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Avatar universal

extended treatment

Hi,

I just came back from my doctor's office (for those who don't know me I am/was 1b, between stages 2 and 3 on my biopsy 3 years ago, high viral load to begin with, 120 IU/ml at 12 weeks, undetectable at 24 weeks).I am on week 39 of Pegasys/Rebetol treatment. I asked my doctor what he thinks about extending treatment beyond 48 weeks and he said it's up to me. He can presribe another 12/24 weeks of treatment at either regular dose or reduced dose. He said that there is no extensive studies done on the benefits of the extended treatment, but the common sense tells him that it may be beneficial to prolong the treatment.

Please let me know any opinions/personal experiences on this subject.

Thank you.

Foreign girl.
39 Responses
Avatar universal
Most of us have heard the claim or theory that whether or not one clears, Interferon has been shown to be beneficial to the liver and some people have experienced a full stage drop in fibrosis after a year of TX.  

When I read about cutting edge stuff whether it's Dr. Cecil or some others, it seems that extending TX is the main thing that these guys do.  

I think it depends on what effects the TX is having on your body.  If you're not anemic or suffering the other blood sides and not severely depressed it might make sense. Another plan would be not to commit yourself mentally  to a certain number of weeks but just do an extra one week at a time and see how you feel.  You might find it easier emotionaly to do it that way.

I asked to do a longer TX after I completed my 24 weeks but I belong to a huge HMO with rules chiseled in stone so they said no.  I think it's great that your doctor is leaving it up to you.   Best of luck. Travsi
Avatar universal
Sorry about mistating your name in the last post.  I've also heard of another variation on the extended TX theme: If someone is not doing well rbc and wbc wise one doctor I read about extends the interferon part of the TX for a while while discontinueing the Riba.
Avatar universal
Thank you for your replies. How are you doing? Have you started new treatment yet?

F.G.
Avatar universal
I'm glad you posted this question - it's been on my mind a lot lately. Along with you and a lot of others on this bus I'm a 1 coming up to that 70% roll of the dice at 48 weeks and wondering whether to push on and if so for how long. I believe I've read extended ranges  from 50 to Mike Simon's heroic 64 in the comments posted here. Obsessive searching (and I do obsess easily) of the medical lit has turned up absolutely no published data to help make this choice. I posted this question on the monitored Hopkins forum but got no response (either the Dr. did not think of it of general interest, or more likely there's no answer yet). I'm trying get a more detailed breakdown of V. Balan's relapse study but all that would show are the characteristics of those who did/did-not relapse at 48.

At the low-level nuts and bolts level, the end-game of treatment remains a mystery. There's lots of tantalising clues but ultimately we don't get it. What happens at end of tx seems to be a replay of what happened at the end of the acute stage of infection  - it has little to do with the meds and a lot to do with the complicated hide-and-seek game the virus plays with our immune response.

Within 12 weeks of when the virus first entered our body our immune system was able to  beat it back down to a very low-level. Then in 20% of people the virus was eradicated and in the rest of us it rebounded and set up permanent housekeeping. Our immune response keeps up  a half-assed attempt at clearing it but all that does is contribute to the build up of scarring. So now the stage is set for a re-enactment, the VL is once again very low, the dice are rolled and ... this time the odds are reversed, only 30% get to "play again".

A very rough approximation based on Balan's data might be that if going from 24-48 weeks reduced relapse from 48% to 28% another 6 months might halve it again. On the other hand there's one line of argument, based on current HIV therapy, that argues that if you depress viral replication enough by meds you're actually undermining the immune response because there's not enough viral antigen around to kick it into action...In short I'm utterly confused, any clues are much appreciated.
29084 tn?1283659640
Hi there, I think just like TravisB said it really depends on your body & how you have handled the Tx so far, if you feel ok & are not excessively anaemic etc then my feelings would be, "Go For It"....  Good Luck .......
Avatar universal
Hi, Foreign Girl,
I agree with Travis.  Think about a 1-week-at-a-time plan.  That way you don't have to feel guilty if you stop, but every week you give it will extend the good probabilities.  Chances are you will be able to carry on for a while longer.  But then keep up the Procrit!
Having had a Riba-vacation, I'm considering going out to 52 weeks.
Maj Neni
Avatar universal
Hello Everyone,

I just wanted to give my comment about extended treatment. My GI wanted to extend mine for another month. I asked him the pros and cons of this. And he stated that there was nothing miraculous about extending. So I asked him to end treatment at 48 weeks. I (Was)A 1A. And am undectable thus far.

Thanks for listening,

Txangelsaunt
Avatar universal
When did you first show undetectable?  I am concerned because I was not clear at 12 weeks (1A) dropped from 576,000 to 6,160, so am starting to toss this extended tx idea around in my head.
ambush :)
Avatar universal
I'm six months post tx and feeling a whole lot better.  In some ways even better than I was before TX.  No, I haven't started tx and am a long way from doing it again.  I'm pretty doubtful about the chances the second time around especially with what are essentially the same drugs.  That's why I feel that if someone has the opprotunity to extend TX they should strongly consider it especially if they are doing ok with the sides.  

Failing TX means that all the physical and emotional suffering was for nothing.  That's why I figure if someone can put in more time while they are already in TX mode, go for it if possible.  Good luck with your decision. Travis
Avatar universal
on an emotonal level, I'd find open-ended tx duration pretty hard to live with. How long do you go on ? and why ? So far I've found the milestones and countdown a big help in getting through the rough times ( get to week 12, then to half-way, then start a countdown..). Just going on as long as you can possibly stand it  with no idea of whether it's doing you any good may be  a good strategy but I'm having a hard time accepting it..
Avatar universal
I have read some stuff about extending tx and the info is pretty sketchy at best. There have been some small studies awhile back that seemed to show that extending tx out to 52 weeks had some benefits but beyond that the risks outweighed the benefits.
In the last year or so I have watched as many doctors have started to take the type 2's and 3's out to 48 weeks instead of 24. It's not the "standard" yet but it appears to be heading that way.
The latest "cutting edge" stuff I read seems to show a new wave of thought that hinges on exactly WHEN you clear and then doing tx for 48 weeks from then.
There is always that little problem with the possible long term toxic effects that the meds can have on us. We ride on the edge when we take these drugs at the levels we need to to kill the virus for an extended time.
I looked at all this myself and decided to do 50 weeks. That was just how my refills worked out. I was looking at a little longer time but I really never considered doing more than 52 weeks. That seemed to balance my desire to give myself the best odds I could but still not take a big chance on having the meds do permanent damage. That was ME. And it worked...for ME. My starting load was not high and all I know is I was clear at 24 weeks....never had a 12 week test.
I like the idea of going a bit longer for type 1's.....but not too much longer. That's just MY thinking.
You have to work this out in your own head and do what you think is right for YOU.
Best of luck whatever you decide.
Avatar universal
One thing I said to foreign girl is not to make it open ended but do one extra week at a time.  When you're running it's not good to think about mile ten but rather grind out one mile at a time.  That's how I am but everyone is different.  

I wanted to do TX longer because I didn't clear at week 12.  Had I cleared at week 12 I probably wouldn't have asked to do more. I tested clear at the end of TX but relapsed 2 months later.

I'm actually not that much of a propenent for TX but I think that once on it, you should do as much as you can to make it a one time thing.  This all depends on how you are handling it.  To me the two main questions are when did you clear and how are you doing in mind and body.  The numbers are not that much better for those that go longer but they sure as hell are not worse.
Avatar universal
I understand in Europe the standard length of tx for 1s is 52 weeks; this was approved by the European Commission. I don't know what they based it on but that's the scoop.

My doctor is considering extending my own tx past the 48 week mark. I would go 52 IF he could point out some evidence this would aid in SVR. I am also worried about the long term effects of the drugs we're all taking.
Avatar universal
thanks for the feedback - if you happen to come across any of the links/references that talk about >48 week therapy please post them: I'm sure they'll be of great interest to all of us trying to pick the magic number.
Avatar universal
I have to add some points:
(1) I was "undetectable" at the first test in week #12
the test was <615 and I had the same result at week #24.
(2) My genotype is most probably 4 which has a better
chance of 67% compared to the 50% of type 1:
http://www.pslgroup.com/dg/222676.htm
(3) My side effects have been minimal except for the
wbc drop that I take Neupogen for.
Avatar universal
I received this email from the HEPATITIS DOCTOR himself today. The fellow who does not follow the cookie-cutter approach to tx and he said:

"With severe fibrosis (stage 3) longer treatment is attractive to me. If you can go longer I think it will improve your chances of cure."

I discuss with my doctor to go 52 weeks (he has already talked about me going a bit longer), or longer, depending on the pros and cons ... meaning the long-term damage these drugs could be doing to me vs. improved odds of SVR.

Take care all!
Avatar universal
I am also stage3 grade 2 geno 1.Have been reading that geno 1's with high viral loads(mine is 5,190,000)are more likely to be non-responders.Also in my case,my gastro said my bloodwork was all normal(except viral load)so he didn't think I would have serious liver damage.He even asked just before biopsy if I wanted to reconsider having it done,and then even after the bx he said the tissue was healthy looking.Then when I got the bx results it wasn,t good.So given these circumstances shouldn,t it be standard that all persons hepc positive have biopsy as soon as possible.
Avatar universal
I want to share with you my experience with trying
treatment extension. I am in the last month of
treatment and asked my doctor to extend the treatment
for one month more to increase my odds.
He did not like the idea and
mentioned something about me being on Neupogen since week #5,
and it would look a bad decision if I get infected in
this extra month. My feeling was, well, I did not have
such problem in 48 weeks so it is a good chance not
to have such infection in these extra four weeks. But
I said to myself, he is the doctor and he must know better
and I decided to follow his instructions and will not take
that strong medicine for more than 48 weeks.
I wish you all the best of luck.
Avatar universal
Hello All, After 48 weeks of Peg-Intron and Riba, My viral load has decreased from 857000 to 15. Hmmmm... My GI wanted me to go on Infergen and Riba for 1 more yr but ,when he sent me to a Hepatologist for a second opinon, the Hepatologist said no. He said NO Riba after 52wks due to unknown permanant side effects and NO infergen because I am not cirrhosed. A new heptimax has revealed that my count has risen to 75. They said "not to worry".
I am still on Peg-Intron at 52wks and have stopped the Riba. A new heptimax was drawn yesterday and I am told if its up...then we will start Pegysis...if its the same or down...we will stay on Peg-Intron at a reduced maintenance type dose to prevent breakthrough. BTW I am 48-1b-stage 1-grade1 and other blood tests are looking good. Any thoughts ? GIPA?
Avatar universal
Hi micro2,

Read your post and just had to comment as I am in a similar situation.  I think your original doc might be on the right track and the Hepatologist you used for a second opinion is....well lets just say you should get another opinion.  

Use of Infergen in tx has nothing to do with the presence of cirrhosis.  It is being pushed as an alternative to the interferon alfa 2a or 2b in cases of relapse or nonresponse.  Its only downside is that it is not available in a peg form so must be injected on a more then 1x per week basis.  This can cause more severe side effects so this drug has been pushed into the backround.  They are working on a peg version.  

In addition, there are no studies showing that use of ribavirin for more then 52 weeks leads to any increase in adverse side effects.  In fact, NIDDK is at present sponsoring a study that will treat patients, who cannot tolerate interferon, with long term doses of ribavirin monotherapy.   Supposed to last 4 years and is a phase IV study.  Look at www.clinicaltrials.gov for more info.

Hope this helps and will be glad to share any other info I come up with with you.

Best to you and hope you are feeling well,
Steve
Avatar universal
you guys might be interested in the following small, recent study that combined high dosage IFN on an induction schedule+riba with extended  (76-week) <a href="http://www.blackwell-synergy.com/openurl?genre=article&sid=nlm:pubmed&issn=1352-0504&date=2003&volume=10&issue=3&spage=205">duration</a>. The results, in high response and low relapse are pretty encouraging - on the other hand 6/24 patients had to be hospitalized...

The hepatologist may simply have been saying that with a  fibrosis score of 1 there's no reason to undergo such dramatic, unproven,therapy - even at 48. Best wishes.
Avatar universal
I have been undergoing treatment for almost 10 months now and after reading other sites, stick only to this one.  I am a lurker - a term I first heard here.  I have laughed and cried with you and appreciated all of the information more than I can say.  No one other than my husband knows about my illness.  I have worked every day and collapsed almost every evening and weekend.  I have met all of my other responsibilities to family, friends and work.  I haven't cleaned my house much, that's for sure.  The thing I wanted to add is that in all the time I have been reading the "flow" of the questions, other than from new folks, seems to be from people who have not cleared the virus, and questions about "what now".  I have to say that is where I am now, having learned last week that I did not clear and hearing what the alternatives are.  I am someone who likes choices and likes to have some control, but honestly, some of these decisions (like switching to Pegasys, or Infergen-be it three times weekly or daily, or doubling up on Peg, or going over 1200 mg of Rib, or quitting and seeing what happens, or doing one or another until Infergen is peglated (sp?)) - are just a bit overwhelming for me.  I consider myself to be somewhat of an "expert" lay person, having read almost all I can stand, but geez, we aren't physicians, we aren't chemists, we are however unfortunate enough to have a disease that is in its infancy in terms of treatment.  I'm sorry to go on but I am being faced with, "here are some options" - and my favorite question - "What do YOU want to do?"  Well, I'd like to stop the madness quite frankly, grow some of my hair back, get my wonderful sex life back, and stop all the associated irritations and infections and many, many medications to deal with them.  But I want to fight the good fight too.  I guess I'm just a bit sad and feeling like I've failed, though I did everything I was supposed to do.  When I read someone say that when you don't clear, you have gone through treatment for nothing, I could cry.  Anyway, after so long reading about all of you, and sending you my love and support in my own way, I thought I'd log on and maybe get some support myself.  Thanks.
Avatar universal
I found the press release on the 12 month treatment but no studies to back up the reasoning for the extra month of tx. The Committee for Proprietary Medicinal Products, I believe this is the supra-European health body, was the agency to make this recommendation.

Interestingly, they are no longer recommending a biopsy.

-------------------------------------------------

Date:  July 18,2003
Sender Name:  PR Newswire

European Commission recognises Roche's pivotal trial in new PEGASYS label for Hepatitis C  
  
Basel, Switzerland, July 18 /PRNewswire/ --

- Label changes set to benefit patients as it relates treatment
recommendations to viral genotype

Roche announced today that the European Commission has approved a new label for PEGASYS (peginterferon alfa 2-a (40KD)) in Europe, as a result of Roche's pivotal study(i) that  demonstrates that the duration of combination therapy and dose of Copegus (ribavirin) for chronic hepatitis C patients depends on viral genotype. This decision is set to benefit patients as they will only continue on therapy for as long as needed to obtain benefit, depending on genotype.

The EC recommends that patients infected with genotype 1 should receive 12 MONTHS OF THERAPY with standard dose Copegus (ribavirin), while patients with genotype 2/3 only need 6 months of therapy and a lower dose of Copegus. The decision was based on the unanimous positive opinion adopted by the Committee for Proprietary Medicinal Products on 24 April 2003.

"We are pleased that the European Commission has approved the label to reflect this new and important data on how best to treat hepatitis C patients who are prescribed PEGASYS and Copegus," said William M Burns, Head of Roche's Pharmaceutical Division. "It's not only a competitive label but one that provides benefits to patients. "

Another change to the label is that PEGASYS combination therapy NO LONGER REQUIRES A PATIENT TO HAVE A BIOPSY confirming the extent of liver disease prior to starting treatment. This is particularly helpful to patients. PEGASYS combination treatment is also the only pegylated interferon hepatitis C treatment in Europe that is indicated for patients with compensated cirrhosis, an advanced stage of liver disease that can lead to liver cancer and the need for liver transplantation.

Excellent Treatment Outcomes

The clinical results examined by the Committee demonstrate that PEGASYS, when combined with Copegus, provides some of the highest sustained virological responses (SVR) ever seen in chronic hepatitis C. New SVR rates included in the label include several firsts.

* Overall, up to 63% of hepatitis C patients treated with PEGASYS combination therapy achieve a SVR - the highest virological response rate included in a European label.

* For PEGASYS patients infected with genotype 1, that is the most common yet one of the most difficult-to-treat genotypes, 52% of patients achieved a SVR - the highest response included in a label for a hepatitis C treatment in Europe.

* For PEGASYS patients infected with the genotype 2/3 viruses, 80% of patients achieved a SVR when treated for 24 weeks and a low daily dose of 800 mg of Copegus.

PEGASYS is the only pegylated interferon with which prospective research has been undertaken that provides for the customisation of therapy according to genotype, and has had the data reviewed and accepted by regulatory authorities. In fact, this seminal research has now been reflected in the US NIH Consensus Conference on the Management of Hepatitis C and it is affirmation of the importance of genotype. A patient's genotype is the most important factor influencing the outcome of treatment.

Roche in Hepatitis

Roche is committed to the viral hepatitis disease area, having first introduced Roferon-A for hepatitis B and then C, followed by PEGASYS in hepatitis C. PEGASYS is also in phase III clinical development for patients infected with the HBV virus. Roche manufactures and sells the Amplicor HCV Test (v2.0) and the Amplicor HCV Monitor Test (v2.0) - two tests used to detect and quantitate the amount of HCV RNA in a person's blood. The company's commitment to hepatitis is further reinforced by the in-licensing of Levovirin, an alternative antiviral. Levovirin will be studied with the objective of demonstrating superior tolerability over the current standard, ribavirin.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 62,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

All trademarks used or mentioned in this release are legally protected.

Notes to the editor:

* PEGASYS was first approved in European Union, just over one year ago, on June 20th, 2002.

* PEGASYS and Copegus have now been approved in over 80 countries, with the latest approval in Australia in June, 2003.

* A SVR denotes that a patient has remained viral negative six months after completing therapy and is considered virus free or 'cured'.

* A biopsy is used to confirm the extent of liver damage (fibrosis).

(i) Hadziyannis, S. et al. "Peginterferon Alfa-2A (40 KD) (PEGASYS) in Combination with Ribavirin ): Efficacy and Safety Results from a Phase III, Randomised, Double-Blind, Multicentre Study Examining Effect of Duration of Treatment and RBV Dose". EASL, 2002.

Contact: Sheila Gies, Roche, +1 973-687-0188 (mobile), Alison Thorpe,
Burson-Marsteller +44 (0)20 7300 6324

Avatar universal
Hi,

Thanks for the link willing, very interesting.  Also, you could be right and as a stage 1 micro2 could be better served by waiting for more proof or other treatments, although, almost having the dragon beat, one just wants to see if the scales can be tipped just a little further....!  I tend to judge by me, aggressive by nature and a late stage 3 who was very symptomatic even before starting tx.  I look at things differently and feel I need to be very aggressive now to get my life back.

Most of my ranting is because of feelings very well expressed by helyn in the previous post.  I feel for you helyn and understand your disappointment, frustration, anger and saddness.  Wish there was more I could do to help.  There are many people on this site who are full of knowledge and many others who are full of support.  By reaching out, I am sure they will come to you and provide info and a shoulder to lean on.

Hope both of you are well as you can be,

Steve
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