viral load week 4/incivek/telepevir/ribavarin

[rayc2001]

Hi to all,
To say I am dissappointed would be an understatement.  My viral load at week 4 is down from 18,227,167 to 307,000.  A wonderful drop, but was really wanting that undetectable.  Now I need to read more.  I guess that would mean a full years treatment.  Ast/alts both normal as the last.  Rest of the numbers not too bad.   


Ray C

[DougV]

Ray,

You sadly are the 1st and so far only person not undetectable at week 4.  According to Vertex prescribing info, if VL > 1000iu/Ml at week 4 or week 12, discontinue treatment.

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

Do not want to be the bearer of bad news, but you might want to check with your doc and see what the plan is. 

Sorry Ray, this blows.

Doug

[MissyMouse]

Well that just really bites.  I'm so sorry Ray.

Mouse

[rayc2001]

Obviously, I am saddened to hear that.  I have read some of the main points in the article.  I will speak with the Dr. and see what his plan is.  Thanks again and will report if they ask me to stop.

Ray

[willy]

Ray, I am sorry to read this.  The deal is that vertex is trying to prevent people from getting built up w/ hard core resistant virii.  The sooner you stop, in theory, the easier is should be to retreat successfully with a PI down the road a piece.

I know that it may feel like you are close and want to keep going.  We'll let you and the doctor talk about it, or even call and talk with the 24/7 nurse, but here is the deal;

If you had a PCR for every week that you had treated you might be a slowing....even a table of sorts in a lot of viral response rates.  People get close..... but their viral load can just end up stalling. At this date, we don't know if yours is going down or even if it going up.

Over 2500 people had been treated w/ telaprevir when the drug went to file for an NDA.  They have seen viral response curves and they have a pretty fair idea of what is going to happen by week 4.  They have to pick a sort of arbitrary cutoff date and it is at 4 weeks.

The bad news is that you are on the wrong side of the 4 weeks.  The good news is that you know in only 4 weeks the result.  there are many who fail, relapse after months and years of TX.  There are very good trials and treatments coming, but for a while, we will be treating with PI's like Telaprevir.  If you are going to re-treat in the future; maybe with 2 or 3  antivirals like Telaprevir you want to not develop a strong set of PI resistant virii.

We are going to see a lot of people cured but there will ba many who either withdraw from treatments of a small percentage who relapse.  Believe me, they are already looking at this issue and i believe that the 4 week discontinue protocols are an effort to set you up for the next go around.

I'm sorry; I know you must be crushed, disappointed and worried for the future.  Maybe your doctor has some infor that we don't or a different plan.

Thinking of you,

willy

[rayc2001]

Looked at bloodwork but not with the specialist yet, and read the reports.  Since I do have access to my medical records I did go straight to viral load.  Now, I am in no way a Dr., however the line graph for my 4 weeks was uninterrupted, without a bump up. So in reality, the way we will find out is at week 12.  I seemed to interpret that people who had relapsed before would go 12 weeks anyway, unless there was no response.   I'ts not the end of the world, and again, my liver has received a good break.  Since clinical studies were of so very few, lets hold out a little hope that my high viral count and drop rate have continued.  I'll be the guinea pig on this one.  If I was a mathamatician, and I'm not, but close, my viral load was 1 day from 0 based on a drop of 629,000 per day.  At 630.964 per day I would have been undetectable. Thats is a 1 day difference.  Now, I don't know if you can calculate it like that, but I do math.  You know me, they will have to kick me off, and, I still will hold on to a sliver of hope.  My wife beat cancer over the last year, and I would just like to be free of the beast.  Still healthy otherwise Willy, and hoping for a cure, just like everyone else.  I will report my next lab reports and or wait to hear from the DR.  He did not call to tell me not to continue with my weekly dose, which is his protocol.  Thanks for still being here, and again, if the news is bad, I'll report the numbers and stats.  Praying for a miricle.  Only other change, small rash starting on 1 hand.  A small area.

Ray C

[DougV]

I would probably want to keep going as well, but I think I would request 8 week VL.  These drugs are toxic and not without risks, if it will not work better to stop sooner than later.  While we all say, including myself, that this gives our liver a break, we also should remember trials went on for years in various formats on doing maintenance with ifn and or riba and those trials failed to prove treatment drugs improved anything. 

I hate that you are the 1st I have known that was not undetectable at week 4, but I'd also hate to see you develop some of the long term issues use of these drugs can cause.

Bottom line, please be careful.

Doug

[rayc2001]

To All,  After review the doctors has just sent this email, and I am to continue.  I will accept what the next test shows.  I am going to try to post my question/plea to the GI and his response is below!!!!

Dr. ...........
With all due respect, I have to ask that you allow me to continue through the 9/6 test, and take viral load. I have read the complete papers from vertex, and I have to question of the 1700 subjects who completed treatment, how many had a count of 18,222,000 The average person with the disease has a quantative of 1.2 million. If my numbers have raised, I will cease immediately, but I am not going to have insurance in the future, and I want to be absolutely sure we gave it our best shot. My graph shows a straight decline without interruption. I am not suffering adverst effects, and wouldn't mind if we beat the curve on so few people who have been studied with this drug.
Thank you for your time and consideration on this matter.

Raymond .......



ToRaymond,
There are "futility" rules that have been recommended by the manufacturer based on outcomes data that suggest patients should stop treatment if viral RNA is over 1000 international units (iu). Your result was over 300,000. That said, you did start with a very high viral load, seem to tolerate the treatment well and want to continue. So let me see about continuing treatment and reassessing at 8 and 12 weeks. I understand your concerns but want you to realize that I am following published guidelines.
PCR

(edit- last identifying names deleted-willy)

[rayc2001]

My prescription refills were granted yesterday for another 3 months.  I treated yesterday, and the current regimen will bring me through week 12.  VLs at 8 and 12, next vl 9/6.  Will keep you posted.

Thanks,
Ray C

[willy]

My prescription refills were granted yesterday for another 3 months.  I treated yesterday, and the current regimen will bring me through week 12.  VLs at 8 and 12, next vl 9/6.  Will keep you posted.

Thanks,
Ray C

I think that this is a good plan and it shouldn't lead to any more resistance than any other person who treats with 12 weeks of triple therapy.  In that you were detectable at 4 weeks your chances may not be as great as a person who cleared at week 2, but lets say a week 5 clearance still stands an excellent chance at SVR, and if it turns out that you are clear at 8 and 12 weeks I think your chances are still pretty good.

willy

[DougV]

I think that is pretty cool of your doc.  Be looking forward to what happens at week 8.  Bet you'd happily go for weekly testing right now. 

Doug

[rayc2001]

Yes somedays l am ready to test.  Tired of the eating habits, and my 93% radioactive butt sucks at times.
Other than that, starting to itch and tire more.rapidly. Thanks for the support.  We will know in less than 2 weeks.
Ray
 

[DougV]

Ray,

Immodium can slow firing rate.  It will not help with the burn but it will cut back on the frequency of occurance.

Glad you are hanging in here.

Doug

[rayc2001]

Radioactive!!!!!  All I can say is flippin ouch!!!  What a pain in the ass!!!!

Ray

[DougV]

Ya gotta admit it wakes ya up better than coffee....
 
Under two weeks, diet time.....

Doug