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RIBA reduction with anemia?
Hi Guys,
I haven't posted lately...so tired. I had my 8 week labs and my HGB dropped to 8.7
The Doctors want me to drop my RIBA from 1200 to 600. I thought this seemed like a huge drop. She also said that they anticipate a transfusion for next week because they beleive it will continue to drop.
What have you guys experienced with anemia? What did your Doctor recommend?
Any feedback appreciated-
Thanks
Vann
I haven't posted lately...so tired. I had my 8 week labs and my HGB dropped to 8.7
The Doctors want me to drop my RIBA from 1200 to 600. I thought this seemed like a huge drop. She also said that they anticipate a transfusion for next week because they beleive it will continue to drop.
What have you guys experienced with anemia? What did your Doctor recommend?
Any feedback appreciated-
Thanks
Vann
"It's better to have the study info in circulation but also I believe in transparency when someone has a financial interest in the success of the adoption of this new drug."
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Rather than posting only thoughts and opinions, you'll notice many such as Will and others that will post a link to the studies they reference. This provides you the opportunity to read further and shows where their thoughts are coming from. I find it valuable to see posted studies referencing SVR rates, riba rates, etc., rather than rely on anecdotal information. Also, knowing if someone has a financial interest in a certain product is important and sometimes difficult to tell. Good question - good answer. Full transparency is important - couldn't agree with you more.
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Rather than posting only thoughts and opinions, you'll notice many such as Will and others that will post a link to the studies they reference. This provides you the opportunity to read further and shows where their thoughts are coming from. I find it valuable to see posted studies referencing SVR rates, riba rates, etc., rather than rely on anecdotal information. Also, knowing if someone has a financial interest in a certain product is important and sometimes difficult to tell. Good question - good answer. Full transparency is important - couldn't agree with you more.
Hi Will,
Thanks for your response. You made me laugh with your fictitious company name. I'm happy for the research and develop side of these drug companies. It's the business management and scumball marketers like me that make me nervous. :)
I'm just frustrated. I'm in my third week now of waiting to hear whether or not the insurance company will approve the Procriut and meanwhile I've had to have a blood transfusion. I just wish doctors could have final say on how they treat there patients verse some insurance admin.
Thanks for your response. You made me laugh with your fictitious company name. I'm happy for the research and develop side of these drug companies. It's the business management and scumball marketers like me that make me nervous. :)
I'm just frustrated. I'm in my third week now of waiting to hear whether or not the insurance company will approve the Procriut and meanwhile I've had to have a blood transfusion. I just wish doctors could have final say on how they treat there patients verse some insurance admin.
Hi Can-do,
Thanks for getting back to me. Sorry for questioning you. I work in marketing by profession and have worked in medical device. I have noticed some of the answers seem heavy on the company standard answer. Quoting studies, deffering to specialists opinion, etc. which is fine and great. It's better to have the study info in circulation but also I believe in transparency when someone has a financial interest in the success of the adoption of this new drug.
And yes, the cherry picking of the CC population is a very big problem with their study results and prescribing recommendations. Within the med/insurance community since the cost of Incivek is quite high, there are questions being raised whether CCs naive to treatment patients even be given Incivek to start and just starting with the SOC instead to see if they can achieve SVR on the cheaper treatment first since their outcomes are so good. Our tx regime is based mainly on this population!
Why would Vertex to this? A) they want the drug to be seen as a highly effective treatment that is well tolerated. B) Vertex knows the competition from bicoprive and the pipeline of new HCV drugs is great. They need to establish their drug as the preferred part of the new SOC treatment now to extract as much profit within the short window they may have before something new and better makes it to market. However, the effectiveness of a later retreatment using a protease inhibitor is uncertain, if a patient fails with Incivek.
Knowing all this, I would rather be given Procriut than have the RIBA reduced. This is probably my best chance to rid myself of this disease and I will have given a year and a half of my life over in trying when one considered the 48 weeks I did the first time I under went treatment. If Procriut was effective the first time in combating my anemia, why can't that be the first protocol now rather than reducing the RIBA? I'd like to see the prescribing information changed so doctors aren't challenged by insurance admins when they request Procriut for their patients.
Thanks for getting back to me. Sorry for questioning you. I work in marketing by profession and have worked in medical device. I have noticed some of the answers seem heavy on the company standard answer. Quoting studies, deffering to specialists opinion, etc. which is fine and great. It's better to have the study info in circulation but also I believe in transparency when someone has a financial interest in the success of the adoption of this new drug.
And yes, the cherry picking of the CC population is a very big problem with their study results and prescribing recommendations. Within the med/insurance community since the cost of Incivek is quite high, there are questions being raised whether CCs naive to treatment patients even be given Incivek to start and just starting with the SOC instead to see if they can achieve SVR on the cheaper treatment first since their outcomes are so good. Our tx regime is based mainly on this population!
Why would Vertex to this? A) they want the drug to be seen as a highly effective treatment that is well tolerated. B) Vertex knows the competition from bicoprive and the pipeline of new HCV drugs is great. They need to establish their drug as the preferred part of the new SOC treatment now to extract as much profit within the short window they may have before something new and better makes it to market. However, the effectiveness of a later retreatment using a protease inhibitor is uncertain, if a patient fails with Incivek.
Knowing all this, I would rather be given Procriut than have the RIBA reduced. This is probably my best chance to rid myself of this disease and I will have given a year and a half of my life over in trying when one considered the 48 weeks I did the first time I under went treatment. If Procriut was effective the first time in combating my anemia, why can't that be the first protocol now rather than reducing the RIBA? I'd like to see the prescribing information changed so doctors aren't challenged by insurance admins when they request Procriut for their patients.
If interested :
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/Battling%20HCV/Interactive%20Virtual%20Presentations/Adverse%20Events.aspx
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/Battling%20HCV/Interactive%20Virtual%20Presentations/Adverse%20Events.aspx
Hi Gizmo...yes I am the CEO of Willdislikesalldrugs Ltd. :0)
Certainly not an expert on the subject of dose reducing, none of us here would be.We all have our own experiences ,mine being part of a trial where the use of Procrit was prohibited and dose reducing and transfusion was protocol,which I thought at the time was very rigid(however personally needed neither)
From everything I have heard here and read ,it seems like there have been a multitude of different approaches. Some doctors have started procrit at 10 or slightly above,before they reduce,some seem to reduce at the first sign of any anemia, then try procrit if it keeps dropping and even others wait until it seems the patient is in real trouble before they wake up and then scramble to do what they can.
The reason I cited Dr Shiffman on the CCO site,,was only because his approach and presentation to doctors on the matter seemed to make the most sense(to me anyway).
With the introduction of the new meds,,first of all he feels because anemia may happen very quickly ,it is imperative to test the patient very often in the begining(at the least every 2 weeks and posiibly every week till week 12)
Secondly he feels that "slight" reductions "(200mg. increments) are acceptable once the patients HGB. gets to approx. the 10 mark,however his advice is "especially" if the patient is UND.,possible because he feels, as many do that the early clearance is the best predictor of SVR success.
However it seems there is not enough yet known about reducing if the patient is still DET.and even the data from the studies(with Tela and Boce) that said SVR was not affected from RIBA reducing did not clearly state when and how that correlated with viral load status.
Sorry about the long winded thoughts..
.Personally I feel the rigid approach on the Ribiviran labeling to immediately reduce to 600 at <10 and stop all Riba at <8.5,iregardless of viral load status possibly has room for flexibility ,as Shiffman seems to advocate..(ie. smaller reductions and more geared to when UND.is established,as well as possibly procrit)
I know others have differing opinions on this,thats just mine. and it is always best to listen to a doctors advice if knowlegable with HCV treatment.
Good luck....
Will
Certainly not an expert on the subject of dose reducing, none of us here would be.We all have our own experiences ,mine being part of a trial where the use of Procrit was prohibited and dose reducing and transfusion was protocol,which I thought at the time was very rigid(however personally needed neither)
From everything I have heard here and read ,it seems like there have been a multitude of different approaches. Some doctors have started procrit at 10 or slightly above,before they reduce,some seem to reduce at the first sign of any anemia, then try procrit if it keeps dropping and even others wait until it seems the patient is in real trouble before they wake up and then scramble to do what they can.
The reason I cited Dr Shiffman on the CCO site,,was only because his approach and presentation to doctors on the matter seemed to make the most sense(to me anyway).
With the introduction of the new meds,,first of all he feels because anemia may happen very quickly ,it is imperative to test the patient very often in the begining(at the least every 2 weeks and posiibly every week till week 12)
Secondly he feels that "slight" reductions "(200mg. increments) are acceptable once the patients HGB. gets to approx. the 10 mark,however his advice is "especially" if the patient is UND.,possible because he feels, as many do that the early clearance is the best predictor of SVR success.
However it seems there is not enough yet known about reducing if the patient is still DET.and even the data from the studies(with Tela and Boce) that said SVR was not affected from RIBA reducing did not clearly state when and how that correlated with viral load status.
Sorry about the long winded thoughts..
.Personally I feel the rigid approach on the Ribiviran labeling to immediately reduce to 600 at <10 and stop all Riba at <8.5,iregardless of viral load status possibly has room for flexibility ,as Shiffman seems to advocate..(ie. smaller reductions and more geared to when UND.is established,as well as possibly procrit)
I know others have differing opinions on this,thats just mine. and it is always best to listen to a doctors advice if knowlegable with HCV treatment.
Good luck....
Will
Hi Gizmo, i am in no way connected to any drug company. I'm a prior relapser also that treated in the boceprevir phase III trial and now SVR.
I agree with what your saying 100%, i never dosed reduced. My doctor suggested procrit instead....... Also like you said about the tip to CC's they also did not use many of us that are cirrhotic, not saying its only vertex as all trials try to cherry pick the very best outcome, at lease early on in trials.... The thing with vertex was this was do or die, if it hadn't made it to market they were in huge trouble.
While i won't speak for will or hector from reading wills past posts it seems he is also unclear about all this dose reducing going on.
Wishing you the best,
cando
I agree with what your saying 100%, i never dosed reduced. My doctor suggested procrit instead....... Also like you said about the tip to CC's they also did not use many of us that are cirrhotic, not saying its only vertex as all trials try to cherry pick the very best outcome, at lease early on in trials.... The thing with vertex was this was do or die, if it hadn't made it to market they were in huge trouble.
While i won't speak for will or hector from reading wills past posts it seems he is also unclear about all this dose reducing going on.
Wishing you the best,
cando
Hi Will,
Thank you for your response. Are you, HectorSF and can-do-man in any way connected with the drug manufacturers for any of the drugs we are on?
In the trials it seems Vertex spiked the patient population with a majorty of genos ending with a CC. I don't know what my geno is beyond HCV 1a, but if I'm a CT or TT I don't find the recommendation to reduce RIBA versus use of Procriut wise. I already relapsed on the SOC after 48 gruelingly long weeks. Knowing the trials were spiked with CC patients, why didn't you guys leave a little more leeway for the docs to prescribe Procriut?
Thank you for your response. Are you, HectorSF and can-do-man in any way connected with the drug manufacturers for any of the drugs we are on?
In the trials it seems Vertex spiked the patient population with a majorty of genos ending with a CC. I don't know what my geno is beyond HCV 1a, but if I'm a CT or TT I don't find the recommendation to reduce RIBA versus use of Procriut wise. I already relapsed on the SOC after 48 gruelingly long weeks. Knowing the trials were spiked with CC patients, why didn't you guys leave a little more leeway for the docs to prescribe Procriut?
Gizmo & Vann
According to proper ( "adverse events management" at CCO) it is recommended when the patient is experiencing anemia and has achieved an UND. status to reduce Riba. in 200mg.(slight) steps.(as cando posted) and/or possibly the use of Procrit
However ,this is to be started ideally at<10 ,according to DR Shiffman at CCO . Being your are at now 8.2 it seems more aggresive steps are needed.
Once UND. the Riba reduction ,had no differing effects on SVR success in TELA trials.
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/Battling%20HCV/Interactive%20Virtual%20Presentations/Adverse%20Events.aspx
Vann: Because your status of UND. is unknown ,according to how Shiffman seems to state it in this presentation ,it may be a little less clear
.
He says specifically the proper protocol is "to slightly reduce RIBA (in 200 mg) increments .where there is anemia <10 ,however he adds the word "Especially" " if the patient is already UND...He doesn"t say whether or not he recommends it or does not ,if the patient is still DET.,as the RIBA labeling does immediately down to 600)).At no time during his presentation does he say you should automatically reduce to 600 mg.
He also highly recommends that (as frijole ) has pointed out ,in the beginiing very frequent CBC"s should be done ( .no less than every 2 weeks or even possibly every week) to ward off "posible problems with the proper mamagement ,before things like anemia get severe
So it would seem like some slightly differing opinions by the experts(doctors) and the labeling ,however always best to rely on your own knowlegable doctors advice...
Good luck..
Will
According to proper ( "adverse events management" at CCO) it is recommended when the patient is experiencing anemia and has achieved an UND. status to reduce Riba. in 200mg.(slight) steps.(as cando posted) and/or possibly the use of Procrit
However ,this is to be started ideally at<10 ,according to DR Shiffman at CCO . Being your are at now 8.2 it seems more aggresive steps are needed.
Once UND. the Riba reduction ,had no differing effects on SVR success in TELA trials.
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/Battling%20HCV/Interactive%20Virtual%20Presentations/Adverse%20Events.aspx
Vann: Because your status of UND. is unknown ,according to how Shiffman seems to state it in this presentation ,it may be a little less clear
.
He says specifically the proper protocol is "to slightly reduce RIBA (in 200 mg) increments .where there is anemia <10 ,however he adds the word "Especially" " if the patient is already UND...He doesn"t say whether or not he recommends it or does not ,if the patient is still DET.,as the RIBA labeling does immediately down to 600)).At no time during his presentation does he say you should automatically reduce to 600 mg.
He also highly recommends that (as frijole ) has pointed out ,in the beginiing very frequent CBC"s should be done ( .no less than every 2 weeks or even possibly every week) to ward off "posible problems with the proper mamagement ,before things like anemia get severe
So it would seem like some slightly differing opinions by the experts(doctors) and the labeling ,however always best to rely on your own knowlegable doctors advice...
Good luck..
Will
If reducing the Ribavirin tablets will not effect SVR rates, then why are so many doctors hesitant to reduce the RIBA? I've heard about more blood transfusion on this site than doctors electing to reduce RIBA. I responded well last time to Procriut, so why can't the insurance companies just get out of the way and let the medical doctors decide when to give Procriut and when to reduce the RIBA? Personally since the RIBA attacks HCV I really don't want to reduce when I know I could be helped on Procriut. This tx has been very hard and I don't want to take any chances that it would be in vain when I darn well know that I could be helped with Procriut.
My hemoglobin is down to 8.2. My doctor does not want to reduce ribavirin dose. Instead he has prescribed procruit, which the prescription is pending approval by the insurance company. I had a blood transfusion 3 days ago and feel better but not able to work or do much of anything. Is not lowering the ribiviran wise?
Stats:
Current tx: Triple therapy with Incivek
On 11th week of tx, 1 week of Incivek to go
White blood cells and platelets low as well
UND at 4 and 8 weeks
Viral load at start: 311,000
Hemoglobin at start of tx: 12.6
6 yrs ago previously replaser after 48 weeks on SOC
Used Procriut on previous tx as well, which did successfully boost my hemoglobin while on interferon and ribiviran (soc)
Stats:
Current tx: Triple therapy with Incivek
On 11th week of tx, 1 week of Incivek to go
White blood cells and platelets low as well
UND at 4 and 8 weeks
Viral load at start: 311,000
Hemoglobin at start of tx: 12.6
6 yrs ago previously replaser after 48 weeks on SOC
Used Procriut on previous tx as well, which did successfully boost my hemoglobin while on interferon and ribiviran (soc)
I wonder if part of the problem is that these doctors need to order more CBCs earlier in treatment with the PIs. It seems that this should have been caught when your hgb got to 10 or 9 and maybe they would not have had to drop the riba so significantly. I hope you are not on weekly CBCs
I take procrit and so far it has kept my hgb in the 10s, although there was a slight drop - from 10.3 to 10.2 this week. I have not had any dose reductions.
frijole
I take procrit and so far it has kept my hgb in the 10s, although there was a slight drop - from 10.3 to 10.2 this week. I have not had any dose reductions.
frijole
Billy, Cando and Hector....thanks for the feedback. Sounds like this is the right appropach....I just have to trust the process. Sure would be nice to know if I am UND....hope to have those results soon.
Thanks All!
Thanks All!
1. The proper protocol is to reduce ribavirin to 600 mg when hemoglobin is less than <10 g/dl. (* One 200 mg tablet in the morning and two 200 mg tablets in the evening).
2. Discontinue Ribavirin Tablets if: <8.5 g/dL.
Once Ribavirin tablets have been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart Ribavirin tablets at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that Ribavirin tablets be increased to the original assigned dose (1000 mg to 1200 mg).
Following these procedures will not effect SVR rate.
Hector
2. Discontinue Ribavirin Tablets if: <8.5 g/dL.
Once Ribavirin tablets have been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart Ribavirin tablets at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that Ribavirin tablets be increased to the original assigned dose (1000 mg to 1200 mg).
Following these procedures will not effect SVR rate.
Hector
Panel Recommendations
Modest RBV dose reduction (200-mg increments) is a good approach for managing anemia in boceprevir- or telaprevir-treated patients, as it does not appear to affect response. Some clinicians may choose to use erythropoietin, particularly for severe or symptomatic anemia. However, use of erythropoietin for HCV anemia is off label, and care should be taken to not allow the hemoglobin to exceed 12 g/dL.
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%206.aspx
Under Managing Adverse Events
Modest RBV dose reduction (200-mg increments) is a good approach for managing anemia in boceprevir- or telaprevir-treated patients, as it does not appear to affect response. Some clinicians may choose to use erythropoietin, particularly for severe or symptomatic anemia. However, use of erythropoietin for HCV anemia is off label, and care should be taken to not allow the hemoglobin to exceed 12 g/dL.
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%206.aspx
Under Managing Adverse Events
that sounds right to me...if your tanking catch it now before it gets a lot tougher to deal with..maybe you have a smart doctor!!!!.good luck...billy
Vann, sooo sorry you are having such a hard time with the enemia...and putting up prayers for you that your results come back UND and soon!! That wait is a killer, isn't it? God bless, Starshine
AJ...I thought 800 sounded right, but I thought 600 was too big of a drop. I did question the Doctor about the reduction and she said 600. OK
Bee...they did the viral load today so I won't have the results for a week. I had a 1.5 log drop at 3 weeks...I am very optimistic that I will be UND, but I don't have the results yet.
Bee...they did the viral load today so I won't have the results for a week. I had a 1.5 log drop at 3 weeks...I am very optimistic that I will be UND, but I don't have the results yet.
Hi Vann,
Sorry to hear this. I forget, were you UND at week 8?? If so, I wouldn't worry about the reduction. If not, hopefully some of the experts will weigh in on this.
For Anemia, everyone's tolerance is a little different, so keep telling your doc how you are feeling. Regardless of how you feel though, at certain numbers, they have to keep you safe. The transfusion will make you feel better either right away or within a day or two. And the transfusion did not hurt or anything. They just hook you up to an IV. Wishing you all the best.
Sorry to hear this. I forget, were you UND at week 8?? If so, I wouldn't worry about the reduction. If not, hopefully some of the experts will weigh in on this.
For Anemia, everyone's tolerance is a little different, so keep telling your doc how you are feeling. Regardless of how you feel though, at certain numbers, they have to keep you safe. The transfusion will make you feel better either right away or within a day or two. And the transfusion did not hurt or anything. They just hook you up to an IV. Wishing you all the best.
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