Whoops!

Hi Serg,

No need to apologise. You presented your case, I presented mine and…..um…..GT2 presented his.

Anyway, I guess we’ll just have to agree to disagree about to what level we take EBM before patients can be treated with reasonable confidence. I am glad to see that you as a F4 are considering starting treatment this year though, that is not a decision that should be put off indefinitely.

And while you are only one voice, never think that it carries no weight at all. The sound of many such voices combined travels a long way.

As for Poses, I believe he does provide a valuable service in questioning the status quo and reminding us that the business, medical and political establishments need to be watched to ensure that their actions are not driven purely by self interest. He also appears to be a strong advocate for EBM but I detect a level of fundamentalism in his advocacy that suggests that he is operating outside of the ‘real world’ of people’s ongoing health and lives while at the same time appealing to their insecurities. In other words he is more interested in the principle than the people it effects as per his bulletpoint comments below from the article you cited.

The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.

I agree with the opening part of his statement, not so much with his conclusion which appears to argue that we should ignore anything that isn’t a “severe complication” to our health. Are we to apply the same rules to areas of health outside of HCV? Is he suggesting that patients with hypertension could not benefit much from treatment because it doesn’t always result in strokes, aneurysms or cardiac events?

There is no evidence from randomized controlled trials that treatment prevents most of these severe complications

Correct! Clinical approval trials were to prove safety and efficacy in achieving SVR. To undertake “randomized, controlled trials” to provide that sort of evidence for the “severe complications” would probably take decades as you note yourself. However, there are now a considerable number of retrospective studies that are showing that achieving SVR results in less risk of progression along the path to those more severe problems than non treatment.

There is no clear evidence that “sustained virologic response,” (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure. 

True dat! It is why it is called SVR and not CURE. We do however have evidence that achieving SVR12 gives about a 99% chance of no relapse over the period that we have been able to study so far and retrospective studies appear to show benefits associated with that.

While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Oh, this is just a classic fear mongering statement. It is designed to scare rather that elucidate or educate and rates number one out of his four statements as justification for my calling him out for use of FUD tactics.

Hi Cruzan,

Sorry to hear your news. Unfortunately even with these new drugs the results are still only about 95% successful overall meaning not all of us manage to acheive SVR on our first attempt. The good news is that for those of us in that position the science and R&D is progressing fairly quickly these days so there are further options available either now or in the very near future depending on our individual situation.

Having recently found myself in a similar situation I would suggest that your best option is to get all your information and results together and have a discussion with someone who understands the HCV retreatment process. One option that I can recommend for that would be a ‘virtual’ consultation over Skype or similar with https://gp2u.com.au who will be able to provide you with good advice as to your various options for the future whether that be retreatment or otherwise.

From the other side, some studies show that virus persists for many years after SVR in majority of people, detected by special ultrasensitive equipment – http://www.ncbi.nlm.nih.gov/pmc/articles/PMC415836/ , onlinelibrary.wiley.com/doi/10.1002/hep.20518/full Is it possible that “eradication of virus due to treatment” – is one of Big Pharma’s “marketing slogans”, which is not supported well by “scientific” data?

Hi Serg,

Both the studies you list in the above quote are from 2004 and well prior to the development of modern DAAs such as Sofosbuvir, Ledipasvir, Daclatasvir, etc, etc. If you are going to cite studies to try to support your claims about the modern DAAs you need to provide more current information. The rest of your post provides no further evidence or support for any of your concerns either other than to quote Roy M. Poses MD, an outlier in the medical community who also presents all his “arguments” in terms of FUD (Fear, Uncertainty & Doubt).

With all new medications at some stage a decision has to be made whether to approve their use or not as has occurred for the DAAs via the FDA, European and other relevant authorities. As you appear to feel this approval has occurred too early, can you clarify at what point you would consider treatment to no longer be “experimental” or “clinical trial”? Is it a matter of years, or numbers of patients treated….how many of either or both? Or is there some other criteria that you believe should be used? Please keep in mind that even drugs like Aspirin and penicillin still have some side effects and risks despite having been used for over half a century.

However, I do agree with most of your statement that “treatment decision (“to treat” or “not to treat” etc.), probably should be individualized, taking into account possible benefits and risks of each alternative, overall health, age, previous treatment attempts.”

Hi Sven,

Short answer is “No”.

The longer answer is that all the studies discussed in this thread were retrospective and conducted via major Hepatology research centres and as a result almost certainly 100% of patients would have used branded DAAs rather than generics so Big Pharma would be shooting itself in the foot to attempt the approach you are suggesting. What we are seeing here is just the normal scientific process of continuing research. One group of researchers think they find some sort of problem in a small study then their peers review that finding and often set up a larger study group that either proves or disproves the original researchers findings. Later, another group of researchers will probably review this area again with an even larger group of patients, just the same as even today there are researchers studying the effects of Aspirin though we already know so much about it.

Also readers should be aware that the studies so far have shown that achieving SVR reduces the risks of getting liver cancer in the first place for those with HCV. What we have been discussing here is the much smaller number of cases where a patient has already had a Hepatocellular carcinoma and then uses DAAs…..and based on the latest and larger study(s) that doesn’t seem to be a problem either.

Welcome Happylady,

Not a doctor either but I would suggest seeing or talking with one as you say there is noticeable swelling of your mouth or gums and the insert recommends that course in case it is an allergy. Don’t try a reduced dose without expert advice. It may also be a candida infection and if so the doctor will tell you straight away and recommend something for it allowing you to restart treatment.