24 or 48 weeks?

Anybody ever heard about specific protocol for people like me,or is that sg. new?I doubt ,but want to share with you what my doctor suggested to me this week.Once again my profile shortly:I am on triple Tx/previous 2x relapser and on maintenance Interferon x2 years post last relapse /This tx -detected at week 4 but unquantifiable <25/that first month I had taken about half of my medicine only due to constant vomiting ,being NPO in hospital and NO help from MD  except him telling me to go to ER or quit  TX but I tried to cont  and  did not give up thanks to you r support-which was the best thing I did.Anyway, then  after this terrible 1st months  I finally got rescue meds and was able to keep it  down since. I am still so mad at that doctor for what he did to me..So I was then undetected at 12 and 24 weeks.This week  my doctor said that I can stop Tx now after 24weeks .,he said he confirmed it with Incivek rep.
First I was overly delighted almost shocked I tought it might be sg new but that feeling evaporated by the time I arrived home.First ,he is another GI with poor knowledge and I really never seen protocol to my specific situation .The closest I am is protocol  to treat for 48 wks since I was detected at week 4  ,period.No 'buts'or 'ifs'


Well I told him I am supprised but  scarred to stop and will try to continue now  till i can  esp. since this is my 5th year  on Interferon  and that must be my last one. He just said  well ,that is OK.Then I called Incivek nurse to see if she can give me some input but she had not know anything and said she  will get back to me and also they will call  my MD?
What a confusion .What do you think?If there is any new protocol /reasearch pls let me know.Thanks

[ceanothus]

I'm not able to give you the correct protocol, but I think someone will come along soon who will be able to provide more info. I just wanted to offer my sympathy, as I can really understand your feelings. Treatment is hard, but stopping it is also hard, as it brings up all the fears of whether you did enough, and double so when you have a history of unsuccessful treatment, and triply so when you have a doctor you don't trust! I wish you all the best. BTW, if it was me, I would continue tx at least until getting good answers.

[pooh55811]

If it was me, I would do 48 weeks. Actually, I was DET <43 at week 4 and I did do 48 weeks. I wanted to give myself the best shot at SVR.

This is your 3rd Tx. If you do 24 weeks and relapse you will be very devastated, especially sine you will always wonder if you would have attained SVR if you had done 48 weeks as per protocol.

According to the protocol, previous relapsers who are UND at week 4 do 24 weeks. Those who are DET at week 4 do 48 weeks. The protocol for you would be 48 weeks of Tx.

Your doctor is wrong. Per protocol you should not stop at 24 weeks. You should treat for 48 weeks. In your case you were vomiting at the beginning of Tx and lost some of your doses (which mayor may not be why you were DET at 4 weeks). At any rate, your best chance at SVR is to do 48 weeks.

There were studies on people who were DET at week 4 and did only 24 weeks. The SVR rate for those people who were DET at week 4 and did only 24 weeks was significantly lower than for those who did 48 weeks. I will try to find that information and the link to it.

Hang in there. Tell your doctor he is not following protocol and you need to do 48 weeks. Plus, frankly, I find it somewhat unbelievable that an Incivek rep would tell the doc that you should do 24 weeks instead of 48 weeks (unless the doc left out some critical information, such as you being DET at week 4).  Anyway, the doctor should know the protocol.

Below is the prescribing information for Response Guided Therapy:

"Telaprevir. The prescribing information for telaprevir in treatment-naive patients recommends that all patients begin with a 12-week period of triple therapy with telaprevir 750 mg 3 times daily (every 7-9 hours) plus pegIFN/RBV.[53] Telaprevir should be administered with food, specified as standard or high fat (standard-fat meal would be 21 g, such as 2 ounces of cheese or a half cup of nuts). After 12 weeks, telaprevir should be discontinued and pegIFN/RBV continued; for individuals with an eRVR (undetectable HCV RNA at Weeks 4 and 12), pegIFN/RBV should be continued to treatment Week 24. Conversely, for individuals without an eRVR, pegIFN/RBV should be continued through treatment Week 48 (Table 6). As with boceprevir, it is recommended that an HCV RNA assay with a lower limit of quantification of 25 IU/mL be used for evaluating virologic milestones for response-guided therapy. The prescribing information notes that treatment-naive patients with cirrhosis may benefit from receiving the longer duration of 36 weeks of pegIFN/RBV (ie, 48 weeks of total treatment), even if they achieve eRVR. For cirrhotic patients, it will be important to weigh this recommendation with tolerability on therapy and any significant adverse effects.

The response-guided therapy strategy with telaprevir is based on the results of 2 phase III trials in treatment-naive patients. Results from the ADVANCE trial strongly suggested that 24 weeks of therapy is sufficient for patients with eRVR.[29] In the T12PR48 arm of this trial, patients with an eRVR received 12 weeks of triple therapy followed by 12 weeks of pegIFN/RBV, whereas patients without an eRVR received 12 weeks of triple therapy followed by 36 weeks of pegIFN/RBV. Among patients who achieved an eRVR and received 24 total weeks of therapy, the SVR rate was 89%, confirming that this strategy results in a very high SVR rate (Figure 11). The robustness of response-guided therapy was confirmed by the ILLUMINATE trial, in which treatment-naive patients with genotype 1 HCV who achieved eRVR after 12 weeks of telaprevir were randomized to receive either 12 weeks or 36 weeks of pegIFN/RBV, for a total therapy duration of 24 or 48 weeks, respectively (Capsule Summary).[30] Among patients with eRVR, 92% achieved SVR with 24 total weeks of therapy vs 88% with 48 total weeks of therapy. Patients who did not achieve eRVR all continued pegIFN/RBV through Week 48, and 64% attained SVR (Figure 12).

Telaprevir. The prescribing information for telaprevir in treatment-experienced patients differs according to previous response category.[53] For previous relapsers, the response-guided regimen is identical to that for treatment-naive individuals: All patients begin with a 12-week period of triple therapy, after which individuals with an eRVR continue on pegIFN/RBV alone to treatment Week 24, whereas those without an eRVR continue pegIFN/RBV alone through Week 48 (Table 6)."

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%204.aspx

[8nickers8]

Then why are you not with a hepatologist who knows his/her stuff?

[can-do-man]

You might want to print this off and give it to your doctor and ask him what makes your case any different from the trials of Incivek, there could be a reason why vertex told him that... Best to you.


In clinical trials, HCV-RNA in plasma was measured using a COBAS® TaqMan® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 10 IU/mL.



For the purpose of assessing response-guided therapy eligibility at weeks 4 and 12 (see Table 1), an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCV-RNA result.

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm

[Idyllic]

It seems as if more an more here lately I am hearing some doctors encourage patients (other than treatment naive) to treat 24 weeks IF they are eRVR.

You however were not eRVR so as Can-do suggests, I think I would want to see evidence (other than his clinical experience) that supports the odds are equally in you favor.

Look I am sorry this is happening. The good thing is you have prior treatment experience and familiarity with Triple so you understand the lvel of your doctor's expertise is limited. Is there another doctor who can follow you and treat your side effects?

If so then all you need to worry about is convincing your doctor that based on present, available data you prefer to adhere to the Incivek Treatment Protocol. This might be a little out of your comfort zone but I encourage you to do it.

If you were eRVR I might think different - but I am Prior partial who is eRVR and I would not treat only 24 weeks. I just have seen too many people relapse lately who deviated from the standard practice. I don't just mean on here either: I mean in my personal life - people I have met over the years.

Best of luck

[Dee1956]

Naya I am so sorry for your trouble.  I am sorry you have such a lousy doctor.  It is so frustrating to be on tx and find out your doctor is no good
I am praying for you.

You are right, you have to be UND at 4 and 12 to only do 24 however saying that perhaps the doctor knows something we don't?

Best wishes

[Naya888]

Thank you all for your responses which just make me ensured i am doing the right thing.I will  still call Incivek nurse and see why their rep is giving  my MD this info. This is already  my second doctor,just having bad luck with them and it is soo frustrating ,now  i am still  waiting  to get set up with hepatologist in Tampa.  Good luck to you all

[pcds]

Wonder why no test at 8 weeks.  Why not call Vertex, incivek helpline.  My concern for you is that you missed a number of doses.  More then a few I presume.  That would make a difference possibly.  When I started treatment with a good doc that did trials with the new drugs, he said if I was undetected at 8weeks, if not at 4weeks, I would do 36 weeks total.  I never had to do that because I was undetected at 4weeks.  Just a bit of information.  Since you have done this 2 other times, I guess you were able to manage this horrible treatment.  I barely survived it myself.  Good luck in whatever you decide.  I would suppose treatment protocols have modified with so many people now having completed treatment.  Those of us first out, like me, were guinea pigs in a way.  You could possibly get a second opinion?

[can-do-man]

"Wonder why no test at 8 weeks."

There is nothing in their guidelines that call for an 8 week PCR, and sure nothing about a 36 week treatment with incivek. So one would wonder what drug your doctor was talking about.

[coraggio]

I would think the only reason someone would be on maintenance interferon is because they have cirrhosis.  If that is the case you probably already know those who have cirrhosis have less odds of attaining SVR, even with triple therapy.  Having advanced liver disease or cirrhosis and not being UND at wk 4 are two factors working against you.  The Vertex treatment guidelines clearly state if not UND at wk 4, treatment duration is 48 wks and they also state those with cirrhosis may benefit from 48 wks.  They can't say those with cirrhosis WILL benefit from 48 wks because not everyone will go on to SVR, regardless of how long the treat but it seems in your case the longer treatment duration will give you every opportunity at attaining SVR.  If it were me, I would not think twice about doing the 48 weeks.

[Idyllic]

This sounds like the treatment protocol for Boceprevir rather than Teleprevir. Not sure where the whole 8 week/36 week treatment duration notion as far as ★Incivek★ is concerned. Sounds like either you or your doctor may be mixing up the two PIs....

In general, with Boceprevir (Victrelis) treatment duration is determined at week 8 (along with a few other caveats):
http://www.medhelp.org/user_photos/show/284656?personal_page_id=1282072

Likewise, with Teleprevir (Incivek) treatment duration is determined at week 4 (again, with a few other caveats):
http://www.medhelp.org/user_photos/show/288854?personal_page_id=1282072

[jules2551]

I think we should be nice here!  That was not cool at all PCDS

Jules

[pooh55811]

We are not all the same genetically. Some people will attain SVR even with dose reductions and/or shortened Tx time (especially CC). Some people will not attain SVR with treatment regimen alterations (especially TT). Interferon response plays an important part in whether we SVR or not. The studies show that people who treat with the recommended protocol/regimen have a significantly higher SVR rate.

So yes, depending on genetics and other factors, some of us may SVR with altered Tx regimens. But a higher percentage of us may not. More people SVR with the recommended Tx regimen than without it.

Since we usually do not know all genetic factors in advance, each person needs to ask himself/herself if it is worth the gamble to guess if he/she has the genetic factors necessary to SVR using an altered Tx regimens.  Big gamble, in my opinion.

[Naya888]

I had no cirrhosis at that time but just relapsed after 6month of tx with Pegintr/Riba and it was believed  based on reasearch that HCV pts might  benefits from low dose -90mcg Pegintron/weekly  maintenance therapy to prevent futher damage till new drugs will come out.This study turned out not to be very effective after all just kept viral load lowered  and It was no longer practised.Anyway, thanks for your comment however I am not that naive not to know whats best for me,I am just not always uptoday on the newest reasearch,that was the point of my quèstion

[Naya888]

Thanks ,as  I mentioned earlier I called Incivek last Wednesday ,day I had appoint with my MD.They said they will talk to my MD also and call me back.I will let you know ,however I do not expect any suprises as I never heard anything different than 48 weeks for my case although I am not always up todate ,but it is now enough I got confirmation from many people on this forum who know more than me And as I said lots of things could've been done from my  so called liver specialist whom I tought I can trust but he only made everything he could worse for me Take care

[nygirl7]

I thought it was proven that maintenance Interferon didn't do anything years ago?

I'm pretty sure about that.

[Asuncion]

I think it is a good thing to question your doctor. I am looking for a new one since I lost faith on the last one. He told me I could take Incivek with no fat. He said he had access to the newest research and that he knew it was no longer necessary to eat fat with Incivek. I called Vertex and they told me that fat was very important and that no research they knew about had proven otherwise.
So, I think it is wise to have a second opinion on anything that you feel is not standard procedure.
It was a good thing I hadn´t begun therapy.
Good luck in whatever you decide.

[coraggio]

NYgirl7, you hit the nail right on the head.  A regimen of maintenance interferon was shown to be ineffective years ago.  Don't know when Naya888 relapsed and was put on maintenance interferon but if it's been within at least the last 3 or 4 years her doctor is not up to date and I'd be looking for another doctor.  Naya888 has not had a biopsy in 10 years, which showed stage 2 at the time. Seems like the doctor would have wanted another biopsy or he might be one of those doctors that thinks he can tell if the fibrosis has advanced from palpating the liver. :)

[Idyllic]

I think the OP just condensed her treatment history for the sake of brevity.

It looks like her first treatment & the Pegintron Maintenance was 7 years ago. She stayed UND 6 months & then relapsed.

She says she had biopsy 7 years ago and an US every 6 months and the results are "grossly unremarkable." I 2nd the bit about the biopsy however she is in the middle of treatment now . .  . .


http://www.medhelp.org/posts/Hepatitis-C/stage-3-with-hep-c/show/1765407#post_8112112

[child24angel]

Maintenance therapy was found ineffective in 2007
with the HALT C studies.  My son was then taken off
the 1/2 peg a week.

All my best
Elaine

[coraggio]

I guess Naya888 is confused about when she had her biopsy and what the results were.  I don't think stage 2 is grossly unremarkable but it doesn't matter now as she is currently undergoing treatment.

http://www.medhelp.org/posts/Hepatitis-C/Hep-c-tx-with-Incivek/show/1727742#post_7916450

Naya888  
May 02, 2012 .To: HectorSF.Hi there I appreciate you see this poor care I am getting as I said I did constantly called the office with no response and when I had an appointment I did confronted him calmly and at the end he reffered me to psychiatrist.So I guess when you complain for reason you are mentally ill.I am already looking for someone else.He did milion tests before my tx but no biopsy.My last biopsy was 10 years ago stage 2,fibr.1.He ordered MRCP which showed nothing specific.I am so tired of these lousy doctors I was toldhe is the best.My first appointment lasted 2 mins I should look for someone else earlier before I got so sick.I also got very scared about my failing kidneys now labs are normal I suspect some weakness there will watch it closely .

[nygirl7]

When I went to Dr. Jacobson in NYC my first appt was two hours.

Something is very wrong here even with a GI it should be a LOT longer than two minutes.

[Naya888]

My maintenance with Interferon was 2005 -2007.Anyway,thank you all for your comments I always learn sg.new from you.In short, this Tx has been mess from the beggining ,however at the end I can blame myself only,I trusted  my doctor and not educated myself enough before the Tx.What was done was done I am concentrated on my future now.