HGB 8.9 amd riba reduced from 1200 to 1000, no procrit. How diminished are chances of success

[spectda]

My hgb at week 12 end was 8.9% (I don't don't feel vastly different from the 10.2 2 weeks previous). I was randomized into the less riba arm of the boceprevir trial rather the procrit. The purpose of the trial is figure out if boce will pick up the slack of the reduced riba. it doesn't seem like that has been the case with other pi studies.

I am at 83% of my original weight based riba, how does that normally effect svr. does this kind of decrease usually have much of an effect on hgb, I am a bit uncomfortable about the hgb going lower without procrit to help and only more reductions of riba as a solution. I can't find clear information. Some studies suggest that after und it will not hurt, other seem to suggest not good. I am also at a lower does of INF because of low platelets and anc, but I am und. I hope my next blood work still comes out und.

Thanks - Dave

[frijole]

I wish we all had doctors like can-do-mans.  I wonder if there is anything in the contract about how much and when the dose reductions will be.  I try to find purpose for all these trials and this one -- well, maybe they are trying to set the criteria for dose reductions without procrit.  There are people who just can't get the extra drugs while treating (like anyone going through the VA, I think) and others who can't afford them.  I am just sorry you ended up on the wrong leg of the trial.  At least you have us (ha ha).

It is amazing how that anemia creeps up on us treating.  I walked 3 mi 3-4 times a week until about week 24.  Then it started getting really sporatic and it was more like shuffling. I also had some bowel issues that made it hard to walk too far but we won't go there.... At least you aren't working.  

  Sounds like you got into California real estate in the heyday and managed to bail before the crash. The motorcycle business does sound a bit more fun though.

frijole

[spectda]

it's really true, some people quit after a short time because they can't take it and they svr. Bill1954 told me of a guy he knows who did either 6-8 weeks and told the doc to take his meds back and got svr. Of course I want it all to be perfect, but I am feeling confident that I am going to be it. Anemia is a good indicator of the effectiveness of the meds.
Take care,
Dave

[dointime]

There was a guy in my telaprevir trial who got a reduction in ifn and riba quite early on, around the 5th week I think.  He was down to 600 riba and 135 ifn.  He was 60 years old, overweight, and stage 2.  He did 36 weeks tx, first 12 with the real telaprevir added, and got SVR.  

It is obviously better not to get reductions but other factors can significantly alter the outcome as well.  I guess this guy was just sensitive to the drugs and even the reduced dose worked on him, whereas others can double dose and get no result at all.  Go figure.

dointime    

[spectda]

You did great Cando! You kicked it's a$$! It's really helpful having your input after your experience with boceprevir. Thanks - Dave

[can-do-man]

Yes i was on full dose all thru tx. Going into the trial we both understood that at stage 4 and a prior relapser this was more then likely my last and best chance.

[spectda]

"Put your seatbelt on dave your in for a rough ride, i think you know that and can handle it though.........."  Uh-oh,  

Yeah my decline in hgb were steady and slow. The first 4  weeks I went from 14.8 to 11.9, then slow after that, then from week 10 to 12 I drop from 10.2 to 8.9. I don't want to see another one of those, but I am going to expect it to rise and it will! :-)

I want some procrit damit! Your doc really did a great job keeping you on full dose inf with your low platelets, did you also stay on full dose riba the whole time!

Have a good one - Dave

[can-do-man]

Yes i was on procrit for both of my treatments, with just SOC 40,000 units a week kept my HGB around 10, in the boce trial my HGB went to 8 taking just 40,000 so i went to 80,000. At the end of the trial i was up in the high 9's.

One thing though is yours didn't drop as fast as mine, i had to start procrit 2 weeks after i started the boce.

Put your seatbelt on dave your in for a rough ride, i think you know that and can handle it though...........

cando

[spectda]

"Also will you be able to go back up to full dose of INF if your platelets level out and your ANC stays up?"

I hope so, but my feeling is that the doc will not jump in with dose increase quickly.

Did you take procrit?
- Dave

[can-do-man]

If you can hang around the 9 area you should be fine, i was in the 8's for most of my tx without to much trouble, also your doing 48 weeks and are already und. Also will you be able to go back up to full dose of INF if your platelets level out and your ANC stays up?

[spectda]

I have my doubts about the riba reduction too. I think they lower riba and possibly boce at some point. It a predicament for sure. Of course like always we most likely stay und throughout tx, Hopefully I will level out or increase a bit, you never know.
Dave

[can-do-man]

Hang in there dave, i have my doubts that your HGB will go back up due to the boceprevir, if it keeps going down do they keep lowering the riba?

I'm sure the bocep is doing the heavy lifting, hoping for the best for you.

cando

[spectda]

Mike-Thanks for the study info I am hoping that since I am over 80% dose and much more then 80% so far for tx that it will be okay. My pegintron dose started at 1.74 mcg per kilo (recommended dose 1.5 per kilo), I have averaged 86% of the recommended 1.5 mcg per kilo dose throughout the 13 weeks so far. No good on the dose reductions, but maybe not critical.

Judy-I guess you can only do so much, I just want to insure I leave no stone unturned. I am really hoping this will be the 1rst and last time for tx, as we all do. Thanks for always checking in and offering helpful suggestions

Kathy-
Being a welder in 100 degrees sounds like torture, I feel for the poor guy. where I live summers are generally 90-113 degrees and most often somewhere in the middle. This year it has been very mild and I am thankful.

I am fortunate to not be working during tx. I was a District manager for a large company for many years and had some real estate investments that were doing well so I quit the job a few years ago, worked part time selling ducati and triumph motorcycles to supplement my real estate and have some fun. (motorcycles are one of my greatest passions). since then the real estate income and the motorcycles sales went south and I am on unemployment trying to hold onto the house. Life changes, we deal with it! Sorry for the ramble!

I guess as I think about it I have slowly tailored my life and have become quite sedate without really realizing how much of a contrast there is. I walked 3-5 miles per day until about 2 weeks ago, now I just do occasional short walks. I don't stay vertical for long periods of time! LOL I got dizzy as the hgb came down, but don't get dizzy much these days.

Does low hgb cause minor brain damage because of less oxygen, I know we have a lot of brain cells, but would like to keep them! I am not comfortable with the hgb going lower without a quick way to recover. Very frustrating to know that procrit would solve all the problem but can't be used, but I got boceprevir in return. I don't think they know if the boce helps sustain the svr the way riba does, or if the boce mainly just gets the load down fast.
The trial is to determine that I suppose. Thank you for always responding in and offering important information from all of your experience, It's really helpful. We are all lucky to have your help.

Deb-Thanks for continually encouraging, I appreciate it. Keep up the fight! your pal Dave

[Deb9991]

Boris -- you are slaying that dragon, I know it.  I can hear it putting up a fight, but you've got the upper hand.

It is great that you are UND and you are on a "load of killer meds" and they are still doing their jobs successfully.

debbie  

[frijole]

I am glad Mike was able to come up with some statistics here.  It looks like you will be all right with the 1000 mg., based on those statistics.  Darn shame you got randomed out into the non-procrit group.  That is one of the biggest downfalls of trials.

I am surprised you don't feel really bad at 8.9 but I have never asked if you are working full time and if so, is it  a blue collar or white collar job  I worked throughout treatment and missed only a couple of days at my desk job, but I woman whom I work with has a son  treating right now (about week 6) who is a welder working outside (it has been in the 100s here lately) and he has been having a really rough time.  He missed 2 days last week and has missed a few days more.  The sun really impacts all of this.

frijole

[mikesimon]

This addresses ribavirin in an SOC setting.

"Impact of Dose Reductions

The impact of dose reduction on SVR was retrospectively assessed by analyzing drug exposure in genotype 1-infected patients randomized to peginterferon-α-2a (180 μg/week) plus ribavirin (1000 or 1200 mg/d) who completed 48 weeks of treatment.[80] Neither EVR nor SVR was adversely affected by ribavirin dose reduction as long as cumulative ribavirin exposure was >60%, whereas the SVR rate in patients receiving ≤60% ribavirin was significantly lower than in those receiving >60% ribavirin (33% vs 64%; P 97% cumulative ribavirin dose over weeks 1-12, the SVR rate was significantly lower in those with ≤80% ribavirin exposure than in those with >80% exposure during weeks 13-48 (48% vs 67%; P = 0.372). In contrast, ribavirin dose reductions during weeks 5-48 had minimal impact on SVR in patients who achieved rapid virologic response (RVR), defined as undetectable serum HCV-RNA levels at 4 weeks, even when the cumulative ribavirin dose was <60%. In patients who did not achieve RVR, however, ribavirin dose reductions after week 4 had a negative impact on SVR rate in all ribavirin exposure categories....."

From: Ribavirin in the Treatment of Chronic Hepatitis C
Paul Martin; Donald M. Jensen
Posted: 09/04/2008; J Gastroenterol Hepatol

See: http://www.medscape.com/viewarticle/578705

[pcds]

It's so hard to get sufficient information when so few have been in trials compared to SOC.  I think the bloodwork will tell the story.  Another round of waiting.  The riba dose doesn't sound that extreme, it's still a good dose amount.  Hold on to the fact you made it to und.  You're still on a load of killer meds against this virus.
Thinking of you,
Judy