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Yes.
I relapsed after 48 week of peg-rib at 2006 with compensated F4 and 1b. Fortunately, there were no very serious side effects during therapy. There was an opportunity to undergo peg-telaprevir-riba therapy several years ago and many people recommended me to do this due to F4… My doc said like that – “if you want, you may try peg-telaprevir-rib, but your case is hard to treat”. Liver function was stable and i decided did not undergo this therapy… Some clinical trials show substantional mortality at therapy with telaprevir and F4 and there was not clear for me – whether possible benefits of treatment with telaprevir outweigh its risks of harm or not. Unfortunately, one guy died on russian-spoken forum during telaprevir-based therapy, probably without cirrhosis. Dr.Koretz wrote in 2013, before the wide acceptance of interferon-free regimens:Given the natural history of chronic hepatitis C, as well as what we know therapy accomplishes, it is very difficult to justify a policy for routinely treating such patients to prevent decompensated liver disease. The surrogate outcomes were not valid in the one occasion when validation information was available. The treatment has not been proven to be efficacious with regard to preventing clinically important disease, it is expensive, and it causes substantial morbidity (including death). It is an inappropriate clinical decision to prescribe a toxic therapy (especially an expensive one) that has never been shown to provide clinical benefit in properly-done randomized trials.
(http://www.news-medical.net/health/Hepatitis-C-treatment-no-benefits-and-possible-harm.aspx)
Now planning to try treatment with indian generics.
Hi LondonGirl, yes, i agree.
He used such schema:
1-7 weeks – sof+dac
8-9 weeks – sof+dac+simeprevir
10-24 weeks – dac+simeprevir+ribavirin
mgalbrai, thanks for sharing links.
If i correctly understand, the problem, mentioned by Dr. Koretz, is that hcv treatment, from point of view of “evidence-based medicine”, really, is a bit experimental treatment, like clinical trials… SVR is “unvalidated surrogate” and we cannot exclude that, in future, for example, new much more sensitive tests may be developed and all people with SVR may become “HCV-carriers”, detected by those very sensitive tests…
There is another text about similar issues – http://www.openhealthnews.com/story/2015-01-18/lack-good-medical-evidence-new-100000-hepatitis-c-drug-treatments
-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.
-There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
-There is no clear evidence that “sustained virologic response,” (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure.
-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.
if these drugs have not been shown to do more good than harm, and the lack of evidence is clearly the responsibility of the drugs’ manufacturers who chose not to do very large and/or long-term randomized controlled trials and not to assess clinical outcomes, what justification is there for the gargantuan prices of these drugs?
Possibly, it may have some consequences… For example, if we will make a strategy “to treat everyone hcv-infected as soon as possible” – what does it mean in terms of “evidence-based medicine”? Does it mean “to involve everyone of hcv-infected in a some sort of large uncontrolled “clinical trial”?
P.S. About tolerability of treatment – i know one guy, who tolerated high doses of interferon without significant problems, but, surprisingly, he did not tolerated several months of sofosbuvir.
He achieved SVR after discontinuation of sofosbuvir.
