4 weeks update Telaprevir Trial - PCR shows 50 VL

Hi All,

My partner is in the Telaprevir trial twice a day, and he did a PCR on the side (the study won't give us results until at 12 weeks, and that was too long for us to wait).  He is still detectable with a 50 VL. He thinks it's great and I dont want to discourage him but its not UND.  At least he is still in the trial and responding somewhat.

I have 2 questions:  what are the chances of SVR if you are still detectable at week 4?  And he;s having to do 48 of treatment, right?  I read on the Incivek precription that if you are detectable at week 4 OR 12 you do 48 weeks - can anyone confirm that?  Thanks...

[willbb]

  That is good your partner had a PCR done at Wk.4 ...it gives you that much more info. going forward. What was there baseline vl and is this a trial where he is guaranteed Tela..or is there a placebo?

Will

[JAY0914]

Hi i.m in this trial   going on week 3  same twice a day dosage...i was told by study nurse that  if not undetectable by week 4 we have to do 48 weeks

[luckyluss]

Oh well it's 48 weeks then.  Bummer for him, and for me as his caretaker. SX are manageable but I'm getting more and more scared as there is always something neew, even though he is a trouper and doesnt complain much.  I was sooo hoping for 6 month aof treatment instead of a year.

Will, he's getting Telaprevir for sure. I think his baseline was 600,000.
But still what are his chance of clearing in this case?

[his3707]

When did you do the PCR?  at the very last day of the 4th week?  If you did it any day before that you might be undetected.  Will they let you know that you have to do the 48 weeks before week 12 or just let you know the VL at week 12.  I hear some people are getting information on VL numbers if they are over 0 or over 1000 since it changes the game strategy  I am in the same trial but on 3x a day.  I was also wondering in general for patients that are getting unfavorable results if anyone had trouble keeping up with the dosing regimen.   So far I have not missed a dose but there have been a couple of times I almost did.   I wonder if missing just a single dose could have an effect on the 1st 4 week results.  

[JAY0914]

Hopefully  their test  shows undetectable....i would think 50 would be close enough...like his3707 said did you do PCR on last day of 4 weeks ....one day could make a difference...as far as missing med times i have been 20 minutes late but now i have alarms set up on my phone....having a little brain fog so a reminder is needed...i will be praying for you and only 24 weeks!!

[willbb]

Protocol would be as Jay was told to be 48 weeks if not UND at week 4 for a geno1

He has had a great response at week 4(4 log drop) now it is crucial when he gets to UND.

Personally I would do another  PCR at week 6  as it is always good info . to know just when UND is reached.
His odds are still good,however the earlier he goes UND the better,and for sure no later at the outside than week 12 as then the odds start to get skimpy

Good luck

Will

[willbb]

TO : jay ,his 3707 and luckyluss

it depends on what the test result says from the trial at week 4 ..... his 3707   brings up a good point.......when the test was done in relation to the trial test.

[JAY0914]

called my nurse and asked her...she said under 43 was considered undetectable...still theres the chance their PCR is below that....did you pay for PCR out of pocket or use your insurance  and if you did how much did it cost you?  was thinking of doing onr tooo..

[luckyluss]

Thanks.  He actually did the PCR 2 full says before his actual 4 weeks.  So maybe there is a chance it dropped even further in the next 2 days?????

We'll do a 6 weeks PCR for our information.

We were told that at 12 weeks we would know if he would do 24 or 48 weeks.  The VL would be revealed then I guess but I'm not sure about that.  I also know that is you are over 1000 at 4 weeks you get kicked out so this is not my BF's case and we're grateful for that.

I'm sending good thought for all of you , Jay and his 3707!  How are you guys (girls) doing so far on the Telaprevir?  

Jay, my BF's doctor says as long as the meds are taken within a 2 hours window you don't need to miss them. They didn't mention an adverse effect about missing a dose although of course you want all the chances on your side.

[luckyluss]

Another thought - would you reveal to your study doc that you are doing your own PCR's and discuss results with them?

[luckyluss]

Jay, he has insurance that covers it.  It's a foreign insurance so I don't know...I'll ask how much it costs though

[JAY0914]

doing good so far...have minimal sides...definitely starting to feel the fatique alot more, especially in the morning for about an hour i feel yucky but passes within an hour...out of juice by 3pm everyday though....expecting the worst and hoping for the best!!  did your buddy know what his il28 gene was?

[willbb]

Another thought - would you reveal to your study doc that you are doing your own PCR's and discuss results with them?

I feel I am an univited quest at this party  :)      On the above...do not discuss with the trial

Good luck to you all..

Will

[JAY0914]

oooooooo nooooooooo i wouldnt tell them about PCR...unless of course PCR said undetectable and theirs said not then it would be hard not to argue the point

[JAY0914]

we appreciate any info you have buddy we newbies here and need all the help we can get!!!!

[luckyluss]

Ditto your answers are informed and thorough.  Thanks!

[luckyluss]

Jay,

My BF is a CT and you?

Ok, got your advice about not talking to the study people....

[JAY0914]

i was lucky to be blessed with the CC gene thank GOD...my starting VL was 1900 so im hoping for the best...my biopsy was between stage 1/2...i feel i need to have PCR ...want to know...12 weeks is a loooooong time...

[luckyluss]

That's great Jay!  You have all chances for success.  Go on and get your PCR!

As for us, since my BF is a stage 3 with a bad genotype, I'm hoping for a miracle.
As his3707 pointed out, I'm counting on these 2 days before the 4 weeks mark for the VL to decrease even more thereby finding him undectectable.

[JAY0914]

he will make it...he had a great response...who knows  2 days could have made a 7 viron difference to 43....keep me posted...me and his3707 started at the same time on this trial...its been nice talking to others in this trial...