New Drugs. New Treatment Decisions.

[jmjm530]

Recently, someone at another discussion group asked me how I thought the newer protease inhibitors like Vertex should affect our current treatment decisions. Here’s an edited version of my answer.
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That's an excellent topic for discussion!

"To treat or not to treat" has always been a controversial issue.

Nowhere is it more controversial than genotype 1's with no or minimal liver damage, i.e. stage 0 or 1.

In this group, doctors are split. Some advocate treatment, the idea being you have a better chance for SVR if you hit the virus early in the cycle, when you're younger, healthier, and when the liver has little or no scarring.

Others advocate a "watchful waiting" approach with regular lipid monitoring and follow-up biopsy in 3-5 years. The idea here being why expose yourself to the side effects of these powerful drugs when your liver is still in decent shape.

In this debate, I tend to favor watchful waiting, although I respect anyone who decides to treat as long as they're making an informed decsion, weighing the pro's and con's. The only right answer is the one that's right for you.

That said, the new protease inhibitors in trials -- like Vertex --  seem to be shifting the "treat or not to treat" paradigm in this select population toward "not to treat".  Because even if we're off with the project 3-5 year release date,  this group still has time to wait.

PART II WILL SHORTLY FOLLOW...

[kconn14]

I'm wondering if any of you have any input on TMC435? It's being developed by Tibotec and from the results of studies, do far, looks pretty good. But I've read this thread and am impressed with the amount of knowledge shown here. I'm geno 1 stage 3/4 and only found out about it 4 months ago. So, I'm told, I have to make a decision pretty quickly. Someone on another thread mentioned this drug and in investigating I find there's a new trial about to begin where I live.
Should I or shouldn't I? That is the question since I don't like the odds much from standard tx but have pretty much been told I don't have much choice. Oh, and I'm 64 but in good general health. My VL is 3.5 mil and ALT/AST are slightly elevated but the rest of my stats are within normal ranges.
Any info would be greatly appreciated.
Thanks,

Karen

[cuteus]

these bottom threads are forgotten after a while, try the upper ones. Hep c is a very frustrating disease indeed!

[shads]

I am genotype 1 with a low viral load and stage 0-stage 1. What frustrates me most in deciding whether or not to treat is that neither the liver function tests nor the viral load tests are clear indicators of the state of your liver. You can have a
high AST/ALT and a low viral load. You can have a high viral load and normal liver function tests. You can have a low viral load and a scarred liver. You can have a high viral load and little or no liver damage. Additionally, some of us can only guess at when we were infected and so how quickly or slowly the disease is progressing.
I had a biopsy 8 months ago. If I were sure that my liver is still at 0-1, I might wait for more clarity on protease or NM283 or other treatments in clinical trials. I wish there were non-invasive procedures( the biopsy is expensive and can add to scarring) that could tell you every few months about the state of your liver. I saw at http://janis7.hepc.com/labs3.htm#blood%20tests that new tests are being developed but are still fairly experimental. If only we could have a monthly look at the liver and monitor closely the progression of the diseaes it would be easier to make a decision.
Does anyone know about new tests ot have more info about the tests mentioned on the janis site or any other thought or comments?

[fishdoc]

Greetings from the deep south.  I am a 48 year old female, and I found out in 93 or 94 about my Hep C. I have had two biopsies, and don't plan on having another. I have only had a couple of elevated enzymes results, by only a few points.  I have had this most likely 28 to 30 years.  I have decided I am going to try the treatment, I have "waited and watched" and it seems to me a 50/50 shot is finally worth the effort.  Plus, even though I have normal enzymes, minimal biopsy results, 600,000 viral load (the only time I had that done), type 1a, I have intermittent bouts of illness that I am fairly certain are related to the virus.  One question I have is related to insurance.  I have the opportunity in October of switching to another carrier, the current one I would have had to spring for a $2500 deductible, but the blue cross blue shield i am looking at has a "$35 dollar copay for mail in non generic prescriptions", with care mark as their pharmacy.  I am troubled by the fact that pegasys/copegasys is on the list of "requires approval".  I don't want to switch and then suddenly be told no.  Does anyone have any experience with that?  Second question, in looking at research, it seems like the best clinical results are the pegasys/copegasys brand.  Is this still true?

[iceboy]

What would I do without you guys. Thank you so much for responding. Jim, you put into words what I was trying to formulate with the shorter treatment plan. Sounds like a "very" intresting option you are talking about....... by the way, the doctor has not mentioned the European directive that allows 24 week treatment. I feel like I have to prepare my presentation of this plan.(and yes, you are assuming right, stage 0)

Like we know, this is a funky virus that behaves somehow differently in each individual, and so little is really known about it. Cutus, I totally forgot to ask for tests for the cryoglobulin. Im pretty convinced I have some sort of that going, and I have read that goes away with tx? (I have one old test with gamma-globulin over limit. does that have anything to do with cryo? Mike, it very scary thinking about this longer treatment. How is it, Im very thin, only 68 kg (I think 150 pounds?) I don

[cuteus]

and others with extra hepatic symptoms, you might want to add to your list of tests the cryoglobulin assay. If they are present, it can lead to vascular and kidney problems. Remember, HCV is not a liver disease only. If the test is negative and you can manage the aches with OTC, wait a year or so, to see where these trials are going. As you age, your svr chances decrease along with it. The effects of the tx are temporary in the majority of cases, as long as the anemia is controlled. Those temporary sides should not keep anyone from treating, unless they are ready to live in peace with the virus.