What is the longest "break" from triple resumed with success?

[HippyHal]

As you know, my Dr. told me to stop taking my meds on Friday evening.. I was UND at 4 weeks, just finishing my 8th week, starting 9th.  If I talk her into it, does taking that 2.5 day break from Friday night until Monday morning really affect anything in the long run?  Just curious if anyones doctors had them stop for a short period to address other issues, then restart the triple (with Incivek)..

thanks!!!

[stormy456]

I'm fairly certain that you cannot re-start INC once you've gone off.  I'm sure someone will chime in with specific info.  What I do wonder, though, is if you can resume the IFN and Riba.  It stinks that they gave you the instruction to stop on a Friday with no further direction, must be a tough weekend for you.  Hang in there, Hal.

[hrsepwrguy]

2.2 Dose Reduction
To prevent treatment failure, the dose of INCIVEK must not be reduced or interrupted. Refer to the respective prescribing information for dose modification of peginterferon alfa and ribavirin [see Warnings and Precautions (5.7)].

• Do not stop taking INCIVEK unless your healthcare provider tells you to. If you think there is a reason to stop taking INCIVEK, talk to your healthcare provider before doing so.
• If your healthcare provider tells you to stop taking INCIVEK, you should not start taking it again even if the reason for stopping goes away.

http://pi.vrtx.com/files/uspi_telaprevir.pdf

[HippyHal]

I cannot tell you all how PO'ed I am..

I just got the results letter in the mail on Saturday (after the call to stop of Friday) and the Dr's note reads:

"These are stable for you.  The mild increase in the bilirubin is likely due to the hepatitis medications.  We can just follow this for now."

WTF!!!????!!!

Now I am even more confused and angry..  maybe if I can at least restart the riba and interferon on Monday, I will increase my chances of SVR..  in either case, they are going to get a serious Q&A period and a potential Dr. change..

[orphanedhawk]

My first reaction is to scream ~sue!
At the very least let them know just how angry you are and more so what they may have potentially done.

This underscores how important it is to have the best experienced hepatologist we can find.

I think restarting SOC could work. This virus and our reactions to tx vary so, why not try it.
But you really should find someone you can trust to oversee your care,not these clowns.

[hrsepwrguy]

There have been people who had to stop incivek early and still reached SVR, restarting the SOC meds should not be a problem but it is best to follow the advice of a doc with expirience treating HCV

Study 108 (ADVANCE)
Study 108 was a randomized, double-blind, parallel-group, placebo-controlled, trial conducted in treatment-naïve subjects (had received no prior therapy for HCV, including interferon or pegylated interferon monotherapy). INCIVEK was given for the first 8 weeks of treatment (T8/PR regimen) or the first 12 weeks of treatment (T12/PR regimen) in combination with Peg-IFN-alfa-2a/RBV for either 24 or 48 weeks. Subjects who had undetectable HCV-RNA at weeks 4 and 12 (extended Rapid Virologic Response [eRVR]) received 24 weeks of Peg-IFN-alfa-2a/RBV treatment, and subjects who did not have undetectable HCV-RNA at weeks 4 and 12 (no eRVR) received 48 weeks of Peg-IFN-alfa-2a/RBV treatment. The control regimen (Pbo/PR48) had a fixed treatment duration, with telaprevir-matching placebo for the first 12 weeks and Peg-IFN-alfa-2a/RBV for 48 weeks.

In the T8/PR group, the overall SVR rate was 72%. The eRVR rate was 57% and the SVR rate for eRVR subjects was 87%. The SVR rate for no eRVR subjects was 52%. More subjects in the T8/PR group experienced virologic breakthrough after Week 12 while receiving peginterferon alfa and ribavirin alone, 16% compared to 10% in T12/PR group.

[Willy50]

When i read this thread I get a different vibe than having skimmed this thread;

http://www.medhelp.org/posts/Hepatitis-C/Week-9--The-747-just-crashed--/show/1688939#post_7717250

" Friday, after my 8 week big labs (and getting 3 liters of fluid removed from my belly) they originally sent me home to continue.. "
=============================

That suggested to me that you have advanced liver damage (I dunno if that is correct) and that the stoppage of TX was due to concern for your health and well being.

Now you are posting and the thread suggests that you were fine and were taken of TX for little reason.  

I myself don't know the answer, not about your health, not about your health while on TX, I don't know about how well you were/ were not responding to triple therapy.

If you are seeing a specialist, I would think you can trust them.  There is a part of interpreting your posts that makes me wonder if there is a less experienced vibe I am getting of your doctor.  I don't know if that is fair though.

The idea of replying by mail in something so time sensitive does not make sense to me.  You are at a critical phase of your treatment and now you have effectively ended the PI phase, and should not restart it, per Vertex and per everything I have read about resistance.  A phone call would have been better; perhaps a letter provides a paper trail and proof.

My sense if that if you restart the PI you may have increased resistance issues; they may become less effective.  IF you were to finish treatment and succeed that would not be an issue.  if you were to retreat and fail, it could be.  As it is it may simply mean possibly diminished effectiveness of this third component of treatment.

So far as restarting just the SOC, it probably isn't an issue or a big one; you may be able to continue with it if tour response was good and early, it may be sufficient for a treatment success.

I would call your doctor and review your options on Monday.  I think sometimes the mark of a better doctor is how they respond when things don't go well and according to plan.  I'm no doctor and not familiar with your medical history or labs and so I  can't/ wouldn't make a recommendation as to what you should do.

You are certainly within your rights checking in with the 24 hour vertex nurse, formulating a plan and running it by your doctor and seeing if you can continue with SOC.  I doubt that anyone will give you a thumbs up on continuing Incivek, but I also have seen doctors treat "off label"; against recommendations and treatment design.  What good it would do is yet another question entirely.

best,
Willy

[HippyHal]

Willy,  I can understand your confusion with the posts.. in fact, that is exactly what I am.. confused.

I took the 8 week labs on Thursday and went to go over them on Friday.  While I was there, they said.. you have fluid on your belly.. we need to remove.  While they did that, they also re ultrasounded my liver.

Then, they told me (around 2:00pm) to go home and continue.  I took my 3pm incivek and then took at nap.  At 5:45, the NP called my house and said in conversations with the Dr. they were worried that the treatment was harder on my liver than I was able to handle and to stop treatment.   I got it together enough to ask a few basic questions.. but was pretty stunned, especially since I was good to go at 2pm.

Then, on Saturday, the normal lab letter that sends you the written confirmation for your lab results shows up.. and says they will "just follow this for now"  Meaning when the Dr. read the labs the first time Friday and signed off on them.. she was ok.

I just need to know what flipped their trigger between 3pm and 5pm that made them change their mind?  The fluids they removed had no infection, no indication of anything other than "fluid", so it was not that "per se"  

Were they just being overly cautious?  avoiding a potential problem for real? imagined? I just dont know at this point and cannot do a damn thing about it until Monday.. sorry to sound confused and frustrated, but that is exactly where I am at right now..  with no real answers..

Best regards, and thanks to all for your support.. will get through this just like everything else...  God Bless!

[flcyclist]

I'm also a bit confused.  It sounds to me like your doctor, after evaluating your current situation with the fluid on the belly, reviewing your ultrasound and possibly some additional consultation made her decision for you to discontinue trt.  The letter was based on your Thursday labs, which your doctor reviewed and signed off on.  These events on your visit on Friday appear to have led your doctor to make this difficult decision.  Hope your discussion goes well at your next appointment.   As mentioned above, several have had to discontinue the Incivek, so perhaps continuing with Inf/Riba will be an option to discuss.  Good luck.

[Advocate1955]

I may have missed this in your posts, but is your doctor a hepatologist or a gastroenterologist?  The sequence of events makes me wonder if there was a miscommunication between the NP and the doctor?  Is there an on-call doctor in your doctor's practice that you could reach today?  I agree with the others above, it would be dangerous to re-start Incivek after 2 1/2 days off without specific doctor authorization based on the prescribing information.  But I also agree that if, in fact, there was a miscommunication of Friday or an overreaction to the series of events that led to the doctor's decision to stop treatment, you may be able to do SOC and stay UND, if your doctor agrees.  I think I have read of several people currently on triple tx needing to have fluid drained but still continuing on therapy.  
Advocate1955

[orphanedhawk]

Here's my guess.
They don't recommend people with decompensated cirrhosis to do tx.
Ascites, the fluid they removed, is a clear sign of decompensated cirrhosis.
Maybe this is why they think you should stop tx?
What makes your situation even more confusing is the fact you were und @ week 4. This isn't very consistent with having decompensated cirrhosis.

HH~ Was your belly swollen that you could notice?
When mine was quite swollen, they removed the fluid simply with diuretics, which didn't take more than a few days. It's less invasive.

I still think you need a new hepatologist.Someone experienced with advanced liver disease as well as hep C.

[lapis]

I know you are distressed with this turn of events.  I looked back at your old posts and you said you had "some degree of cirrhosis, not sure what stage."  In your 747 post you said

they "hope" (are you freaking kidding me???) that my liver returns to pretreatment capabilities

It seems to me that your doctors are concerned about your well-being and did not want to do any harm.  Did they overreact to something?  No way to know, but hopefully you will learn the answer to more of your questions tomorrow.  I would want to know if they saw something on ultrasound or labs that concerned them, how did they make the decision to stop tx, and what your options are.  If you're going to restart it should be ASAP, of course.

Meanwhile, you have completed 8 wks of Incivek plus SOC and you were UND, and that is good!  Hopefully you can start back on SOC tomorrow and continue this trend towards SVR.  Since you did have an interruption of a couple of days, maybe you could get your doc to do a viral load after your first week back on SOC, that might be reassuring.  You can't restart the Incivek but remember that in the trials an 8-week dosing of Incivek, compared to the 12-week dosing, was just a few percentage points behind in SVR's.  

Also I agree with the others, if treating doc isn't a liver specialist you might want to get another opinion, since you have cirrhosis and that complicates tx.  Really hoping this works out okay for you.

Lapis

[AjaLee]

So  sorry  to  hear  that.  What an  awful disapppointment.  Just a thoought - maybe the letter was sent  before all  of the other things that caused them  to rrrreecommend stopping, and you    just didn't get it?  It IS snail mail, after all.

As a  total aside, you said " said in conversations with the Dr. they were worried that the treatment was harder on my liver than I was able to handle and to stop treatment."   A lot of my being able   too   stand  gooing throought this   ttttrriple  treatment, was that I  was at least giving my liveer a chance to  reejuvenate   itself, even  if I didn't get SVR.. This statement sounds like that was a mistake   on  my part and I   could even   be making things worse.  Areeee there  any studies/reeports/anecdotes about this.

Again, hope all work outs weell  for you.