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233616 tn?1312787196

to JMJM 530---Jim, your doctor advocates xtra log tx

Hi Jim, could you please elaborate on whether your doctor still advocates for 2 yr tx for those with more liver damage?

If you know of the studies he based this on they would be much appreciated.

many thank, as always,

mb
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233616 tn?1312787196
here's that study I referenced 2 posts ago....very exciting stuff, don't you agree?

I realize only 9 SLRs completed the ext. tx, but ALL of them SVR'd. That spell hope in anybodies language.

http://www.jstage.jst.go.jp/article/internalmedicine/47/14/1301/_pdf


also shiffman has changes his mind as well, and recently had something to say:

By: Mitchell L. Shiffman, MD
Source: New Management Strategies for HCV Nonresponders and Relapsers

"Three recent studies have now demonstrated that relapse can be significantly reduced in slow-to-respond genotype 1 patients—those who achieve undetectable HCV RNA after Week 12—by extending the duration of treatment from 48 to 72 weeks.[8-10,20] In each of these studies, the relapse rate was reduced from more than 50% to less than 20%. Two of these studies suggest that this benefit may be less or nonexistent in patients with higher HCV RNA levels at baseline and at Week 12.[8,9] However, these observations will need to be confirmed in future studies before these patients are not considered for treatment extension. Therefore, for now it appears that prolonging the duration of therapy will increase SVR rates in patients who are slow to respond and should be routinely practiced".

8. Sanchez Tapias JM, Diago M, Escartìin P, et al. Peginterferon alfa2a plus ribavirin for 48 versus 72 weeks in patients with detectable hepatitis C virus RNA at week 4 of treatment. Gastroenterology. 2006;131:451 460.

9. Berg T, von Wagner M, Nasser S, et al. Extended treatment duration for hepatitis C virus type 1: comparing 48 versus 72 weeks of peginterferon alfa 2a plus ribavirin. Gastroenterology. 2006;130:1086 1097.

10. Sanchez-Tapias JM, Ferenci P, Diago M, et al. How can we identify HCV genotype 1 patients who may benefit from an extended treatment duration with peginterferon alfa-2a (40KD) plus RBV? Program and abstracts of the 42nd Annual Meeting of the European Association for the Study of the Liver; April 11-15, 2007; Barcelona, Spain. Abstract 641.

20. Ferenci P, Laferl H, Scherzer TM, et al. Customizing treatment with peginterferon alfa-2a (40KD) (Pegasys) plus ribavirin (Copegus) in patients with HCV genotype 1 or 4 infection: interim results of a prospective randomized trial. Program and abstracts of the 2006 Annual Meeting of the American Association for the Study of Liver Diseases; October 27-31, 2006; Boston, Massachusetts. Abstract 390.


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Avatar universal
Yes, many of the studies did use 800 mg of riba, and that must be factored in. That said, I believe other studies used weight-based. But frankly, since I've stopped treating, I'm not is up on the studies as I used to be. And the studies just keep rolling in.

But all said, he decided to continue on, and at this point you really just have to figure out for how long. As stated, either 72 or 78 weeks makes as much sense as anything else. Assuming of course, that you have remained undetectable. Don't know when your last viral load test was, and I know they could be costly, but may be time to throw one in now. From one phone call I made, it appears that at least some labs may be negotiable as to the prices they charge, especially if they know you are paying out of pocket. Whatever you end up negotiating, is still probably more than they get from the insurance companies who only pay a percent on the dollar.
Helpful - 0
233616 tn?1312787196
here's one study that showed a 20% increase in SVR with ext. tx. in co-infected HIV patients.

http://www.natap.org/2006/ICAAC/ICAAC_58.htm
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Avatar universal
Did you have a to log drop at week 12? Been some controversy here surrounding that. Number of studies suggesting that even 72 weeks will not help. And then a more recent one I believe suggesting that extending might help. But in any event, given the fact that you were undetectable between 12 and 24, 72 weeks sounds about right -- but personally I see no problem with 78 weeks if you can tolerate the drugs. As to the hundred percent SVR figure, I vaguely remember that study and a lot but not make sense. 100% is a guarantee and there are no guarantees with SVR. Possibly a very small sample size. Don't want to be negative, just realistic.
Helpful - 0
233616 tn?1312787196
I'll post the study I was referencing in a minute, but wondered what's your opinion of this one. I believe it is now fatally flawed in that in only used 800 Riba throughout the study, and since 1200 is now SOC we need to throw this study to the wind, the numbers and differences are bound to be less or non-existance if one drug is reduced by 1/3.
What do you think?

Optimizing Outcomes in Hepatitis C: Is Treatment Beyond 48 Weeks Ever Justified?
Robert J. Fontana
Gastroenterology
April 2006 (Vol. 130, Issue 4, Pages 1357-1362)
Full Text | Full-Text PDF (103 KB)  

Background & Aims: The treatment of patients infected with hepatitis C virus (HCV) type 1 remains a challenge necessitating innovative strategies to improve treatment outcome. The extension of treatment duration beyond 48 weeks is one possible strategy to address this problem. Methods: The efficacy and safety of 48 weeks (group A, N = 230) vs 72 weeks (group B, N = 225) of treatment with pegylated–interferon-alfa-2a (180 μg/wk) plus ribavirin (800 mg/day) were studied in treatment-naive patients with HCV type 1 infection. On-treatment and sustained virologic response (SVR) 24 weeks after stopping treatment was assessed by qualitative reverse-transcription polymerase chain reaction (sensitivity 50 IU/mL). Results: Overall, no significant differences could be observed in the treatment outcome between both groups. End-of-treatment and SVR rates in groups A and B were 71% vs 63% and 53% vs 54%, respectively. Patients with undetectable HCV-RNA levels already at weeks 4 and 12 had excellent SVR rates ranging from 76% to 84% regardless of treatment group, whereas patients shown to be still HCV-RNA positive at week 12 achieved significantly higher SVR rates when treated for 72 instead of 48 weeks (29% vs 17%, P = .040). A particular benefit from extended treatment duration was seen in patients with low-level viremia (<6000 IU/mL) at week 12. The frequency and intensity of adverse events was similar between the 2 groups. Conclusions: Extended treatment duration generally is not recommended in HCV type 1 infection and should be reserved only for patients with slow virologic response defined as HCV-RNA positive at week 12 but negative at week 24.
mb
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233616 tn?1312787196
no I became undectable somewhere between 12 and 24.  Unfortunately it took my doctor time to warm up to my twenty questions and studies in hand approach to my disease.
He kind of got fed up with me wanting the more expensive PCR's not done in his lab and also I ended up insisting for the tenth time that my doc do a HIDAScan and that GB had to come out.

So my hep guy concluded let's not do a monthly for the next 3 months, "you are much too focused in on that, and  it's not the only thing going on. We'll evaluate you at 6 months, and then continue out to 72 if you are UND then." that;s a quote

Right then I was in so much paid from the GB I didn't feel like arguing with him.

trouble is, now I'm stuck not knowing...did I clear at 16 or 24. Chances are it's closer to 16 because I was down to 50,000 at 12 wks.  But we don't know for sure, so now he says we will split the difference (assume I was und at wk 18.
Thats an important number to me BECAUSE of the study showing 100% SVR of Super late responders when treated out >60 wk beyond going under.

I think it's very signifigant that even though it was not my genotype (the study was type 1b, and I'm 1a)  YET STILL the super lates treating out had 100% SVR vs. the 90% average for the group!!!  

So in other words the best arguement I can find for going out 78 vs. 72 wks is that those who did had the highest rates of SVR....Higher than even the earliest responders.
I find that fact to be unusually signifigant, but am still looking for other studies that might also support similar findings.

guess I'll just have to get by boolean hat on and go back to work.

mb
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Avatar universal
fourth and fifth paragraphs should read in part...

There is also the older DRUSANO model, which some doctors still use and/or modify

If I remember correctly, you may have become UNDETECTIBLE  after week 24.
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Avatar universal
I think you may have confused a few things that I've said. My doctor does not advocate two years treatment for those with more liver damage.

What I have said, is that my doctor often treats longer patients who have either more liver damage or who are older. So in my case, because I fit both of the criteria, we therefore we came up with a plan to treat 54 weeks which happened to be 48 weeks after I became undetectable. On the other hand, my nurse practitioner, only thought I needed 48 weeks. Two other consulting hepatologist agreed with her. This study literature is mixed, but also seems to agree that 48 weeks is adequate as long as there is a good viral response.

What you may have read from me, is that there is another doctor, who used to be quite popular on the Internet, who routinely recommends two years of treatment for those stage III or four, regardless of viral response. I disagree with that approach as I'm sure my doctor does, as I'm sure most liver specialists do.

What the studies do show, is said Geno one slower responders need to treat longer than 48 weeks. How much longer can get complex, but one commonly used formula is to treat 72 weeks if undetectable between weeks 12 and 24. There is also the older to some of model, which some doctors still use and/or modify

If I remember correctly, you may have become on the technical after week 24. If this is the case, then you're outside of most study guidelines in terms of how long to treat, although someone did post a study a month or so ago which dealt with even longer treatments -- longer than 72 weeks I mean -- for very slower responders. Maybe someone can dig up those studies for you. As as I'm sure you know, most studies suggest you stop treatment if still detectable at week 24.

I don't know how much liver damage you have, but if your liver damage is not significant, I would weigh a very extended treatment approach against the risks of long-term exposure to the treatment drugs. Also, you should probably be getting very sensitive monthly viral load tests to make sure there are no breakthroughs along the way.

All the best,

Jim

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Avatar universal
I havent seen any studies that have treated for 2 years.

This decision should be based on when you became UND as much if not more so than the degree of damage

CS
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