treatment

[janv83158]

My hepatologist told me that after the first few weeks on interferon and riba if I don't show a response there is another drug he will start me on that will increase my response rate to 70%. I asked why he wouldn't just start with that drug to begin with and he said something about insurance wouldn't cover it that way cause of something to do with it being approved of. My gastro Dr. never heard of any drug like that and told me that maybe because he was in a transplant center he had access to things that other Dr.s couldn't get yet. Has anybody ever heard of anything like what I just described. When I asked my nurse at the transplant center if they had access to newer drugs than other Dr.s may he said yes.

[T246]

Thanks Mike for the abstract, I have read it and others too.

Trinity, any benefit to your liver, SVR, or not is a benefit, give it a chance.

[Trinity4]

Thanks for the abstract.

I guess I'll find out whether that abstract applies to me or not as I will be having a biopsy in the fall, however, I'm still inclined to believe I'm pretty much where I was before treatment.

Trinity

[pennylanem]

If you see my answer I asked her timeframe not the 70% SVR. I am well aware that the odds with infergen are less than that. I figured it would be infergen because it sounds like treatment is starting soon and I didn't think PIs would be approved by then. I could be wrong.

[mikesimon]

This is a recent article that is relevant to the issue - though certainly not determinative.


Histologic outcomes in hepatitis C-infected patients with varying degrees of virologic response to interferon-based treatments.

Pockros PJ, Hamzeh FM, Martin P, Lentz E, Zhou X, Govindarajan S, Lok AS.

Scripps Clinic, La Jolla, CA.
Abstract

Patients with chronic hepatitis C with partial virologic response or nonresponse to interferon-based therapies can experience treatment-related improvements in liver histology. This retrospective analysis assessed the histologic response to treatment in patients with varying degrees of virologic response (sustained virologic response [SVR], breakthrough, relapse, or nonresponse), time to hepatitis C virus (HCV) RNA undetectability, and duration of viral suppression. Patients (HCV genotypes 1-6) with baseline and follow-up liver biopsies from eight phase 2 to phase 4 interferon-based trials were analyzed. Blinded biopsies were evaluated by a single pathologist. Improvements or worsening of METAVIR necroinflammatory activity and fibrosis were defined as increase or decrease of >/=1 grading category from baseline to 24 weeks after end of treatment. A majority of the 1571 patients with paired biopsy data were white, male, with HCV genotype 1/4, baseline HCV RNA levels >800,000 IU/mL, and baseline alanine aminotransferase levels </=3 x upper limit of the normal range; mean baseline activity and fibrosis scores were 1.8 and 1.7, respectively. Overall, 80% of patients received peginterferon alfa-2a monotherapy or peginterferon alfa-2a/ribavirin combination therapy. Mean treatment duration was 46 weeks. There was a positive correlation between the degree of virologic response and improvements in METAVIR activity and fibrosis, and an inverse correlation with worsening activity and fibrosis (all comparisons, P < 0.0001). Patients with SVR had the greatest histologic benefit. As a combined group, relapsers and patients with breakthrough had significantly greater benefits than nonresponders (activity, P = 0.0001; fibrosis, P = 0.003). Consistent with these results, a better histologic response was correlated with a shorter time to undetectable HCV RNA and a longer duration of viral suppression (all comparisons, P < 0.0001). Conclusion: In patients with chronic hepatitis C who were treated with interferon-based therapies, histologic benefits may be observed even in the absence of an SVR. (HEPATOLOGY 2010;).

PMID: 20658462 [PubMed - as supplied by publisher]

[Trinity4]

"  If you treat and eventually relapse you still will have given your liver a year away from the virus which is enough time to reverse a lot of damage to the liver. "

I don't think one year on antiviral therapy is enough time to reverse "a lot" of damage to liver.  Perhaps no further damage to the liver.  Once we become SVR the liver will start to repair itself but even that takes a certain amount of time.

Do you have a study that supports a lot of damage to the liver is repaired during a 48 week course of antiviral therapy?

Trinity

[T246]

Decision to treat is up to the individual.  If you are undet at week 4 it increases predictability you will clear the virus, but it doesn't mean you cannot clear If you are not detectable until 12 weeks, or shortly thetreafter.  If you treat and eventually relapse you still will have given your liver a year away from the virus which is enough time to reverse a lot of damage to the liver.

I have two injections left and will stop TX at week 64.  I have no regrets SVR, or not.
Good luck

[desrt]

If it's simply an insurance issue, another possibility is Alinia, since it's still considered an 'off-label' use, though it's generally predosed and I've never heard a "70%" stat quoted for g1.

[Bill1954]

Oops, I see this has been covered already. I started this comment an hour ago, and only just now hit the post button.

Bill

[Bill1954]

You’re doctor might have been referring to ‘Infergen’; this is a form of interferon now available that is labeled for non-responders. It has actually been available since the late 90’s, and while some folks respond readily to it, it does have drawbacks including a rather rough side effect profile, daily as opposed to weekly injections, etc. Here’s a quick link to the drug:

http://www.infergen.com/

It's very likely insurance would require other forms of therapy to be tried first before they'd consider covering it.

Good luck—

Bill

[Trinity4]

Infergen doesn't increase the odds of SVR to 70%.  Currently, the PI's are the only drugs which have shown 70% odds of SVR.

Trinity

[pennylanem]

If you are treating soon (as in this year) and he says that he'll switch you I suspect he may be talking about infergen and ribavirin. Infergen is reserved  for people who have failed prior treatment. I failed pegintron and ribavirin 8 years ago and am retreating with infergen now. otherwise, if he meant protease inhibitors, those are not yet approved by the fda the only way to get it is through a clinical trial right now.

[pcds]

Your doctor is right on.  If you are geno 1, unless you have a rapid response to tx in first 4 weeks, I would not continue.   Tx is tough and success with current SOC is poor.  So your doc is saying wait for the new stuff.  Many people are not going into treatment today bec success is not good and treatment is bad for your health, not to mention 48 wks vs 24 wks. The new stuff will here in 2011, second half.  All the trials are completed.
Judy

[janv83158]

My Dr. knew I was getting ready to start tx in the next few weeks. I can only tell you for sure that he said it's something he can't start with cause of insurance and that he would use it if in a few weeks I wasn't responding, but we were referring to now not next year and we also had already discussed the inhibitors that weren't out yet of which he told me that at stage 3 grade 3 he wants me to start now and not wait cause even though they say next year it could be lots later than what we are hearing before they are available. I go in Wed. to learn about the injections and I will ask again and post what he tells me.

[Trinity4]

There are no new drugs available yet.  I'm sure your doctor was talking about the protease inhibitors which are in the process of finishing up the trial phase but have not yet been approved as part of the standard of care to date.  Approval of Telaprevir and Boceprevir are expected sometime in 2011 but are we are not certain of that yet.

If you are not planning on treating until next year what your hepatologist told you may be a very good plan because the addition of a protease inhibitor along with interferon and ribavirin does does increase the odds of SVR for geno 1 from 45 percent to 70 percent in most cases.

Trinity