24 or 48 weeks..if i was less then 43 at 4 weeks

[working dog]

thats vl...then und at 8 weeks and und through the first 24 weeks of tx...i wonder what my chances are of staying und...if its like 95 percent und..but if i go another 24 more weeks its 98 or 99 percent und..then is the 3 or 4 percent worth putting my body through this???,..what about possible long term sides??..long term sides made worse from being on tx.an extra 24 weeks...and we all know new tx will be coming soon that are better....week 10 is a tough one...billy

[crossroadsec]

I was sitting in the grocery store parking lot and think I switched posts n commented stupid question.  Sry..

[crossroadsec]

So based on ur comments Hector - they reduced my peg to 90 a weeks 8 & 9. latelets r up. I want the full dose tonight. They still want me at 1/2.... Whadduyah thi k?

[working dog]

i'm quite sure i did my 4 week blood work at almost 5 weeks...i know i stopped the riba well before taking my first shot of procrit...i was asking for procrit but they told me to cut down the riba....i cut down the riba from 1200 to 1000 to 800 to 400...400 for about a week then to 0....0 for i think 5 or 6 days maybe a week....i might have only reduced my riba before starting the procrit...then i went back up to 400 for a week...then 800 then back to 1200....maybe ill read my old post and try to make sense of it...i know when i went to do the 4 week test i could be in trouble because i hadn't been taking the right amount of riba for a while ......i couldn't even say a few words at a time...it was bad....billy

[can-do-man]

"I did my 4 week blood work and saw my nurse practitioner today....i started procrit....stopped the riba.....i'm still on the telepriver...hopefully in a few days my hgb will go up and i'll go back on riba....billy"
-------------------------------------------------

So billy you did NOT stop the riba until AFTER your 4 week pcr and you were not und.......... So being a cc, not cirrhotic, and STILL being detectable with Incivek at week 4 while still being on the riba should answer the 24 or 48 week question with no doubt.

[willing]

if in real estate it's "location,location,location" in tx, success is "vl drop, vl drop, vl drop". You can get a good idea of the impact of week-to-und on svr with 24 vs 48w of tx from table 2, page 26 of the Merck FDA   submission:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252343.pdf

since the data is based on VIC, you have to add the 4w lead in (that is tw8 corresponds to inci w4). Among those who first came und after 8 w of PI and did shortened tx only 1/5 (20%) go to SVR whereas among those who pushed through the whole 48w 4/6 (67%) got there.

Best hope is that after you finish the 12w of inci, the sx should be a lot more manageable. Hang tight!

[willbb]

billy...the guys above have said it well....we must remember ,,the first  and really only goal of treatment is to eradicate the virus to stop damaging our livers so you don't end up with possible  decompensated cirrhosis.

The goal is not to see how little time we treat or how little sides we may suffer.   I know this is tough for you and you are struggling...but please keep in mind what the objective is.... the alternative  is just not feasible because you are struggling ...

Best to you billy

Will.

[nygirl7]

Billy you know it's a gamble......and if it doesn't pay off what are you going to do? The 'new' new meds might not pan out (it's happened before as you know) and you could have to wait years.  I'd just suck it up and get every damn bit of the odds on my side so you can put it behind you FOREVER!

Forever is a good word :D

[lynda607]

Statistically, with eRVR the SVR rate is above 80% for naives and relapsers.  Very slight difference in SVR rates with 24 vs 48 wks.

Without eRVR, the SVR rate goes down to around 60% but that is with a full 48 weeks of treatment.

[lynda607]

Yes Billy, you stopped riba completely and then went back on reduced dosage and that could have been what prevented UND.  Can't rule it out.

Unfortunately, almost UND doesn't qualify the patient for the 24 wk RGT but you can roll the dice twice - your call.

[working dog]

you've been a great help to many here deb...i'm not dead set on 24 weeks...i just want to understand for real what my chances are for svr if i did have to stop at 24 weeks....thanks...bily

[working dog]

thats also a point...i did have to stop the riba for 4th week...and then got back on it..still almost was und at 4 weeks...so the riba does its job...i'm on 1200 and its nasty...i'm sure the incivek is also making me sick...a couple more weeks of that...i never stopped the incivek or the interferon...billy

[nygirl7]

Billy I think everybody on this forum reallizes that you are totally into making your own treatment protocol and most likely have no intention of doing 48 weeks anyways so it's kind of like beating a dead horse just asking isn't it?

[sandysf]

Hector,

Question for you regarding the statement "What matters is that they are eliminated when the 12 week VL test is performed"    Do you think this would also be true in my case?  I had a 4 log drop from baseline to week 4 on SOC, (vl was 453), week 5.5 VL was 20 and then was UND at week 7.  Started VIC at week 8 and VL at week 12 of tx was UND.   At that point I had only had 4 weeks of Vic not 8, so do you think at this point the drugs have "stopped the replication of the mutants viruses"?  

[lynda607]

Billy, IMO had you been able to tolerate the ribavirin, not stopped dosing totally during that initial 4 weeks and received intervention earlier I think you would have been UND at 4 weeks.  Ribavirin is extremely important.  Dose reduction is totally different from omitting ribavirin completely but even dose reduction can impact response.  I know you hate ribavirin but it is one of your best friends when treating.

[streamline569]

I'm a cc and 1A started out early child stage 4 cirrhosis and I was under 43 week 4 and week 8. The more sensitive TMA also is undetectable. Shooting now for week 12.

[working dog]

thanks hector....i have to wonder were they all cc?..and then i have to wonder if they were all 2/2 like me...and of the 60 percent how many were less then 43 at 4 weeks.....i'm not trying to beat a dead horse hear i'm just looking at apples to apples...billy

[HectorSF]

There seems to be a lot of misunderstandings of how the drugs actually work. Assuming we are talking about Incivek...
eRVR is what is important and lynda607 says. The week 4 VL test shows how effective the DAA is in stopping the replication of the wild virus. The main hepatitis C virus itself. Often we will see a many log drop. It also shows how effective the peg-IFN and ribavirin are in ridding the body of the hepatitis C mutant viruses. Week 12 is a confirmation the the Peg-IFN and ribavirin have stopped the replication of the mutants viruses which become the majority of the virus in the body after the wild virus is suppressed. There is no need to know whether there is virus remaining at weeks 6, 8 or 10. It is irrelevant. If there is still virus it is the mutant virus. What matters is that they are eliminated when the 12 week VL test is performed. This is similar to the old 12 week VL testing that was done. Both the wild virus and all mutants must be stopped in order to achieve SRV.

Treatment-Naïve Adults
Study 108 (ADVANCE)

Overall SVR                          79% (285/363)
eRVR                                   58% (212/363)
- - SVR in eRVR subjects         92% (195/212)
No eRVR                                42% (151/363)
SVR in no eRVR subjects        60% (90/151)

That is quite a difference! 92% vs 60%.
So as you can see there is a rhyme and reason for following the treatment protocols.

For people retreating the odds of SVR is determined by the type of viral response they had to Peg-INF and ribavirin. Prior relapsers, Prior partial responders, Prior null responders. For exact data refer to the Study C216 (REALIZE).

Cheers!
Hector

[lynda607]

Vertex prescribing guide recommends PCR's at wk 4 & 12 only and I'm sure many doctors will follow that protocol and some insurance companies may only pay for 2 PCR's during the 12 wks of Incivek.  If a person tests UND at wk 4, without a PCR at week 6, 8 or 10 they could have had a viral load under 43 IU/mL but detected or perhaps even above 43 IU/mL but way of knowing.  When tested at wk 12, the PCR is UND and they meet the criterion for the 24 week treatment course.  Will they go on to SVR?  No one knows.

[lynda607]

Billy's numbers are not published data.  Response guided therapy is based on eRVR and if the subject achieves eRVR there seems to be a very small difference between the SVR rate for those who treat 24 wks vs 48 wks.  Again, that was based on eRVR - UND at wk 4 & 12 so no eRVR it's like rolling the dice twice.  

Perhaps there is some statistical data from Vertex showing the actual odds of attaining SVR without eRVR when a 24 wk course of treatment is done.  I don't have that info.

[his3707]

no need to apologize.  I have often wondered about this same question.  It seems to me in my perfect world that once you start treatment, the week you become undect, you should have to have x number of weeks after you reach that status of treatment.  It just seems so cookie cutter, and they call that response quided treatment.  How do they know if they only test at week 4 and 8 and 12 and so on.  Why not start at week 4 with this tripple therapy , (I know they are doing daily VL on the new stuff coming out) and then go from there week to week if not undect until then, and then go every 4 weeks as long as you stay undect, then it is a certain number of weeks after that..makes perfect sense to me.

[working dog]

i just was taking a shot in the dark....sorry ...i really don't know the right #s...billy

[Bali05]

I think we need to remind ourselves from time to time that what happens in our bodies is not a mathematical equation but a biological
process. By following the data established by the trials we are hoping
to achieve best possible outcome.
Beyond that is anybody`s guess...

[his3707]

please let me know what the verdict is.  Are these percentages just something that your thinking about or is there some published data  showing this could be true.  If I was detected but under 43 the morning before I took my 5th shot, and then 48 hours later und. why do we have to do 5 more months of treatment.

[working dog]

btw im cc....2/2....1a....