New drugs won't be available for 3 to 5 years

Hello,
My favorite HepC resource is HCV Advocate out of San Francisco it always has well researched information. Here is a paragraph from the article on the first page of this months Newsletter. I get it every month. It's excellent. I recommend it for all HepC patients. To read the entire article and get a PDF of this months Newsletter just go to the address below :

http://www.hcvadvocate.org/news/newsLetter/2007/advocate0207.html#1

The media has done a great job of making us believe that new and better drugs are going to be available soon. Almost every day we hear of a new drug that is sure to

[copyman]

i hope this is one time HCV Advocate is wrong. i heard with my own ears the ceo of vertex say he feels with the fast track status that they could have vx-950 on the market in 2008. i have to believe what this ceo says, im sure they want to start making the billions by selling this drug ASAP.

[jmjm530]

The writer could indeed be correct but I found the article sorely lacking in references, quotations, etc., even off-the-record quotations with authorities in the field.

Here, the writer misleads by over simplifying/misleading in one of his main points.
------------------------------------------------

From Advocate article:

Since hepatitis C is a slowly progressive disease (for most people), most experts would recommend that someone with mild liver damage could safely wait until the newer medications are approved. Unfortunately, there is no

[Cindy10]

My doc said 5 to 7 years, thats why I didn't wait.

[Sincebirth]

It seems that the article is true except for VX-950.  I will bet it will be out mid 2009.

[jmjm530]

http://www.natap.org/2006/DDW/DDW_27.htm


From background, discussing older studies which suggested SVR tied to liver damage other than F4 ... the studies the reporter probably used as a basis...

"
Most studies are small and do not contain a significant proportion of patients with cirrhosis. Patients with F3 fibrosis and cirrhosis (F4) are often analyzed together rather than separately"

From summary:

".. Cirrhosis (F4) is the major histological determinant of SVR according to F stage..?

[jmjm530]

Oh well, here's a take on same study:

"...In the entire population of patients, logistic regression showed no statistically significant difference in SVR rates between stage 0 (44%), stage 1 (46%), stage 2 (44%) and stage 3 (44%) except in fibrosis stage 4 which only achieved an SVR of 34%."

It does say however, that F1's and F'2's do better than F3's and F's with fixed dose riba but I don't know of any geno 1's who treat fixed dose. So where I come out is if a stage 3 follows a weigh-based riba protocol, they will have the same chance of SVR as a stage 1 or 2. Stage 4's, on the other hand do not have as good a chance. Again, at least according to the article, the reason the studies you remember say stage 3's have a more difficult time is because those stuides lumped stage 3's and stage 4's. FWIW I had this same discussion with three hepatologists and the 2 of the 3 told me that my stage 3 status was no reason to extend. In fact, one kept asking me rhetorically, "you don't have cirrhosis, do you ?" In other words he was telling me not to sweat it and go 48 weeks.

Here's the other link. And now back to "24". ...
http://www.hcvadvocate.org/news/newsLetter/2006/advocate0806.html

[jmjm530]

rev prev: (please don't ask me to dig them up because that would be a task).
----------------
LOL. So *I'm* the one that has to dig them up :) Anyway, there was another study -- or maybe just an analysis of this one I was going to look for, but instead I think I'll go back and watch "24"....it is a task :)

-- Jim

[Hepatitis Researcher]

The HALT-C trial report  " Impact of disease severity on outcome of antiviral therapy for chronic hepatitis C: Lessons from the HALT-C trial" shows a clear and not pleasant picture after analysis of over one thousand patients that were retreated after prior relapse of the impact of disease severity on outcome. It compared two stages 3 - briding fibrosis-, split by platelet# and two stages 4 _-cirrhosis - split by platelet#s. The four groups had  SVR rates of 23%   17%  10%  and 9% percent.
Hepatology 2006;44:1675-1648

[jmjm530]

How do you then reconcile the quote and study I posted above? Two well-known hepatologists who are aware, and possibly involved in Halt C, told me that as a stage 3 I needn't extend treatment beyond 48 weeks, and that my predicted outcome would not be affected by being a stage 3 -- only if I was a stage 4.
Also, keep in mind that this whole discussion started as a result of the Advocate article which was directed toward treatment naive's, not those re-treating. The relevant figures, 23 per cent and  17 per cent seem very low. Is it possible to post a link to the study. Thanks.

-- Jim

[jmjm530]

I got this from some commentary over at the HIV/HCV site:

"..The study included 1046 patients enrolled in the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) trial who had failed prior treatment with convention or pegylated interferon, with or without ribavirin, and had Ishak fibrosis scores of 3 or higher..."

The fact that this group lumps older and newer treatment protocols may account for at least some of the discrepency. The other study differentiated between those on weight-based versus fixed dose riba and I believe did not include those on non-pegalayted interferon or those who treated with ribavirin.

[jmjm530]

I found the study abstract. The two studies appear to be at odds. Was weight based ribavirin used?

[bobbyullc]

i heard that 2 years ago.