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
Sunshine.. sorry I guess my post was not very clear.. I mentioned above:
" For relapsers that did 24 weeks of Telaprivir in the "Realize Trial"(irespective of allele type) and were UND at week 4... 94 % achieved SVR...."
However I forgot to add and you are certainly correct that the the ad hoc part of that study the results were what you stated for the TT"s
Still very attractive % and I hope your INR is ok and you can continue.
Good luck...
Will
" For relapsers that did 24 weeks of Telaprivir in the "Realize Trial"(irespective of allele type) and were UND at week 4... 94 % achieved SVR...."
However I forgot to add and you are certainly correct that the the ad hoc part of that study the results were what you stated for the TT"s
Still very attractive % and I hope your INR is ok and you can continue.
Good luck...
Will
regarding morning appointment - they are going to do an INR to see if clotting is an issue won't have results until Tuesday or Wednesday, in the meantime no aspirin products, or advil or tylenol to be on the safe side. Platelets have nose dived. It's more of a wait and see game, trying real hard to hang in and finish the INC
Will - 94% SVR in my case is not accurate, they said 72-76% I am IR, FL and TT but it is much more attractive than the 48-60% chance I had just doing SOC
Will - 94% SVR in my case is not accurate, they said 72-76% I am IR, FL and TT but it is much more attractive than the 48-60% chance I had just doing SOC
For relapsers that did 24 weeks of Telaprivir in the "Realize Trial"
sorry...... meant 24 weeks of "treatment "
sorry...... meant 24 weeks of "treatment "
The above study Vertex is currently doing is interesting. and hopfully successful.however it is only for the easiest to treat.. as you say (patients with the CC allee).
I believe the poster we are addressing here is a TT alelle. which could be a much different scenario.
SunShine Girle: For relapsers that did 24 weeks of Telaprivir in the "Realize Trial"(irespective of alelle type) and were UND at week 4... 94 % achieved SVR........ as Willy says...if you stay the course it will almost assure success .
Best to you.....
Will
I believe the poster we are addressing here is a TT alelle. which could be a much different scenario.
SunShine Girle: For relapsers that did 24 weeks of Telaprivir in the "Realize Trial"(irespective of alelle type) and were UND at week 4... 94 % achieved SVR........ as Willy says...if you stay the course it will almost assure success .
Best to you.....
Will
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."
" I have 7 days left of INC and I am seriously thinking of stopping treatment. "
------------------------------------------------------------------------------------
You mean stopping treament altogether?? I see from your earlier posts you were UND. at week 4. As a prior relapser if you are UND again at week 12 this gives you approx. 94% chance of success.
Sorry to hear about how crappy you feel especially ,if the HGB. is very low ,it can certainly be tough ,however with those odds of success in your pocket I hope you and your doctor give stopping very serious second thought.
Best to you...
Will
I have 7 days left of INC and I am seriously thinking of stopping treatment. My anemia is bad and my white count is at 1.2 I feel and look like ****. I was able to tolerate it up until about a week ago and the crap hit the fan. I am waiting for my recent labs today. They took me down to 800 riba with procrit twice a week. Billy have yiu had your 8 week PCR? - Sunny
http://pi.vrtx.com/files/uspi_telaprevir.pdf
(see 5.2 and 5.3 on pages 3 and 4. -- willy)
5.2 Serious Skin Reactions
Serious skin reactions, including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson Syndrome (SJS) were reported in
less than 1% of subjects who received INCIVEK combination treatment compared to none who received peginterferon alfa and ribavirin alone. These serious skin reactions required hospitalization, and all patients recovered. The presenting signs of DRESS may include rash, fever, facial edema, and evidence of internal organ involvement (e.g., hepatitis, nephritis). Eosinophilia may or may not be present. The presenting signs of SJS may include fever, target lesions, and mucosal erosions or ulcerations (e.g., conjunctivae, lips).
If a serious skin reaction occurs, all components of INCIVEK combination treatment must be discontinued immediately and the patient should be promptly referred for urgent medical care.
5.3 Rash
Rash developed in 56% of subjects who received INCIVEK combination treatment [see Adverse Reactions (6.1)]. Severe rash (e.g., a generalized rash or rash with vesicles or bullae or ulcerations other than SJS) was reported in 4% of subjects who received INCIVEK combination treatment compared to less than 1% who received peginterferon alfa and ribavirin alone. The severe rash may have a prominent eczematous component.
Patients with mild to moderate rashes should be followed for progression of rash or development of systemic symptoms. 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. Patients should be monitored until the rash has resolved. INCIVEK must not be reduced or restarted if discontinued due to rash. Treatment of rash with oral antihistamines and/or topical corticosteroids may provide symptomatic relief but effectiveness of these measures has not been established. Treatment of rash with systemic
corticosteroids is not recommended [see Drug Interactions (7)].
===============================
Since many people on TX also may see a drop in WBC and RBC it is not uncommon that bacterial infections may occur easier and may be tougher to treat. People with low WBC can get sick easier and rather quickly.
Just be careful out there....
willy
(see 5.2 and 5.3 on pages 3 and 4. -- willy)
5.2 Serious Skin Reactions
Serious skin reactions, including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson Syndrome (SJS) were reported in
less than 1% of subjects who received INCIVEK combination treatment compared to none who received peginterferon alfa and ribavirin alone. These serious skin reactions required hospitalization, and all patients recovered. The presenting signs of DRESS may include rash, fever, facial edema, and evidence of internal organ involvement (e.g., hepatitis, nephritis). Eosinophilia may or may not be present. The presenting signs of SJS may include fever, target lesions, and mucosal erosions or ulcerations (e.g., conjunctivae, lips).
If a serious skin reaction occurs, all components of INCIVEK combination treatment must be discontinued immediately and the patient should be promptly referred for urgent medical care.
5.3 Rash
Rash developed in 56% of subjects who received INCIVEK combination treatment [see Adverse Reactions (6.1)]. Severe rash (e.g., a generalized rash or rash with vesicles or bullae or ulcerations other than SJS) was reported in 4% of subjects who received INCIVEK combination treatment compared to less than 1% who received peginterferon alfa and ribavirin alone. The severe rash may have a prominent eczematous component.
Patients with mild to moderate rashes should be followed for progression of rash or development of systemic symptoms. 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. Patients should be monitored until the rash has resolved. INCIVEK must not be reduced or restarted if discontinued due to rash. Treatment of rash with oral antihistamines and/or topical corticosteroids may provide symptomatic relief but effectiveness of these measures has not been established. Treatment of rash with systemic
corticosteroids is not recommended [see Drug Interactions (7)].
===============================
Since many people on TX also may see a drop in WBC and RBC it is not uncommon that bacterial infections may occur easier and may be tougher to treat. People with low WBC can get sick easier and rather quickly.
Just be careful out there....
willy
7 days left of incivek myself and the itching is unreal. My body is covered in rashes, and I am bleeding from head to toe. My eyes are swollen with appears to be infections in the eye lids. An entire pharmacy of medication does not stop the itching. I have acne all over my body and raised bumps where the rash is. I understand where you are coming from and have considered giving up myself. The goal is to near for me to quit now. Get some rest and take care of yourself. Does any one know how long after the teleprevir can one expect the itch and rash to go away?
I would not worry for a second about stopping 5 days early.
If the rash develops into stevens johnson grade rash it is life threatening.
I know a person in the hospital right now who had a bad rash, it became infected, developed a blood infection, and has been in the hospital, out to a conservatory and now back to the hospital.
Huge expense, life threatening sick, edema and has been taken off riba at about week 12. Right now the sides from the rash have overshadowed TX.
IF people have a rash, take care of it, seek medical attention and do not try to ride it out as you get worse.
http://www.natap.org/2010/AASLD/AASLD_36.htm
12 weeks of triple therapy vrs 8 weeks;
75% SVR rate versus 69% SVR rate respectively.
That is 6 percent difference by treating 28 additional days......
A subjective method of working the math would suggest each 5 days = a 1% improved outcome, so stopping 5 days early might have a 1% cost in efficacy.
Ignoring ones sides caused by a rash....on the other hand..... could put you in the hospital, could end your TX. This could leave you with the virus AND resistance issues.
The treating of the rash should be done in according to Vertex treatment recommendations, or updated AASLD recommendations, (I think some just came out, I've not read em yet) and your doctors council.
Personally, I think you made the right decision.
best,
Willy
If the rash develops into stevens johnson grade rash it is life threatening.
I know a person in the hospital right now who had a bad rash, it became infected, developed a blood infection, and has been in the hospital, out to a conservatory and now back to the hospital.
Huge expense, life threatening sick, edema and has been taken off riba at about week 12. Right now the sides from the rash have overshadowed TX.
IF people have a rash, take care of it, seek medical attention and do not try to ride it out as you get worse.
http://www.natap.org/2010/AASLD/AASLD_36.htm
12 weeks of triple therapy vrs 8 weeks;
75% SVR rate versus 69% SVR rate respectively.
That is 6 percent difference by treating 28 additional days......
A subjective method of working the math would suggest each 5 days = a 1% improved outcome, so stopping 5 days early might have a 1% cost in efficacy.
Ignoring ones sides caused by a rash....on the other hand..... could put you in the hospital, could end your TX. This could leave you with the virus AND resistance issues.
The treating of the rash should be done in according to Vertex treatment recommendations, or updated AASLD recommendations, (I think some just came out, I've not read em yet) and your doctors council.
Personally, I think you made the right decision.
best,
Willy
I've been taking plain old Reactine. Switched from the OTC stuff to the Rx stuff a few weeks ago. Works great for me. :)
If you haven't tried promethazine (Phergan) I think you should. There shouldn't be any trouble in getting it prescribed. Joe has it for nausea and it does well for that. It isn't a very expensive drug so I can't think of why you wouldn't be able to try it.
Blessings,
Ev
Blessings,
Ev
I take promethazine, it's an antihistimine designed for patients who have to take large doses of opiate based pain meds, it controls the nausea and itching caused by the opiates. It has been working well for me for the nausea and itching caused by the incivek and has no interactions with the tri tx drugs, might be worth running by your doc.
I agree, after all the years of research there should be a drug thay can give you to stop the itching/rash. I thought that was what the trials were for, guess that is what I get for thinking :)
I am still waiting (since last week) for someone to decide what med is compatible with Incivek to stop the itching.
Thanks for all your posts
Dee
I am still waiting (since last week) for someone to decide what med is compatible with Incivek to stop the itching.
Thanks for all your posts
Dee
I just have a few thoughts to offer.
Were you ever on a medication specifically for the itch? I am reading a lot about the itching from many people on the forum, but, i have missed how the physicians are treating this problem.
A steady itch is usually considered a serious thing by dermatologists and patients alike as it can really get a big problem going and lead to infection etc. In this case it is influencing the continuation of these very important medications and your treatment plan.
I know of one drug, atarax, that is specific for itch and allergies. It is a pill, and a prescription drug. It is also an anti anxiety agent. I do not know about toxicity but it has been in use for decades for itchy skin conditions. Maybe there are more, but I am only aware of this one drug. They need to find something to counteract the itch so people can keep going without being driven crazy and off treatment due to itch.
If you cannot continue, you cannot continue. The 80% rule does apply for most circumstances with medicines. I wish you the best.
Were you ever on a medication specifically for the itch? I am reading a lot about the itching from many people on the forum, but, i have missed how the physicians are treating this problem.
A steady itch is usually considered a serious thing by dermatologists and patients alike as it can really get a big problem going and lead to infection etc. In this case it is influencing the continuation of these very important medications and your treatment plan.
I know of one drug, atarax, that is specific for itch and allergies. It is a pill, and a prescription drug. It is also an anti anxiety agent. I do not know about toxicity but it has been in use for decades for itchy skin conditions. Maybe there are more, but I am only aware of this one drug. They need to find something to counteract the itch so people can keep going without being driven crazy and off treatment due to itch.
If you cannot continue, you cannot continue. The 80% rule does apply for most circumstances with medicines. I wish you the best.
In the same boat but am still pushing to finish. 3.5 more days to go of the Incivek! Wondering if anyone else has my issue. My viral count is not undetectable. It recently went from 120 to 240 (of course much lower than pre-tx). My enzymes went from 60 to 95. Dr. says I'm not a success because my virus is still struggling to hold on, but I haven't failed since it hasn't out and out broken through. If I stay under 1000 next week, he'll keep me on dual therapy for 12 more weeks and by the end, I must be undetectable to continue for the remaining 24 weeks. Does anyone know of anyone who went to und after the Incivek ended? All the side effects will be worth it to me (and there are a lot) if it clears the virus! This limbo is so deflating!
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