Aa
Your "Great" labs might mean the opposite of what you think they do.
Always killed me when people here report that my doctor said "my labs look 'great"" or that "my hemoglobin is great" -- when in fact an association between anemia and riba absorption has been known for some time. Now, we have the logical association between anemia/riba absorption and SVR. Bottom line IMO is that having little or no anemia should at least signal a discussion with your doc about increasing your riba dose, regardless if it's weight based. Espeically if your viral decline isn't what it should be. Also note Procrit's role in keeping people on tx with their anemia. Thanks to "CoWriter" for bringing this particular presentation to my attention.
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Oral Presentations
http://www.kenes.com/easl2009/Orals/276.htm
Session Title: Parallel Session 15: HEPATITIS C VIRUS NATURAL HISTORY AND THERAPY
Presentation Date: Apr 25, 2009
HEMOGLOBIN DECLINE IS ASSOCIATED WITH SVR AMONG HCV GENOTYPE 1-INFECTED PERSONS TREATED WITH PEGINTERFERON (PEG)/RIBAVIRIN (RBV): ANALYSIS FROM THE IDEAL STUDY
M. Sulkowski1, M. Shiffman2, N. Afdhal3, R. Reddy4, J. McCone5, W. Lee6, S. Herrine7, S. Harrison8, W. Deng9, C. Brass9, K. Koury9, S. Noviello9, J. Albrecht9, J. McHutchison10
1Johns Hopkins University School of Medicine, Baltimore, MD, 2Virginia Commonwealth University Medical Centeru, Richmond, VA, 3Beth Israel Deaconess Liver Center, Boston, MA, 4University of Pennsylvania Health System, Philadelphia, PA, 5McCone Endoscopy Center, Alexandria, VA, 6Clinical Center for Liver Diseases, Dallas, TX, 7Thomas Jefferson University, Philadelphia, PA, 8Brooke Army Medical Center, Fort Sam Houston, TX, 9Schering-Plough Research Institute, Kenilworth, NJ, 10Duke Clinical Research Institute, Durham, NC, USA
Background and aims:
Peginterferon (Peg)/ribavirin (RBV) causes significant hemoglobin (Hb) decline leading to side effects and RBV reduction in ~30% of patients (pts). The effect of Hb loss on sustained viral response (SVR) is unknown.
Methods:
3070 HCV genotype-infected pts were treated for 48 weeks with Peg2b 1.5 or 1.0mcg/kg/wk + RBV 800-1400mg/day, or Peg2a 180mcg/wk + RBV 1000-1200mg/day. Anemia was defined as Hb 3 g/dL, 43.7% (984/2250); ≤3 g/dL, 29.9% (231/773) (P8 weeks):
Anemia/no EPO, 59.3% (162/273);
Anemia/EPO, 55.0% (116/211); P=0.33.
Among anemic pts, EPO was associated with less early (< 0.001).
Conclusions:
Among HCV genotype 1-infected pts treated with Peg/RBV, the magnitude of Hb decline is strongly associated with the likelihood of SVR.
The effect of EPO varied by time to anemia;
no benefit was observed for pts who became anemic after treatment week 8.
These data suggest that Hb decline may be a pharmacodynamic marker of treatment effectiveness and that the primary effect of EPO was to prevent treatment discontinuation in pts with early anemia.
------------------
Oral Presentations
http://www.kenes.com/easl2009/Orals/276.htm
Session Title: Parallel Session 15: HEPATITIS C VIRUS NATURAL HISTORY AND THERAPY
Presentation Date: Apr 25, 2009
HEMOGLOBIN DECLINE IS ASSOCIATED WITH SVR AMONG HCV GENOTYPE 1-INFECTED PERSONS TREATED WITH PEGINTERFERON (PEG)/RIBAVIRIN (RBV): ANALYSIS FROM THE IDEAL STUDY
M. Sulkowski1, M. Shiffman2, N. Afdhal3, R. Reddy4, J. McCone5, W. Lee6, S. Herrine7, S. Harrison8, W. Deng9, C. Brass9, K. Koury9, S. Noviello9, J. Albrecht9, J. McHutchison10
1Johns Hopkins University School of Medicine, Baltimore, MD, 2Virginia Commonwealth University Medical Centeru, Richmond, VA, 3Beth Israel Deaconess Liver Center, Boston, MA, 4University of Pennsylvania Health System, Philadelphia, PA, 5McCone Endoscopy Center, Alexandria, VA, 6Clinical Center for Liver Diseases, Dallas, TX, 7Thomas Jefferson University, Philadelphia, PA, 8Brooke Army Medical Center, Fort Sam Houston, TX, 9Schering-Plough Research Institute, Kenilworth, NJ, 10Duke Clinical Research Institute, Durham, NC, USA
Background and aims:
Peginterferon (Peg)/ribavirin (RBV) causes significant hemoglobin (Hb) decline leading to side effects and RBV reduction in ~30% of patients (pts). The effect of Hb loss on sustained viral response (SVR) is unknown.
Methods:
3070 HCV genotype-infected pts were treated for 48 weeks with Peg2b 1.5 or 1.0mcg/kg/wk + RBV 800-1400mg/day, or Peg2a 180mcg/wk + RBV 1000-1200mg/day. Anemia was defined as Hb 3 g/dL, 43.7% (984/2250); ≤3 g/dL, 29.9% (231/773) (P8 weeks):
Anemia/no EPO, 59.3% (162/273);
Anemia/EPO, 55.0% (116/211); P=0.33.
Among anemic pts, EPO was associated with less early (< 0.001).
Conclusions:
Among HCV genotype 1-infected pts treated with Peg/RBV, the magnitude of Hb decline is strongly associated with the likelihood of SVR.
The effect of EPO varied by time to anemia;
no benefit was observed for pts who became anemic after treatment week 8.
These data suggest that Hb decline may be a pharmacodynamic marker of treatment effectiveness and that the primary effect of EPO was to prevent treatment discontinuation in pts with early anemia.
Apache: While this conclusion is probably correct for geno 1, not sure geno2, or maybe even geno3, need to get to the level of Anemia that geno 1 needs for the best chance at svr.
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This is correct. The study was for geno 1's and as far as I know the previous studies on serum riba levels via HPLC testing was also for geno 1's. This does of course not mean there is no relevancy for geno 2's and 3's, just perhaps less.
JD: "...anemia is not fun."
Jim, how can you say such a thing? Why, its the best way I know (short of arson) to fill your house with cute firefighters!
----------------------------------------------------
Well, I guess if some cute female firefighters showed up at the house I might revise my opinion :)
-- Jim
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This is correct. The study was for geno 1's and as far as I know the previous studies on serum riba levels via HPLC testing was also for geno 1's. This does of course not mean there is no relevancy for geno 2's and 3's, just perhaps less.
JD: "...anemia is not fun."
Jim, how can you say such a thing? Why, its the best way I know (short of arson) to fill your house with cute firefighters!
----------------------------------------------------
Well, I guess if some cute female firefighters showed up at the house I might revise my opinion :)
-- Jim
"...anemia is not fun."
Jim, how can you say such a thing? Not fun to huff and puff and gasp for air? Not fun to have your vision go out and suddenly hit the floor like a sack of grain? Why, its the best way I know (short of arson) to fill your house with cute firefighters!
I got slammed with anemia early, but then I also got RVR. Could never get my hgb much above 10 so I took procrit for the duration! I did not want to dose reduce and found the tradeoff was worthwhile for me.
jd
Jim, how can you say such a thing? Not fun to huff and puff and gasp for air? Not fun to have your vision go out and suddenly hit the floor like a sack of grain? Why, its the best way I know (short of arson) to fill your house with cute firefighters!
I got slammed with anemia early, but then I also got RVR. Could never get my hgb much above 10 so I took procrit for the duration! I did not want to dose reduce and found the tradeoff was worthwhile for me.
jd
Well, will play the devils advocate here
While this conclusion is probably correct for geno 1, not sure geno2, or maybe even geno3, need to get to the level of Anemia that geno 1 needs for the best chance at svr.
Also does the damage riba does to ones red blood cell producing marrow ever come back to pre tx levels ?... mine hasn't yet.
HGB was 16.7 before tx, now 4 months post eot (und@12wk post) hgb hovers around 15.
My endurance levels and stamina when running and exercising is not back to pre tx levels yet. I am wondering if it ever will be, and if the hgb killing riba had anything to do with it.
Even though the highest riba levels are associated with the best svr rates... be carefull promoting high dosage riba. My Dr uses procrit, but does so with caution. NP says its a nasty drug.
I know we all want to get a SVR status, but our Dr's are the best ones to make the decisions of what we should or have to tolerate in order to get there.
All I am saying is be very careful with High Riba dosing and Anemia. Dangerously low HGB levels can occur. For someone with stage 0-1 liver disease, and a weak cardio-vascular system, this can't add years of life, and might not be the best compromise...
IMO your Dr should be the one to determine proper riba dose. If you pressure him to up your dose because of studies like the above one,
and you have adverse advents (that might take you off tx or dose reduce) your Dr might not be 100% responsible, and you have no one to blame but yourself.
That being said, I know some of us can, and have, tolerated very high ifn and riba dosage.
All the power to them, and it will probably help them reach SVR.
I just would hate to see the 105lb elderly lady self-increase her dose because of a study like this, along with her less than desired hgb drop, then suffer an adverse advent.
jmho,
apache
While this conclusion is probably correct for geno 1, not sure geno2, or maybe even geno3, need to get to the level of Anemia that geno 1 needs for the best chance at svr.
Also does the damage riba does to ones red blood cell producing marrow ever come back to pre tx levels ?... mine hasn't yet.
HGB was 16.7 before tx, now 4 months post eot (und@12wk post) hgb hovers around 15.
My endurance levels and stamina when running and exercising is not back to pre tx levels yet. I am wondering if it ever will be, and if the hgb killing riba had anything to do with it.
Even though the highest riba levels are associated with the best svr rates... be carefull promoting high dosage riba. My Dr uses procrit, but does so with caution. NP says its a nasty drug.
I know we all want to get a SVR status, but our Dr's are the best ones to make the decisions of what we should or have to tolerate in order to get there.
All I am saying is be very careful with High Riba dosing and Anemia. Dangerously low HGB levels can occur. For someone with stage 0-1 liver disease, and a weak cardio-vascular system, this can't add years of life, and might not be the best compromise...
IMO your Dr should be the one to determine proper riba dose. If you pressure him to up your dose because of studies like the above one,
and you have adverse advents (that might take you off tx or dose reduce) your Dr might not be 100% responsible, and you have no one to blame but yourself.
That being said, I know some of us can, and have, tolerated very high ifn and riba dosage.
All the power to them, and it will probably help them reach SVR.
I just would hate to see the 105lb elderly lady self-increase her dose because of a study like this, along with her less than desired hgb drop, then suffer an adverse advent.
jmho,
apache
From study posted above:
"no benefit was observed for pts who became anemic after treatment week 8."
"Anemia was defined as Hb 3 g/dL, 43.7% (984/2250); ≤3 g/dL, 29.9% (231/773) (P8 weeks).."
I don't understand that second line. What is the study's definition of anemia and what does "3 g/dL" mean in the language of my lab reports.
"no benefit was observed for pts who became anemic after treatment week 8."
"Anemia was defined as Hb 3 g/dL, 43.7% (984/2250); ≤3 g/dL, 29.9% (231/773) (P8 weeks).."
I don't understand that second line. What is the study's definition of anemia and what does "3 g/dL" mean in the language of my lab reports.
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