pretty much anywhere else in the world, and unlike Big Pharma trials where the results are presented with a "trust us this is what we got", this forum makes our results pretty transparent - if generic DAAs were not delivering results you would be reading a whole lot more relapse and a whole lot less SVR.
If you've got a strong stomach read this
fixhepc.com/blog/item/26-pharma-scores-rap-drug-cover-ups.html which is an article from the Australian called "Pharma Scores Rap Drug Cover Ups" reporting on this article from the BMJ
bmjopen.bmj.com/content/5/11/e009758.full.pdf
where it is noted that with Gilead's new HIV drug Stribild they did 34 trials BUT only reported 21% of them (ie 7). You do have to wonder what the other 27 unpublished trials turned up, but it would be naive to think they contain better results.
Please let me know how one calculates the generic Harvoni with branded Harvoni successes and failures.
You do it by taking a group of CONSECUTIVE patients - 448 - in our case - and keep a log of what happens counting all the successes and all of the failures.
Interestingly we are also keeping a log of originator medication patients in Australia and, as expected seeing both success and relapse.
I have patients who have replapsed post anything and everything you could name - Harvoni, Sovaldi, Ribavirin, PEG, Olysio, Daklinza, Zepatier, V-pak - we have good, we don't have perfect.
Treatment is a gamble. There are risks, there are benefits, there are failures and successes. There will always be better drugs just around the corner. For some people waiting may be a good option. Others will die waiting..... 500,000 last year to be more precise.
But do generics deliver similar results to the branded medications, yes, just like the HIV generics taken by about 15 million people around the world. These medications are largely made by the same companies in both originator and generic forms.