Resume full dose riba or reduce procrit dose?

A very informal poll, if you will:

Undetected at week #13, reduced riba from 1200mg to 1000mg since week #30 due to anemia, procrit 2x a week, hgb at 9+ weeks #31-41,  10+ weeks # 42-52, and now, finally at week #54, hgb at 11.3.  (Whew!) Question is:
What would you do if you called the shots (no pun intended)? Resume 1200mg riba?  Space out the procrit?  Reduce the procrit?  None of the above?  

Two things I keep tossing back and forth in my mind is the risk of relapse vs. the risk of procrit use... and I'm aware that members here aren't doctors, but plenty of you know more about treatment than the average GI specialist, and I'd greatly value your feedback.  (And those who don't feel they know much are welcome to comment too :] !) Besides, for the most part, treating hep c seems like a balancing act based on the heaviest data any particular doctor is weighing at that particular moment...  please weigh in (and Brain Mass Index is not a factor).  Thanks!

~eureka
PS: Additional question for those of you who have AFP readings regularly... what's been your highest reading?

[can-do-man]

UND at week 13, already at week 54, myself i would reduce procrit to once a week but would have at least bi-weekly labs to keep an eye on my HGB.

Or one could go back to 1200 and stay on the same procrit, still would want at least bi-weekly labs..............Best of luck to you, looking good.

[jacksonblue]

I think increase riba to 1200 see how hgb holds can always reduce again i personally did not tolerate procrit well ended up damaging valve in leg and had to have surgery most tolerated procrit well from what i have seen here regards steve

[FlGuy]

I assume this is about hubby.  Now 41 weeks at UND and 54 into treatment, how many weeks does he intend to go.  And, why?
If he is near the end of  tx, probably not increase riba.  If he is going to say 72 maybe increase the riba and keep steady on the procrit until hgb goes down and then make the procrit increase decision when he gets to a pre-determined level (like 10.5).  My thinking is that if the plan is to be long and aggressive he may as well be long and aggressive.

[Trish77]

I thought about this from the point of view of "what would I want to do if it were me?"  I remember your previous post asking about extending to 72 weeks and I'm thinking that's what the aim is here.   It's also the aim to clear the virus.  So if he's tolerating the procrit right now then I would hold the procrit at current levels and increase the riba and see how he does with his hgb. While it's true that dosage reductions later in treatment have less of an impact than dosage reductions earlier in treatment, considering his stats, I would still aim to hit this thing with whatever he can tolerate.  Depending on what his hgb does, then you can decide to go to maintenance procrit if his hgb holds steady enough.  

The thing is, reducing the procrit or raising the riba is both going to like result in a decrease in hgb potentially.  I think I would rather have a decrease in hgb from increased tx drugs hitting my system if I had to pick one and if the decrease is not so much, then bonus to have the extra tx drugs working on the virus.

The concern for me with lowering procrit only is that it takes awhile to do it's stuff while reducing riba back to current from an increased amount if necessary seems to have a faster result.  So if you need to bring riba back down, you haven't lost much and might have gained a bit from the added riba.  If you're able to add riba with little/tolerable impact to the hgb then maybe you can go to maintenance procrit which would be double bonus - increased riba and decreased procrit.    

Is the risk of procrit use higher to him because of his stats or are you talking risk of procrit use in general?  I'm wondering where your concern is there as a number of people here have been on procrit throughout their treatment and I'm not sure I've read of serious concerns of the ill effects as a result?  

Trish

[mikesimon]

A recent article presented from Journal of Viral Hepatitis concludes:

"....In conclusion, our results have demonstrated that ribavirin is dose-dependently correlated with a relapse in patients with CH-C genotype 1 responding to Peg-IFN plus ribavirin. Maintaining a high dose (≥12 mg/kg/day) of ribavirin during the full treatment period could strongly suppress the relapse in such patients, while Peg-IFN α-2b could be reduced without affecting relapse in patients with c-EVR. This possibility should be explored in a prospective study."

The study attempts to distinguish the Schiff'man et all conclusion that SVR is not impacted by ribavirin dose reduction so long as the cumulative dose is above 60%. Although I was not thoroughly convinced by the argument my personal view is to maintain as high of a ribavirin dose as possible throughout treatment, even if that means supplementing with epoetin alfa.

Read the article as it is rather detailed.


See: http://www.medscape.com/viewarticle/709163

From Journal of Viral Hepatitis
Ribavirin Dose Reduction Raises Relapse Rate Dose-dependently in Genotype 1 Patients with Hepatitis C Responding to Pegylated Interferon alpha-2b Plus Ribavirin

Good luck,
Mike

[nygirl7]

"The thing is, reducing the procrit or raising the riba is both going to like result in a decrease in hgb potentially.  I think I would rather have a decrease in hgb from increased tx drugs hitting my system if I had to pick one and if the decrease is not so much, then bonus to have the extra tx drugs working on the virus. "

AGREE. I took epogen for 69 weeks of treatment at full dose (Plus) riba.  At week 46 Dr. J made me drop some riba (I was taking way over my weight based) and it helped a lot. However at week 46 I figured it was alright to finally do this and I was still over weight based anyway.  He insisted that too much epo for too long was a risk that shouldn't be taken. I believed him but had already been UND for what 22 weeks at least and I knew I was going to do the extra six months at weight based - not UNDER.

Good luck.

[newleaf09]

I hold to the full riba concept.  There have been studies relating reduced riba to potential relapse.  I'd try to get back to full riba dose and if you can hold hgb up, then I'd see about reducing the procrit frequency.  My doctor was okay with reducing the peg (and I was reduced for about 2/3 of my TX) but adamant about staying at full riba.

[RCM829]

I believe your husband is treating for 72 weeks.

Therefore, I would increase Riba to 1200 mg. and watch HGB closely. Hit this thing with everything you've got Eureka.

I'm rooting for you...

[Joey_M]

I would also consider the quality of life issues here. Not sure why your husband needs to do anything differently than he is now. Can't he just enjoy a higher hgb level for his remainder of tx? I seriously doubt that increasing riba back up at this point would have any impact on his odds of SVR.

[Trish77]

"I seriously doubt that increasing riba back up at this point would have any impact on his odds of SVR. "

I disagree.  He's at Week 54 out of 72 and went UND at 13 weeks.  I think, especially in light of what Mike posted, the rule of thumb of 100% of the drugs 100% of the time as much as possible, the impact of relapse here considering his advanced stage and what it would mean to retreat, I would want to hammer it, if it were me, as long as it's tolerated and not risking overall health.  

If quality of life is so compromised that it threatens adherence to treatment, that's a consideration.  If I'm going to compromise one or the other, it's going to be quality of life for awhile - I say that while recognizing it is an entirely personal decision and that is my opinion only.

Trish

[nygirl7]

Can't he just enjoy a higher hgb level for his remainder of tx? "

Something about black box warnings over having epogen have you go up and over 12 is important althought I can't remember exactly what it is.....epo is a dangerous drug - even though it is an absolute miracle worker you have to be VERY careful how high your hemo goes.

I agree with not dose reducing to get SVR but as well doctors are pretty leery of epo just cause of that reason.

" I think, especially in light of what Mike posted, the rule of thumb of 100% of the drugs 100% of the time as much as possible"

I agree with this I"ve never understood the 80/80/80 because it almost makes you feel like you can screw up and miss a couple and not have it matter.....like a permission or something It is CRUCIAL to bev 100% compliant to beat this crappy disease (as best as anyone can be compliant anyway)

[Trish77]

Well, the 80/80/80 rule was the MINIMUM - preference is 100/100.

[jessiejames1973]

epo given when Hb IS ABOVE 10  is a bad idea above 11  is stupid and above 12 dangerous,

[Trish77]

"epo given when Hb IS ABOVE 10  is a bad idea above 11  is stupid and above 12 dangerous, "

What do you base this on? Many persons on HCV treatment are on procrit above 10.0 and for males, 11.0 can be quite low for hgb.  Furthermore, many HCV patients are on maintenance doses of procrit for a significant portion of their treatment above the 10.0 level you've stated as being a bad idea to prevent hgb from dropping too low, which it would do without that procrit maintenance dose.

This is a previous discussion on procrit and ribavirin dosage reduction here and a number of the posters had procrit above that 10.0 mark.

http://www.medhelp.org/posts/Hepatitis-Social/How-long-can-you-take-Procrit/show/646267

I only went below 10.0 once.  They reduced my ribavirin at that point at 13 weeks.  After that week, my hepatologist put me on procrit and I stayed on it for most of the rest of my 34 weeks to keep me above 10.0 to avoid dosage reductions as the trial mandated they were required when hgb dropped below 10.0.  When they took me off procrit for a time, my hgb dropped close to that 10.0 mark after getting up around 13 or so.  He put me back on it and I stayed on it until treatment stopped for me.  It had nothing to do with tolerability, I was managing okay with my hgb staying in the 10's most of the time.  It had everything to do with avoiding dosage reductions and is a very valid use of procrit.

[FlGuy]

It's a good idea to get knowledgeable advice and a good idea to understand the rules of the game. There is nothing wrong in not getting hemoglobin whacked on treatment.  I saw a hematologist for the blood side of things and we agreed that my hgb would stay between 11 and 12.  He did a great job with the Aranesp (not Procrit) and I stayed in range the whole time.  Since I got it in a clinical setting (his office) it was handled on the medical side of insurance and he was allowed to administer under 12.  If he had prescribed Procrit he'd have to wait until 10 and then I'd have to pay an Rx copay.  The Aranesp in the office I got sooner and cost free. Being functional in tx2 made a big difference.

[RCM829]

I agree with Trish.

Risk of relapse - no matter how small - far outweighs quality of life issues.

Further, my doctors have done a great job of keeping my HGB within range (we keep it between 10 and 12) with a Procrit injection every  two to three weeks. For me, it's kept me active and most importantly, able to continue treatment. I have had no side effects from it.

[jessiejames1973]

the risk of stroke for one!!!!  increase risk of cancer later in life the list goes on ,  hb of 10 might not be great but it is doable for most people especialy females

[Trish77]

Eureka, I realize also that saying "what would I do if it were me" is easier when it's not me.  Joey_M's point on QOL is valid in context and it's finding that balance you're talking about that we all run into on treatment -  between getting rid of the virus, not compromising our health too much and not compromising QOL beyond a mentally healthy place.  Hard stuff.  Good luck to both of you in determining what's right for you.

Trish

[Trish77]

You're ignoring the dosage reduction we're trying to avoid.  Many of us on procrit were on it above 10.0 to AVOID dropping into a range where a dosage reduction might be required.  Procrit takes awhile to kick in - 3 weeks is the norm - for me it took six weeks before any significant change.  Once our hgb levels were at a certain place, maintenance doses of procrit were necessary to keep those hgb levels up and out of dosage reduction territory.  Stopping procrit completely tends to drop the hgb back down again and same problem is back.  We're trying to get a cure here and hopefully to only have to do this treatment once. It's definitely a balancing act.

[jessiejames1973]

balancing correct

i am not suggesting procrit is not used, just use with caution 10 is the cut of hence why i said ABOVE  10 is a bad idea , yes i know it takes time to work but 10 is easily manageable for a female in particular in fact 8.5 is doable i know plenty of people including men who coped on 8.5!!!!!!!!! here in the uk it is not dished out, sometimes to the detriment sometimes for good reason , the OP is und at wk 13 now wk 54 a small drop would not be an issue , also hb tends to stabalise with in a gram so they would not see a big drop, also the OP has a HB of over 11 why do they need to risk a stroke ???? they dont do they

[Trish77]

I have already told you...in my case it wasn't a tolerability issue.  I was tolerating just fine.  I was on procrit to keep my hgb above dosage reduction level as are a number of people.  Tolerability is relative as well.  If an hgb of 11 as a man lays you flat, then it lays you flat.  No point in pretending it doesn't and just looking at a number and treating based on what you SHOULD feel like.  I'd be repeating comments I've already made to say more so I'll leave it that we have different viewpoints on this.

[Rockerforlife]

10 is the magic number,mine was 10 average all the way tru TX...i was lucky.

[mikesimon]

8.5? I don't know what your baseline Hgb is but 8.5 was too low for me. At 9.5 I would sit in my car for 10 minutes trying to get the energy to walk the 100 feet to my office. I guess it's a very individual thing. I was lucky to get Epogen. It made a world of difference and, in my opinion, didn't expose me any unnecessary risks.
The problems I have seen with epoetin alfa occurred in renal impaired patients, cancer patients, patients with cardiac disease, uncontrolled hypertension, clotting issues or a history of stroke or seizures.
I am likely missing some disorders but I cannot recall seeing any of these epoetin issues in patients who treated for TX induced hemolytic anemia. I would guess that some do exist but I can't remember reading about them.

Mike

[jessiejames1973]

i didnt say i had a hb of 8.5 i said others,
yes hb is a personal thing some will cope better than other at lower levels , it does not change the fact that procrit can be dangerous if abused, a hb of 11.3 does not warrant procrit it is not needed the risk out weighs the benefit at THIS level.

[newleaf09]

I agree that 11.3 does not warrant Procrit but if she goes back to full riba, she will likely end up continuing the procrit.  Some people become more accustomed to the drugs as TX drags on but not all of us do.  Low HGB is no better for a woman than a man.  Below 10 is breathless, exhausted and weak for anyone.  Can you keep plugging along just the same? Sure.  You do what you gotta do.  Do people drop out of TX because they are so incapacitated by low HGB that they can't work? Sure again. In the U.S. 8.5 will get you a tranfusion.  The use of Procrit is at the discretion of the physician.  If he sees that you have difficulty functioning in the 10's, you'll get Procrit.  No point memorizing all the negative side effects of a drug.  That's one of the things that keep perfectly sensible people from starting the peg/riba therapy until they are verging on liver failure.

[mikesimon]

Generally a Hgb of 11.3 would not warrant Epo.
But, it is easy to imagine a scenario in which Epo might be appropriate with an 11.3 Hgb.
Say, for instance, a man is 3 weeks into TX and his HGB drops from 16 to 11.3.
Starting Epo might be prudent in that situation. It's always about the individual circumstances.
Mike

[nygirl7]

I think the point was that the black box warnings say not to let the hemo go rapidly up over 12, isn't that it?  I know my doc wanted me to stay right where I was at 10.5 or so and when I had gone up over 12 (from taking 40,000 x 2) he went berserk and I didn't understand why until the warnings came out.

AT 11.5 or 12 one might "think" they needed procrit but really that is almost a normal perfect hemo for a woman.  Two years later and I believe mine is 12.3 or something like that............CERTAINLY manageable to anyone.

When Iost six points in ten days from 15+ to 9 - THAT was bad...it's not only the number but how fast you go down that is key to the issue.  Going back up 10.5 was tolerable (not pleasant but safe and tolerable).

[nygirl7]

The use of Procrit is at the discretion of the physician. "

PS I think mostly it is the insurance company that says no...........at 6grand a box of 10 I can see how they would feel it should be warranted.  I could use a shot now to tell you the truth I'm so tired ;)

[nygirl7]

Ooops I didn't check when I had my allergy panel run he did my hemo too it's over 13 now......but that is three years post tx.

Normal 11.7 - 15.5

So now at 11 someone would definitely not really be prescribed it as it's in the normal range still especially for a woman.  It makes sense I guess why they make us suffer.

[RCM829]

To clarify:
My HGB went from 17.8 to 10.2  three months into treatment. After the initial drop, it continued to  fall every month. I am on enhanced dosages and my doctor did not want to risk having to reduce the Ribavirin. I appreicate everyones viewpoint on this.

[Trish77]

i didnt say i had a hb of 8.5 i said others,
yes hb is a personal thing some will cope better than other at lower levels , it does not change the fact that procrit can be dangerous if abused, a hb of 11.3 does not warrant procrit it is not needed the risk out weighs the benefit at THIS level.

"ABOVE  10 is a bad idea , yes i know it takes time to work but 10 is easily manageable for a female in particular in fact 8.5 is doable i know plenty of people including men who coped on 8.5!!!!!!!!!"

You know plenty of people including men who coped on 8.5?  Plenty?  I find that hard to believe.  8.5 hgb is getting dangerously close to blood transfusion territory and a man at 8.5 is even worse than a woman at that low level of hgb.  I think once hgb starts going below 10.0 it becomes a watchful concern and moreso in a man.  

ABOVE 10 is a bad idea for taking procrit?  Above 12 is the known cutoff point for procrit.  If you STOP taking procrit at 10.0 , you've hardly begun even to get your hgb level up into safer ranges with regards to healthier levels of hgb and to be able to adhere to ribavirin dosages without reduction. It's reckless of you to keep saying "epo given when Hb IS ABOVE 10  is a bad idea above 11  is stupid and above 12 dangerous, "

The only part of that which is true is the above 12 part - that's the known fact.

As well, procrit for those with, as Mike put it, hemolytic anemia due to HCV treatment are in a whole other category.  The duration of our treatment is quite long and adherence to that therapy is critical along with keeping decent levels of ribavirin. The persons in the studies in the following article were mostly and almost entirely above 10.0 hgb and as you read through it all, the benefits of procrit for those on combination therapy are clear when the conditions warrant it - dropping hgb and to assist with maintaining full adherence to dosages as much as possible.  


Alfa for the Treatment of Combination Therapy-Induced Anemia: Focus on Epoetin Alfa

Authors and Disclosures

http://www.medscape.com/viewarticle/507060_9

[eureka254]

Wow, some great dialogue here, thanks so much to everyone for your responses and opinions.  And, btw, for those who don't know me, I apologize if I was unclear, but the stats posted by me are those of my husband --  (I'm not on treatment, just a member who is the caregiver/administrater).

Can-do-man, jacksonblue, newleaf09, RCM829:
My thoughts were to go back up to full riba too -- the dosage reduction has been an  underlying concern in my head -- but I was voted down by both my husband and his nurse, because...

Joey_M:
My husband is indeed glad to get some QOL back, and for the moment he was told by the nurse that he doesn't need to do anything differently, and he's quite enjoying his current energy level.  

FlGuy:
The plan at the moment is 72 weeks -- as you once said, as stage 4, geno 1, he really doesn't have any other good options. However, having tolerated hgb between 7.3 and 10.4 since March, and already on the maximum dosage of procrit the doc will prescribe (2x a week) -- and still punctuated with a couple of transfusions in between -- hubby's quite glad to not whack down his hgb again and be functional, even if it's only for a week.

Trish77:  I was hard-pressed not to sneak in the extra riba pill ;), but this time, honor got the better part of valor.  Similar to your experience, procrit seems to work slowly on my husband, so my thoughts were to resume full dose riba in hopes that hgb would hold, but nurse has decided to wait one more week due to his having had unpredictably quick drops in hgb (there was one week when he had a drop of 1.3).  The biggest concern I have about procrit is the increased incidence of cancer:  being one of the rare survivors of hcc, the rx literature is somewhat unsettling, but we were offered reassurances that hepatoma recurrence would not be impacted by procrit.

Mikesimon:
My husband's nurse seems to be of the Schiffman camp, but your link to the JVH article is a most interesting counterpoint.  I wonder if the nurse would appreciate the article from you as much as I do, or find it offensive if I offered her a copy...
Of note, though, the current dose is still pretty close to 12mg/kg.  In my mind, I'm hoping the current 200mg reduction is counter-weighed somewhat by a loss of some 32 lbs since his starting treatment.

nygirl7:
I've also heard too much procrit for too long is not good... but no one has actually stated to us what is "too long."  Although my husband has not been 100% (he's missed a total of 3 doses of riba during the 54 weeks), he's well above the 80/80/80 guideline -- the way his hep doc explained it, if he's able to do at least 80% of the 2 meds for at least 80% of the treatment duration, it's considered "compliant."  

jessejames1973:
My husband's former insurance company adopted the guidelines you mentioned:  they refused to honor the doctor's prescription for procrit at one point because his hgb was 10.1 -- when his hgb dropped to 9.6 the next week, the delay in getting the procrit approved and waiting for it to take effect resulted both riba reduction and my husband needing blood transfusion.  Yes, my husband was coping -- in fact, initially, he "coped" until his hgb hit 7.3, at which point his cardiologist commented "and you're still alive and walking?!?" In his case, the no-procrit-unless-below-10-rule became a life-threatening issue.  Because of a pre-existing heart condition, his PCP and hep doc decided they would transfuse below 10 until we changed insurances (which we did).  Mikesimon pointed out accurately what research seems to demonstrate about the risk of epo:  the warnings of complications were largely in patients with a history of existing conditions before using procrit (lymphomas, leukemias, stroke patients...) -- conditions that are significantly impacted by stimulated bone marrow activity.  With low platelets, my husband's risk for stroke is low; and being that his previous cancer was a direct result of his hcv and not impacted by blood cell production, it was considered a worthwhile risk.

My husband wants just this one week of feeling pretty good before the decent New England weather's gone for good this year -- being it's the 1st time since March that he's had hgb above 11, he was glad to get the breather, and plans on resuming 1200mg riba if his hgb is as good or better next week.  The added bonus is we received news that his CT-Scan Tuesday cleared up concerns about another hcc suspected on CT-Scan back in August -- it's been a long three months, but this time, it's "No suspicion of recurrent hepatoma."  YEAH! It's a great week for us!

Thank you all again so much for your honest opinions, good suggestions, and well wishes.
~eureka

[Trish77]

Superb analysis, Eureka.  I don't think it's a matter of honour over valour at all - I think you and your husband consistently display both and his decision maintains that.

Oddly...when I read your comments, that scene from the movie "Wayne's World" came to mind  where Garth and Wayne suddenly drop in front of Alice Cooper proclaiming "we're not worthy" ... you're Alice and he's Cooper. :)

I hope he very much enjoys his break and his higher hgb.  Well-earned.  A week at a time.  Rooting for both of you in my heart all the way.  

Trish

[RCM829]

Beautifully thought out response Eureka. May you and your husband achieve the success you so richly deserve. Hang in there!