Have to be clear at 4 weeks

[hondapatches]

ok Well I will try the question again..lol My doctor told me that if I am not clear of the virus after four weeks or if I am under 100 viral load that they would stop the treatment. He said by week 4 they will know or not weather the meds are going to work. My question is has anyone ever been told this? My viral load now is 338 thousand and my alt and ast are around 40.

[pooh55811]

Please include the starting viral load and the drops and then his 12 week viral load. Also include if this is his first treatment or if he has treated before and what happened if he treated before. The more details the better so the knowledgeable people can respond.

[pooh55811]

I am not sure he has to stop treatment. I was trying to find the data and cannot. However, I know that some people on this forum will know whether the futility rules state he has to stop at 12 weeks if he is detectable. I know some have continued with a detectable viral load at 12 weeks (but there may be some intricate details that I do not know).

I would suggest that you go to (near) the top right of this page and you will see an orange bar/rectangle. Please repost your data/question in a new thread and several of the knowledgeable people on the forum will respond. I would title it something like: Does one have to stop at 12 weeks if virus is detectable. Then explain the situation (undetectable and now detectable). Give the actual viral load number for the 12 week blood test.

I really hope you will repost because I am sure people have continued even though they were detectable at 12 weeks. It would be a shame if he stops treatment when he does not need to.

[amw48]

sorry i meant he stayed on the incivek for 12 weeks, and has been off for about 2 weeks, and the viral load is showing again. sorry for the confusion

[amw48]

yes we were told that by the end of 4 weeks your viral load must less than 1000.  My husband viral load was undetectable at 4 weeks, and has stopped taking the incevick, but continued with the pegasys interveron, and now at 12 weeks, his viral load is starting to go up.  They are checking the blood one more time to make sure he is not a false positive,, but if it is positive he will have to stop everything and pray whatever they come out with next works.  Very sad we were so thrilled it was gone, but that was short lived.

[willbb]

meant to include the labeling of both drugs.... this includes all info.from A  -Z   including  dosing times ,discoutinuation rules,,adverse effects,  etc.

Will

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf

[willbb]

lynda &all:

Yes ..I believe you are right...we may  be seeing some "wacky stuff" in the next little while in regards to treatment protocols.

Possibly there was a rush  get the new meds on the street  and not enough instructional training given by the reps on proper dosing protocols. I believe it was cando that said..".lets hope the doctors have not just got  caught up in the P.I. hype...thinking  every body will do just 24 weeks of treatment now."

IMO everyone here treating with triple or starting soon  would be well advised to link to the "incivek or "victrelis " dosing labeling  and  read thru all the different time frames to dose and discontinuation rules etc.

It is not a "one size fits all "   .depending on whether you are a first time treater(naive) a  prior partial .a null or relapser,,a cirrhotic  ..the regimes all can differ.

The labeling spells out very clearly the recommended treatment.for all these...it may be 24 .28...36.. or 48 weeks depending on many factors..or you may have to discontinue(given poor resonse and resistance issues)

If a  doctor is suggesting something different than the protocols that were put together  after approx 8 years of data  with hundreds of millions of dollars spent and  thousands of trial patients that went thru it ...  I for one would certainly want to know very explicitly why he would vary from this so early in a drugs clinical use  before he/she want s to use me for an experiment ...the trial participants were already the experiment....and now the dosing has been recommended for us to have the best possible chance of a cure.

After the first batch of us (so to speak) go thru the tried and true treatment  and they get an even better look at results in the general public...then possibly some tweaks to protocols will be made....however  that remains to be seen down the road a ways.

We have to always keep in mind I believe...the only goal of treating is to get rid of the virus...  and the dosing protocols have spelled out what they feel is best to do that....the goal is not to see how short a time we treat .  Many of us may get to do 24 ,however many of us also will have to do 48...that's just the reality still...

just my cent...

Best to everyone
Will

[lynda607]

However you shake it out Clyde, a total of 24 weeks equals 6 months give a take a few days. IF you are also UND at 12 weeks, you will do another 12 weeks (3 months) of pegylated interferon and ribavirin and your treatment is done.  When you stop treatment, you will have done a total of 24 weeks (6 months) of pegylated interferon and ribavirin.

I am currently not on any treatment for hepc.

[Clyde4360]

Thanks for the great info I will call Vertex. I donot have cirrhosis and this is my first time treating. I'm on Insivik for 3 months and P/R a total of 6 months so my dr is correct or should the total of P/R be 24 weeks? Thanks for the info on Procrit. Where are you on your treatment and how do you feel? Have a good day, Clyde

[lynda607]

As the standard of care for genotype 1's transitions over to triple therapy I suspect we will be seeing a lot of wacky stuff.  Uninformed doctors and patients.  Poor patient.....just hope it ends up being in their best interest.

[lynda607]

Do you have cirrhosis?  If so, you're doctor may think 48 weeks would be best.

If you have treated previously with pegylated interferon and ribavirin and were a null or partial responder than you are required to do 48 weeks of treatment even if you are UND at week 4 & 12.

If you are treatment naive or have relapsed previously and you are UND at week 4 and 12 you do 12 weeks of INCIVEK, pegylated interferon and ribavirin then an additional 12 weeks of pegylated interferon and ribavirin.  The total treatment duration is 24 weeks.  

Perhaps you're misunderstanding your doctor's statement and view that as an additional six months after stopping the INCIVREK at 12 weeks.  If you are UND at wk 4 &12 you will be on peg & riba a total of 6 months but 6 additional months of peg & riba is not necessary, only an additional 12 weeks if the patient is UND at the 4 and 12week mark.

Procrit is taken subcutaneously in the tummy (like the interferon) once or twice a week.  It is not fast acting so if your HGB is low you should prompt your doctor to order it as soon as possible.  As far as side effects, perhaps those who have used Procrit can chime in as I have no experience with it, however, it seems most people tolerate it well.  

Here is a link to the Vertex Prescribing Guide.  You may want to print it out and give it to your doctor.  It has the information I have given you.  You can also call the Vertex patient support hotline and they will give you the same information or maybe your doctor should call Vertex?  1-855-946-2483).

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

[hondapatches]

Thank you all for your comments I will have to ask my doctor again about the 1000 IU/ml I really don't know what that means, maybe you could clearify that for me. I know that I will be here a lot during my treatment I'm glad to know that we all have questions..

[Clyde4360]

Hi: I read your post about treatment with the 3 meds, I am on Incivek, peg and riba. I am going on my 5th shot this Friday. At 4 weeks I was UND YAY!!! my Dr has told me the next test for viral load will be 12 weeks.

He has said I will be on Incivek for 3 months and peg and rib for 6 months is this what you said I thought you said if you were UND at 4 weeks you only have to do P/R for 24 weeks should I get a 2nd opinion from another Dr. I don't want to take this longer than I have to.

I have a question about Procrit my next blood work is next week and I have a feeling I will be needed Procrit soon. Where do you get the shot and how often do you take it  and are there side effects from that too?  I thank you for all the advice this forum has helped me alot. Clyde

[his3707]

yikes!  This is seriously screwy!    Maybe these docs should try a little bit of this treatment on themselves before prescribing their protocol for anyone else.  I'll bet then they all get it right!  This is too serious to be messed with.  We're talking people's lives here.  Jeeze

[willbb]

lynda...seems like every doc has his./her own protocol  and studies be damned  :)

[lynda607]

HCV-RNAa Triple Therapy INCIVEK, peginterferon alfa and ribavirin Dual Therapy

Treatment-Naïve and Prior Relapse Patients Total Treatment Duration
Undetectable at Weeks 4 and 12 First 12 weeks INCIVEK - peginterferon all and ribavirin, then an additional 12 weeks P/R for a total of 24 weeks

Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 First 12 weeks INCIVEK, peginterferon and ribavirin then an additional 36 weeks P/R only for a total of 48 weeks

Prior Partial and Null Responder Patients
Total Treatment Duration Triple Therapy INCIVEK, peginterferon alfa and ribavirin Dual Therapy


INCIVEK, peginterferon alfa and ribavirin first 12 weeks.  Additional 36 P/R for a total of  48 weeks.  Must be under 1000 IU/mL at week 4 or 12 to continue, UND by week 24 - otherwise stop all treatment.

Treatment Futility Rules: All Patients

HCV-RNA Action Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)

Week 24: Detectable Discontinue peginterferon alfa and ribavirin

[willbb]

sorry missed the thousand  338,000  :)

[willbb]

I just read your post again.. and it seems your doc is incorrect saying that you need to be  <100 in order to continue...it is <1000 a t week 4

you say your VL is 338...what week are you on now??

Will

[willbb]

If you are tking Incivek and are a first time treater(naive) it goes like this


Treatment-naïve and prior relapse patients

HCV-RNA levels undetectable at weeks 4 and 12: Administer triple therapy first 12 weeks, then dual therapy an additional 12 weeks
HCV-RNA levels detectable at weeks 4 and 12 (ie, 1000at 4 weeks or 12 ..discontinue all treatment.

Good luck
Will