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238010 tn?1420406272

Slow responder SVR w/less than 72 weeks?

I was wondering if there is anyone in the community who achieved SVR who was a slow responder but did less than 72 weeks tx.  My doctor said she wants at least 36 weeks of tx beyond getting und.

So, if a person goes und at say week 16, he/she would do 52 weeks of tx, not 72.  Thoughts on the pros and cons of  this approach?

smaug
15 Responses
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Avatar universal
interesting to see some treating/treated essentially by adding 48 weeks to undetectable.
This makes the most sense to me when looking at all the studies as a whole. If one considers worse case senerio of clearing at 24 weeks and adding 48 weeks to that number....bingo-72 weeks. If one considers Drusano's,Berg's and Lindh's models, all leaning toward exponential, individual treatment, fills that criteria also. If one weighs in Berg's and Lindh's studies concluding there could be improvement to the Drusano models, again, +48 past undy could apply.
So, right or wrong, I could sleep at night treating 48 weeks past undectable, whether undectable comes in 6 weeks like Jim or 19 weeks like Bigfloyd.
Helpful - 0
Avatar universal
Drusano is not the devil and Berg/Tapias is not the holy grail :)

What your doctor actually said was they want AT LEAST 48 weeks past UND. That is quite different from saying they want 48 weeks past UND, no matter what.

No doubt the exact number will be arrived at based on when you actually become UND, and your side effect profile as treatment moves on.

As Proacive suggests, there is nothing magic in the number "72" and to think that the virus somehow disappears at 71 days 11 hours ...Nor is 72 weeks "optimum" in the sense that more time wouldn't give even better results. No studies beyond that time I am aware of.

The other thing to keep in mind is that the 72 week studies cited used fixed-dose (800 mg./day) ribavirin and not the weight-based that most of us treat with now.

Drusano, like Tapas are simply tools/guidelines that are available to a good clinician to bang out the best/reasonable results in a given case. My treatment doc, for example, had me treat for 54 weeks, which was his tweak on Drusano given my age and level of fibrosis. He added 48 to 6 (week UND), insead of adding 36. In his eyes, had I been younger, with less Fibrosis, he probably would have suggested 42 weeks. And no doubt, had I not been UND by week 12, my hunch is he would have scrapped Drusano and jumped to 72-weeks. Again, taking whatever tools out of box that seemed best in an indvidual case.

-- Jim

Helpful - 0
238010 tn?1420406272
Yes, I certainly don't like the thought either. I may or may not be undetected by week 12, but I am resigning myself to the thought that I'm doing 72 weeks.  

Like Mouse said, doing 72 the first time sure as heck beats doing 48 and then another 72.  Seems like giving it the best shot the first time makes sense.

smaug
Helpful - 0
Avatar universal
You must have posted shortly after I did. I think your 411 went a long way to understanding why the powers that be have decided that I need to undergo the 72 week regimen when I was UND at 12 weeks. Understanding doesn't mean I'm liking the thought much though!  :  (

Thanks for the 411!!!
Helpful - 0
Avatar universal
Hey! I gotta check out your link! This paper is from my former home town. Magnus Lindh is actually the doctor I mentioned above who suggested I should add 4-8 weeks! Wejstål is my old doctor, Lagging is the present doctor of my ex! Will be interesting to read what the Swedes have to say about this.
Helpful - 0
Avatar universal
It's the simplicity of just adding 36 weeks to UND I react to. So if I am UND by week 15, my tx would be just 3 weeks longer than everybody else's. If UND by week 20, it would be 8 weeks longer.

But yes, there is simplicity in adding 24 weeks to SOC as well. Maybe that is why extended tx has a greater success rate the lower viral load you have at week 12. In the Berg study 6000 IU/ml at the most is suggested. In a magazine article by Berg: 30'000 IU/ml. I have seen comments suggesting that high viral loaders at week 12 probably will not make it, but that there have been no studies to back this up yet, so (as long as they are UND by week 24) they are letting them go for extended tx until proven otherwise.

How is your day today? Wonderful, right? First med free day in 505 days!
Helpful - 0
254544 tn?1310775732
Do the 72 weeks if given the option.  I'm on my second round of treatment and am going 72 weeks this time.  I did 48 the first time and really wished I had done 72.  Back to back treatments kinds of suck so ya should really consider going as long as you can the first time.

Just my 2 cents.

Mouse
Helpful - 0
238010 tn?1420406272
Thanks for the input, much appreciated!  (Still hoping to be und by week 12 so that this discussion will be moot for me, though.  I'll find out in April.)  

Pro, zazza, and nygirl, thanks especially for pointing to specific studies, will check them out during spring break next week.  Nygirl, I never heard of hep c tx being associated with going for the gusto before!

Pro, congratulations on taking the last riba!  Looking forward to hearing good news in the coming months.

Bigfloyd, thanks for the update.  Please let us know how things go for you.

smaug
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Avatar universal
I went UND between 15 and 19 weeks and I am going an additional 48 weeks for a total of 67. 10 more shots to go. 1A
BF
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Avatar universal
"Mathematical model" but all these extended treatment studies are mathematical models to some extent,extrapolated from either in house study data or borrowed results of patient data from other studies, even Berg's. While the quote you provided above does speak of an exponential course of treatment, it does suggest a 24 week extension..Both models (and the Lindh et al study I linked above) pretty much come to the conclusion of an exponential model based on a multi-phase viral slope decline, with more significance on the 1st phase and baseline vl as main predictors. Summed up- 24 weeks(super early responder), 48 weeks soc,36 weeks past undy or 72 weeks total, I've yet to hear of anyone treated outside this criteria for geno 1's, but I guess it is more exponential than linear. Well, I finished my last 4 riba this morning and on that note will take a break for awhile...;^ )pro
Helpful - 0
179856 tn?1333547362
What is happening is your doctor is following the "older" study that was done that said 36 would work. The same exact Doctor, Dr. Jacobson, was ALSO involved in Berg and interpreting Sanchez Tapias and he is now disregarding the first UND + 36 older information.

Can someone SVR with less? Sure. The odds aren't as good but they could. OF course anything is possible.

But the fact is that we do the full 72 to get the BEST most OPTIMUM chance of getting SVR. That's what I did and it worked.

My own GI had no idea about the newer studies until I showed him. Then I went to Dr. J and he called my doctor and explainned them to him. Doctors need to keep up learning what new studies have been done and how the new courses of treatment are going. It's a shame that some of them (like yours) will listen to the old information because they just haven't read the newer info and then they pass it on to you.

I'd print out the studies and give them to your doctor asap. Heck you don't want to do this tx again do you - do it once and go for the gusto!

By the way Dr. J told me that there was NO basis to believe that doing 60 weeks would change the odds any. (I had wanted to do 60) he said it's 48 or 72 and that is it. So...I did the 72.
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Avatar universal
When I was detected with a borderline value in week 12, I went for a second opinion. This doctor told me to add 4-8 weeks to SOC. But I had read on the forum about 72 weeks, so I started doing research and reading about extended tx.

Here is a quote from the Berg study which made my mind up that the Drusano model (adding 36 weeks) was of no interest to me:

"Drusano and Preston recently presented a mathematical model to predict whether patients may achieve SVR or suffer from relapse. It was concluded that type 1-infected patients require the continuous abscence of detectable HCV RNA in serum for 36 weeks to attain 90% probabilities of an SVR (ie, relapse rate of 10%). We agree only to some extent with this predictive model, realizing that our week-12 rapid virologic responders who were HCV-RNA negative for at least 36 weeks also had low relapse rates (= or < 15%). However, group B late responders who first became HCV-RNA negative at week 24 (ie, who also had undetectable HCV-RNA levels during the last 36 weeks of the total 72-week treatment period) still had relapse rates of 40%, a finding that clearly contradicts the proposed Drusano and Preston model. Obviously, the HCV-RNA negative phase required to prevent a relapse must be calculated in a more exponential way and seems to be dependent on how early a patient becomes HCV-RNA negative during treatment."

(Berg 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)

"Mathematical model"! I am not going to follow a "mathematical model" unsupported by studies, and I don't expect the virus to either! I do love math, but this is my limit.

"Obviously, the HCV-RNA negative phase required to prevent a relapse must be calculated in a more exponential way and seems to be dependent on how early a patient becomes HCV-RNA negative during treatment."

I have read other quotations of Berg where he puts out the thought that if one is detectable at week 12, this suggests that your hepatocytes (liver cells) tend to live longer than usual and this is why one has to calculate in an exponential way the amount of extension needed. One cannot just add 36 weeks and think one is done. If one is going to bother to extend at all, why not go the full distance. Of course, 60 weeks COULD be enough, but who knows? Not I. I am not willing to put my bet on a shortcut in this matter. Even doing the full 72-week course is uncertain enough to me.
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Avatar universal
There are number of studies suggesting if not clear at 12 weeks (but did obtain a 2 log drop in vl), and clear before  24 weeks to extend treatment to 72 weeks (main studies are from Berg, Sanchez, pubmed docs etc.)
  I've read as many of these studies as I could find, and one interesting fact is, I have never been able to figure out how the "72 week" number was arrived at scientifically..Seems to simply be based on 48 weeks past the worse case 24 week cut off.
There is another train of thought based on a study done by Drusano (he's over in Albany) suggesting 36 weeks past und as your NP suggests..
http://jcm.asm.org/cgi/reprint/45/8/2439.pdf
I cleared before 18 weeks and was slated to go a total of 54 (18+36). My decision to push for 72 was really based on my feeling of hey, if I'm going to have to do 54 weeks anyway, I might as well do the 72 weeks..
But understand, many insurance companies will fight you tooth and nail on the extension, considering 48 weeks to be standard of care.
Best of luck, and hope your treatment is going well (as well as can be expected(g))
Helpful - 0
Avatar universal
yes, people have been cured as a poor responder with 48 weeks. they got lucky,
the odds were against them. more is better, go as long as you can  to increase your
odds. depending on circumstances, docs recommend all different timing formulas.  the
obvious ones are  6 months of und,   9 months of und,  and  1 year of und.  most 72
people will end up with 1 year of und.  i made 45 weeks of undetectable.
Helpful - 0
362971 tn?1201987034
  I had a neighbor that was a slow responder and she achieved SVR about 7 years ago with the old Interferon that you took 3 times a week along with the Ribavirin. She didn't have too much damage as she only had it for 5 or 10 years. She wa a slow responder and treated for 48 weeks. She is still SVR 7 years later. So you never know.

Bobby
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