Week Four Results answer to question:

In answer to Trish77's question:

I started July 15th, 2011
I took 1200 ribavirin every twelve hours
one shot of pegasys in the little glass syringe with the red plunger once a week on Fridays.  I'm a BIG girl, so it was the full amount.
and 2 inciveks every 8 hours.

because i was in need of financial assistance to be able to afford the high cost of treatment, the "gifting association" contacted my doctory and had him change my prescription. (I did not know this had happened)  My ribavirin was changed to rebetol1200 every twelve hours.
i was changed to the interferon redi-pen - again full dose.
and stayed the same with the Incivek.

the blood test results that are posted are both from my first four weeks when I was on pegasys and ribiviron. I have not had a blood test since the switch-over.  

So you see, this just gets curiouser and curiousier every moment.....

I called the Nurse Help Line and she said that my doctor is right.  For me to stay the course until I have the blood work done on this Friday and when the results come in we will know better what action to take.  This IS just my 5th week.

Feel free, everyone, to blast away and let me have it.  I'm just here, home on a weekend, trying to not fall apart from the news - AND I'm trying to let many of these strong opinions roll off of my back - I thank you for your help, but sometimes yall come on pretty strong and scare a person.  I was ready to call the undertaker last night.  Was ready to give up - many folk were saying THAT'S IT -you're ruined for next time, - on & on & On. So thank you to those of you who gave the kind words.  Thank you, also for the strong words, but know the kinder ones oft time spoke the same meaning in an easier to understand and acceptable fashion to the person in need.

[lynda607]

With a viral load of 293 at two weeks and 9380 at 4 weeks it is apparent PI resistant variants developed and as stated before, the peg & riba were unable to eliminate those variants.  We see so many 4 week UND's with triple therapy but it doesn't happen to everyone and in some patients the PI isn't enough to suppress the virus either.  If the viral load were less than 293 or even detected by not quantifiable according to the sensitivity of the PCR it would make more sense but 9380 was a hefty jump and it's highly unlikely the PCR was incorrect.  It's termed breakthrough and when that happens the viral load will usually keep increasing but it's not etched in stone that you won't see a decline in viral load or maybe even UND next PCR.  There are still many unknowns with triple therapy but there was also years of trial data used to establish the futility rules.

If you have the three months of Incivek on hand and you and your doctor are willing to push the envelope and at the 12 week mark you are UND then you take your chances, do the full 48 weeks and hope it works.  Hope is always a good thing; hopefully the outcome will be positive.    

[indy531]

You are in my prayers that you go lower VL this week and have peace of mind and soul. Don't give up!

[hrsepwrguy]

I am so glad you got to talk to the nurse and that she had encouraging news for you.Hang in ther and you are in my prayers.

Keith

[can-do-man]

"I called the Nurse Help Line and she said that my doctor is right.  For me to stay the course until I have the blood work done on this Friday and when the results come in we will know better what action to take.  This IS just my 5th week."

So the nurse disagrees with vertexs own site? All one needs to do is go to Incivek.com, click on Prescribing information and go down to 2.3 Discontinuation of dosing.

These places ought to get their act together for patients.....cctex really wishing you the best.

[hrsepwrguy]

The number she called is inciveks own 24/7 nurse help line listed in vertex's own incivek treatment reference treatment guide.Number is listed on the cover.The guide also includes all info your are refering to.

[researchmonkey326]

I hope that you get good news this week. If this door closes for you, remember that there is another opening for you.  Don't give up.

[willbb]

cctex...nobody here is trying to scare you...all anyone wants to do is make sure you have the best possible outcome. When you are asking for facts on here ...sometimes those facts are given with no intent to make you feel good or bad ..they are relayed as others understand them

In this case it is Vertex"s own biochemists and doctors that put on their labelling that if a patient was>1000at 4 weeks and 12 weeks...due to the possible  emergence of resistant viron it was a stopping rule.

It seems odd (to me anyway) that the labelling would say one thing and then a rep from the company would say ...:don"t worry to much about the labeling just stay the course .

If it was me.I would demand to speak with a very knowlegable doctor at Vertex about your situation and find out why  the labeling says one thing and your doc and a nurse with vertex basically say another.That way hofully you get a definitive answer on what you should do.

Again ...nobody is tyring to scare you...just trying to make sure everything works out the best for you.

Will

[dixiechicdana]

sometimes on these groups (suppose to be support) people can be harsh. When I was first diagnosed I quit these online support groups because they depressed me more than helped.
People had me so scared, I was scared to sleep thinking I wouldn't wake back up. But I have come to my own conclusion to live with hep C not for it and to not stay on these groups too long at a time. And #1: there is always hope. heads up, hang in there.

[willbb]

This is known as one of the best forums on the internet...HCV or otherwise...both for receiving solid (usually fact based knowledge) and unequivocal  support in sometimes trying circumstances.

I never recall seeing a post on here(albeit I have not been here all that long) that  from the info they got would scare  them into thinking if they went to sleep they wouldn't wake up.

[dixiechicdana]

It wasn't on here. It was another support forum. But I am just saying that sometimes other peoples frustrations come out in there posts and they can be too factual when sometimes hope is a better answer.

[willbb]

wellll   hope is always a great thing....but there can never be enough facts discussed ...in order for us to help each other..IMHO

[can-do-man]

I don't think people want to be harsh here, if you don't want to know the truth then why bother? In this case future tx can become a real problem. We really do want to see people cured of this, i for one am cirrhotic and don't want to see anyone get to that place let alone somebody having future tx problems.

Treating with these new PI's are a whole lot different then just treating with SOC, alot more at stake.....
--------------------------------------

“It’s essential to adhere to the futility rules,” said Dr. Jensen.

[Trish77]

It is such an unusual result at the 4 week mark after such a great result at the 2 week mark. I wouldn't see any issue with going one more week and waiting on a re-test of your viral load.  I think I'd want that just to confirm in my own mind that things really are what they are.  I'd stay the course also until I know for sure things are taking an unexpected u-turn.  That's just what I would do and my own penny's worth opinion on it, keep in mind.  I guess that's not quite the hard and fast guidelines but many of the experienced docs know where to bend those guidelines on a patient by patient basis.  And for some of us, thankfully they do because if we only did things strictly by the guidelines, we would have been tossed off treatment or it might not have worked out so well for us.

You certainly aren't ruined for next time if this time doesn't work out.  It does mean considering potential resistance in your future treatment plans for this class of PI's but there are other classes of PI's you won't be resistant to and potentially after some time has passed you won't be resistant to these PI's either and you can get tested for that with a test to the sensitivity of what's available at the time.  There are a number of other drugs coming along and more and more is known all the time.  No reason to not be hopeful if this round truly does not work out.

Here's hoping for your next test....and take it a step at a time.

Trish

[willbb]

Please Be very careful taking any ones advice when it comes to these new meds  especially in regards to the discontinuation data  ..other than a knowledgeable doctor in the use of them.....most clinicians still have somewhat limited experience with them and especially in regards to the discontinuation  protocols to start making up rules as they go along. as they are brand new on the market ..other than data by trial..

Again.. my advice would be to try to speak as soon as possible  with a knowledgeable doctor(in the explicit use of the P.I"s about the stopping rule )



Best of luck

[lynda607]

With a viral load of 293 at two weeks and 9380 at 4 weeks it is apparent PI resistant variants developed and as stated before, the peg & riba were unable to eliminate those variants.  We see so many 4 week UND's with triple therapy but it doesn't happen to everyone and in some patients the PI isn't enough to suppress the virus either.  If the viral load were less than 293 or even detected by not quantifiable according to the sensitivity of the PCR it would make more sense but 9380 was a hefty jump and it's highly unlikely the PCR was incorrect.  It's termed breakthrough and when that happens the viral load will usually keep increasing but it's not etched in stone that you won't see a decline in viral load or maybe even UND next PCR.  There are still many unknowns with triple therapy but there was also years of trial data used to establish the futility rules.

If you have the three months of Incivek on hand and you and your doctor are willing to push the envelope and at the 12 week mark you are UND then you take your chances, do the full 48 weeks and hope it works.  Hope is always a good thing; hopefully the outcome will be positive.    

[crossroadsec]

Hang in there chica. Sry to hear you had a rough weekend. I know this is mentally draining. We need to stay informed. We gotta know the truth. And I lurked sites off n on for a year w/o finding one as supportive, honest, and caring + well informed as this group. I think they try to take in all the possible variables.
You just keep doing what you're doing to take care of yourself. Keep asking Dr. questions, look for a new one if you think it's best. Pull out ALL the stops girlio. There are important decisions to make regarding resistance. Heck, it's all so new and hard to wade thru the internet documents. I believe our little band of bros n sistas on here have best intentions. I know it's hard not to feel fear. Don't let it paralyze you.
I think a lil grieving is due here. You're spirits were so high. so you've gone thru shock. Get mad next. lol. I love a legit reason to fight for a cause, don't you? xoxoxoxo Karen :)

[willing]

Take a look at panel D of

http://www.medhelp.org/photos/show/281461?personal_page_id=1188743&type=user_journals

a diagram from a recent review on failure issues in  triple tx
http://www.ncbi.nlm.nih.gov/pubmed/21374691

It expresses graphically what lynda wrote above. One of the problems with the inci approach to tx is one has no idea of  the strength of one's  baseline ifn/soc effect (the green arrows) until w4 of tx.

However now that you know, there is some urgency to getting off the PI. Every additional Inci pill enables the PI resistant variants to get a stronger hold making it less likely that you will  be able to use an ns3/4a-based PI (like inci or vic) in the near future. I'd suggest talking with your Dr. about  doing a quick VL check (just go to the lab and reuse your existing order if you can't get in touch) to rule out a possible bad test result and if it's still above 1000 quit the PI pronto. Good luck.