Aa
5 days left on incivek and stopped it
almost made it...too many sx...i hope some of this rash is from the incivek...its bad...lots of bleeding from clawing ..can't help it...it also is over more then half my body now...folks were saying "you look good" not saying that anymore....so i figure i'll see if things get better in a few days...i plan on staying with the tx ...not stopping that...yesterday i fell in the driveway and almost really got hurt...just too exhausted......fell down over nothing really...anyway...thats that part of tx for me......billy
http://pi.vrtx.com/files/uspi_telaprevir.pdf
"Telaprevir treatment emergent resistance substitutions emerged in the majority of isolates from subjects who did not achieve SVR (Table 8): in almost 100% of subjects who failed during 12 weeks of T/PR and in the majority of subjects who failed on PR after Week 12 or who relapsed."
===============================
(interesting info/commentary of resistance, post PI)
http://www.natap.org/2011/EASL/EASL_54.htm
HCV Drug Resistance
"from Jules: This is a controversial issue & was at this just completed EASL. Where a number of researchers said flatly 'we will be able to re-use HCV protease inhibitors after patients develop resistance if we wait 2 years for the mutations to disappear & this was pretty much said with regards to telaprevir following the oral presentation by Sullivan of Vertex reporting that mutations mostly disappear after 1.5 years following stopping telaprevir therapy'. This may end up being true but right now this is just a theory without any evidence, no data to support this supposition, it cannot be considered true until a study or real clinical evidence supports this. Until we have data on this question one cannot say flatly patients will be able to re-use a HCV protease after resistance and receive viral load reductions from the drug. Will such a study ever be done, I don't know."
==================================================
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=617274
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the initiation of a Phase 3b study called CONCISE that will evaluate the potential for treatment with INCIVEK™ (telaprevir) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the ‘CC' variation near the IL28B gene. INCIVEK (in-SEE-veck) is administered in combination with pegylated-interferon and ribavirin. Approximately one-third of people with hepatitis C have the ‘CC' genotype, which has been associated with higher sustained viral response (SVR, or viral cure) rates and faster response to interferon-based treatment. In this study, INCIVEK will be taken twice a day. The study is expected to enroll 350 people in the United States and Europe who are new to treatment or who have relapsed after at least one prior course of treatment with pegylated-interferon and ribavirin alone. The primary endpoint of the study is the proportion of patients who achieve a sustained viral response 12 weeks after the last planned dose of study drug (SVR12).
========================================
I have mentioned in a similar thread that vertex has experimented w/ a 12 week total triple therapy treatment. The numbers were small and the groups were randomized treatment niaves.
In this case Vertex is looking at the easiest to treat genotype 1's and seeing if indeed they can treat in 12 weeks. I believe it is quite possible and I surmise that Vertex would not embark on this unless they too felt that it was possible.
This is not to say in any way that you should shorten treatment. I would stay the course. It will virtually assure you of an SVR.
best,
willy
"Telaprevir treatment emergent resistance substitutions emerged in the majority of isolates from subjects who did not achieve SVR (Table 8): in almost 100% of subjects who failed during 12 weeks of T/PR and in the majority of subjects who failed on PR after Week 12 or who relapsed."
===============================
(interesting info/commentary of resistance, post PI)
http://www.natap.org/2011/EASL/EASL_54.htm
HCV Drug Resistance
"from Jules: This is a controversial issue & was at this just completed EASL. Where a number of researchers said flatly 'we will be able to re-use HCV protease inhibitors after patients develop resistance if we wait 2 years for the mutations to disappear & this was pretty much said with regards to telaprevir following the oral presentation by Sullivan of Vertex reporting that mutations mostly disappear after 1.5 years following stopping telaprevir therapy'. This may end up being true but right now this is just a theory without any evidence, no data to support this supposition, it cannot be considered true until a study or real clinical evidence supports this. Until we have data on this question one cannot say flatly patients will be able to re-use a HCV protease after resistance and receive viral load reductions from the drug. Will such a study ever be done, I don't know."
==================================================
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=617274
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the initiation of a Phase 3b study called CONCISE that will evaluate the potential for treatment with INCIVEK™ (telaprevir) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the ‘CC' variation near the IL28B gene. INCIVEK (in-SEE-veck) is administered in combination with pegylated-interferon and ribavirin. Approximately one-third of people with hepatitis C have the ‘CC' genotype, which has been associated with higher sustained viral response (SVR, or viral cure) rates and faster response to interferon-based treatment. In this study, INCIVEK will be taken twice a day. The study is expected to enroll 350 people in the United States and Europe who are new to treatment or who have relapsed after at least one prior course of treatment with pegylated-interferon and ribavirin alone. The primary endpoint of the study is the proportion of patients who achieve a sustained viral response 12 weeks after the last planned dose of study drug (SVR12).
========================================
I have mentioned in a similar thread that vertex has experimented w/ a 12 week total triple therapy treatment. The numbers were small and the groups were randomized treatment niaves.
In this case Vertex is looking at the easiest to treat genotype 1's and seeing if indeed they can treat in 12 weeks. I believe it is quite possible and I surmise that Vertex would not embark on this unless they too felt that it was possible.
This is not to say in any way that you should shorten treatment. I would stay the course. It will virtually assure you of an SVR.
best,
willy
Please get to your doctor for any help you need with sides and stick it out. After the incivek you will start to feel so much better and being hep c free will be such a plus. Good luck
Good luck at the doctors appoint. Just to add to what Willy says above in regards to the resistance issues.
If you stop all treatment at week 11 the chances of virus returning is almost assured,and the virons you are left with may well be resistant until something else in a different class comes along(and even then the data is still out on whether there will be cross resistance) and that may not be for up to 5 years from now
From my knowledge I don"t think anyone has died as a direct result of treament( might feel like it some days) ,however the stark reality is many dozens die each day from ESLD.
Not sure of your current fibrosis stage ,hoewever ,again...be very mindful of what the consequences "could" be,especially in light of the fact you currently have approx. 94% chance of success.
Best ..
Will
If you stop all treatment at week 11 the chances of virus returning is almost assured,and the virons you are left with may well be resistant until something else in a different class comes along(and even then the data is still out on whether there will be cross resistance) and that may not be for up to 5 years from now
From my knowledge I don"t think anyone has died as a direct result of treament( might feel like it some days) ,however the stark reality is many dozens die each day from ESLD.
Not sure of your current fibrosis stage ,hoewever ,again...be very mindful of what the consequences "could" be,especially in light of the fact you currently have approx. 94% chance of success.
Best ..
Will
thank you guys. I got an early morning appointment with the Doc tomorrow to discuss all this. I just feel so bad all of a sudden. Someone posted in here awhile back that they felt like they were slowly dying, that is how I have felt for a week. I am not usually a complainer but this royally *****! lol
Not so Sunny
Not so Sunny
If you can hang on a few days you'll feel measurably better once you stop incivek. I would not stop IFN or riba unless your doctor is in the loop and in agreement.
Will is right; your odds look very good based on your response data he posted. Quitting at this point *could* bring about a TX failure and you certainly have PI resistant virii at this point.
Obviously, monitor the rash, and if you must stop Incivek, but strongly consider before stopping all TX. It isn't clear from your post if you meant just Incivek or all triple therapy; Incivek, IFN and RBV..
You can consult w/ your doctor and you can certainly call the 24 hour nurses w/ Incivek to help you navigate this.
willy
==================
(posted in my above post, info directly info Vertex;)
"If rash progresses and becomes severe or if systemic symptoms develop, INCIVEK should be discontinued. Peginterferon alfa and ribavirin may be continued. If improvement is not observed within 7 days of INCIVEK discontinuation, sequential or simultaneous interruption or discontinuation of ribavirin and/or peginterferon alfa should be considered. If medically indicated, earlier interruption or discontinuation of ribavirin and peginterferon alfa should be considered."
Will is right; your odds look very good based on your response data he posted. Quitting at this point *could* bring about a TX failure and you certainly have PI resistant virii at this point.
Obviously, monitor the rash, and if you must stop Incivek, but strongly consider before stopping all TX. It isn't clear from your post if you meant just Incivek or all triple therapy; Incivek, IFN and RBV..
You can consult w/ your doctor and you can certainly call the 24 hour nurses w/ Incivek to help you navigate this.
willy
==================
(posted in my above post, info directly info Vertex;)
"If rash progresses and becomes severe or if systemic symptoms develop, INCIVEK should be discontinued. Peginterferon alfa and ribavirin may be continued. If improvement is not observed within 7 days of INCIVEK discontinuation, sequential or simultaneous interruption or discontinuation of ribavirin and/or peginterferon alfa should be considered. If medically indicated, earlier interruption or discontinuation of ribavirin and peginterferon alfa should be considered."
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