Video Insight: Using Hepatitis C Virus Protease Inhibitors in Cirrhotic Patients

[yodennis]

I'm presuming you will need to sign up to view this newer information (It needs to be seen rather than capsulized) but it would seem the SVR stats are going to rise for cirrhotics on triple therapy.....The operational theme throughout this video is safety for cirrhotics on triple tx. with new relative stats but it is not unrealistic to gleam some added SVR hope for us "hopeless" ones! Video Insight: http://www.clinicaloptions.com/inPractice/Hepatology/Hepatology/ch8_Mgmt_of_Hep_C_Infection/Pages/Page%207/Subpage%205a.aspx

[can-do-man]

"As far as the Riba dose reductions and SVR in the cirrhotic population, I think we are hearing what he is saying differently."

I agree, one shoe does not fit all when it comes to treating, and new drugs or not IMO never will.

[pooh55811]

I do think the presentation contained a great deal of important information and observations concerning the treatment of cirrhotics, especially since the cirrhotic population was not well represented in the original trials.

As far as the Riba dose reductions and SVR in the cirrhotic population, I think we are hearing what he is saying differently.

[HectorSF]

A very interesting study. Thanks for the heads up on it.

I agree with yodennis. This is preliminary data from week 16. Very early in treatment. And differences in SVR between dose reduction of Riba, Procrit usage and transfusion won't be known until after trial in completed and analyzed. Also he talks about Ribavirin dose reduction 'early in treatment'. When is early? Before week 4, 8, 12?

What I found most interesting is the different experiences of each subgroup of compensated class A cirrhosis. A lot of this data seems to show what we already know...The more advanced your liver disease the harder it is to successfully treat for a variety of reasons. So It really does matter to know if someone has what we call 'early cirrhosis' with no portal hypertension vs others with portal hypertension vs those close to decompensated cirrhosis. Those 3 subgroup on average have different risks vs benefits of treatment.

Also who is more likely to have servere anemia, decompensation and liver failure that may result in death. As we have both said for I think years now, anyone with cirrhosis should see a hepatologist at a transplant center because they are the only ones that know how to intervene and manage these something serious side effects of treatment. Otherwise as we see in this study about 25% have to stop treatment due to servere adverse advents. So 1/4 of the people won't even be able to make it to week 16! Never mind up to 48 weeks!

I won't go into the details of particulars but this study is helpful into predicting what cirrhotics will face when they do this treatment so if this info in factored into what they can expect they will be better prepared for what is to come.

Main Findings

Both telaprevir- and boceprevir-based regimens associated with high rates of serious adverse events

6 deaths in telaprevir group from sepsis (n = 2), pneumopathy (n = 1), bleeding of esophageal varices (n = 1), encephalopathy (n = 1), and lung carcinoma (n = 1)

2 deaths in boceprevir group from bronchopulmonary infection (n = 1) and sepsis (n = 1)

Most common grade 3/4 adverse events
* Telaprevir-based therapy: thrombocytopenia, anemia, infection, and rash
* Boceprevir-based therapy: anemia, thrombocytopenia, and weakness

What is important to keep in mind is if the Gilead studies with peg-INF, Riba and Sofosbuvir are successful in cirrhotics I doubt anyone will you PIs again. As we already know that a lot of this serious issues either don't happen with Gilead's treatment or it is no where near as extreme as Grade 3/4 anemia, thrombocytopenia, etc.

Time will tell.

my two cents worth...
Hector

[Dee1956]

Wanted to come back and say that I relapsed the first time I treated.  I think it was due to my inf being reduced early on.
Then I got to SVR after the Incivek
I wish you the best Dennis.

[Dee1956]

Hey there, thank you for sharing!
You are not hopeless.  There is always hope
Take care
Dee

[yodennis]

I heard it slightly differently. I felt Dr. M. B. was speculating (pending SVR results form the study) that Ribo reduction in the cirrhotic population and it's potential to lower SVR rates in such a population did not justify decreasing Ribo as the first or second choice in mitigating anemia (epo and transfusion being the the first choices)..Two points: The future will tell!, and with my ADD I'd be more inclined to go with your interpretation than mine....It was an earnest and heartening presentation imo. My best. d

[pooh55811]

I watched that video last evening and found it very informative. I think it is particularly significant because this is the first study that studies a large number of cirrhotics (as opposed to the very few in other studies). Plus many of these cirrhotics had more advanced liver disease than those in the drug company studies.

One thing I noticed is that Dr. Marc Bourlière, MD, Head of the Department of Hepatology and Gastroenterology with the Hospital Saint Joseph in Marseilles, France, and with the French National Agency for AIDS and Viral Hepatitis in Paris, stated several times that they are reluctant to lower the Ribavirin dosage in Cirrhotics due to the adverse effect it has on the SVR rates. He was quite adamant that Ribavirin dose reduction does, in fact, adversely affect SVR in Cirrhotic patients.  

Thanks for posting that link, Dennis.