Incivek duration?

[Johnee1]

Has anybody stayed on Incivek longer than 12 weeks?  If so, what were results?

I am Geno Type 1a  Hep C foe 30 yrs. VL 11.4 at start of treatment.  VL 470 @ 27 days after first shot.

Little sx so far. Tired, shortness of breath, slight rash. All manageble so far.

[Dee1956]

Hi day late dollar short Dee
When I got to 12 weeks nd was not well my physician said not many could go past 12 weeks.
He had many people drop out at 3 weeks.,
I am still plugging along.  Wait til your get closer to 12 weeks, see how sx hit you.  Everyone is different I had every side effect and it was difficult. much harsher than the triple drug trial I did in 2008
Good luck to you
Dee

[Johnee1]

Thanks Horse, I'm good to go.  Just tryin to get an edge.....lol....always scammin'........bloodwork tomorrow.

[hrsepwrguy]

I was still detectable at wks 4 and 6, didn't have an 8 wk test but was UND at 12 wks and I am a 48 wk guy myself, hang in there there is a good chance you will be UND by wk 12

[Johnee1]

I don't care about the cost.  My insurance company *****. This is my life I'm talking about.  I'll find a way to pay for it if I have too.

[Johnee1]

I'm at week 9 now and I don't have very many sx.  I'm treating the rash with hydrocortisone cream and moisturizure.  Very tired at times but i take naps. And I'm working 6 days a week still. If I thought and my Dr agreed that staying on Incivek for a few more weeks would help me,  I'd do it in a minute.  I will use anything possible to help me clear this virus.  I don't care what it is.  I have suffered way more at different times in my life than so far on this triple treatment.  In fact, it's been a piece of cake compared to other stuff I've been through.  Thanks for all the responses.  I'm getting an education for sure.

[Willy50]

I have not seen other trials in which telaprevir was used in longer dosing periods.  Prove 3 is the only one I've seen.  I took a look at the tibotech sponsored trials and didn't see any, so the only data I've seen came from the better known Vertex sponsored ones.

In Prove 3;
http://www.hivandhepatitis.com/2008icr/aasld/docs/111108_a.html

• A total of 224 patients discontinued therapy prior to week 24:

    • Due to stopping rules: 72% in the PR48 arm, 28% in the T12/PR24 arm, 50% in the T24/P24 arm (this was the TVR and IFN; no riba-willy)  and 49% in the T24/PR48 arm; (this last one is 24 weeks of TVR w/ SOC-willy) ((Stopping rules-I believe this would be due either to non-response or viral breakthrough-willy))

    • Due to adverse events (AEs): 4%, 7%, 8%, and 22%, respectively.


(you'll note that nearly 1/4 of the trial participants had to stop *at some point* and never finished the full TX.  Adverse events doesn't mean; "i was uncomfortable; more like serious ER type interventions where there was no choice other than to stop TX or risk serious damage to the patients"-willy)

Factor in this....... there is information that most of the wild type HCV virus that telaprevir (or other protease inhibitors) excel at combating is largely gone in 10 days.  the remaining viral load starts to be replaced with other more fit and resistant virii strains.  For this reason 12 weeks is barely required; actually overkill for most people. You might as well be taking an antibiotic hoping it will work as a PI since it is targeting a strain of HCV which probably no longer exists in one's blood serum.

willy

[copyman]

Like the others said risk & cost outweigh the benefit.The PI's main purpose is to kill the virus fast. Usually within days. At 12 weeks the PI hopefully has kept the virus dead. Then the SOC drugs riba & inf finish the job to achieve SVR.

[dointime]

Back in the trials I believe Andiamo did 24 weeks or near to.  He got to SVR.  

But I agree with what the others have said, 12 weeks is plenty.

dointime

[lupette]

Some of the early trials, that were conducted in Europe, went beyond 12 weeks. I don't remember exactly how long or the specifics right now but I can tell you that the rash became a VERY significant issue and almost kept the drug from getting to market. There were some cases of Steven Johnson Syndrome and DRESS that were horrible to read about. Eventually, they learned how to manage the rash better, and they shortened the treatment to 12 weeks. (At first they treated the rash like it was a pro tease inhibitor rash, similar to the ones AIDS patients on treatment get. The treatments didn't work and may have made the rash worse. Eventually they learned that plain antihistamines worked much better.) The shortened treatment and the antihistamines, made the treatment safe enough to pursue.

[Johnee1]

Yes, I've been taking it since the beginning and monitoring it.  Bloodwork Monday and i'll see where it's at.

[flcyclist]

One thing to have checked if you haven't already considered is your Vitamin D level.  I had mine checked after reading on this forum and learned that I was deficient.  There are several positive benefits to taking Vitamin D if your levels need to be supplemented.  

http://www.hivandhepatitis.com/2010_conference/easl/docs/0518_2010_b.html

www.viraled.com/modules/info/files/files_4dbeda6600d27.pdf

[Johnee1]

I agree bikeman, not worth the hassle for such a small %, if that is even correct.  I just thought if the sx were not that bad, to do it for another few weeks might be worth it, but it looks like it's not.   Just trying to improve my chances any way possible.  thanks

[flcyclist]

Unless the 2% is statistically significantly different, the 2% difference might be meaningless.  I haven't read the studies, but it depends how the test was designed and if it was a head to head comparison.

[Johnee1]

My insurance company aint paying for it now so that's not a even a concern.

[Johnee1]

It is actually 2% better according to the Prove Trials.

[Willy50]

It hasn't been tested otherwise, the results would be the same on tx experienced versus tx naives, no doctor worth their salt is going to prescribe it and your insurance won't pay for it anyway.

not on a boat, not on a goat, not on a train, not in the rain,
not in a trial or in a red sweater
24 weeks just isn't better!!

willy

[willbb]

If you mean a trial with naive"s that did 24 tela...no .The prove 1 and 2 were both naive"s  tela 12  and then prove 3 was tx. exp.  where there was a tela 24 arm...
Best ..
Will

[Johnee1]

Is there a Trial with naieve patients?  never been treated before?

[Johnee1]

Thanks Will , exactly what i was looking for.

[willbb]

There is no benefit whatsover with incresed risk of  adverse events

Best.
Will

Final PROVE 3 SVR Results   Arm 1:
12 weeks of telaprevir, Peg-IFN & RBV, followed by 12 weeks of only peg-IFN & RBV*

  Arm 2:
24 weeks of telaprevir, Peg-IFN & RBV, followed by 24 weeks of only peg-IFN & RBV*

  Arm 3:
24 weeks of telaprevir & Peg-IFN (no ribavirin)*

  Arm 4:
48-week Control Arm of Peg-IFN & RBV*

Prior Nonresponse1   39%   38%   11%   9%
Prior Relapse2   69%   76%   42%   20%
Prior Breakthrough   57%   62%   36%   40%
All Patients   51%   53%   24%   14%      

Read more: New England Journal of Medicine Publishes PROVE 3 Trial Showing Telaprevir-Based Regimens Significantly Increased Sustaine - FierceBiotech http://www.fiercebiotech.com/press-releases/new-england-journal-medicine-publishes-prove-3-trial-showing-telaprevir-based-regimen#ixzz1ee6hfy1X
Subscribe: http://www.fiercebiotech.com/signup?sourceform=Viral-Tynt-FierceBiotech-FierceBiotech

[Johnee1]

Looking for someone who has info on people treated longer than 12 weeks on Incivek is my ?  thanks

[Johnee1]

I have that info but it doesn't say anything about longer than 12 weeks.  I'm a 48 week guy looking to improve my chances.  And for the record, my insurance company *****.....lol....

[Johnee1]

thanks