Aa
EPO and SVR
The following is a study on the SVR rates when using EPO. Some interesting results for anyone using or considering EPO to conteract anemia. Even more interest is High Dosing RBV.
Below is the Abstract
CS
Treatment of Chronic Hepatitis C Virus Genotype 1 with Peginterferon, Ribavirin, and Epoetin alpha
Mitchell L. Shiffman, Jennifer Salvatore, Sarah Hubbard, Angie Price, Richard K. Sterling, R. Todd Stravitz, Velimir A. Luketic, and Arun J. Sanyal
Abstract
Successful treatment of chronic HCV with peginterferon (PEGIFN) and ribavirin (RVN) is often limited by anemia. We performed the present study to determine if utilizing epoetin alpha (EPO) with or without a higher dose of RVN could enhance sustained virologic response (SVR). We randomized 150 treatment-naive patients with chronic HCV genotype 1 into 3 treatment groups: (1) PEGIFN alpha-2b (1.5 _g/kg/week) _ weight-based RVN (WBR) 13.3 mg/kg/day (800 to 1400 mg/day); (2) PEGIFN alpha-2b _ WBRVN _ EPO (40,000 U/week); or (3) PEGIFN alpha-2b _ higher dose WBR 15.2 mg/kg/day (1000 to 1600 mg/day)_EPO.We initiated EPO at the onset of therapy to maintain the hemoglobin between 12 and 15 g/dL. When required, we reduced RVN by 200-mg steps. African Americans compose 36% of the population. A significantly smaller percentage of group 2 patients had a decline in hemoglobin to less than 10 g/dL (9% versus 34%; P < 0.05) and required that the RVN dose be reduced (10% versus 40%; P < 0.05) compared to group 1 patients.
Despite this, SVR was similar in these groups (19% to 29%). SVR was significantly greater (P < 0.05) in group 3 patients (49%). This resulted from a significant decline (P < 0.05) in relapse rate; only 8% versus 38% for groups 1 and 2.
Conclusion: We conclude that using EPO in all subjects at the initiation of PEGIFN and RVN treatment will not enhance SVR given the same starting dose of RVN. In contrast, a higher starting dose of RVN was associated with a lower relapse rate and higher rate of SVR. (HEPATOLOGY 2007;46:371-379.)
Below is the Abstract
CS
Treatment of Chronic Hepatitis C Virus Genotype 1 with Peginterferon, Ribavirin, and Epoetin alpha
Mitchell L. Shiffman, Jennifer Salvatore, Sarah Hubbard, Angie Price, Richard K. Sterling, R. Todd Stravitz, Velimir A. Luketic, and Arun J. Sanyal
Abstract
Successful treatment of chronic HCV with peginterferon (PEGIFN) and ribavirin (RVN) is often limited by anemia. We performed the present study to determine if utilizing epoetin alpha (EPO) with or without a higher dose of RVN could enhance sustained virologic response (SVR). We randomized 150 treatment-naive patients with chronic HCV genotype 1 into 3 treatment groups: (1) PEGIFN alpha-2b (1.5 _g/kg/week) _ weight-based RVN (WBR) 13.3 mg/kg/day (800 to 1400 mg/day); (2) PEGIFN alpha-2b _ WBRVN _ EPO (40,000 U/week); or (3) PEGIFN alpha-2b _ higher dose WBR 15.2 mg/kg/day (1000 to 1600 mg/day)_EPO.We initiated EPO at the onset of therapy to maintain the hemoglobin between 12 and 15 g/dL. When required, we reduced RVN by 200-mg steps. African Americans compose 36% of the population. A significantly smaller percentage of group 2 patients had a decline in hemoglobin to less than 10 g/dL (9% versus 34%; P < 0.05) and required that the RVN dose be reduced (10% versus 40%; P < 0.05) compared to group 1 patients.
Despite this, SVR was similar in these groups (19% to 29%). SVR was significantly greater (P < 0.05) in group 3 patients (49%). This resulted from a significant decline (P < 0.05) in relapse rate; only 8% versus 38% for groups 1 and 2.
Conclusion: We conclude that using EPO in all subjects at the initiation of PEGIFN and RVN treatment will not enhance SVR given the same starting dose of RVN. In contrast, a higher starting dose of RVN was associated with a lower relapse rate and higher rate of SVR. (HEPATOLOGY 2007;46:371-379.)
Cruel: will they even tell me the truth on this? do they actually know the truth?
No,.
Cruel: will they even tell me the truth on this? do they actually know the truth?
No.
Cruel: ill pay and we will all gang up somewhere and terrorize some unsuspecting town for a few days. we can exchange some exaggerated sx war stories, embarrass some girls and maybe even get thrown in jail. sounds like fun eh?
Yes.
No,.
Cruel: will they even tell me the truth on this? do they actually know the truth?
No.
Cruel: ill pay and we will all gang up somewhere and terrorize some unsuspecting town for a few days. we can exchange some exaggerated sx war stories, embarrass some girls and maybe even get thrown in jail. sounds like fun eh?
Yes.
thanks for all the help, i owe yall one. when i get rich and famous (a very high possibility LOL!) ill pay and we will all gang up somewhere and terrorize some unsuspecting town for a few days. we can exchange some exaggerated sx war stories, embarrass some girls and maybe even get thrown in jail. sounds like fun eh?
jim, i started with my hometown gastro and only just met with the liverhead once 2 weeks ago. this is why pcrs were scarce. i feel better hearing that you agonized for weeks over this issue just as i am. i guess everyone does.
i am much relaxed to get you alls opinions. it has helped me immeasurably. i am setting up the big boy meets as soon as possible. once i can get comfortable with a decision, all thats left is doin the time. relatively easy. a big question for the liverheads is recovery time and permanent sx for 72 death march people. will they even tell me the truth on this? do they actually know the truth? i hope so.
thanks again and i wish all to have a happy and fatigue free day!
over and out
cruelworld
jim, i started with my hometown gastro and only just met with the liverhead once 2 weeks ago. this is why pcrs were scarce. i feel better hearing that you agonized for weeks over this issue just as i am. i guess everyone does.
i am much relaxed to get you alls opinions. it has helped me immeasurably. i am setting up the big boy meets as soon as possible. once i can get comfortable with a decision, all thats left is doin the time. relatively easy. a big question for the liverheads is recovery time and permanent sx for 72 death march people. will they even tell me the truth on this? do they actually know the truth? i hope so.
thanks again and i wish all to have a happy and fatigue free day!
over and out
cruelworld
Just want to add that if you decide to extend, I'd watch your hemoglobin carefully as well as monitoring how you feel. If it drops much more and/or you start feeling worse, I wouldn't hesitate to either drop back down toward weight based (1200?) or add Procrit (epo). In the past I'd advocate adding the Procrit, but not so sure anymore, especially later in treatment. The very high dose ribavirin studies used epo liberally throughout tx but those doses were well beyond what you're on. Also, not sure adding more Peg or moving the shots closer together is such a hot idea either. Maybe just the last month. Dunno. I thought about it myself but ended up finishing on a standard dose. A lot I would think depends on how you're handling side effects. Just remember that there is a lot of life after treatment and you want to arrive there in as good a condition as possible. Sometimes we lose track of this when in the heat of battle (treatment) but doctors are well aware of this fact and therefore most will not advocate too agressive dosing in most cases, unless the patient forcefully advocates it. I know I did in the beginning of my treatment, and I did get myself into trouble. Looking back, not sure all the xtra meds helped my case.
-- Jim
-- Jim
-- Jim
-- Jim
To put it bluntly:
Its time to suck it up and ride that train all the way into the station. That's Stop #72. If you are forced to get off early, say at Stop #64 or #66, you may still be allright, and able to limp into the big SVR terminal. Its a crapshoot as you clearly can see by now. The willingness to keep riding is the biggest trick.
DD
Its time to suck it up and ride that train all the way into the station. That's Stop #72. If you are forced to get off early, say at Stop #64 or #66, you may still be allright, and able to limp into the big SVR terminal. Its a crapshoot as you clearly can see by now. The willingness to keep riding is the biggest trick.
DD
OK. I'll go out on a limb. Factoring in the fact your 3.1 log drop at week 9, etc --
My guess is that the 'magic' number for you is between 60-68 weeks. (The average of which (64) coincidently is right smack in the middle of your doctor's suggestion (54 weeks and the 72 weeks the studies are based on.).
If you feel any better treating "72" weeks because someone doing a study picked that number, by all means go ahead, but if you're not cured by 60-68, what makes you think you will be cured with 72. Certainly no studies on that one.
I would still follow my suggestions in the above post, at least if you're as compulsive about treatment as I was. It will also give you something to keep yourself occupied :)
BTW I have a feeling you will beat this thing.
All the best,
-- Jim
My guess is that the 'magic' number for you is between 60-68 weeks. (The average of which (64) coincidently is right smack in the middle of your doctor's suggestion (54 weeks and the 72 weeks the studies are based on.).
If you feel any better treating "72" weeks because someone doing a study picked that number, by all means go ahead, but if you're not cured by 60-68, what makes you think you will be cured with 72. Certainly no studies on that one.
I would still follow my suggestions in the above post, at least if you're as compulsive about treatment as I was. It will also give you something to keep yourself occupied :)
BTW I have a feeling you will beat this thing.
All the best,
-- Jim
Cruel: Remember, rather than choices i really want to know -
what single choice would you make "if it were you"
-----------------------
LOL. You're talking to someone who agonized for weeks -- and spoke to 4-5 top-dog hepatologists -- re whether to stop at week 48 or extend (I ended up doing 54 weeks), and you want a *single* choice :) Anyway, I'll do my best to answer, but maybe not what you want. Probably not what you want :)
First, you had a very nice drop at week 9 (3.1 log). I'm assuming you did not test at week 12, but wonder why your major league doc didn't do that test? Anyway, week 18 showed very little virus and you were UND at week 19. One might even ponder the fact that the week 18 test was a false positive, or some sort of intermittent thing, but certainly can't rely on it. Still, I can why given your week 9 drop, your doc might consider extending, but less than 72 weeks. Keep in mind that studies using fixed dose riba cut two ways. Yes, they suggest you might have a better chance of SVR with 72 weeks on weight-base dose, but they also suggest you may not need 72 weeks on weight-based.
What would I do? Here's how I would most probably handle it, based on what I did myself.
First, I'd order up FULL-TEXT copies of all the extended tx studies, including Berg, the one just posted here, and any others. Then after studying them yourself, I'd make an appointment and review them with your doc. Where I would want to come out of that meeting is your doc's estimation of your chance of SVR with 72 weeks of treatment versus 56 or 68 weeks you mentioned earlier. And if he sticks to his guns -- less than 72 weeks -- then querry him why less, and based on what, given the 72 week studies. You don't just want his opinion, you want his logic, his reasoning. I would then repeat the same process if at least two other well-respected hepatologists who do a lot of trials -- someone like Schiff, Afdahl, Dieterich, Jacobsen, etc. At that point, hopefully there will be a consensus, or at least things will start getting clearer. That's what I would do because that is similar to what I did.
My guess is that you will get opinions ranging from 56 to 72 weeks -- the 72 week number because it's become sort of a conservative standard for slow responders (Im pretty sure my tx doc would recc 72 weeks in your case) and the lesser numbers based on your excellent week 8 response which brings up the possibity of a false positive at week 18, since you were UND at week 19.
As to the Vertex thing -- first, I'd try and figure out as best I can what my odds will be with extended tx, per some expert opinions. Unless the consensus was below 50%, stopping now and hopping on the Teleprevir bandwagon at a latter date is certainly an option, but not one I think you'll find too many doctors recommending, and probably for good reasons -- some of which I mentioned earlier.
Hope this helps a little.
-- Jim
what single choice would you make "if it were you"
-----------------------
LOL. You're talking to someone who agonized for weeks -- and spoke to 4-5 top-dog hepatologists -- re whether to stop at week 48 or extend (I ended up doing 54 weeks), and you want a *single* choice :) Anyway, I'll do my best to answer, but maybe not what you want. Probably not what you want :)
First, you had a very nice drop at week 9 (3.1 log). I'm assuming you did not test at week 12, but wonder why your major league doc didn't do that test? Anyway, week 18 showed very little virus and you were UND at week 19. One might even ponder the fact that the week 18 test was a false positive, or some sort of intermittent thing, but certainly can't rely on it. Still, I can why given your week 9 drop, your doc might consider extending, but less than 72 weeks. Keep in mind that studies using fixed dose riba cut two ways. Yes, they suggest you might have a better chance of SVR with 72 weeks on weight-base dose, but they also suggest you may not need 72 weeks on weight-based.
What would I do? Here's how I would most probably handle it, based on what I did myself.
First, I'd order up FULL-TEXT copies of all the extended tx studies, including Berg, the one just posted here, and any others. Then after studying them yourself, I'd make an appointment and review them with your doc. Where I would want to come out of that meeting is your doc's estimation of your chance of SVR with 72 weeks of treatment versus 56 or 68 weeks you mentioned earlier. And if he sticks to his guns -- less than 72 weeks -- then querry him why less, and based on what, given the 72 week studies. You don't just want his opinion, you want his logic, his reasoning. I would then repeat the same process if at least two other well-respected hepatologists who do a lot of trials -- someone like Schiff, Afdahl, Dieterich, Jacobsen, etc. At that point, hopefully there will be a consensus, or at least things will start getting clearer. That's what I would do because that is similar to what I did.
My guess is that you will get opinions ranging from 56 to 72 weeks -- the 72 week number because it's become sort of a conservative standard for slow responders (Im pretty sure my tx doc would recc 72 weeks in your case) and the lesser numbers based on your excellent week 8 response which brings up the possibity of a false positive at week 18, since you were UND at week 19.
As to the Vertex thing -- first, I'd try and figure out as best I can what my odds will be with extended tx, per some expert opinions. Unless the consensus was below 50%, stopping now and hopping on the Teleprevir bandwagon at a latter date is certainly an option, but not one I think you'll find too many doctors recommending, and probably for good reasons -- some of which I mentioned earlier.
Hope this helps a little.
-- Jim
he inglorious stats of cruelworld
race and gender, dirty white boy
age, 48
height 6,0
weight pre tx 175 BMI 23.7
weight now 157 BMI 21.3
body state pre tx healthy, strong, good shape
symptoms pre tx asymptomatic
medical history normal childhood illnesses, tonsils taken out,
mild hypertension taking atenenolol for 1 year
unremarkable otherwise
liver histology stage 3 grade3
septal fibrosis noted (bridging not mentioned)
no cirrhosis
rescue drugs none
hgb pre tx 15.9
hgb 3rd week 12.8 (highest during tx)
hgb avg on tx 11.7
hgb now 11.2
hgb lowest 10.6 (riba induction)
anc current 2313
all other bloodwork good - if out of range, only slightly so
INF dosing pegintron 120 mg (centered on weight based chart)
100% compliance no variation
riba dosing week 1 - 19 1000mg (at bottom cusp of weight chart)
week 20-26 1200mg
week 26 - 36 1400mg
infection maturity 30 years
pre tx viral 1,630,000 iu ast 127 alt 206
week 9 1280 iu (3.1 log drop) 138 192
week 18 89 iu 103 142
week 19 >5 iu heptimax
week 27 >5 iu heptimax 72 93
week 34 >5 iu heptimax 89 105
viral curve interpolated to .3 log per week
sx all the normal stuff
middle of the road severity
can work a week at a time here and there
riba induction pretty hard but stable now and better
treatment status naive
remember, rather than choices i really want to know -
what single choice would you make "if it were you"
race and gender, dirty white boy
age, 48
height 6,0
weight pre tx 175 BMI 23.7
weight now 157 BMI 21.3
body state pre tx healthy, strong, good shape
symptoms pre tx asymptomatic
medical history normal childhood illnesses, tonsils taken out,
mild hypertension taking atenenolol for 1 year
unremarkable otherwise
liver histology stage 3 grade3
septal fibrosis noted (bridging not mentioned)
no cirrhosis
rescue drugs none
hgb pre tx 15.9
hgb 3rd week 12.8 (highest during tx)
hgb avg on tx 11.7
hgb now 11.2
hgb lowest 10.6 (riba induction)
anc current 2313
all other bloodwork good - if out of range, only slightly so
INF dosing pegintron 120 mg (centered on weight based chart)
100% compliance no variation
riba dosing week 1 - 19 1000mg (at bottom cusp of weight chart)
week 20-26 1200mg
week 26 - 36 1400mg
infection maturity 30 years
pre tx viral 1,630,000 iu ast 127 alt 206
week 9 1280 iu (3.1 log drop) 138 192
week 18 89 iu 103 142
week 19 >5 iu heptimax
week 27 >5 iu heptimax 72 93
week 34 >5 iu heptimax 89 105
viral curve interpolated to .3 log per week
sx all the normal stuff
middle of the road severity
can work a week at a time here and there
riba induction pretty hard but stable now and better
treatment status naive
remember, rather than choices i really want to know -
what single choice would you make "if it were you"
Hopefully "Cruel" did have at least a two-log drop by week 12, but I couldn't find his post on that. That does appear to be key, at least by this study.
As to "90%" chance of SVR, I think that very optimistic.
I was given around a 75% chance of SVR with an RVR* (not EVR) and 54 weeks of treatment. Still, 77% is a very encouraging number, and if it turns out that he fits the studies criteria, my suggestion would be for him to print the study out and discuss with his doctor who is head of Hepatology of Baylor. At least that would be my next step.
* Almost two-log drop at week 1; two-log drop at week 2: UND to <50 at week 6.
-- Jim
As to "90%" chance of SVR, I think that very optimistic.
I was given around a 75% chance of SVR with an RVR* (not EVR) and 54 weeks of treatment. Still, 77% is a very encouraging number, and if it turns out that he fits the studies criteria, my suggestion would be for him to print the study out and discuss with his doctor who is head of Hepatology of Baylor. At least that would be my next step.
* Almost two-log drop at week 1; two-log drop at week 2: UND to <50 at week 6.
-- Jim
I think cruelworld did have a 3.1 log drop by week 9, which puts him in a VERY strong statistical position to get the SVR in a 72 week course of tx, I believe. I would bet that with the 3.1 log drop, and with the above standard Riba dosing that his real odds of SVR would be over 90%. Just an educated guess.
DD
DD
my stats are about 8 posts up
Well, I guess my own question is answered in the title of the study LOL which I apparently didn't read:
Title Study:
72 Weeks Pegasys/RBV in Genotype 1 Improves SVR Rate For Patients With Early Viral Response (2 log reduction at wk 12) But HCV RNA >50 IU/mL
------------------------------------------------
So, yes, per this study, extending to 72 weeks is only recommended if you have a two-log drop by week 12. If you do not have a two log drop by week 12, this particular study appears to offer less hope than Berg, for example.
Title Study:
72 Weeks Pegasys/RBV in Genotype 1 Improves SVR Rate For Patients With Early Viral Response (2 log reduction at wk 12) But HCV RNA >50 IU/mL
------------------------------------------------
So, yes, per this study, extending to 72 weeks is only recommended if you have a two-log drop by week 12. If you do not have a two log drop by week 12, this particular study appears to offer less hope than Berg, for example.
Just to clarify a little. "EVR" appears to be defined by the authors (see chart) as a >2 log drop by week 12, but viremia >50 IU/ml. Hopefully "Cruel" will get back to us with his viral load results both pre-treatment and at week 12.
Maybe I'm reading it wrong, but for me the study seems to suggest that only EVRs benefit from extending treament to 72 weeks and not those in the non-EVR population who were >50 at week 12 but were not EVR.
From the treatment alogorithm:
----------------------------------------------------------------------------------
- patients with an EVR but with HCV RNA >50 IU/mL at week 12 could benefit from a longer treatment duration of 72 weeks
- consistent with treatment guidelines,[1] patients without an EVR should not continue treatment as the likelihood of achieving an SVR is minimal (2 log drop by week 12 but viremia >50 IU/ml. At least I *think* this is how they define it.
So the question here -- assuming my take is correct -- is if "Cruel" had >2 log drop by week 12, i.e if he was EVR. If not, then the "77%" figure you quote is not relevant at all.
Lastly, later in the paper there seems to be some sort of typo where "350" should read ">50". This occurs a few times.
Certainly hope I'm wrong here.
-- Jim
From the treatment alogorithm:
----------------------------------------------------------------------------------
- patients with an EVR but with HCV RNA >50 IU/mL at week 12 could benefit from a longer treatment duration of 72 weeks
- consistent with treatment guidelines,[1] patients without an EVR should not continue treatment as the likelihood of achieving an SVR is minimal (2 log drop by week 12 but viremia >50 IU/ml. At least I *think* this is how they define it.
So the question here -- assuming my take is correct -- is if "Cruel" had >2 log drop by week 12, i.e if he was EVR. If not, then the "77%" figure you quote is not relevant at all.
Lastly, later in the paper there seems to be some sort of typo where "350" should read ">50". This occurs a few times.
Certainly hope I'm wrong here.
-- Jim
can i come live with yall if i end up with permanent riba rage, brain fog and fatigue?
being the consumate diplomats that you are, you both will probably say yes!
touche! thats the one great thing about this experience, we all become brothers and sisters for life. what a fraternity. does anyone know a 72 person without long lasting battle scars? its an interesting question that i dont know the answer to.
dd
i do need more pro opinions at this point, but anymore i dont even trust the docs on the issues of permanent problems. i think ive seroconverted from riba rage to riba paranoia! its driving me nuts! the funny thing is, my treatment is going easier and better than ever. i made another 22 min skating session last night and i still feel
energized 12 hours later. im running around right now doing housework. what a basket case i have become.
being the consumate diplomats that you are, you both will probably say yes!
touche! thats the one great thing about this experience, we all become brothers and sisters for life. what a fraternity. does anyone know a 72 person without long lasting battle scars? its an interesting question that i dont know the answer to.
dd
i do need more pro opinions at this point, but anymore i dont even trust the docs on the issues of permanent problems. i think ive seroconverted from riba rage to riba paranoia! its driving me nuts! the funny thing is, my treatment is going easier and better than ever. i made another 22 min skating session last night and i still feel
energized 12 hours later. im running around right now doing housework. what a basket case i have become.
DoubleDose’s 80% figure would be close to the mark, your chances maybe even higher.
The article below produced 77% SVR with 72 weeks for G1 slow responders. http://www.natap.org/2006/AASLD/AASLD_34.htm.
This was Per Protocol whereas Bergs was ITT with 800 mg RBV.
It also discusses shortening Tx for G1&4s who RVR.
Add this to the Study above and your SVR chance could well be higher, so long as you remain UND and don’t need to dose reduce the RBV too much.
You asked Jim what he would do in your situation. I know what I would do, and that’s Go all out now. I am in total agreement with DD on this. Why wait when you can kill it with the drugs you are already taking.
Just my view
CS
The article below produced 77% SVR with 72 weeks for G1 slow responders. http://www.natap.org/2006/AASLD/AASLD_34.htm.
This was Per Protocol whereas Bergs was ITT with 800 mg RBV.
It also discusses shortening Tx for G1&4s who RVR.
Add this to the Study above and your SVR chance could well be higher, so long as you remain UND and don’t need to dose reduce the RBV too much.
You asked Jim what he would do in your situation. I know what I would do, and that’s Go all out now. I am in total agreement with DD on this. Why wait when you can kill it with the drugs you are already taking.
Just my view
CS
Here's one final suggestion: Speak with one or two prominent HCV docs and describe your situation (you might e-mail them). Most of the major docs out there have confronted cases like yours many times, and know all the ifs, ands, and buts regarding the various options you describe. I think that getting some really qualified input would make your decision easier, and provide some 'expert' opinion tailored to your specific situation.
Also, sometimes you just need to 'grit things out' for a few weeks when going through a period of uncertainty or confusion. Often the right solution for you will make itself obvious, and you will feel it from within. Right now you are forcing the issue a bit, and maybe prematurely.]
DD
Also, sometimes you just need to 'grit things out' for a few weeks when going through a period of uncertainty or confusion. Often the right solution for you will make itself obvious, and you will feel it from within. Right now you are forcing the issue a bit, and maybe prematurely.]
DD
remember, rather than choices i really want to know -
what single choice would you make "if it were you'
what single choice would you make "if it were you'
the inglorious stats of cruelworld
race and gender, dirty white boy
age, 48
height 6,0
weight pre tx 175 BMI 23.7
weight now 157 BMI 21.3
body state pre tx healthy, strong, good shape
symptoms pre tx asymptomatic
medical history normal childhood illnesses, tonsils taken out,
mild hypertension taking atenenolol for 1 year
unremarkable otherwise
liver histology stage 3 grade3
septal fibrosis noted (bridging not mentioned)
no cirrhosis
rescue drugs none
hgb pre tx 15.9
hgb 3rd week 12.8 (highest during tx)
hgb avg on tx 11.7
hgb now 11.2
hgb lowest 10.6 (riba induction)
anc current 2313
all other bloodwork good - if out of range, only slightly so
INF dosing pegintron 120 mg (centered on weight based chart)
100% compliance no variation
riba dosing week 1 - 19 1000mg (at bottom cusp of weight chart)
week 20-26 1200mg
week 26 - 36 1400mg
infection maturity 30 years
pre tx viral 1,630,000 iu ast 127 alt 206
week 9 1280 iu (3.1 log drop) 138 192
week 18 89 iu 103 142
week 19 >5 iu heptimax
week 27 >5 iu heptimax 72 93
week 34 >5 iu heptimax 89 105
viral curve interpolated to .3 log per week
sx all the normal stuff
middle of the road severity
can work a week at a time here and there
riba induction pretty hard but stable now and better
treatment status naive
double dose,
i certainly didnt mean to "2nd rate" your opinion (compared to jim). its just that he never really gave me any really clear recommendation as you emphatically and specifically have. now that i read yalls comments i realize that this argument boils down to predicted SVR rates for each choice. on the 72 option, your guess of 80% SVR rate may be a little overestimated but maybe not. it does help (in my mind) that your doc suggested this number. very persuasive.
jim,
i believe that double dose's opinion could be characterized as "youve got a good shot if you go all out to 72, go ahead and get this overwith and be prepared for the risks of heavy INF exposure"
you on the other hand, you appear to be more cautious in regards to exposure
and this is the reason for the need of your possibly contrasting opinion.
i included everything i could think of. my personal input is this, i can easily
make 72 but i do harbour fears of exposure and as a personal choice im not
all that prepared to live with permanent sides. as far as vertex goes i will
not accept a trial with dead arms, so i will have to wait for FDA and this requires a
"worst case scenario outlook". i do think that because im asympomatic and
healthy i could hang on safely for a few years. also i still have the option
to go for very high riba dosing as this was my intention. its just been delayed because i havent found the right doc yet. the liverhead talked me out of it
and maybe i should reconsider?
race and gender, dirty white boy
age, 48
height 6,0
weight pre tx 175 BMI 23.7
weight now 157 BMI 21.3
body state pre tx healthy, strong, good shape
symptoms pre tx asymptomatic
medical history normal childhood illnesses, tonsils taken out,
mild hypertension taking atenenolol for 1 year
unremarkable otherwise
liver histology stage 3 grade3
septal fibrosis noted (bridging not mentioned)
no cirrhosis
rescue drugs none
hgb pre tx 15.9
hgb 3rd week 12.8 (highest during tx)
hgb avg on tx 11.7
hgb now 11.2
hgb lowest 10.6 (riba induction)
anc current 2313
all other bloodwork good - if out of range, only slightly so
INF dosing pegintron 120 mg (centered on weight based chart)
100% compliance no variation
riba dosing week 1 - 19 1000mg (at bottom cusp of weight chart)
week 20-26 1200mg
week 26 - 36 1400mg
infection maturity 30 years
pre tx viral 1,630,000 iu ast 127 alt 206
week 9 1280 iu (3.1 log drop) 138 192
week 18 89 iu 103 142
week 19 >5 iu heptimax
week 27 >5 iu heptimax 72 93
week 34 >5 iu heptimax 89 105
viral curve interpolated to .3 log per week
sx all the normal stuff
middle of the road severity
can work a week at a time here and there
riba induction pretty hard but stable now and better
treatment status naive
double dose,
i certainly didnt mean to "2nd rate" your opinion (compared to jim). its just that he never really gave me any really clear recommendation as you emphatically and specifically have. now that i read yalls comments i realize that this argument boils down to predicted SVR rates for each choice. on the 72 option, your guess of 80% SVR rate may be a little overestimated but maybe not. it does help (in my mind) that your doc suggested this number. very persuasive.
jim,
i believe that double dose's opinion could be characterized as "youve got a good shot if you go all out to 72, go ahead and get this overwith and be prepared for the risks of heavy INF exposure"
you on the other hand, you appear to be more cautious in regards to exposure
and this is the reason for the need of your possibly contrasting opinion.
i included everything i could think of. my personal input is this, i can easily
make 72 but i do harbour fears of exposure and as a personal choice im not
all that prepared to live with permanent sides. as far as vertex goes i will
not accept a trial with dead arms, so i will have to wait for FDA and this requires a
"worst case scenario outlook". i do think that because im asympomatic and
healthy i could hang on safely for a few years. also i still have the option
to go for very high riba dosing as this was my intention. its just been delayed because i havent found the right doc yet. the liverhead talked me out of it
and maybe i should reconsider?
I agree with your 'devil's advocate' comments. There are many 'unknowns' and variables in this decision. You have pointed out the real pros and cons, as well as the fuzzy areas. I really do believe that someone on high dose riba, who has been undetected since week 20 or so, and who stays undetected to the final 72 weeks, at full dosing, has a much higher odds of SVR than 40%. I remember my doc telling me that 80% was more likely the real odds in my case, and my situation was somewhat similar to this one. With the pedal to the metal for just another 36 weeks, I think that the odds of success in this case are pretty compelling. You present just about every issue that might be a factor, and your analysis should be a good foundation for reaching a decision.
DD
DD
While waiting for your reply, I'll play devil's advocate with some of DD's thoughts -- and even devli's advocate with some of my own thoughts -- not so much to rebut them, but to help point out what I consider to be the complexities of making this kind of decision.
DD: Why throw out 36 weeks of hard fought tx, to wait for something that might also call for 24 to 36 weeks of concurrent interferon dosing? Just do another 36 weeks from today, and you have finished the full extended protocol.
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If you stop now and then do 24 weeks of Telaprevir protocol, you will have treated a total of 60 weeks with perhaps an 80% chance of SVR. If you extend to 72 weeks, you will have treated of course a total of 72 weeks which what appears to be a 40% chance of SVR according to Berg if memory serves me. So that means double the chance of SVR with the stop and Telaprevir approach with less time treating.
However, on the other side of the coin, the extended tx studies used fixed-dose ribavirin (800mg) so perhaps the 40% SVR rate has been understimated. In the same breath, perhaps the 72 weeks has been overestimated. Also, if you stop now there is no guarantee you will get into a Telaprevir trial right away, and what if something happens and it doesn't reach market in a couple of years?
Also, even though very promising, final data still isn't in on the 24 week group and lastly, will previous slow responders match the 80% SVR rate that the tx naive groups seems to be achieving. The other thing is that you are already treating and stopping and then re-starting is probably not the easiest thing to incorporate into your life.
DD: Why throw out 36 weeks of hard fought tx, to wait for something that might also call for 24 to 36 weeks of concurrent interferon dosing? Just do another 36 weeks from today, and you have finished the full extended protocol.
------------------------------------------------------------------------------------------
If you stop now and then do 24 weeks of Telaprevir protocol, you will have treated a total of 60 weeks with perhaps an 80% chance of SVR. If you extend to 72 weeks, you will have treated of course a total of 72 weeks which what appears to be a 40% chance of SVR according to Berg if memory serves me. So that means double the chance of SVR with the stop and Telaprevir approach with less time treating.
However, on the other side of the coin, the extended tx studies used fixed-dose ribavirin (800mg) so perhaps the 40% SVR rate has been understimated. In the same breath, perhaps the 72 weeks has been overestimated. Also, if you stop now there is no guarantee you will get into a Telaprevir trial right away, and what if something happens and it doesn't reach market in a couple of years?
Also, even though very promising, final data still isn't in on the 24 week group and lastly, will previous slow responders match the 80% SVR rate that the tx naive groups seems to be achieving. The other thing is that you are already treating and stopping and then re-starting is probably not the easiest thing to incorporate into your life.
Also how long do you think you've been infected.
Choices. Choices. Choices. :) I do agree with DD that #2 doesn't offer very good odds, so let's nix that one.
Just so I don't confuse things, could you please recap all your stats again, including:
Age, Sex, Race, stage of fibrosis, height, weight before tx, current weight, hgb pre tx, current hgb, current ANC, dose of peg and riba, any dose varitaions or reductions, any helper drugs (Procrit/Neupogen), pre-tx viral load, PCR history during treatment including test results, test sensitivities; side effects during tx, other health issues, first treatment for HCV or have you treated before? And anything else you might think important for your profile.
Just so I don't confuse things, could you please recap all your stats again, including:
Age, Sex, Race, stage of fibrosis, height, weight before tx, current weight, hgb pre tx, current hgb, current ANC, dose of peg and riba, any dose varitaions or reductions, any helper drugs (Procrit/Neupogen), pre-tx viral load, PCR history during treatment including test results, test sensitivities; side effects during tx, other health issues, first treatment for HCV or have you treated before? And anything else you might think important for your profile.
I'll just add my two cents as well:
1. Why throw out 36 weeks of hard fought tx, to wait for something that might also call for 24 to 36 weeks of concurrent interferon dosing? Just do another 36 weeks from today, and you have finished the full extended protocol.
2. I would suggest numbers 4 or 5, for the best odds, right now, rather than good odds several years from now. You are on your way to success, and have acclimated pretty well to the meds. Why start over.
3. Number 2, quitting at 48 weeks, is not a good choice at all. You will be still doing additional tx time from today, and will almost certainly relapse, from a statistical standpoint. Choice #3 is hardly any better, and still leaves you having done a 'partial tx', with lots of effort and time, and leaving you with very little odds for SVR.
From my perspective its a great opportunity for you to beat this virus, NOW, and in just 36 more weeks. Quitting and starting over, with the significant progress you have made to date, does not really sound like the best plan to me, since you will eventually have to do the interferon again, along with the vertex, and possibly for as much as the 36 weeks that it would take you right now, to get your SVR.
I didn't mean to butt in, but I couldn't resist.
DD
1. Why throw out 36 weeks of hard fought tx, to wait for something that might also call for 24 to 36 weeks of concurrent interferon dosing? Just do another 36 weeks from today, and you have finished the full extended protocol.
2. I would suggest numbers 4 or 5, for the best odds, right now, rather than good odds several years from now. You are on your way to success, and have acclimated pretty well to the meds. Why start over.
3. Number 2, quitting at 48 weeks, is not a good choice at all. You will be still doing additional tx time from today, and will almost certainly relapse, from a statistical standpoint. Choice #3 is hardly any better, and still leaves you having done a 'partial tx', with lots of effort and time, and leaving you with very little odds for SVR.
From my perspective its a great opportunity for you to beat this virus, NOW, and in just 36 more weeks. Quitting and starting over, with the significant progress you have made to date, does not really sound like the best plan to me, since you will eventually have to do the interferon again, along with the vertex, and possibly for as much as the 36 weeks that it would take you right now, to get your SVR.
I didn't mean to butt in, but I couldn't resist.
DD
Let's talk about tolerability. I plan to double dose Peg and up the Riba. I hear that there are dangers. What, specifically are the dangers of anemia besides fatigue? What if procrit was was administered prior to tox? Can we get proactive on this regimen? And what are the long term effects of severe anemia?
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