Aa
2b, week 7, holding dose's
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
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
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
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
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
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?
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?
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
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
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
-- Jim
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