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Extension beyond 72 weeks for late responders
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Extension beyond 72 weeks for late responders

Does anyone know of any studies (besides Arase) providing information on extended TX (beyond 72 weeks SOC) for slow responders? My doc is OK with me doing it, but he says if he were I, he'd quit at 72 weeks (two more weeks for me). I thought I was decided to go an extra 12, but I am starting to wonder in light of what my doc said and how I am feeling about now, after 70 shots of this.

I started TX a Genotype 1 at 1,000,000 VL and dropped > 2 LOG at 12 weeks. My 24 week test was mishandled and returned no result, so I had another one in week 26 which showed UND. So, that makes me a late responder for sure and perhaps a super-late responder. No way to know for sure.

In my favor, I have done 100% of all doses,180ug Peg weekly and 1200mg Riba daily, except for one Peg shot after hospitilization for TIA. Working against me is the fact that I take immunosupressants for liver transplant.

Not sure I can do another 12 weeks, but I am pretty sure I can't do another round of TX, so I want to do everything I can to SVR (I am sure I am not the only one here that feels THAT way).

Any suggestions, info or opinions are welcome.

Thanks,
Brent
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17 Comments Post a Comment
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419309_tn?1326506891
I remember smaug48 being in a similar situation and posed the question to Dr. D, but only got a partial response:

http://www.medhelp.org/posts/show/579284

You've certainly given it your all, and whatever your decision, I wish you the best.  Wishing I could be of more help... I'll be praying for your SVR in either case!

~eureka
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Avatar_f_tn
I know you want to do everything you can - what with the retread and all ;)  I don't have any studies or anything like that but I ALWAYS have an opinion (have you noticed?).  I think in this you really have to follow your heart.  This tx has been kicking you pretty hard and you've had the TIA on top of it.  If you feel its time to give your poor body a rest then do it.  The prospect of 12 more weeks is pretty daunting.

What does Liz think?

keeping a good thought for you, always...
jd
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476246_tn?1310999221
I have no studies nor am I knowledgeable on the subject. Just wanted to let you know that you are in my prayers and that I will try to give as much support as I can... Maybe it would be an idea to try to extend and if you start feeling that you cannot do it, you stop. Then you will have given it all you can.

Hugs, Marcia
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408795_tn?1324939275
I went to pubmed and ran a search for hcv AND 72 weeks AND transplant, there were a few hits that came up, but not many, only 7.  I’m not sure how to locate exactly what you’re looking for, but pubmed is one of the best sources I’ve run across.  You could also run a search with just hcv AND 72 weeks.  You could also set Limits, you'll see the tab.  They will allow you to just search for humans instead of plus animals, men and not women, a certain age group, clinical trials, and publications done within the last two years etc.  Also, this other site may help you, in your search, but you will have to register prior to using it.   http://clinicaloptions.com/hepatitis.aspx   Here’s a little clip I grabbed off of pubmed..  Good luck

Treatment of patients with recurrent hepatitis C after liver transplantation with peginterferon alfa-2B plus ribavirin.

Neumann U, Puhl G, Bahra M, Berg T, Langrehr JM, Neuhaus R, Neuhaus P.

Klinik für Allgemein-, Viszeral-, und Transplantationschirurgie, Universitätsklinikum Charité, Campus Virchow-Klinikum, Humboldt-Universität, Berlin, Germany. ulf.***@****

BACKGROUND: Recurrent hepatitis C virus (HCV) after liver transplantation (OLT) is a major cause of graft loss in HCV-positive patients. In this study, we evaluated the efficacy and safety of pegylated interferon alfa-2b (peginterferon) and ribavirin treatment for recurrent HCV after OLT and analyzed the influence of antiviral treatment on the histological course of recurrent hepatitis. METHODS: Twenty-five patients with recurrent HCV (genotype 1 n=20 and 2-4 n=5) received peginterferon (1 mg/kg/weekly) and ribavirin (600 mg) for 48 weeks. Viral load prior to treatment was below 1,000,000 (IU/ml) in 11 of 25 patients. Sustained antiviral response was defined as undetectable HCV-RNA in serum 6 months after stopping of therapy. All patients underwent liver biopsy prior to treatment and after 72 weeks. RESULTS: Seventeen of 25 patients became HCV-RNA-negative after treatment (68%). Sustained virologic response (SVR) was achieved in 9/25 (36%) patients. Liver specimen showed increase of fibrosis from 1.7 to 2.0 within 72 weeks. Side effects like neutropenia (60%) and anemia (36%) were treated with G-CSF, erythropoietin, and dose reduction of peginterferon and ribavirin. CONCLUSIONS: The use of peginterferon is safe and effective in patients with recurrent HCV. Treatment of side effects, especially neutropenia or anemia, helped to maintain antiviral therapy. Despite a viral response of 68% during treatment, the patients showed further progress of recurrent hepatitis in liver specimen.

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87972_tn?1322664839
Hi Brent,

Boy, the only thing I can offer is my own personal, anecdotal experience. I was a slow responder my first Tx, and upped my riba to 1800 mg, and extending to 56 weeks. I relapsed within 30 days post. Second try, I treated with 200 µg IFN and 2g riba daily for 96 consecutive weeks; still waiting for 6 month post results, but was clear at 30 days post.

Fortunately I tolerated both treatments well; subjectively and from a hematological standpoint, so the time and dose weren’t a big consideration for me. I am grade 3, stage 3/4 with low (~125,000) VL. I was not using celcept, prednisone, or any other immune suppressants; obviously, this needs to be taken into consideration.

I’m unaware of any studies (published or otherwise) to support your position… given the particulars of your situation, I’d personally want to push the envelope though. Is your doctor supportive of continuing?

My most sincere best wishes to you- please let me know your decision, and stay in touch—

Bill
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419309_tn?1326506891
Brent:

The data out there seems to support that if you do the 72 weeks, you'd have a 90% shot at SVR. This article suggests that 36 weeks of treatment after UND increases your chances (but admittedly not much literature dealing with the question of >36 weeks):

http://www.wjgnet.com/1007-9327/14/3621.pdf

Didn't find any articles about how to help you close that 90% gap, but thought the engineer in you might also find some useful info here:

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6W7C-4P9K74F-2&_user=483692&_coverDate=10%2F31%2F2007&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000022720&_version=1&_urlVersion=0&_userid=483692&md5=edcdc2c206643a916314fddb8c5d5f07

I hope MH allows the links! (If not, let me know I'll be happy to PM them to you.) Hope this helps.
~eureka


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Avatar_m_tn
Brent:

SVR rate for transplant patients is generally lower. I had a transplant in 2002, after completing 72 weeks of tx this May the virus came back in less than a month. VL > 50 mln. I too got UND late, at about week 24. I have many complications now. If I were you and if your side effects are tolerable, I would go for another 12 weeks. IMO it is easier to continue than to start all over again. I had to stop because of the family situation.

Best of luck. Jeff.
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338734_tn?1377163768
Thanks for the responses!

Eureka: I looked for a post on this issue because I thought I remembered one on Dr. D but I couldn't find it. Thanks for finding it. I did rember smaug as a potential extender and pm'd him on the subject. Also a re-reading of the article from World Gastro was enlightening. I think I got more out of it than before. Double thanks!

JD: Liz thinks I should stop at 72 but she'll be supportive if I choose longer. Not sure if I feel sorrier for myself or her. Thanks for your support also.

Marcia: I like the way your are thinking. I am thinking maybe extending for an extra 4 weeks or 8 weeks as it goes. This would get me within Dr. D's guideline of treating for 52 weeks after UND, as well. Thanks for the support.

Bill: I am all about personal anecdotal evidence. :-) I think what I need is a shot of your courage. I feel pretty lucky that I have made it to 72 weeks (nearly).

Fretboard: I am registered on PubMed, but not the other link you give. I need to get back on there to read some more. I always love your posts (and monkey business ;-)

Jeff: I am sorry to hear your TX was unsuccessful. But, thanks for the incentive for extension. I think in your situation I would be the first to make your recommendation. Best luck to you, my friend.
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186344_tn?1278268245
I remember drofi talked to the famous German doctor Thomas Berg in person. Drofi was undetectable at week 26. He asked Berg about extending past 72 weeks and Berg supported it. I think drofi did 88 weeks or so in total.

I so want you to SVR, Walrus. I think it would be wise of you to extend. Of course even then there is no guarantee, but hopefully some more weeks will increase your odds yet a bit.
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439539_tn?1233469415
Look at your name.Does that look like a name that would give up without one last smack.Just teasing.I also want to send my strength your way.I'm sure you'll find the answers you need and do what has to be done.I'm pullin for you on this side of the world.
God Bless,
Tammy
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Avatar_m_tn
I am in the same situation UND @24 weeks 84th shot this week -not sure when to stop the DR wants 96
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Avatar_f_tn
thats what I am doing now,   Nov 11 for me was a year, then I stopped one week,  Resumed Jan.

I think Brent we need to do what our bodies will let us,  complications are different,  I know I will not question myself did I do everything, should i relapse,  But I also know I want to know  that i did everything I could to change  the past results.   I want no second guessing here,

Not sure how transplant changes that,  or how infergen does,   But brother  we will go on  till we can't any more.   We have our Elaine kicking our booties!  Along with quite a few others!  
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Avatar_m_tn
I think you take it one DAY at a time. I believe that the longer spent undetectable the better your chance of SVR but there is risk/reward somewhere in the mix - where that is I haven't a clue. I stopped when I felt it was time and I treated before there was much information on extending and none in the transplant population. I chose 73 weeks. It worked for me. I was undetectable per Heptimax at week 12 but I believe I was clear at week 11 or maybe week 10. I tested at week 9 and my VL was in the teens but not again until week 12. I thought 60 weeks undetectable (72 weeks total) would give me the best chance but I had another week of the meds so I did another week. I am rooting big time for you Brent. I really believe for us SVR is very important and I believe you're going to make. I see no reason to think otherwise.
Good luck,
Mike
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619345_tn?1310345021
Brent  that was my brother's name nice name I miss him a lot  Hey I downloaded this information and you may already have it but it is from the last symposium in SF just recently as I most likely could be a non responder being I do not know a lot yet nor as much as the others here I still want to put this up for you to read hope it gives you some info to consider  


AASLD 2008 Annual Meeting

You may print by clicking on this button. To return to the previous page, close this browser window or click the 'X' button in the top right corner of the page.

ID# 1224
Location: West Hall (Moscone West Convention Center)
Time of Presentation: Nov 03 8:00 AM - 5:30 PM
Category: Q07. HCV: Treatment



Extended treatment with peginterferon alfa-2b and ribavirin combination therapy can suppress the relapse rate after treatment of chronic hepatitis C genotype 1 patients with late viral response.
T. Oze1; N. Hiramatsu1; T. Yakushijin1; M. Kurokawa1; T. Igura1; K. Mochizuki1; K. Imanaka2; A. Yamada3; M. Oshita4; H. Hagiwara5; E. Mita6; T. Ito7; Y. Inui8; T. Hijioka9; H. Yoshihara10; E. Hayashi11; A. Inoue12; Y. Imai13; M. Kato6; Y. Yoshida1; T. Tatsumi1; K. Ohkawa1; S. Kiso1; T. Kanto1; A. Kasahara1; S. Tamura14; T. Takehara1; N. Hayashi1
1. Gastroenterology and Hepatology, Osaka University, Suita, Japan.
2. Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka, Japan.
3. Sumitomo Hospital, Osaka, Japan.
4. Osaka Police Hospital, Osaka, Japan.
5. Higashiosaka City Central Hospital, Higashiosaka, Japan.
6. National Hospital Organization Osaka National Hospital, Osaka, Japan.
7. Kansai Rousai Hospital, Amagasaki, Japan.
8. Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Japan.
9. National Hospital Organization Osaka Minami Medical Center, Kawachinagano, Japan.
10. Osaka Rousai Hospital, Sakai, Japan.
11. Kinki Central Hospital of Mutual Aid Association of Public School Teachers, Itami, Japan.
12. Osaka General Medical Center, Osaka, Japan.
13. Ikeda Municipal Hospital, Ikeda, Japan.
14. Minoh City Hospital, Minoh, Japan.

Background & Aim: Chronic hepatitis C genotype 1 patients with late viral response (LVR) to peginterferon (Peg-IFN) alfa-2b and ribavirin (RBV) combination therapy (detectable serum HCV RNA at week 12; undetectable at week 24) show a low SVR rate due to frequent relapse after treatment. We evaluated the efficacy of Peg-IFN alfa-2b and RBV administration for 72 weeks in HCV genotype 1 patients with LVR, compared with that for 48 weeks.
Patients & Methods: This study, conducted at Osaka University Hospital and institutions participating in the Osaka Liver Forum, enrolled 775 patients treated with combination therapy of Peg-IFN alfa-2b and RBV. Among the patients who responded, 48-week treatment was done for 365 with early viral response (undetectable serum HCV RNA at week 12). Among 164 patients with LVR, 86 were treated for 48 weeks (46 males, 40 females, mean age 56.4 ± 9.3 y.o.), and 78 were treated for 72 weeks (33 males, 45 females, mean age 59.5 ± 8.3 y.o.). Relapse was defined as undetectable serum HCV RNA at end of treatment but detectable at 24 weeks after the treatment using the COBAS AMPLICOR HCV test, v2.0 (<50 IU/ml). Drug exposure was calculated as the average dose actually taken during the treatment per body weight.
Results: Among the patients with LVR, the relapse rate with 72-week treatment (37%, 29/78) was lower than that with 48-week treatment (66%, 57/86) (p < 0.001). The relapse rate in aged patients ≥ 65 y.o., which was higher than in younger patients with 48-week treatment (85%, 15/20 vs. 61%, 40/66; p = 0.06) markedly decreased with 72-week treatment (85% vs. 39%, 11/28; p < 0.001). With extended treatment of 72 weeks, the timing of the HCV RNA disappearance showed a strong correlation with relapse. The relapse rate was 16% (6/38) in patients with undetectable HCV RNA at week 16, 53% (10/19) at week 20, 75% (9/12) at week 24 (p < 0.001). Analysis of the relationship of relapse and drug exposure for patients given 72-week treatment showed the relapse rate to be lower in those receiving ≥ 1.0 µg/kg/week of Peg-IFN (Peg-IFN ≥ 1.0 µg/kg/week, 32%, 20/63 vs. Peg-IFN < 1.0 µg/kg/week, 60%, 9/15; p < 0.05), and also for those receiving ≥ 8 mg/kg/day of RBV (RBV ≥ 8 mg/kg/day, 31%, 18/59 vs. RBV < 8 mg/kg/day, 58%, 11/19; p < 0.05).
Conclusion: Extended treatment of Peg-IFN alfa-2b and RBV combination therapy up to 72 weeks significantly suppressed the relapse rate in LVR patients. An earlier response predicts a lower relapse rate in LVR patients given 72-week treatment. Drug exposure to both drugs still affected the viral relapse after the treatment among LVR patients completing 72 weeks of treatment.





Abstract Central® (patent pending). © ScholarOne, Inc., 2008. All Rights Reserved.
Abstract Central and ScholarOne are registered trademarks of ScholarOne, Inc.
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Avatar_f_tn
I have to say I'm with the "take it a day at a time" camp.  I don't even want to tell you what to do ... I guess I'd extend if it was me and my body could take it.  These drugs are nasty and things can change in short order so take it a step at a time, keep an eye on your numbers and anything past 72 weeks is bonus time, Brent. How incredible that you've made it this far post transplant and working throughout all of this and blessing us all here with your humour and spirit. Good luck with your decision and my heart is with you, my friend ... will be doing one incredible happy dance when I get to read your SVR post.  

Trish
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Avatar_f_tn
Well said Trish.  You really have inspired me Brent.  I know how difficult it is to work and try to maintain some semblance of normalicy during this ordeal but you have done it with elegance and determination.  You have remained positive, keeping the focus off yourself and continually trying to encourage others on this board with your kind words and wonderful sense of humor.  Bravo Brent -  you are one class act!!  
You will know when the time is right to stop.  That little voice deep inside is usually right when we stop and listen to it.  Stay well, wish you only the best.
Trinity
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Avatar_f_tn
He def is,  been through a lot,  Mike Simon also, love them both and admire them much dearly!  

Mike nailed it and continues to for me,  think positive, try and not look to the worse, his grand advice to me lately is to drop my motto, hope for the best and expect the worse.

Sky  do take up Mike up on his  offer he is a calm and awesome person to answer questions!
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