Viral Load is 20 at week 5.5

[sandysf]

As many of you know, I am on Gilead study with SOC, potentially 9451 and Tegobuvir.   I had some bad news last week as week 4 VL was 453 which means I automatically get rolled into doing 48 weeks instead of 24.  :(   But I just got VL back from week 5.5 results and my VL is 20.  Is that considered UND?   For the study if I had been at 20 on week 4 it would have changed everything.  I will have to research what that would have meant if I was on Incivek/Victrellis.

I know it will be against study protocol, but I am thinking if my VL stays where it is now/goes lower, I would stop myself at week 28 maybe?  

[ek_66]

Great News !
Ed

[willbb]

Sandy...The study protocol probably says specifically."If you were UND. at week 4 and remained UND at week 12 then you would be assigned to the 24 week treatment." The UND. would have been according to the sensitivity of whatever lab the study was using...some are <25 some (like mine was<15) and others I believe use <5.  So the fact that you were still detected at week 4 .given whatever lab they were usuing...yes , means 48 weeks by study protocol.

Sounds like a good move on yours and their part to  postpone a dose reduction..as this is never ideal ,,especially early.Did they say how low they would let it go  and did you not say Neupogen was  ok in this study..or maybe I"m mistaken.

Again...you are having a good result ..so hang in and let us know when you get the official UND.

Will

Will

[sandysf]

Dave, Will,

I do feel more encouraged now.. the thought of 48 weeks really *****.. but I am not focusing on it now.  I am happy to be close to UND and believe I am by now for sure!

My study protocol indicated that if I was under 25 at week 4 I would qualify for 24 weeks, I was only 10 days late so the thought of that doubling treatment time due to 10 days just doesn't make sense to me.  But what do I know!  They wanted to reduce my dose yesterday and I pushed them to wait since my neuts were  .75.    How long should I hold off dose reduction?

[willbb]

Agree with Dave .. You  are most likely UND. now and at 5 weeks this is still considered a great result.It is always preferable to treat for the shortest time possible ..however as Dave mentions  the goal is SVR and you have an excellent chance of this.

Best ..
Will

[spectda]

I forgot to say that a viral load of 20 at week 5.5 is a great result. I know you don't want to have to treat for 48 weeks, but there is a very good chance that you will be und soon and you will have a great chance of SVR.
-Dave

[spectda]

In my trial they used the same pcr taxman 2. When I was und it stated hcv ran not detected. once it said detected under 25 which meant somewhere between 9.3 and 25 iu/ml
-Dave

[spectda]

The taqman 2 is quantifiable to 25, but qualifiable to 9.3


www.fda.gov/downloads/AdvisoryCommittees/.../Drugs/.../UCM254079.pd...
File Format: PDF/Adobe Acrobat - Quick View
Apr 27, 2011 – Boceprevir Phase 2/3 Clinical Program. SPRINT-1. (Treatment-Naïve) ....Roche TaqMan 2.0. LLD 9.3 IU/mL. – Used to define undetectable ..."

[sandysf]

Nygirl and FLGuy,  thanks for your input.  I did have the heptimax and you are right the study uses the Taqman and under that test, I would have shown UND as their lower limit is 25.   In any event, I know the number means good news!

[FlGuy]

You previously wrote that you had two didderent PCRs in the trial, one being Heptimax and the other Taqman (Amplicor?).  The lower limit of detection is less than 20 for Heptimax so that would imply that you are not yet undeteced if that was the PCR you're talking about.  Low viral load, but still present.  Relating the trial that you are in with Incivek/Victrellis results I think would be like comparing papaya to mango.

[nygirl7]

PS I dont know why you would go off protocol being UND is only a part of the battle.......being SVR is the battle.

[nygirl7]

No only UND is UND - if you had a less sensitive test you might THINK you were UND but not honestly be so.  But you probably are by now that is the good thing.........