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How bad is 1b?

How bad is 1b?
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264121 tn?1313029456
I was a 1b acute patient who cleared after treating acutely for 6 1/2 to 7 months.
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Avatar universal
No, it is 2 of 55 patients who SVR with 48 weeks and 6 of 54 patients who SVR with 72 weeks. That is 8 out of 109 patients, which equals an SVR rate of 7.3% if you choose to lump all patients with less than a 2-log decrease at week 12 together regardless of tx duration.

2 of 55 equals 3.6% which Berg rounds off to 4%.
6 of 54 equals 11.1% which Berg rounds off to 11%.

What is more interesting to me is that actually 26 out of these 109 patients, which equals 23.8%, had an EOT response and thus might have a shot at SVR either with long enough tx or, which is probably to prefer, in the future with the new drugs coming.
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Avatar universal
==
(From Berg) Only 26 of the 109 patients with a less than 2 log10 decrease at week 12 (24%) achieved an end-of-treatment virologic response. The relapse rates in these 26 end-of-treatment virologic responders was 87% (13 of 15 patients) when treated for 48 weeks (group A) and 46% (5 of 11 patients) when assigned to 72 weeks treatment(group B)."
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Zazza: No, I don't come up with the same figures. I think the mistake you are making, Jim, is that 109 patients is both tx groups added together (55+54).

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But the above quote clearly states that only 26 out of the 109 non-responders had EOT and then it whittles that figure down with the high relapse rate from 26 to 6 who were SVR. That then means that only 6 out of 109 non-responders (less than two logs at week 12) were SVR. That equals 5.5%. Perhaps someone else who has read the study and is mathematically inclined will chime in.
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Avatar universal
Actually, my last sentence should end with "AT LEAST a 54% SVR rate instead", since we actually don't know if all the EOT responders were UND already by week 24.
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Avatar universal
"Only 4% of patients with a less than 2 log10 HCV-RNA decrease treated for 48 weeks achieved an SVR whereas in patients treated for 72 weeks the SVR rates reached 11%."
"SVR rates...in those without a 2 log10 decrease were 4% (2 of 55 patients) and 11% (6 of 54 patients), respectively"

No, I don't come up with the same figures. I think the mistake you are making, Jim, is that 109 patients is both tx groups added together (55+54).

What I am thinking is that the reason for the difference between the 11% SVR rate for these "less than 2-log decrease at week 12" patients with 72 weeks and the 46% relapse rate for the same group, is that the SVR rate was heavily reduced by non-responders who never became UND and thus never relapsed, and could have been picked off tx by week 24. So for the patient UND by week 24 and then successfully completing 72 weeks without a breakthrough, that would mean a 54% SVR rate instead.
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179856 tn?1333547362
I had 1a and 1b at the same time and cleared them both and have been SVR for almost two years.

I had a three log drop by week 4 but did not clear until between 12 - 24.  Had I not had a two log drop I doubt that I would have continued treatment (DEFINITELY would not have if I was still detectible at week 24) but as I did I chose to extend to 72 weeks.

Even though we study Berg it is not the definitive tell all end all for every person involved in treatment Sanchez Tapias neither.  This disease has no hard fact rules to go next to it and alot of treatment decisions need be tempered by someones desire to get rid of it and what they are willing to do.

Unfortunately there are no guarantees - no matter how many times you want to look at the data.  It's still a crapshoot.  It depends on how much you like to gamble what your decision are and the rest.............you just have to wait and see.


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Avatar universal
Yes, but given the high relapse rate (46%) on the 26% who did not get a two-log drop, you only come up with a 5% SVR rate in the 72-week group. Is that the figure you also come up with? Because if so, the quote in "Berg A" doesn't make sense.
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Avatar universal
I am diving in from the deep end here to try to understand how Berg came up with his conclusion that it would make sense for people who did not have a 2-log drop at week 12 to treat. And by the way, both excerpts above ARE from the same paper.

I find it logical to assume that the 26 patients with less than a 2-log drop at week 12 who achieved an EOT virologic response probably also were UND by week 24, and that the majority or perhaps all of the 83 patients with less than a 2-log drop at week 12 who did not have an EOT virologic response still were detectable at week 24.

I wonder how many of these 26 patients had a viral load of less than 30'000 IU/ml at week 12. I am presuming that at week 24 they were all UND. With 48 weeks of tx these patients only had a 13% SVR rate, but with 72 weeks of tx they had a 54% SVR rate.

54%! Some geno 1s might find that SVR rate worth treating for, especially if their liver calls for a tx sooner than later.

My thinking is that MerryBe on this forum actually fits in this group. Berg's thinking would put some logic in her continuing to treat. I am not sure, but I do think she did not have a 2-log drop by week 12? But was UND by week 24? And she is now doing 72 weeks.

There have been others on the forum who did not have a 2-log drop but also were not UND by week 24, and still continued to treat. I don't think any of them has had any success with reaching SVR.

So I understand it to be that Berg suggests that if you have less than 30'000 IU/ml at week 12, and become UND by week 24, you might want to consider tx'ing for 72 weeks even if you did not have a 2-log drop by week 12. Berg seems to think that the 2-log rule only applies to 48 week tx.
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Avatar universal
Berg A: "..."Our study also raises the issue of whether the generally accepted stopping rule for patients with a less than 2 log10 decrease of HCV-RNA level within the initial 12 weeks of therapy should be reconsidered because the high negative predictive value of this stopping rule of 98%-100% could be confirmed only for the 48-week treatment group but not for the 72-week..."
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Berg B: (From Berg) Only 26 of the 109 patients with a less than 2 log10 decrease at week 12 (24%) achieved an end-of-treatment virologic response. The relapse rates in these 26 end-of-treatment virologic responders was 87% (13 of 15 patients) when treated for 48 weeks (group A) and 46% (5 of 11 patients) when assigned to 72 weeks treatment(group B)."
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How many Berg papers do you have and what is the most recent. Berg (A) seems to contradict Berg (B). My analysis was based on Berg (B).
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Avatar universal
Zazza,

I came up with an SVR rate of around 2% for non-responders who treated for 48 weeks and an SVR rate of around 5% for non-responders who treated for 72 weeks. Based on this, I can understand why even extended treatment is not recommended for those who do not have at least a two-log drop at week 12.

For discussion's sake, I'm defining a non-responder as someone who did not make a two-log drop by week 12 but was UND at week 24. Hopefully, someone with a reasonable serum sugar level will double check as mine may not be from a double desert tonight :)

Here's my partial worksheet based on what you just posted, exerpt at the bottom:
---------------
(109)  non-responders (NR) i.e. had  less than 2 log drop at week 12
(26)  NRs had EOT response
(13) EOT responders relapsed (.87) in the 48 week group meaning (2) achieved SVR
(5) EOT responders relapsed (.46)  in the 72 week group meaning (6) achieved SVR
(2) out of the 109 were SVR when treated for 48 weeks
(6) out of the 109 were SVR when treated for 72 weeks

===========
(From Berg) Only 26 of the 109 patients with a less than 2 log10 decrease at week 12 (24%) achieved an end-of-treatment virologic response. The relapse rates in these 26 end-of-treatment virologic responders was 87% (13 of 15 patients) when treated for 48 weeks (group A) and 46% (5 of 11 patients) when assigned to 72 weeks treatment(group B)."
========================
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Avatar universal
At week 24, check if UND and in that case go 72 weeks.
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Avatar universal
Berg again:
"Our study also raises the issue of whether the generally accepted stopping rule for patients with a less than 2 log10 decrease of HCV-RNA level within the initial 12 weeks of therapy should be reconsidered because the high negative predictive value of this stopping rule of 98%-100% could be confirmed only for the 48-week treatment group but not for the 72-week group. Only 4% of patients with a less than 2 log10 HCV-RNA decrease treated for 48 weeks achieved an SVR whereas in patients treated for 72 weeks the SVR rates reached 11%. We further could confirm that the previously proposed stopping algorithm based on absolute HCV-RNA levels at week 12 (ie, less than 30'000 IU/mL) was highly predictive for nonsustained response in both groups."

I can see in another paper I have by Berg that he there also talks about continuing tx until week 24 as long as the viral load at week 12 is not above 30'000 IU/ml, no mention of a 2-log drop. Interesting, huh?
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Avatar universal
Anyone interested in reading the Berg study yourself, just send me a PM with an email adress and I will send it to you.
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Avatar universal
Found something interesting here (I am getting dizzy of all the numbers and different patient groups so I will just quote it.):

"HCV-RNA Log10 Decrease at Week 12 as a Measure of EVR
In contrast to absolute HCV-RNA levels, HCV-RNA log10 decrease at week 12 was less useful to identify patients who eventually may benefit from extended treatment duration. SVR rates in patients with EVR defined by a 2 log10 or more HCV-RNA decrease at week 12 was 68% (119 of 175 patients) in group A and 67% (115 of 171 patients) in group B, and in those without a 2 log10 decrease were 4% (2 of 55 patients) and 11% (6 of 54 patients), respectively. Only 26 of the 109 patients with a less than 2 log10 decrease at week 12 (24%) achieved an end-of-treatment virologic response. The relapse rates in these 26 end-of-treatment virologic responders was 87% (13 of 15 patients) when treated for 48 weeks (group A) and 46% (5 of 11 patients) when assigned to 72 weeks treatment (group B)."

I think I have to revise my statement in my post above:
"To find out the SVR rate for those with "SLOW VIROLOGIC RESPONSE (HCV RNA GREATER OR EQUAL TO 50 IU/mL) AT WEEK 12 BUT LESS THAN 50 IU/mL AT WEEK 24" I figure one can use the relapse rates for said groups, i e with a relapse rate of 64% with 48 weeks the SVR rate would be 36%, and with a relapse rate of 40% with 72 weeks the SVR rate would be 60%. I don't know why they almost never state the SVR rates for slow responders, only the relapse rates.

This just goes to show, always try to get hold of the studies you read about here on the forum and read them yourself before making final treatment decisions. There are so many factors involved, it is difficult to sort things out and easy to mix them up when trying to relate what one has read.
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Avatar universal
It was a while since I read the entire Berg study myself. Looking at a graph of the trial profile I can see that 175 out of 230 patients completed 48 weeks, and 133 out of 225 patients completed 72 weeks. Patients were listed under therapy discontinuation because of adverse events, lost to followup, therapy failure, voluntary withdrawal, breakthrough and "other reasons". Therapy failure and breakthrough would be the non-responders I presume, i e 26 out of 230 in the 48 week-group and 42 out of 225 in the 72 week-group.

To find out the SVR rate for those with pEVR and UND by week 24 I figure one can use the relapse rates for said groups, i e with a relapse rate of 64% with 48 weeks the SVR rate would be 36%, and with a relapse rate of 40% with 72 weeks the SVR rate would be 60%. I don't know why they almost never state the SVR rates for slow responders, only the relapse rates.

Just to define the terminology, the term non-responder I take to include null responders, patients with a 2-log drop at week 12 but not UND by week 24 = partial responders, and patients with breakthrough.
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Avatar universal
OK, then we're in fundamental agreement. Did Berg break out the extended treatment SVR figures for both pEVR group and what we might term the non-responder group (less than two-log drop by week 12) ? I did notice that in some of the papers the pEVR group is said to have done better than the non-responders as if to suggest that the non-responder group should continue treating for some chance of SVR that is not given. Then, there are papers  like from Shiffman (where we both apparently agree) that non-responders should stop at week 12. A real minefield of information that I'm glad I didn't have to walk through in my treatment but which really must be carefully searched if someone in that position  is to make an intelligent decision.

As to the Berg study you sent me, if you took one look at my livingroom today you would understand why certain things may not be as accessible as they should be :)


-- Jim
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Avatar universal
The first paragraph in my post above should read:
I completely agree that those with less than a 2-log drop at week 12 should stop tx. I am just pointing out that the non-responders are included in the total patient group OF THOSE STILL HCV-RNA POSITIVE AT WEEK 12 in the Berg study where the SVR rate is 29% for 72 weeks versus 17% for 48 weeks, i e 17 % is not "a 48-week figure for EVRs
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Avatar universal
I completely agree that those with less than a 2-log drop at week 12 should stop tx. I am just pointing out that the non-responders are included in the total patient group in the Berg study where the SVR rate is 29% for 72 weeks versus 17% for 48 weeks, i e 17 % is not "a 48-week figure for EVRs".

Look at the graphs on page 1092 of the Berg study. (I know you have it, since I sent it to you myself.:)) Confusingly enough, on these graphs Berg defines EVR as "being HCV-RNA negative by qualitative PCR test (detection limit, 50 IU/mL) at week 4 or week 12". The terms I prefer to use to avoid confusion are RVR (for UND at week 4) and complete EVR (cEVR) (for UND at week 12). The percentages mentioned in the above paragraph are for those with "no early virologic response (HCV RNA greater or equal to 50 IU/ml) at week 12". This includes non-responders.
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Avatar universal
Unless I'm reading it incorrectly, the analysis/conclusion of the study which you provided a link for in "Willful's" thread, concludes that those without a two-log drop at week 12 should stop treatment. They only recommended extension for those with what they termed "pEVR" which was defined as detectible virus at week 12 but under two logs. Couldn't copy the word since it's a PDF file but it's the last few paragraphs on page 3.
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Avatar universal
"...patients who still were HCV-RNA positive at week 12 showed significantly higher SVR rates when treated for 72 weeks instead of 48 weeks (29% vs 17%)."
(Berg et al: "Extended Treatment Duration for Hepatitis C Virus Type1: Comparing 48 Versus 72 Weeks of Peginterferon-Alfa-2a Plus Ribavirin"

The above numbers actually include those who did not have a 2-log drop by week 12. That is why those EVR week 12 and UND week 24 instead should concentrate on the relapse rates for 72 and 48 weeks for their particular patient group. In this study those numbers are 40% for 72 weeks and 64% for 48 weeks. That is a 37.5% decrease in relapse rate by extending. So worth it to me.
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Avatar universal
HCA
1b is the same as 1a in terms of treatment.
All genotypes are the same in terms of disease progression.
I did see some studies years ago that gave a worse prognosis for 1b in terms of  treatment response and progression, but nothing recent.
Age,gender,length of infection, and lifestyle are far more significant the genotype..
2 and 3 are easier to clear.
3a is a bit trickier with more relapsers (I need to check all of this but don't have time right now,so don't flame me if I'm wrong)
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388154 tn?1306361691
Wow 20% null, and they are all in the statistiks 40-50% of all geno 1. If they were excluded wonder waht the SVR % for geno 1 is then.
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Avatar universal
Although it could be written more clearly -- as often is the case in medical articles -- the following appears to state that null-responders should stop treatment at week 12 while extension is reserved for those who have the two-log drop by week 12 (EVR) but still detectible.

Null response is defined as:

"...These patients do not have at least a 2 log reduction in HCV RNA by treatment week
12. Continuing treatment will nt result in a further reduction in HCV RNA. Treatment
should be stopped at treatment week 12 in these patients. Approximately 20% of
patients with HCV genotype 1 have a null response..."

http://tinyurl.com/3ocw8a
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Avatar universal
I agree that the quoted statement was incorrect and moreover agree that everything here has to be double-checked with outside sources, including what has been stated in this thread :)

When talking about extending treatment, it's important to keep in mind what the 72-week studies actually are talking about in terms of increased of SVR in slow responders with 72 weeks of treatment vs 48. "Slow responders" are actually defined as EVRs (two log drop or greater at week 12 but still detectible).

The 18% figure 'CA" quotes, for example, is a 48-week figure for EVRs, not just for anyone detectible at week 12. What that means is that someone who has a two-log drop by week 12 but still detectible and then becomes UND by week 24 has an 18% chance of SVR with 48 weeks and around double that with 72 weeks.

It does not mean that you have these odds if you have less than a two-log drop at week 12 and either treat for 48 or 72 weeks. My guess based on statistics is that both Zazza and Bobby's friend had a two-log drop by week 12.


http://www.ncbi.nlm.nih.gov/pubmed/18046717
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