Well than I did an extra 24 weeks for nothing.

Incivek protocol/treatment duration/futility rules/PCR testing

Jan 19, 2012 - 0 comments


2.7.1 Duration of Treatment in Treatment-Naive Subjects
In subjects who have had no previous treatment for HCV (treatment-naive), treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks.
Subjects with undetectable HCV RNA at Weeks 4 and 12 receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
Subjects with detectable HCV RNA at either Weeks 4 or 12 receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
HCV-RNA levels should be monitored at Weeks 4 and 12 to determine treatment duration.
Treatment with telaprevir should be discontinued in subjects who do not have an adequate viral response during treatment.

2.7.2 Duration of TreatmentPreviously Treated Subjects
In subjects who have had previous treatment for HCV, treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks. Subjects who had a partial response to previous treatment (partial responders) or minimal response
(null responders) to Peg-IFN plus RBV receive an additional 36 weeks of Peg-IFN and RBV treatment alone for a total treatment duration of 48 weeks.
In subjects who had relapse after previous treatment to Peg-IFN plus RBV, a responseguided regimen is recommended.
Subjects with undetectable HCV RNA at Weeks 4 and 12 of telaprevir-based treatment receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
Subjects with detectable HCV RNA at either Weeks 4 or 12 of telaprevir-based treatment receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
Telaprevir must be dosed with Peg-IFN and RBV to prevent treatment failure

I have left a message with my doctor's PA. I have most of this information boiled down in an email that I will send to her once we talk on the phone.

I deserve to have this answered appropriately, and I will let you guys know the response.

Thanks again for all the support.

Bob

Bob I am only telling you about my experience with my doctor and my treatment.Maybe also you could call the incivek people and see what they say.

Bob sorry that you're dealing with all of this. How crazy to be here but I think Mike's idea about calling the Incivek people is a great one. I don't know the answer but many people are told different things by their physicians and some get misinformation or a lack of information. You don't want what you did to not count. I hope that you get the answers that you deserve.

Ozzie, understood truly. I'm done. It was just more of an experience for some of us behind the scenes than we ever bargained for. Many of us were not prepared for the experience due to our health care teams ill-preparing us for it. Yes I was caught up in it and on it before I truly knew all of the factors that I should have been told. Many here withheld the truth from members historically before I ever started here, which was not at all helpful IMO. Seriously if you've started you have to plow through it. I certainly did for 32 weeks. For the many that have not started with orals coming, it's important that they know it was not at all easy. I was pissed two days ago and I mean truly pissed. I hadn't even shared all that I experienced and I've bad mouthed it lately you're right. It's just not something to consider lightly unless one truly cannot wait. I apologize to those on tx but for the many who have not started and might now focus on healthier living to wait it out...you're welcome. Anyway point well taken. I'll be done with my venting about the drugs. Best to you and didn't mean to upset you.

Well I've spent several hours on the phone - I spoke to the Incivek nurse, my pharmacist as well as my doc's PA. None were able to give me a correct answer, and the PA seemed to either be making stuff up or lying. I finally sent the doc a fax because they would not allow me to send an email due to HIPPA.

At any rate, the doc just called me back and seemed embarrassed, but said I was correct, and that the protocol is to continue for 48 weeks. Part of me is completely bummed, I've had my hopes up only to get shot down. But I don't want to go through this for naught.

So, I'm going to do shot #23 tonight, then see if I can find a big enough tub of ice cream to make me feel better.

MrOso I'm glad you stayed in there and got verification from your dr as to the treatment plan and protocol. Drs are human too and sometimes they make mistakes. At least he was willing to correct it before it was to late. Even though you are discouraged about having to go another 24 weeks I'm glad you question the plan and pinned him down on the treatment. Don't forget there will be an end date and we are going to celebrate big time for you.

Meanwhile enjoy that big tub of ice cream! You deserve it MrO!

Sorry Bob but I did not want you to short change yourself.

Bob, great catch on your part. You have a reason to be bummed for sure but it is best that you did not waste the time/pain invested.
I feel for ya

Yes Bob, good thing you questioned it. It's very disappointing tho. I went through a similar thing of being told 24, then it changed to 48. but I'm done now, and before you know it, you will be too.
Come on Mr O grab your shot & your sled, & let's go to a mountain & have a shot party.

Reference Reply #18:

You didn't do those extra 24 weeks for nothing. Here's the thing:

You're saying that only a VL of "0" counts as UND, and that anything other than zero requires 48 weeks of treatment. And I agree, that IS the protocol.
BUT we also know that your lab tests can come back as UND even if you still have a small amount of virus (less than the detectable amount of 7 IU/mL) in your system.

So if you can still test UND with a VL of 6; or have a VL of 7-25 at Week 4 and still SVR after only 24 weeks of treatment; then I would say there's a fair bit of fudge factor there.

If you take 100 people that all tested UND at Week 4; then some of them actually have a VL of "0", and others have a VL somewhere below the detection level of the test; but all are "UND".

Look at it another way: if a person with a VL of 6 tests UND at Week 4; and a person with a VL of 7 tests DBLOQ at Week 4; who can say for sure that the person with a VL of 6 will be cured in 24 weeks; or the person with a VL of 7 must do 48 weeks?

My doc didn't follow the protocol to the letter...
I had a DBLOQ at Week 4 (VL between 7-25).
UND at Week 8
UND at Week 12
UND at Week 24 (stopped treatment)
UND 12 weeks after treatment
UND 24 weeks after treatment (which is an SVR cure)

I'm not saying every doc would make the same call, or that it's always the right call. But I'm living proof that you don't have to be UND at Week 4 - or absolutely do 48 weeks - to be cured. It's a judgement call for you and your doc to make...

Table 1: Recommended Treatment Duration (See also Table 2 for Treatment Futility Rules)
Treatment-Nave and Prior Relapse Patients
HCV RNAa
Triple Therapy
INCIVEK, peginterferon alfa and ribavirin
Dual Therapy peginterferon alfa and ribavirin
Total Treatment Duration
Undetectable (Target Not Detected) at Weeks 4 and 12
First 12 weeks
Additional 12 weeks
24 weeks
Detectable (1000 IU/mL or less) at Weeks 4 and/or 12
First 12 weeks
Additional 36 weeks
48 weeks
Prior Partial and Null Responder Patients
Triple Therapy
INCIVEK, peginterferon alfa and ribavirin
Dual Therapy peginterferon alfa and ribavirin
Total Treatment Duration
All Patients
First 12 weeks
Additional 36 weeks
48 weeks
This is from the incivek web site

4 of 27
2.3 Discontinuation of Dosing
Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology (12.4)]. Discontinuation of therapy is recommended in all patients with (1) HCV RNA levels of greater than 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV RNA levels at Treatment Week 24 (see Table 2).
Table 2: Treatment Futility Rules: All Patients
IIf peginterferon alfa or ribavirin is discontinued for any reason, INCIVEK must also be discontinued.
Also from the incivek web site

Yeah...I got that. I understand the protocols. :-)

Nevertheless:
I was Detectable But Below Quantifiable at 4 weeks.
I did 24 weeks of treatment.
I was UND at the end.
I was UND at the SVR point six months after treatment. Doing great!

You can insist on 48 weeks if you want; or maybe your doc insists on it. In my case, my doctors advice - and he treats a lot of HCV - was to stop at 24 weeks. He probably doesn't advise that for everyone, but he did for my case.

All I'm saying is that I did NOT follow the protocol to the letter, and I'm SVR.

I was told going in that since I was a previous non responder to other treatments ans geno type 1a that I was in for the long haul 48weeks no matter what. People that never under went treatment were only required to do the 24 weeks. Didn't matter what the readings are at any point. I was undie at week six and have been since completing TX Jan 18th. Never would have considered quitting no matter what the labs said at any point. At stage four and bridging cirrhosis quitting never crossed my mind. Now hopefully I bought a few more years on what's left that I can get back to living life and watching the grand kids grow up..