2b, week 7, holding dose's

[Lady Lauri]

  
   Okay! hgb now at 10.3 in 6 week labs. Was told as we have already dose reduced, that if it drop's to 10 or below next labs, they may 'hold dosing' until back up. Confused as has been posted that it could go as low as 8.5 before that happened (but in a trial).
   Now I am worried. I will get shot 8 in before next labs, but very concerned as isn't this when, even with RVR at week 4 , the virus can sneak back in....missing dose's?

  To refresh: 2b, VL at start 1, 550,000
  5 weeks at 180mg Peg/ 800 Riba
  RVR week 4 labs
  Reduced at 6th shot to 135mg Peg/600 Riba

  6 week labs: Posting all
   Glucose: 53 (whats up with that, way low, eating LOTS of suger?)
   T. Protein 6.3
   Alb. 3.7
   LD 161
   T. Bili 0.5
   AST 22
   Alt 12
   Alkphos 59
   GGT   17
   Amylase  54
   NA    135
   K (?) 4.3
   Mag 2.3
   Bun  9
   RBC 3.19
   Hgb    10.2
   Hct     30.8
   Plt       173
   WBC      4.3
   ANC    2.3   (what are these? Where's neuts this time??)

Pigeona, Ladybug….you both had to stop early, both SVR, but why did you have to stop?
Ladybug…think you did the 16 weeks, why was that decided? He did say last week I could just get to week 16 and he’d be comfortable with SVR for me.
I'm stressing :{   Really want to at least get to 13-16 weeks. Any input on how bad this could affect RVR. SVR if I miss a few weeks dosing? OR if I ask if we could try the 90mg Peg/400 Riba first?

                                           Thanks, not happy with this :{                           LL

[jmjm530]

As a couple of us noted earlier, it's understandable that they reduced your ribavirin, especially since you're a 2b. However, unclear why they reduced your Peg with an ANC of 2.3 which happens to be in the normal range and in fact is about the same as my ANC and I've been off treatment for over a year.  You might point out your current ANC value to your doctor and ask why the peg dose reduction.

-- Jim

[Lady Lauri]

Agree, I will. My only guess is he saw I was UND at 2 weeks ?? (as I am not told yet.) Let alone said could reduce to even 90mg Peg if needed.

Don't understand the 'holding dose's' at Hgb 10 or under either. Except for the ol' no rescue drugs deal??

Googling labs to understand them more now!

                                                                                                     LL

[pigeonca]

I had to stop because of an autoimmunne condition that didn't respond well to the meds.  But riba was the bigger problem, not INF.  Also, when my hgb dropped precipitously from 15.6 to 11.5 in 4 weeks, they gave me epogen, which is the same thing pretty much as Procrit, but it's generic.

I stopped riba after 12 weeks, did an additional week on Peg-Intron alone, then stopped.  Am SVR.  Why can't you get a helper drug like epo?

[Lady Lauri]

  That's the problem, in the trial at Shands, Fl. and no rescue drugs allowed. Don't understand that either, especially when I 'drew' the norm -Pegacy-and not the actual trial drug-Albuferon.

My Hgb dropped from 13.7 to 11.3 from week 2 to 4, than 6 weeks labs to 10.2, so figure that is what's slammed me to ...the bed! Just DON'T want to 'hold dose's', would rather go as low in dose's as I can or something. But 'rules are rules' in trials.

                                                                             LL

[CockSparrow]

Apart from your hgb everything looks good so I would happy with these results.
Your hgb is continuing to drop because Riba has a long half life and takes a while to reduce in your blood. In the next week or so your hgb should rise. I have copied some extracts and VR data from the Accelerate trial which may help in understanding when shortened Tx is an option.

Q. Any input on how bad this could affect RVR. SVR if I miss a few weeks dosing?
A. Don’t miss any doses unless you absolutely cant help it as this will impact your SVR chances.
Reducing Riba to 400mg is an option for you but try not to reduce the Interferon if you can help it.

Your Reduced Riba probably isn’t a worry as you are still taking more RBV per kg than the average Accelerate patient. Your lower PegIFN dose would be of concern to me personally, and I would need to be dragged kicking and screaming into lowering it to 90. But your labs a really good so the drugs are still working. And you are still taking a lot of IFN per kg anyway.

There was a study done in Austria that treated G2s and 3s with 400mg RBV and their conclusion was that this was non inferior to 800mg.

The following comes from Shiffman, and according him dose reductions have minimal impact on SVR so long as the drugs aren’t interrupted, and you are UND before you reduce.

Several years ago, it was felt that any dose reduction could potentially impair the ability to achieve SVR. However, it is now recognized that small reductions in the dose of peginterferon alfa and/or ribavirin, particularly after patients achieve undetectable HCV RNA, are less likely to impact SVR as long as dosing is not interrupted.


The extracts below come from Accelerate.
Reduced durations of therapy may also be reasonable in patients who have adverse events and are unlikely
to tolerate 24 weeks of therapy.
The decision to reduce the duration of treatment must be balanced against the increased risk of relapse. Patients who do not have a rapid virologic response should not be considered easy to cure and should not be offered abbreviated treatment.

However, patients with a low pretreatment viral load or a rapid virologic response appear to have the highest probability of having a sustained response with 16 weeks of therapy, and such therapy may be a reasonable option for these patients.


Below are the G2 stats from the Accelerate trial. Hope the formatting holds.
(24 week arm No G2s=356, 16 weeks arm No G2s=372)


G2 Weight kg 84.2±19.8 (185 lbs)
G2 BMI          28.7±5.8

Per Protocol SVR 82% ITT SVR 75%

16 Weeks                 24 Weeks
RVR 69% (247/356)  69% (257/372)
EVR 91% (338/372)  94% (333/356)
EOT 90% (335/372)  84% (299/356)
SVR 62% (232/372)  75% (268/356)

ITT SVR Rates by sub group

Pretreatment VL
                                16 Weeks          24 Weeks
≤400,000 IU/ml        83% (52/63)         82% (45/55)
>400K–800K IU/ml  68% (13/19)      79% (27/34)
>800,000 IU/ml        58% (167/290)   73% (196/267)

Cirrhosis or bridging fibrosis
        16 Weeks          24 Weeks
No    67% (367/547)  79% (210/266)
Yes  48% (88/185)     64% (58/90)

Liver steatosis at baseline
       16 Weeks           24 Weeks
No   65% (220/338)   79% (151/192)
Yes 54% (83/154)     77% (27/35)

Rapid Virologic Response
       16 Weeks          24 Weeks
Yes  78% (200/257)  85% (210/247)
No    26% (27/103)   53% (53/100)

If you can hang in there, your SVR chances do look good
CS

[pigeonca]

I agree: I'd try to resume the full dose of INF.  Judging from your anemia, I'd have a hunch that you are feeling an intense reaction to the riba, which may very well mean that the riba is doing its job.  In that case, a dose reduction could be safe.  But your sides just don't sound like Interferon intolerance, so - if I were in your shoes - I'd want to get back up to 180mg. on the Peg.

If you can hang in there for just 5 more weeks, with that RVR, AND if you cannot tolerate any more, then your odds of SVR are within playing range if you stop after 12 or 13 weeks.  But longer is always safer.

[susan400]

ANC = Absolute Neutrophil Count

Susan

[jmjm530]

If feasible, why dont you get  second opinion from a good hepatologist outside of the trial? Combining the facts that: (1) you're in the control group; (2) both riba and peg have been lowered; (3) no helper drugs are allowed; and (4) they have threatened to "hold dosing" if you hgb drops less than half a point -- if it were me, I'd minimally get a back up plan in place. Treating privately, outside the trial restrictions, may be in your best interests at this point.

-- Jim

[CockSparrow]

Just to clarifiy
Should have read the Accelerate stats a bit closer. I have got some of the numbers in each arm around the wrong way. The Pecentages are still correect except for the cirrhosis stat which is 50% instead of 48%. I posted the combined stat by mistake.
CS

[CockSparrow]

I like the way you are thinking. Having a plan B is a damn good idea.
CS

[Lady Lauri]

All...my plan B is the H*ll with that, I have my drugs and I'm doing them!! (kidding, sort of:}  7 weeks of Peg and a bottle of Riba!
I can hang in there, they may not!

Seriously tho, CS where do you get these studies, stats so quick, on hand? I am by no means 'dingy' but my comp. exp. is mainly typing, faxing, copy, folders, etc. and never spent a lot of time researching (until now) so how the heck do you decipher thru the 20,000 web sites, advertisement sites to get to what you need????  Drives me nuts. Can you send me the links for accelerate or others off post, maybe save YOU some time, LOL

  I agree totally with a back up plan, problem is my insurance won't cover, I can cover some but not all, and if I was to start with someone else, I'd have to cover all and be out of trial. I am going to find another Hep Dr. for a back up in my area, anyone remember who it was that had one in Lake Land, Or Lady Lake Fl.??

I also agree with NOT lowering Peg anymore and my only guess they lowered it to 135mg. is the Dr. seeing RVR at 2 weeks (don't know?) and that he saw anemia coming and is trying to lower all and keep me on longer, also being small- weight.. These are all guess's here! It is all run thru their 'Monday pow wows' so I am -sort of- getting more than 1 Dr. plus trial coordinators.


Pigeonca......I also think it's all the Riba! At the risk of jinxing myself--you know as soon as you say it, you get it!!----but I have had very little 'bad' shot nights/days. Not one fever, a few sweats and only more fatigued a couple days after. Muscle throbbing I've had for years from hep, so nothing new there.
I am desperate to do as you said....a least get to 12-13 weeks as did do a lot of research in that, 2b's and 12-14-16 weeks etc. plus a lot of info from CS.

Now here's my idea! As in a control group, BUT it's still my life, my SVR.........and I have to take some control here TO stay in tx. , I am thinking of dropping my Riba to 400 for just 7-8 days until next labs’.
   CS had posted previously about-put simply- the importance of lowering but not interrupting meds.  I am afraid they'd know if I went elsewhere, got epogen,etc.

What IS the 'dangerous' level of anemia?
If it gets to that level, will just stopping the meds bring it up, or am I in trouble and have to get rescue drugs somewhere? (going off trial)

If I can get to 12 weeks, I'd let them 'hold dose's' and still go back and do more!

  Thanks much all,                                                   LL

[Lady Lauri]

  Thank you :)

Always had 'Nuets' on it than had ANC. I do have the list of normal ranges for all.
This medical mumbo jumbo has been quite a learning exp.!

Get my e-mail to you :}  And have a 'light at the end of the tunnel' day :}

                                                                                        LL

[Lady Lauri]

Another help the medically illiterate girl question :}

  WOULD that make sense that he cut the Peg also because of UND at 2 weeks?

I had been in bed 9-10 days , with that "Oh God, I gotta walk 12 feet to the bathroom" feeling.
(bed pan anyone, LOL)
When he asked % of time in bed and I said 100%, he said "oh, no, that won't work".

                                                                                                        LL

[jmjm530]

The reason I suggested seeing a "back up doc" is because in general lowering doses is inferior in terms of SVR than using helper drugs. Problem is that your study won't allow helper drugs so your SVR is in some respects being sacrificed to a certain degree.

That said, as CS studies show, you may be able to get away with a lowered riba dose as long as they don't force you to stop the riba which they apparently have threatened.

But if it were me, the main question to your docs would be why the Peg reduction with such high ANC (absolute neuts). Peg reduction is associated with lower SVR and I'd def bring that up with your doctors.

-- Jim

[Lady Lauri]

"your study won't allow helper drugs so your SVR is in some respects being sacrificed to a certain degree."

Exactly and why I have to take some control here!
My thought (plan?) after info. from you guys and a bit of my own, is the Peg needs to go up, the Riba down 200 more (to 400)  for awhile, to get hgb up.

Sound okay? E-mailing them now, they respond fast, normally.

                                                                                                  LL






E-mailing them now, they respond fast.

[pigeonca]

That sounds like an excellent plan, at least to my layperson's mind.  Good luck on it.

[Lady Lauri]

Does's to stay the same until next labs, tho I still feel dropping 1 Riba ( for a week or so)
would help Hgb stay or go up! (maybe drop 1 every other day? Desperate to not miss dose's totally!)

CS........"The extracts below come from Accelerate.
Reduced durations of therapy may also be reasonable in patients who have adverse events and are unlikely to tolerate 24 weeks of therapy.
The decision to reduce the duration of treatment must be balanced against the increased risk of relapse. Patients who do not have a rapid virologic response should not be considered easy to cure and should not be offered abbreviated treatment."


  The above is why I figure he reduced both ...."unlikely
to tolerate 24 weeks of therapy." Explained to me that it was okay with my EVR/ RVR and he was not happy with how I was after week 4 into this, labs or not, the 'bedridden' part, sick, etc. I figure he also takes into account keeping weight on a must as not much to spare here and had dropped 6 in @ a week, & by week 4.  (AKA..not eating or puking all food and some Riba up!) 15-20 more lbs. loss on me will be bones.


"However, it is now recognized that small reductions in the dose of peginterferon alfa and/or ribavirin, particularly after patients achieve undetectable HCV RNA, are less likely to impact SVR as long as dosing is not interrupted. "

So, I'll be keeping that in mind.

                              Thanks CS, that was very helpful,      LL

[ladybug52]

Here's the same info on ribavirin and anemia.
http://hcvadvocate.org/hepatitis/factsheets_pdf/anemia.pdf
Basically echos what Cocksparrow and Jim have said, but it's in pdf form and I'm unable to copy and paste.
Here's the highlights:
Riba dose reduction or the use of a growth factor harmone (erythropoieton) is recommended when the hemoglobin goes below 10. Stop the ribavirin completely if the hgb goes below 8.5. It also states it's better to reduce than stop.
Ribavirin has a 1/2 life of 12 days---in other words, 12 days for the ribavirin to achieve 1/2 of it's original value. Peg-intron is approximately 40-60 hours. I have read studies that state the peg-intron is harsher than pegasys although they are basically the same drug.
My ribavirin dropped from 14.3 to 10.1 after three weeks of tx, but I started procrit, then stopped because my hgb rose again and stayed stable thru tx.
My stopping at 16 weeks was by choice, not dr's recommendation. I felt lousy, was working, did not have much of a brain and was afraid of long term side effects. I felt that I would be ok with my early und at 3 weeks. Jim had posted studies re: 12 weeks tx with peg-intron and 16 weeks with pegasys. I did 16 weeks with peg-intron and was willing to take the chance.
The meds (don't know which one but I bet it was the riba) stayed in my system for about 4-6 weeks after because I  continued to lose hair by the handful, and developed severe itching and hives. I felt worse after tx with the itching plus hip pain. I got a steroid shot, finally, that saved me.
Good luck, I hope you lower the dose and keep at it till at least week 12. Just do what's best for you and make the decision on your own. You'll get a lot of opinions and advice (probably already noticed!)
hugs,
Bug

[Lady Lauri]

  THANK YOU! Never quite 'got' the 1/2 life thing, you explained in layman’s terms, which I need:} Also was looking for that answer of when Riba MUST be stopped , (as you said 8.5) since in the trial they lean towards 10 and below?? I will reduce the Riba more if it gets to even 9.5. Just no ‘extra’ room here, per trial.
I also think the Riba is the worst for me, just going from 800 to 600 seemed to make a difference, but than 4 days later, he also reduced the Peg. And of course, my body could also be adapting to the drops in hgb now.

  My Dr. suggested at last app. that I could 'safely' stop at 16 also, so my own personal 'goal' is to do 18-20, than I'll feel safer. At this point, now grasping for 16 , as per them stopping. From all the help here, and my own SLOW research, it is pretty clear that reducing, Riba,  (even if I have to without telling them!) is a much safer step than holding dose's. (I could also increase my own Peg. a bit! 180mg. in each syringe still. ) I am the stubborn type to take things into my own hands, if need be, and not be just a # in a trial nor take their 'standard' advice when it's obvious theirs a better way, for me. Never been much of one for rules, being told what to do, LOL.
  For now, next labs will tell, but must keep hgb at 10.2 or up!! Going to check out the site you sent.
                                      Thanks much, Bug :}..............................LL

[ladybug52]

I am the stubborn type to take things into my own hands,


Me TOO! I decided when I didn't need the procrit even when the dr was still telling me to continue taking it. I stopped when my hgb got to 11.3 and she thought I was still taking it when it rose again to 12. I thought I'd save it for someone who would need it more later, and luckily that was the right decision for me. I also decided to end tx on my own and I had many wonderful well wishers who wanted me to continue so that I would have a higher chance of success. I appreciated every ones concern, but I had to do what felt right for me.
When I find a website I like, I save it in favorites under Ladybug. It's an easy reference tool for me to pull things from later.
Hope you stay stubborn!
hugs,
Bug

[Lady Lauri]

   Be thinking of you when I get to my 'thats it' point, gut feeling!  Course will have facts to decide on, not JUST 'had it'!  (We'd all quit at week 5 if that was the case :}

  Do the favorites thing, need to clean it out actually. Pulled up that site and couldn't get it at 1st. Got it, saved it, great site for reference, questions. And staying stubborn, doubt that will EVER be a problem, LOL.

   Going to meet some heppers at the Ocala, Fl. camp out tomorrow! ( I'm in Ocala) So cool they do this. Can't wait..... a SOCIAL event....1st one in mths. Whoo Hooo! Thought about walking up with a big Smirnoff bottle.....with WATER in it, heh, heh! But don't know their sense of humor yet :}

Gotta go 'foo foo' a bit! Been walking around in jogging pants and hair in a bun for weeks. Make up.....do I even still own make up ???? Car keys??? Purse???? Money, do I have any money???
LOL.....joining the land of the living for a day is sounding a bit hectic:}

                                         Hope to join you in SVR land soon,   LL

[alagirl]

Stop the ribavirin completely if the hgb goes below 8.5. It also states it's better to reduce than stop.
-----------------------------------------------------------
I just wanted to say here that there are two ways to come at that problem.  You can either stop or reduce the ribavirin or the other option is to increase the blood cell count (or some of both).  My doctor's office has all of the combo treatment guidelines that pegasys gives printed at the bottom of the testing schedule chart they give you to keep track of when you need to come in for viral loads and other labwork.

It has the guidelines you list above.  However, in practice my doctor actually prefers to attempt to manage the side effects before taking the step of changing or withdrawing doses.  And I have to say that I have never been bustled into a hematologists office as fast I was by my HCV doctor when he saw what was happening with my red blood cell lines.  It actually was remiss of me not to say something to him sooner because my blood draws with him are monthly and I was monitoring my own cbc's but not taking them to him until each monthly visit.  After seeing that I was getting into trouble with my cbc's he did not waste any time but was very proactive about the consult.  At the first point that they became aware I was having issues they got me in to see the hematologist asap with hardly even a waiting time (due to my hx of anemia).  Usually, they handle the procrit scrips and things in house.  But it encouraged me to know that A) they took it seriously and that they wanted quick intervention, and that B) even though they have about 400 HCV patients, they are are able to respond to the individual treatment issues of one patient.  (When I say they, I mean his office.  His nurse still sucks.)  lol

Also, my hematologist seems very bright and he is willing to do whatever he can for me and is following me very closely.  The next time (if it happens) that my count crashes he wants me to come there immediately so they can admit me at his hospital so he can get a testing battery done prior to transfusion diluting the results because it will better allow him to get a complete picture of exactly what is happening in my body at that time just prior to the intervention.  He said I did the right thing going to the ER and going ahead with the transfusion this last time given the time constraint and the fact that I needed to be in court, but he really wants me there if and when there is a next time so he can tailor the intervention to the exact cause of the anemia.  There are apparently some additional modalities they can use to stop hemolysis other than just blood transfusions and/or the addition of procrit.  Which was news to me, I'd thought those were the only options.  Also, the hematologist followed up immediately with the GP at Rapid Care where I get my blood draws because I saw a note in my chart that he had called right after he talked to me and made them highlight my chart so that he'll get immediate faxes on my twice weekly cbc's with reticulyte counts.  

So yes, I am working to get an outside consult also which will include him and my HCV doc so we can plan for contingencies but I guess I am just impressed that my current doctors are working so well together to help me.  I have had health issues most of my life and I am used to having to practically fight for intervention at times.  So this little synergy my providers have going at the moment is really sweet.

Extreme Treatment - that's what I've decided to call my course on this combo therapy.  

I know that a lot of people complain about their docs really not paying attention to their concerns all the time but all of my doctors, even the ones I interface with at the ER really seem to have this committed attitude towards MY treatment.  In other words, while it may eventually come to pass that there is a dosage change made in my therapy, they all seem willing to do everything they can to support me so that I can stay on it and they all seem to agree that due to the fact that I'm treating while in the acute phase there isn't even a question about "whether" I should stay on it even though I'm having some health issues.  But I mean, transfusions in the ER?  That was really them going totally out of their way.  I had no idea that it was such a complicated time consuming process, and it also meant that literally one of the ER nurses had to sit next to my bed for the entire first hour of each unit of blood.

We are talking about a smalltown ER that was willing to provide this type of support when they were already having a busy night and were short staffed, just so I could have a successful treatment.  Then there is my local rapid care who is not charging me a copay but letting me come in twice a week for bloodwork AND they are going out of their way to run an additional quick cbc in their office on each draw just so they'll know right away if it looks like I'm really in trouble (that quick cbc is what gave us the alert on Monday that I'd taken a dive in hgb that put me kind of into the danger zone).  Since the lab they send off to doesn't come back until usually at least the next day if not two days this is a really helpful quick check.  And the staff there especially was so excited to see my 4 week negative/UND when I brought it in for them to add to my chart.  So, I just feel very fortunate and grateful for the attitude of so many of my providers.  They take me seriously, they listen to me, and most of them just seem to be so invested and working so hard to see me through treatment that it really just touches me.  All of the support I've been given is definitely one of the things I'm drawing on when I have these difficult days like today.  And that's to say nothing of my family.  They call and check on me constantly and whoever is in town (which is sometimes a bit more problematic because the family I have here is gone a LOT) but anyone who is here will always drop everything if I just can't drive to a medical appointment.  And with all of these specialists it just seems like I have multiple physician visits every week.

And then there's my actual primary care doc who just has made it a habit to call me twice a week to get an update on my condition and usually he'll stop by here on Saturdays and check on me too.

Anyway, I just feel so fortunate that my providers seem to CARE.  It makes me feel a greater commitment to my own treatment since so many seem to be going out of their way to help me get through it.

[alagirl]

oh sh^t! Sorry, didn't realize that was a novella on your thread.  Brain addled.

[beamishboy]

alagirl-nice novella and straight on thinking...you have a great buncha people there!..sweet home alabama...                                  
                                                                                                                                                                                           Laurie-at the risk of promoting a kinda wildcard selfsaving intervention ,i absolutely concur with jimjim and seriously think you should consider trxin outside the box...and remember,PROCRIT does take awhile to bump up the rbc's.....don't let them interrupt your dosage unless you feel they are totally TREATING YOU RIGHT !.....go arab on 'em.