72 week club

Four months ago, when I was discussing with my GI extending treatment to 66 or 72 weeks, I told him that of all the people on this forum, who did 72  weeks, no one relapsed. Relying just on memory, I thought there were at least a dozen of cases that I can back up my claim with.

Now I've just searched the forum archives and I'm surprised to find only 3 people who did 72 weeks and can actually show 6-month post-Tx PCR for SVR: DoubleDose, Cuteus and Jaroman. Am I missing someone?

Anyway, here is a list of the 72 week club (nicks and end of Tx dates):
DoubleDose - 10/04/03
Cuteus - 11/15/04
Jaroman  - 10/06/06
NYgirl - 2/08/07
Sincebirth - 6/09/07
Bill1028 - 7/07/07
MustangShelly - 8/01/07
Kalio1 - 8/24/07
Valtod - 8/27/07
St. George - 9/07/07

And those on their way:
NYCMark - 66 of 72
BThompson4 - 63 of 72
Proactive - 45 of 72
zazza - 43 of 72
Wyntre9 - 37 of 72

Can you please correct and add to the list.

I'm not sure what exactly happened with Kalio1 and BThompson4. Also, Sincebirth (Darryl) never posted after the end of Tx. And Bill1028 did 76 weeks.

Please share your stories, stats, latest PCRs and post-Tx side effects!

For example, here's the story of DoubleDose:
http://www.medhelp.org/forums/hepatitis/messages/38781.html

Thanks,
Val

[CockSparrow]

Thanks for the link and flash back in time. Interesting thread, hasnt Jim changed.
CS

[Proactive]

Congrats on finishing the marathon!!!. I would also be interested in how many of the 72 weekers were/are treatment naive vs. 2nd/3rd timers etc. Myself, first time treater...
Pro

[Proactive]

I'd also would be interested on 72 weekers med dosages, say based on kg and finishing hgb (was your hgb 14.7 at finish?)
1.57mcg/kg pegintron
21mg/kg riba
(current hgb @ 12)
stats are in my profile
pro

[zazza]

I saw on the UK forum that Sincebirth has relapsed. He was however not UND until week 28. He switched interferons during tx.

Cruelworld is probably doing 72 weeks as well. What week is he on?

I started tx with (baseline weight 67 kg/148 lbs):
1.49mcg/kg pegintron
14.9mg/kg riba

Dosage since week 41 (weight 74kg/163lbs):
1.62mcg/kg pegintron
13.5mg/kg riba

(current hgb 9.5, mostly during tx 10-11, baseline hgb 15.2)

I found this in the archives in a post by friole (05/23/07):
"candoman VL at wk 12 - in the thousands, -- just finished 72 and is on maintenance dose"

Very good idea, Valtod, to keep track of the 72-weekers' results.

[zazza]

You forgot Mikesimon! He did 72 weeks as well and SVR:ed.

[zazza]

Found some more 72-weekers from 2004 in archives. Mikesimon and DoubleDose were around then, maybe they know their results. Seems people were doing 72 weeks already at this time.

layla - did 71 weeks - UND at 3 months post
ral
doll face

[zazza]

On his way:
Bill1954 - 50 of 72 (prior relapser after 56 weeks)

[jmjm530]

Congratulations on finishing up treatment!

The best way to reach these people is to post to them directly using their name in the subject line of your post. A lot of people monitor the discussion group but probably don't read every thread. Using their name in the post title hopefully will flag them down.

-- Jim

[Bill1954]

Zazza- Good detective work finding some of the rest of us!
_______________

Valtod-

My sincere congratulations to you for reaching the finish line. My heart goes out to all that are experiencing such wicked side effects. I’m currently on track for 72 weeks, and am having a comparatively easy go of it so far. Thanks for refreshing my memory of what I could be facing; it makes me grateful that I tolerate treatment as well as I do.

A quick overview of my history and stats for anyone interested:

Dx 11/04 with HCV GT-1
Grade 3, Stage 3/4 per biopsy 1/05
Commence treatment 2/05 with Pegasys/Riba
Slow response at 12-week juncture; did not achieve 2-log drop
Increase riba dosage to 1800 mg/day, and extend Tx to 56 weeks.
Achieve UND (<50 IU/mL) by week 20
Experienced moderate sides with mild depression, severe fatigue, and significant diarrhea.
Relapsed at 30 days post Tx.

Commence re-treatment with PEG-Intron/riba 9/06.
Assigned dosages are as follows:
PEG-Intron 200 µg/week (~2.31µg/kg/week)
2.0 g ribavirin/day (~23.1 mg/kg/day)
Baseline HGB was 17.4; currently at 13.1 (no EPO required)
Duration of treatment extended to 72 weeks based on prior relapse as well as my ability to tolerate treatment.
I achieved UND (<5 IU/mL) approx. week 8
I’m currently in week 51/72. *So far* the sides have been tolerable; I no longer walk or run, and this has effected my blood glucose control somewhat. I’ve experienced some moderate fatigue and occasional nausea to date. I know there’s plenty of time left for that to change ;o), but I’ll take what I can get.

I’m sure I left data out- please feel free to ask additional questions. I hope your VL sticks, and you get to join the truly elite; SVR!

Take good care,

Bill

[cruelworld]

we will all have to write books on how to survive a world war. im only at week
37, so i havent tasted real prolonged torture. i hope it doesnt get much worse.

bill 1954,
i cant believe youre still marching through such heavy overdose land!
you are almost double dosing everything! OMG! i knew it was high but i didnt realize it was that high! if you cant walk (exercise) anymore it must be a lot worse than you let on. you should consider joining the military! they would take you even if you were 100 years old!

good luck all!

[lostpass]

I did 12 months of Rib and Peg  Geno type 1 post treatment 6 months ended on June 19th' 07.  My Dr. says I am cured.  On the 19th of this month I will be 3 months and holding beyond post treatment.  I do have side effects. Muscle aches and pains, fatique and short term memory loss. I have gained weight and need to lose.  Started working out at Curves for women again ... going easy.  I do feel much better, but not back to myself... I am told, it all takes time the Ribaviron attacks the ammune (immune) system esp. at your weakest point.  It is hard for me to get up out of a chair.... Once I get moving, it isn't so bad.  I fall asleeep late afternoon, but compared to sleeping most of the day this is a change.  I sleep well at night... no more insomnia.  I am optimistic that as time goes on, I will feel better and better. A member of the 72 Club and wishing the best to all on treatment.

[Bill1954]

Cruel- I’ve missed your sense of humor; I’m glad to see your still lurking out there. I’d send any recruitment officer running right now; my liver, pancreas, and ****** all need an overhaul. I just had to enlarge the font on my ‘puter *again*, trying to avoid reading glasses, and besides; us old hippies hate the war. Come to think of it, I sound like typical officer material, huh? Maybe there’s still a chance…

I suppose I could still run, at least physically. My problem lately has been apathy. I really don’t have bad sides, at least not constantly. Weeks 35 thorough 40 seriously tested my sense of humor, but then things eased up a bit. I still feel a little queasy now and then, but I’m gaining weight and trying not to eat like a horse.

What’s up on your end, bud? I haven’t been participating as much here as I used to, so I don’t keep track of everyone’s progress. I recall you were considering increasing your ribavirin; how is that going? Good to hear from you, and stay in touch. I should be finishing treatment in Feb ’08; late March, I’ll try to post preliminary results.

Take care, and keep us posted when you can—

Bill

[Bill1954]

BTW; ****** rhymes with decker, if you hadn’t guessed…  

[jmjm530]

"Wrecker" ?

[BThompson4]

Sorry to hear about Sincebirth.  I think he had consulted with Dr. Cecil on his old forum about switching interferons.

Saw my new hep doc at post transplant clinic Thursday and he is hinting at extending to 78 weeks, which I am not very excited about after getting a pcr of 43 IU/ml during week 55 (had had 15 or so UNDs prior to that; was UND week 58).  He also wants me to maintenance dose if I relapse.  Hard to decide since I am pretty happy with my biopsy at week 36 of tx which showed fibrosis fell from F2 to between F0 and F1.  That improvement I hope would get me healthy enough to wait for Vertex, which is way preferable to the current SOC.

[Bill1954]

Hehehe, only in my dreams :o). I knew I left one on the table when hit the post button, but I didn't realize it was a good one. I hope your weekend is a good one, old friend--

Bill

[wyntre9]

Good idea, listing extenders on one post.

thanks for that.

wyntre

[Valtod]

Updated list of Extenders:

DoubleDose - 10/04/03
layla - 7/14/04
mikesimon - 15/06/04
Cuteus - 11/15/04
Jaroman  - 10/06/06
NYgirl - 2/08/07
Randalee - 3/01/07
Sincebirth - 6/09/07
Can-do-man - 07/20/07
Bill1028 - 7/07/07
MustangShelly - 08/01/07
Kalio1 - 08/24/07
Valtod - 8/27/07
St. George - 9/07/07

NYCMark - 66 of 72
BThompson4 - 63 of 72
Bill1954 - 51 of 72
Proactive - 45 of 72
zazza - 43 of 72
Wyntre9  - 37 of 72
cruelworld - 37 of 72

This thread should be considered a follow up on:
"okay I need some stats for all the 72 weekers"
http://www.medhelp.org/posts/show/223991

Proactive, zazza, jmjm530, Bill1954, cruelworld, BThompson4, wyntre9 thanks for the responses.  

Zazza - great data mining :-) I remember frijole was maintaining a spreadsheet of people on Tx. Hopefully, she'll see this thread too and help us with this list.

Bill1954, I agree with Cruel - you're like a real war hero or a Rambo of Hep. Hats off to you!

Jim, thanks for the congrats and the advice, which I'll follow.

BThompson4, I sincerely hope you won't relapse. But even if you do, F0-1 is great news. If one doesn't have autoimmune reactions and severe rashes, no doubt Vertex would be a way preferable to what most of us have to endure on SOC.

Does anyone know more about Randalee? Posted only once to announce end of 72 week Tx:
http://www.medhelp.org/forums/hepatitis/messages/45269.html

[meki]

You can get an overhaul on "THAT"?

Woohoo --- the world is definetely changing! LMAO!

Meki

[zazza]

Wondering about antman, didn't he decide on 72 as well? He was UND at week 15, had a viral load of 55 at week 12.

[drofi]

Drofi, Geno 1b, Stage 3/3 of four.
Startet with 180 ug Pegasys + 1200 mg Riba. Inreased Ribavririn after 3 weeks and after all the weeks have an average of 17.8 mg /kg in week 34 today.

Respose was slow: Got a 2log drop in week 12, but still 830 IU/ml, week 16 still 70 IU, <10 in week 20 and 24, UND in week 28.

Do you think it makes sense to continue? I would appreciate your opinion very much. I am in week 34 now, tolerate it quite well, and my strategy is to go for 72 weeks and add a low-dose reduction period of 8 weeks or more before I quit completely. A low-dose reduction period (half dose) should offer the body the chance to adapt.

[Lonestar823]

LoneStar 73 weeks 8/8/06 - undetected five months post - no 1 year.  was told infergen was my last option for the time being.    When the new meds get closer I'll recheck.  1A  grade 1-2 stage 2.

[NYCMark]

[glucklich]

Curius as the the indications that 72 weeks would be a good treatment. can someone tell me more about it.
I did 1200 rib in round 1 and what a difference in round 2 with only 1200. Anyone with more riba has all my sympathy.

[NYCMark]

This is my 4th cycle of treatments. First was years ago with plain Interferon. Second was  interferon and ribavirin. (These two treatments had insufficient response.) The third was in a study with Dr. D. using Pegasys and Ribavirin for 48 weeks. I relapsed.

Liver bipsy before this current round: 2/2. I started this round of treatment in June 06 using 360 ug of Pegasys weekly plus 1200 mg ribavirin daily for 12 weeks. I was undetectable somewhere between weeks 2 and 6 (we failed to get a week 4). After 12 weeks, we cut the Peg back to the normal 180 ug weekly, and reduced the riba to my weight-based dose of 1000 daily (I was suffering from terrible riba rashes). I have been undetectable since (except for a "blip" one month of 62 iu.)  I've usded Procrit now and then, and even Neupogen on occasion when my ANC went to 300 (although it was more at my urging than Dr. D's suggestion).

Hope this recap helps.

Mark

[zazza]

Curious about what you are implicating: "<10 in week 20 and 24, UND in week 28".

Am I understanding you correctly that with a test of the sensitivity of 10 IU/ml, you were still detectable but not quantifiable at week 20 and 24?

[drofi]

Yes. It is the Abbot RealTime. The VL was below 10 IU/ml in week 20, but still detectable, not UND. VL was UND at week 28. With a less sensitive test (eg. <50), it would look like UND at week 20, but it was only below 10.

[zazza]

I understand your predicament. I was in a similar situation at week 12, being detectable but not quantifiable with a test of the sensitivity of 15 IU/ml. I had much anguish in deciding whether to classify myself as an early responder (UND by week 12) or a slow responder. Especially since the studies used tests with the sensitivity of 50 IU/ml. Of course the decision you have to make is more difficult than mine was, since you have to choose between classifying yourself as a slow responder versus a non-responder.

I finally let MD Thomas Berg's chart of a possible future consensus for tx make my mind up. He draws the line at > or = 10 IU/ml at week 4, 12 and 24.

I figure you have not done a viral load test in the weeks between 24 and 28? Most likely you were UND before week 28. This is not a clear cut decision. I remember seeing someone on this board who actually SVR:ed after treating 48 weeks although not UND until week 26 or so. So apparently it does happen. Your biopsy seems to tell of an urge to treat, but it might also tell that you will have harder to SVR? Anything less than 72 weeks is out of the question in my opinion. It is either 72 weeks or quit, but you know that already, right? You did have a low-level viremia at week 12, that is good. Did you have a high baseline viral load?

I think you have to weigh in how motivated you are to give this a go now. Are you prepared to accept the result if it turns out you relapse after having done 72 weeks?

You are almost halfway. How bad sx do you have? How much is it affecting your life and work? I see you say you "are tolerating it quite well". You know what, this is not an advice, but if it was me, I think I would go for it. Others probably have differing opinions, but that is my take on it. In the end, you are the only one who can make the decision that feels right for you. Best wishes, Zazza

[zazza]

When I told one of the hepatologists I consulted (who also works as a researcher at the laboratory) that I was detectable at <15 at week 12 and now was going to do another viral load test week 15, his comment was: "That is unnecessary, I know you are UND by now." I did the test, and he was correct. This is what makes me think you were UND before week 28.

[drofi]

I had a VL of about 2.600.000 at start. My motivation to continue is high and there is some balance between sides (weakness, bad mood) and benefit (no itching/pruritus anymore). Before starting treatment  I a have done sports for some years and I have been in good physical condition. My strategy is to continue, but t do PCR at week 36, 40, 48, 60 and to decide again.
There is promissing (?) info about Alinia http://www.clinicaltrials.gov/ct/show/NCT00495391?order=5
and I hesitate to add it t the cocktail. The safety profile looks great and it is already available in the pharmacies. So I will wait what the AASLD tells us about Alinia and perhaps this will enhance the chance for SVR after week 72.

[Valtod]

Your situation is very similar to mine - I had a 3.6 log drop at week 12 but still 645 IU/mL. I was UND by week 18 (< 5 IU/mL Heptimax). My Doc thought I was probably UND between week 14 and 16. But if I had used Abbott RealTime - who knows? - I might seem UND even later.

By the way, Abbott should report < 12 IU/mL as UND according to their own specs:
http://international.abbottmolecular.com/RealTimeHCV_1988.aspx

What we should all understand that at level < 50 IU/mL interpretations get fuzzy and different tests difficult to compare. Also, unfortunately there is no standard formula for converting the amount of HCV RNA reported in International Units to copies/mL. So 10 IU/mL may mean 9 copies/mL in test A, but 52 copies/mL in test B. This is almost a 6 TIMES difference.

Anyone interested to know more about different viral load tests, please see:
http://hcvadvocate.org/hepatitis/factsheets_pdf/VIRALLOAD.pdf

All the studies (that I know), where treatment was extended to 72 weeks for delayed responders, used relatively low sensitivity tests < 50 IU/mL and cut-off date for UND at week 24. Since these studies are the only firm data, on which we can base our decision for extended treatment, it's reasonable to apply their standards for UND.

See Ferenci's study, for example http://www.natap.org/2006/AASLD/AASLD_34.htm

So if you were in this study, you'd be considered UND by week 24 and one of the 13 people in the 72 week arm.  See the last bar in the chart:
http://www.natap.org/2006/images/110606/Figure3-4.gif
As you can see, only 3 of the extenders relapsed, the other 10 achieved SVR. Since it's plausible that at least 1 or 2 of these group had a set of negative predictive factors worse than yours, it's reasonable to expect that you'd be among the 10 lucky ones with very high probability.

See also http://www.medhelp.org/posts/show/98287

This was my personal rational argument for extending my own treatment. And I think it may apply to you too.

However, one important thing missing in this whole argument is the severity of the side effects during and post treatment and the possible long-term damages. This is a big scary and almost unpredictable variable in the equation “Should I extend or not?”

Only you, carefully consulting your own body, can decide on it.

Wish you luck!

[drofi]

I completely agree! Thank you for your thoghts, drofi

[cigaso]

Sorry to hear you have to do 72 weeks. I am at crossroads myself. I was wondering if you could tell me what your bx was at the time you began tx and was that part of your discussion with your Dr to extend tx? Thanks for your response.

[wyntre9]

valtod, zazza,

How lucky we extenders are to have such knowledgeable people on forum!

thanks for the explanations!

Drofi,

I didn't reach UND <10 until week 16 or 17, either.  i'm now at week 37 and trying my best to finish 72 weeks as I'm 1A.

Good luck in whatever you decide.

wyntre

[Valtod]

The only (but absolutely crucial) reason to extend Tx was that I was delayed responder not only in my last Tx but in the previous one too. There was no doubt that my only chance for SVR is extending. The only question was for how long. My Doc wanted me to do 60 or 66 weeks. Finally, I decided to stay 72 weeks trying to cover all bases :-)

Actually, for a number of different reasons, I never had a biopsy.

I did FIBROSpect on 03/17/04: METAVIR F0-F1

I did FibroSure on 09/02/05:
Fibrosis Score: F2 – Bridging fibrosis with few septa
Necroinflammatory Score: A1-A2

But as I know today, these tests are not very reliable.

If you want to know more about my story, you may check out:

6th week PCR - not quite 2log
http://www.medhelp.org/forums/hepatitis/messages/41138.html

Still here - week 18th UD
http://www.medhelp.org/posts/show/94447

TX without a biopsy?
http://www.medhelp.org/forums/hepatitis/messages/44074.html

Wish you luck!

[drofi]

Hi club,

I just found this fanstastic new paper, it reviews the existing studies quite well. See full text at link.
Best regards and thanks for your thoughts, drofi

http://tinyurl.com/2xx2vb

1: J Hepatol. 2007 Jul 30;
Which patients with genotype 1 chronic hepatitis C can benefit from prolonged treatment with the 'accordion' regimen?
Marcellin P, Heathcote EJ, Craxì A.

The on-treatment virological response to pegylated interferon plus ribavirin therapy is a useful tool in the management of patients with chronic hepatitis C. The time at which hepatitis C virus RNA becomes undetectable by a sensitive PCR assay has a huge impact on the probability of achieving a sustained virological response, particularly in genotype 1 patients, and may be useful in selecting patients for prolonged therapy. Indiscriminate extension of treatment in patients with hepatitis C virus genotype 1 is not beneficial. However, there is a subgroup of patients - the so-called 'slow responders' - who benefit from extending treatment from 48 to 72 weeks and can be readily identified after 4-12 weeks of combination therapy. Thus, it is important to distinguish slow responders from null responders. In the TeraVIC-4 study virological relapse rates were significantly lower, and sustained virological response rates were significantly higher, in those treated for 72 weeks with peginterferon alfa-2a (40kDa) plus ribavirin (45% vs. 32% with 48 weeks, P=0.014). Patients are best served by quantitative determination of the hepatitis C virus RNA level at weeks 4, 12 and 24. The results of these determinations can then be used to tailor the length of therapy.
PMID: 17692991

[Valtod]

You wrote "post treatment 6 months ended on June 19th' 07.  My Dr. says I am cured."

I'm a little bit confused... When was the last week of your Tx (the week of the last injection)? How many weeks was your Tx exactly? Was it Pegasys or PegIntron? Your dosage? Are you Genotype 1a or 1b?

Thanks!

[Valtod]

kalio, are you still around? Did you finish your Tx? If you read this, please let us know how's your treatment treating you :-)

[Valtod]

Drofi, great article!

I think the concept of accordion regimen validates my formula(s) and length of Tx model  proposed here:
http://www.medhelp.org/forums/hepatitis/messages/46062.html

The linear version of the formula is:
Length of Tx = 3X + 12

Fig. 3 in the article suggests the 'curved' version of the formula:
Y3= (10+X/8)X/4+13.5

Here's the relationship between 'week of 1st time UND' and length of Tx:
wk 4: 24
wk 8: 36
wk 12: 48
wk 16: 62
wk 20: 76

[drofi]

Quote:
"I think the concept of accordion regimen validates my formula(s) and length of Tx model  proposed here:
http://www.medhelp.org/forums/hepatitis/messages/46062.html "

Valtod, good work, did not notice the original posting. What was the definition od UND in your formula? I'm asking, because I have been <12 in week 20 and 24, but UND in week 28. You mentioned, that the old studies used a less sensitive test. What is you honest opinion (I don't need any consolation) about a realistic  "X" for me?

[Valtod]

My model was based on Ferenci and other studies that all used relatively low sensitivity tests < 50 IU/mL and cut-off date for UND at week 24. As I wrote above, you're covered   by this criteria as a delayed responder who would benefit from 72 week regime.

If you were <12 at 20 and UND at 24, I'd say your X=18. However, you were still <12 at 24, which suggest some very low level plateau. You have to understand that such models and formulas are based on assumptions for a large statistical group and continuity of viral decay.

[wyntre9]

OK, I admit I'm 'challenged' when it comes to interpreting hep-c scientific papers.

I don't understand;

"In the TeraVIC-4 study virological relapse rates were significantly lower, and sustained virological response rates were significantly higher, in those treated for 72 weeks with peginterferon alfa-2a (40kDa) plus ribavirin (45% vs. 32% with 48 weeks, P=0.014)."

Does that mean  1A slow responders who go for 72 weeks have a 45% chance of SVR whereas those who do only 48 weeks have only a 32% chance?

Could you please clarify?

thanks,

wyntre

[nygirl7]

I DID 72 weeks and my four month post was UND - should have already had my six month post but due to a bunch of problems in my personal life have had to evaluate and put it off.  Hoping to get it done next week now that things are slowing down...


Drofi - if you were not UND until wwek 28 you definitely should pursue the 72 weeks remembering that NONE of this is guaranteed in any way to give us SVR no matter how long we go.

[nygirl7]

PS I think Kalio is on a step down version of treatment ending that HepResearcher advised rather than just discontinuing cold turkey at the end.  I speak to her often enough when I have the time and will shoot her off a quick email to come in an post if she can.

[ponyshel]

hello all and sorry haven't posted for awhile..been busy with family stuff...
I go to dr today and will chat...
I am geno 1a..2/2 bridg fibrosis,small mass ll lobe
I cleared at week 17.so extended tx to 72
I am now almost 6 weeks post tx..did peg/riba 1000mg
slowly coming back....feeling better on a daily basis
my thyroid went bonkers week 30??
still having trouble with that..I am getting a tsh,t3,t4 drawn today
I wish svr for all...........:) shelly

[drofi]

Quote: "In the TeraVIC-4 study virological relapse rates were significantly lower, and sustained virological response rates were significantly higher, in those treated for 72 weeks with peginterferon alfa-2a (40kDa) plus ribavirin (45% vs. 32% with 48 weeks, P=0.014)."

Hi, your English is better than mine, but this is how I understand the data too. However, do not forget the comments: "Limitations of Tera-VIC-4 include the use of a lower than recommended
dose of ribavirin for genotype 1 (800 mg/day rather than 1000 or 12000 mg/day), inclusion of non-genotype 1 patients, and a high rate of voluntary withdrawal in
patients randomised to prolonged treatment."

As someone stated before, do not forget that we all are not more than a tiny piece of the statistics. I know someone here, who had a VL <50 in week 16 and was UND in week 20. He did 48 weeks and got SVR. Another guy was UND in week 4 and after 48 weeks he relapsed. We do not know much about the prognosis factors today, I think the influence of the genetic components is underestimated.

[frijole]

I'm a 72 week club wannabe

I didn't keep records on who was doing 72 but I can add a couple

Lvdbygod
Eisbein

Both did 80 plus and finished sometime in 06.

You are a tough bunch, you 72'ers!

frijole

[wyntre9]

Thanks drofi,

I guess I've got the stats all wrong (as usual).

After reading the Berg report and portions of the Drusano and Tapias-Sanchez  I thought SVR rates for extenders increased from less than 50% to around 70%.  (can't find the studies to quote exactly).

And I also thought the odds of genotype 1A folk were about 50% for achieving SVR with 48 week SOC.

But maybe that last stat was for response rates in people who reach UND by week 12.

I dunno.

i'm a little confused (understatement) now about just what the benefits ARE of extending to 72 weeks for slow responders.

Anyone who can help me understand, pleeeeze chime in!

Wyntre

[Valtod]

see http://www.medhelp.org/posts/show/299660

[antman]

hey guys- i saw my name come up concerning going 72 weeks. good memory zazza! i'm @ week 33 now and have been UND since between week 12 and 15. when i asked my Dr. about the studies showing 72 weeks increased SVR he said he would look into it but didn't think it would be neccessary. i have mixed feelings. i still have plenty of time to decide and would need his & the insurance co. blessing anyway. hope everyone is doing well. my sides have been almost non-exisant lately. just itchy sking and lehargy. i,m working full time, no problem and feel weel mentally. take care!

[Tallahassee]

Sign me in...
98+ weeks of daily high dose Infergen (~18 mcg) + riba (~24-28 mg/ kg) + Neupogen (300 mg 2-3 times per week).

Non-responder (zero!) to 48 weeks of regular Interferon + riba 1000 mg (clinical trial of 1995-1996).  Failer other X (?) number of treatments with Infergen + Interferon combinations.

12 weeks post treatment still was UND ...fingers crossed.

All the best!

[Proactive]

Is this your final week coming up Bill, or do you have one to go after that?
Hope all is well...Weren't you going to consult your doc and discuss the possibility of extending past 72, or was I just dreaming?
pro

[ponyshel]

I had to change my screenname as to a move. stangshelly i.e ponyshel is now 6+ months post tx of the 72 weeks and I am happy to report cleared the 6 month mile marker still undetected ! I also am a first time txer geno 1a 2/2 and doing well . I did manage to damage my thyroid but there is still hope. I do notice a big difference in being clear. I wish you the best of the best results! Hugs :) shelly

[Proactive]

Congrats and thanks for the update Shelly...I have updated this simple list with you info (best to keep it simple)..Any other updates, please copy and repaste this simple format..thanks Pro
Updated list of Extenders:

DoubleDose - 10/04/03
layla - 7/14/04
mikesimon - 15/06/04
Cuteus - 11/15/04
Jaroman  - 10/06/06
NYgirl - 2/08/07
Randalee - 3/01/07
Sincebirth - 6/09/07
Can-do-man - 07/20/07
Bill1028 - 7/07/07
MustangShelly - 08/01/07 ---cleared -svr
Kalio1 - 08/24/07
Valtod - 8/27/07
St. George - 9/07/07

NYCMark - 66 of 72
BThompson4 - 63 of 72
Bill1954 - 51 of 72
Proactive - 45 of 72
zazza - 43 of 72
Wyntre9  - 37 of 72
cruelworld - 37 of 72

[Proactive]

DoubleDose - 10/04/03
layla - 7/14/04
mikesimon - 15/06/04 ---cleared---svr
Cuteus - 11/15/04
Jaroman  - 10/06/06
NYgirl - 2/08/07 --cleared--svr
Randalee - 3/01/07
Sincebirth - 6/09/07
Can-do-man - 07/20/07
Bill1028 - 7/07/07
MustangShelly - 08/01/07 ---cleared -svr
Kalio1 - 08/24/07----cleared---svr
Valtod - 8/27/07
St. George - 9/07/07

Still treating..........update when completed please
NYCMark - 66 of 72
BThompson4 - 63 of 72
Bill1954 - 51 of 72
Proactive - 45 of 72
zazza - 43 of 72
Wyntre9  - 37 of 72
cruelworld - 37 of 72

[BJ1fish]

I did 72 weeks of infergen and riba finished I think March 06. Relasped. Have been on mono treatment 1st 6 months infergen  and  then the last year peg intron. (Maitenance) I have been und and will soon come off of the peg. If I relaspe again they have study for me to get into.

[sldb]

geno 1a und. stage 4.  did 96 wks  und bw wk 12 & 16, i did this b/c  i did not feel it would be successful txing for 72 wks. due to my staging and geno type. SVR17mths now. I tolerated the medication pretty well so it wasnt a hard decision.

[Bill1028]

DoubleDose - 10/04/03
layla - 7/14/04
mikesimon - 15/06/04 ---cleared---svr
Cuteus - 11/15/04
Jaroman  - 10/06/06
NYgirl - 2/08/07 --cleared--svr
Randalee - 3/01/07
Sincebirth - 6/09/07
Can-do-man - 07/20/07
Bill1028 - 7/07/07 - Relapsed - did 72 weeks + 4 week dose reduction
MustangShelly - 08/01/07 ---cleared -svr
Kalio1 - 08/24/07----cleared---svr
Valtod - 8/27/07
St. George - 9/07/07

Still treating..........update when completed please
NYCMark - 66 of 72
BThompson4 - 63 of 72
Bill1954 - 51 of 72
Proactive - 45 of 72
zazza - 43 of 72
Wyntre9  - 37 of 72
cruelworld - 37 of 72

Relapsed, VL 260,000, AST 70's, blood work is normal except for elevated AST and ALT. My platelets are in the low 100's, slightly higher than pretreatment.  I have most of the negative predictors including cirrhosis.  Minimum sides during treatment and none post.  I feel 100% and hair returned as curly, thick, and less grey as pretreatment.  I'll try to get into a trial in the next 6 months or try maintenance since I do respond to interferon, until something better comes along.  They say 3 times the charm!

[FloridaMouse]

DoubleDose - 10/04/03
layla - 7/14/04
mikesimon - 15/06/04 ---cleared---svr
Cuteus - 11/15/04
Jaroman  - 10/06/06
NYgirl - 2/08/07 --cleared--svr
Randalee - 3/01/07
Sincebirth - 6/09/07
Can-do-man - 07/20/07
Bill1028 - 7/07/07 - Relapsed - did 72 weeks + 4 week dose reduction
MustangShelly - 08/01/07 ---cleared -svr
Kalio1 - 08/24/07----cleared---svr
Valtod - 8/27/07
St. George - 9/07/07

Still treating..........update when completed please
NYCMark - 66 of 72
BThompson4 - 63 of 72
Bill1954 - 51 of 72
Proactive - 45 of 72
zazza - 43 of 72
Wyntre9  - 37 of 72
cruelworld - 37 of 72
FloridaMouse - 6 of 72

Relapsed, VL 260,000, ASTAbdominal wall surgery
Abdominoplasty - series
Adjustable gastric banding
Allergy testing
Angioplasty
Ast
Asthma
Asthma and allergy - resources
Asthmatic bronchiole and normal bronchiole
Astigmatism
Bacterial gastroenteritis 70's, bloodAmylase - blood
Bleeding
Blood cells
Blood clot formation
Blood clots
Blood culture
Blood differential
Blood gases
Blood gases test
Blood glucose monitoring
Blood in semen work is normal except for elevated ASTAbdominal wall surgery
Abdominoplasty - series
Adjustable gastric banding
Allergy testing
Angioplasty
Ast
Asthma
Asthma and allergy - resources
Asthmatic bronchiole and normal bronchiole
Astigmatism
Bacterial gastroenteritis and ALTAcupuncture and pain
Alt
Consumer rights and responsibilities
Day care health risks
Diet and good health
Galactose-1-phosphate uridyltransferase
Healthy diet
Obesity and health
Pharmacy alternatives
Physical exam frequency
Pregnancy - health risks. My plateletsPlatelet associated antibodies
Platelet count are in the low 100's, slightly higher than pretreatment.  I have most of the negative predictors including cirrhosisCirrhosis
Cirrhosis of the liver
Liver cirrhosis, ct scan
Primary biliary cirrhosis.  Minimum sides during treatment and none post.  I feel 100% and hairHair loss
Hair transplant
Male pattern baldness returned as curly, thick, and less grey as pretreatment.  I'll try to get into a trial in the next 6 months or try maintenance since I do respond to interferon, until something better comes along.  They say 3 times the charm!

[DoubleDose]

You can add after my nickname:  DoubleDose  10/04/03  cleared  - SVR, along with the other extender SVR's.  I am a big believer in extending tx, if the profile of the treating individual fits the appropriate pattern.  I think the extension usually works for slow responders, especially if dosing is kept at maximum levels throughout tx.  Best wishes to all of you who posted on this subject.  I like to see the above sort of public record-keeping, and follow up.  It helps everyone out there see real living examples of tx strategies that have worked, for real people, not just statistics in studies.  Our forum can serve as a great sounding board for those new to HCV treatment and treatment problems/ challenges.  Hats off to all of you for the ongoing involvement and input.  The information disseminated is invaluable, and the discussions are always stimulating.  Lots of bright and concerned people to be found here.  

DoubleDose

[willing]

two other old-timer names are bobk and revenire both of whom extended and relapsed. Bobk did abot two years, rev I can't recall but perhaps someone else will.

Anyone interested in 72 might want to take a look at a recent study in hepatology:

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

which tracked 112 slow responders at full-dose rbv, unlike the earlier studies.

Also it's worth digging through the abstracts of aasld'07 for a japanese study that reported positive results with 72 weeks.

Overall, the success rate for 72 on this board does seem much higher than observed elsewhere!

[Proactive]

Updated list of Extenders:Tx completion date: results
(please copy and repaste-add/update etc.)

DoubleDose - 10/04/03----cleared--svr
layla - 7/14/04
mikesimon - 15/06/04 ---cleared---svr
Cuteus - 11/15/04
Jaroman  - 10/06/06
NYgirl - 2/08/07 --cleared--svr
Randalee - 3/01/07
Sincebirth - 6/09/07
Can-do-man - 07/20/07
Bill1028 - 7/07/07 - Relapsed - did 72 weeks + 4 week dose reduction
MustangShelly - 08/01/07 ---cleared -svr
Kalio1 - 08/24/07----cleared---svr
Valtod - 8/27/07
St. George - 9/07/07
bobk                --------------relapsed
revenire            -------------relapsed
sldb (98 weeks) ----cleared svr

Still treating..........update when completed please
NYCMark - 66 of 72
BThompson4 - 63 of 72
Bill1954 - 51 of 72
Proactive - 45 of 72
zazza - 43 of 72
Wyntre9  - 37 of 72
cruelworld - 37 of 72
FloridaMouse - 6 of 72

[BThompson4]

Sincebirth and bthompson4 relapsed.  NYCmark recently did or will soon do three month pcr.  Revenire did 53 of full peg and riba and then 1/2 peg for thirty weeks with no riba, so he did not do the 72 week regimen.

[nygirl7]

St. George unfortunately relapsed.
You didn't note down that Cuteus is SVR but she definitely is!

I personally think the newer bunch will have much higher rates of SVR.  With the new group - we now have the Berg and Sanchez Tapias studies. Med reductions have been almost done away with because the docs now know better. People are treating harder and sticking to the plan in a major way.

Prior to these two studies it was pretty much just a desperation move that these guys were smart enough to pick up on without any data.  Now, it's a real medical viable course of treatment.

You know..it's not going to be so hit and miss because it's a completely different course of therapy than guesswork.

Thanks for the list - clear and going strong month 11 1/2

[jmjm530]

Thanks for the study. Yes, I do think out 72-week rates are higher than the 38% stated, and that could be accounted for by a number of reasons.

But assuming even 50-50, I do think that it's an important *decision* at the 12 week mark, for the slow or partial responder and not a far gone conclusion to just chug away. In my mind, certainly liver histology would play a big part in the decison to treat another 60 weeks (after investing 12). The alternative would be to cut losses, gather the troops, and fight another day with hopefully a better drug regimen and a shorter duration -- in the case of Telaprevir that would potentially be 24 weeks against the 60. In other words, I see the 12-week point (with partial responders) as a decision point -- not as a stop or go point.

The other important stat in this study and others, is that extension appears only recommended if a two-log or greater drop by week 12 and I believe that is all this particular study dealt with. If the patient does not have a two-log drop by week 12, then the SVR numbers should be significantly lower and in most cases would suggest stopping treatment.

Willing, don't know if you caught this thread here: http://www.medhelp.org/posts/show/407302

In it, you might find some additional reasons for ordering frequent viral load tests, esp in the early stages. Besides other utilities as already discussed,at least according to one well-known clinician, the data could be very useful in a re-treatment scenario to help predict applicability.

-- Jim

[Proactive]

To: updated
Updated list of Extenders:Tx completion date: results
(please copy and repaste-add/update any added info on the list)

DoubleDose - 10/04/03----cleared--svr
layla - 7/14/04
mikesimon - 15/06/04 ---cleared---svr
Cuteus - 11/15/04
Jaroman  - 10/06/06
NYgirl - 2/08/07 --cleared--svr
Randalee - 3/01/07
Sincebirth - 6/09/07 --Relasped
Can-do-man - 07/20/07
Bill1028 - 7/07/07 - Relapsed - did 72 weeks + 4 week dose reduction
MustangShelly - 08/01/07 ---cleared -svr
Kalio1 - 08/24/07----cleared---svr
Valtod - 8/27/07
St. George - 9/07/07
bobk                --------------relapsed
revenire            -------------relapsed
BThompson4---------relapsed
sldb (98 weeks) ----cleared svr

Still treating..........update when completed please
NYCMark - 66 of 72  
Bill1954 - 51 of 72
Proactive - 45 of 72
zazza - 43 of 72
Wyntre9  - 37 of 72
cruelworld - 37 of 72
FloridaMouse - 6 of 72

[willing]

I found that japanese 72 week study from the last aasld;  see abstract 1321, "Comparison of standard vs extended pegylated interferon plus ribavirin treatment according to the time of HCV RNA negative in patients with genotype 1 and high viral load." from Ide et al. There's a copy here if you scroll to it and there might be a standalone version somewhere:
http://www.hcvadvocate.org/news/reports/AASLD_2007/Abstracts/Tuesday%20posters.htm

relapsers who are retreating might also want to look at abstract 1310. "Retreatment of HCV Genotype 1 Relapse Patients to Peginterferon/Ribavirin Therapy with an extended Treatment Regimen of 72 weeks with Consensus Interferon/Ribavirin versus Peginterferon alpha/Ribavirin" by  Kaiser et. al  There does seem to be some argument for going with CIFN, though they don't give the N of patients involved.

Also regarding that Pearlman'07 study above, it's worth noting that those 38% and 18% SVR rates reflect patient selection. As noted in the study and in the commentary letter by Hoefs and Morgan published in the same issue of Hepatology, 48% of patients were African-American, a factor associated with unfavorable SVR outlook.  

The important point, IMHO is that 72 weeks cut the relapse rate in half - thus regardless of where  age/race/sex/fibrosis etc. put your SVR odds, if you're a slow responder who stayed UND-to 48,  it looks like (a) you're facing much worse than average relapse risk and (b) you can make a big dent in that risk by continuing to 72.

jim : I've never had any issue with the futuristic, tentative, forward-looking aspects of frequent/sensitive VL testing. My objection is simply that given the data currently available for interpreting test results,  drs are not guilty of practicing inferior care by not ordering more tests than those set out in that JAMA review (baseline, 4, 12,24). With all  due respect for the eminent Dr. Shiffmann, given what's available today, I don't believe he has anymore of a clue than anyone else as to how interpret a result  like  that of MO's 3 week test.

Of course all of this is evolving. However, I wouldn't be at all surprised if part of that evolution were not only a move towards better characterization of the VL-curve-to-SVR correlation but  also towards tests, like hcv-specific CD8+ T cell response, that more directly measure what's actually going on in the trenches. For example, no amount of  VL tests would have helped skipinca understand why his rvr fell apart.

[jmjm530]

I think we're pretty much in agreement here. Just trying to make the point that extension to 72 weeks is only one of two reasonable options at week 12 for some of us. The other is to stop, re-group, and perhaps fight again, another day, with better, safer ammo.

-- Jim

[nygirl7]

There is no safer ammo at this time and there might not be for many years, if ever.  Thats the thing - with no guarantee that fibrosis won't turn to cirhosis that is a big "IF" involved.

Anyway everyone knows my opinion on treating for 72 IF you do not clear until between 12 and 24.   I'd say that doctors are beginning to agree that cutting the relapse rate down so tremendously is a huge IN FAVOR of doing it.  The more fibrosis you develop potentially the harder time to achieve SVR so it only makes sense.  Half is a LOT of percentage to drop dont you think?

If there was any drug in the pipeline that was coming close to fruition that was a safer ammo this would change my opinon but the fact is there isn't any.  

The government needs to realize they are leaving an awful lot of people out here in the rain without pretty little bows to make us feel any better (thanks Deb_c for putting that into my mind!).

[zazza]

Updated list of Extenders:Tx completion date: results
(please copy and repaste-add/update any added info on the list)

DoubleDose - 10/04/03----cleared--svr
layla - 7/14/04 --- 71 weeks --- UND 3 months post
mikesimon - 15/06/04 ---cleared---svr
Cuteus - 11/15/04 --- cleared --- svr
Jaroman  - 10/06/06
NYgirl - 2/08/07 --cleared--svr
Randalee - 3/01/07
Sincebirth - 6/09/07 --Relapsed
Can-do-man - 07/20/07 --- relapsed - did 72+ weeks
Bill1028 - 7/07/07 - Relapsed - did 72 weeks + 4 week dose reduction
MustangShelly - 08/01/07 ---cleared -svr
Kalio1 - 08/24/07----cleared---svr
Valtod - 8/27/07
St. George - 9/07/07 --- relapsed
bobk                --------------relapsed
BThompson4---------relapsed
sldb (98 weeks) ----cleared svr
Lonestar823--- 8/8/06 --- did 73 weeks --- cleared ---svr
Tallahassee (98+ weeks of daily high dose Infergen + riba) --- cleared --- svr

Still treating..........update when completed please
NYCMark - 66 of 72  
Bill1954 - 51 of 72
Proactive - 45 of 72
zazza - 63 of 72 - will be done 03/26/08
Wyntre9  - 37 of 72
cruelworld - 37 of 72
drofi - 34 of 72
FloridaMouse - 6 of 72