Michael,
Makes perfect sense to me!!!!!!!
That form was from 2004.
HALT-C Trial
Local Lab
Form # 30 Version C: 04/22/2004
The Halt-C Trial was "designed to evaluate the safety and efficacy of long-term use of pegylated interferon for the treatment of chronic hepatitis C in patients who failed to respond to previous interferon therapy."
I think that "Breakthrough/Relapser" referred to those study participants who either relapsed following treatment or had a viral breakthrough during treatment but were undetectable at some point during their previous treatment. The other group was "Non-responders" who failed to clear in their prior treatment. So Breakthrough/Relapser referred to 2 different groups and was not a term meant to apply to a distinctly different response to treatment.
Mike
Things were quite different in 2003/2004 nobody would ever use such a term now as they are two quite different things.
Breakthrough/Relapser is a term my doctor used in 2003. The experience RRichard described correlates to what I experienced in 2003 so I used the same term.
Here is a reference from 2004 that contains the term Breakthrough/Relapser.
https://www.niddkrepository.org/niddkdocs/HALT/Forms/Form030_LocalLab_VersC.pdf
OK. I have never heard of Sanchez Tapies or the The Berg Study until just now.
I think stuff like IL28B testing, Sanchez Tapies, The Berg Study all are not personal experiences but instead scientific information that can easily be ascertained just by searching this website or the net. Understanding the difference between breakthrough and relapsand partial responding and null responding as explained several times also is 'scientific' and not personal experience.
Ribavirin has nothing to do with the 'rash' (riba-rash) that is actually caused by the interferon so if your doctor reduced you for that it was the completely wrong thing to do, so perhaps you had severe anemia and forgot?
Either way adding a PI will be rough 1. the rash and 2. the anemia (which ever your doc reduced your riba for, which should have been for anemia and not rash) that only leaves a trial or 72 weeks of SOC but yes you need to be treated as a null responder regardless.
NYgirl:
I may have not been UND until week 24, I really can't remember but I do know I had an excellent doctor that I am sure would have recommended extending to 72 weeks if I was a candidate. One thing I do remember him saying was that since my liver was only stage 1 that I could wait for further tx.
I feel like that when I post something I am being ridiculed for not knowing the answers already! I try to do my research but I like to talk with people about their person experiences instead of scientific lingo I don't understand. I know there are a lot more people out that are way more educated on the subject than me by far!
You're right... I said I wasn't clear by 12 weeks but then I said I was:
"I cannot really remember but I think my Riba was reduced because of a rash. I ordered my records and will have to look. I know at week 12 I was still detectable and the doctor told me since I was clear by week 12 I could be tx resistant but we pushed on anyway!"
No, saying you are confused was not what was condescending. It was mostly because of the way you answered a previous post:
"I cannot really remember but I think my Riba was reduced because of a rash." (RR)
Odd one can't remember reducing or not, while past treatment is a fog , taking the meds is not....:) (CDM)
What is that supposed to mean? I treated over 6 yrs ago and I am not 100% sure if Riba was reduced or not, but I believe it was. Sorry that info is not fresh in my brain.
Your first response was helpful... Maybe it's computer humor I am not picking up on! I apologize!
I did not clear until somewhere right before week 24. As a result, I and many others did thorough research and found that according to the Sanchez Tapias Study - if we were to EXTEND treatment until week 72 we would have better odds at SVR. Which I have.
You on the other hand had a viral breakthrough - whether or not you did not get to UND (which obviously you did not) at week 20 or 21 or 22 or 23...the cut off date to not extend is week 24.
So you continued, had a breakthrough and did not SVR.
I think Candoman and Will have summed it up very nicely.
PS Candoman is one of the LEAST condescending people on this forum, he's a GREAT guy always willing to help and gives EXCELLENT advice.
You had a breakthrough. Cando gave you excellent advice (as others have told you) on the very first post on this thread.
Best to take his advice into consideration when you speak with your doctor about treatment paradigms ..
Will
Maybe you should read your own thread here...... Saying one is confused is a condescending manner???
Can-do-man:
Did you read all of my posts?? My doctor said that for best results I had to clear by 12 weeks. I didn't. He said we can keep going just to see what happens or we can quit. I chose to keep going. I finally cleared about week 20 or so and about 6 weeks later the virus came back while still on tx and then we called it quits. Understand? If you don't, please tell me nicely instead of in a condescending manner!
You had breakthrough, you can't relapse until you go OFF the medications. There is no such animal as a break-through relapser - it makes no sense at all.
It's a cute new made up term though. Kind of like a Detectible-SVR, I guess that would be a DSVR. ;)
"When I treated last time on Interferon/Riba I cleared and then about 6 weeks later (while still on tx) the virus came back."
" Like I mentioned before, since I didn't clear by week 12 we knew that my odds weren't the best to SVR but I continued on anyway."
---------------------------
Now i'm confused...
I definitely never stopped taking anything! Like I mentioned before, since I didn't clear by week 12 we knew that my odds weren't the best to SVR but I continued on anyway.
"I cannot really remember but I think my Riba was reduced because of a rash."
Odd one can't remember reducing or not, while past treatment is a fog , taking the meds is not....:)
Whats a Breakthrough relapser??? Your either one or the other
I have never heard of having a breakthrough -relapse doing HCV treatment?
As cando mentioned above to the OP:
"One would then treat like a null responder with 48 total weeks, since there was not many prior breakthoughs in either of the drugs trials. If none of the above applys your odds would more then likely be that of a null responder........ "
Will
http://www.medscape.com/viewarticle/713174_2
Relapse and nonresponse are defined on the basis of the virological response to treatment (Fig. 1). A patient is said to have experienced a virological relapse if HCV RNA decreases and remains below the limit of detection during treatment but becomes detectable after cessation of treatment.
If HCV RNA rebounds and becomes detectable in such a patient before treatment is completed, this is referred to as virological breakthrough.
Hi RR: Like you, I was previously a breakthrough-relapser. This time around, I'm treating for 24 weeks (Incivek). Cheers, GB
http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf
http://pi.vrtx.com/files/uspi_telaprevir.pdf
Also, since I was a non responder is it definitive I will have to do 48 weeks on either of the P.I.s or will it just depend on response? I have been researching it but not really finding anything.
IL28B is available through lab corp or quest, it is a specific test your doc will have to request.
http://www.questdiagnostics.com/testcenter/testguide.action?fn=TH_AccuType_IL28B.htm