High Hemoglobin on Treatment isn't Good

[jmjm530]

At least at first glance, according to this study from AASLD 2008. Haven't digested it fully, but it appears to be yet another study suggesting that while dosing ribavirin by weight (weight based) is better than a flat dose -- weight based dosing is still crude compared to what the author's speculate might be finer tuned dosing such as serum riba levels which appear to relate to the degree of anemia. So...if your hemoglobin is dropping early-on in treatment -- maybe time to print out this study, order the full-abstract, and bring it to the attention of your medical team.
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AASLD 2008 Annual Meeting


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ID#


1851

Location:


West Hall (Moscone West Convention Center)

Time of Presentation:


Nov 04 8:00 AM - 12:30 PM

Category:


Q05. HCV: Clinical Trials and Therapeutic Developments


Treatment-related anemia but not epoetin use (EPO) is associated with higher SVR rates among persons treated with peginterferon (PEG)/ribavirin (RBV): Results from the IDEAL Study
M. Sulkowski1; M. L. Shiffman2; N. H. Afdhal3; K. Reddy4; W. Deng5; S. Noviello5; J. K. Albrecht5; J. G. McHutchison6
1. Johns Hopkins University School of Medicine, Baltimore, MD, USA.
2. Virginia Commonwealth University Medical Center, Richmond, VA, USA.
3. Beth Israel Liver Center, Boston, MA, USA.
4. University of Pennsylvania Health System, Philadelphia, PA, USA.
5. Schering-Plough Research Institute, Kenilworth, NJ, USA.
6. Duke Clinical Research Institute, Durham, NC, USA.


Background: Anemia due to PEG/RBV affects ~30% of persons treated. Epoetin alfa has been used to increase hemoglobin (Hb) levels to improve quality of life and RBV dose. The relationship of anemia, EPO use and sustained viral response (SVR) is unknown.
Methods: 3070 HCV genotype 1 infected patients (pts) were randomized (1:1:1) and treated for 48 weeks with PEG2b 1.5µg/kg/week or PEG2b 1.0µg/kg/wk + RBV 800-1400mg/day, or PEG2a 180µg/wk + RBV 1000-1200mg/day. Patients with virologic failure at treatment weeks 12 or 24 stopped therapy. Anemia was defined as Hb <10 g/dL. Anemic patients underwent protocol-defined RBV dose reduction after which EPO was permitted at investigator discretion. Viral response rates (ITT) were assessed in 3 groups: 1) No anemia; 2) Anemia/No EPO; 3)Anemia/EPO.
Results: No anemia was observed in 2158 pts (70%); of whom, 67% were male; 83% were older than 40 years; median Hb maximum decline was -3.60 g/dL. Anemia was observed in 865 pts (28%); of whom, 41% were male; 90% were older than 40 years; median Hb maximum decline was -4.65 to -5.20 g/dL. EPO was used in 449 (52%) anemic pts. Median nadir Hb level and median Hb maximum decline were similar in anemic pts with and without EPO use. Median RBV exposure (mg/kg/day) during treatment: (PEG2b1.5/PEG2b1.0/PEG2a, respectively) – No anemia, 12.6/12.6/13.5, Anemia/No EPO, 11.7/12.0/12.6 Anemia/EPO, 11.9/11.9/12.5. The proportion of pts completing ≥ 12 weeks of therapy: No anemia, 94%; Anemia/No EPO, 92%; Anemia/EPO, 99%. Discontinuation due to adverse events (AEs)/virologic non-response: No anemia, 10%/31%; Anemia/No EPO, 18%/20%; Anemia/EPO, 12%/19%. End-of-treatment, relapse, and SVR rates are shown in the Table. P-value <0.0001 using Mantel-Haenszel test for the association of Anemia with SVR adjusting for treatment.
Conclusions: Compared to those with no anemia, anemic pts were less likely to have virologic nonresponse and significantly more likely to achieve SVR despite receiving less RBV (mg/kg/day) during treatment. Although potential selection bias for comparing the groups may exist, this suggests that other host and treatment factors (e.g., plasma RBV concentration) contribute to viral response in this group. Among anemic pts, EPO use was associated with lower AE-related discontinuation and higher on-treatment viral response but not higher SVR rate.

No Anemia, % (n/n) Anemia/No EPO, % (n/n) Anemia/EPO, % (n/n)
PEG2b1.5/R PEG2b1.0/R PEG2a/R PEG2b1.5/R PEG2b1.0/R PEG2a/R PEG2b1.5/R PEG2b1.0/R PEG2a/R
EOT

Relapse

SVR 50
(342/684)
26
(86/331)
36
(249/684) 48
(355/747)
23
(76/337)
35
(265/747) 61
(445/727)
32
(130/408)
38
(279/727) 61
(90/147)
13
(11/84)
50
(74/147) 53
(64/121)
13
(8/60)
45
(54/121) 67
(99/148)
23
(21/91)
48
(71/148) 70
(110/158)
24
(26/108)
53
(83/158) 61
(81/133)
14
(11/78)
50
(67/133) 78
(123/158)
37
(42/113)
46
(73/158)



Abstract Central® (patent pending). © ScholarOne, Inc., 2008. All Rights Reserved.

[jmjm530]

I don't think that's what's stated but honestly haven't studied it carefully and don't have access to the full-text.

My guess is that it's better to treat the anemia with helper drugs because it allows for potentially higher serum riba levels while making it easier to stay on treatment. But if it were me, I'[d def try and get hold of the full-text report before coming to any definitive conclusions and discussing with my medical team.

-- Jim

[kittyface]

Does this mean that it's better in terms of SVR to experience some anemia with reduced riba dose than to treat the anemia and return to full riba dose?

Kittyface

[orleans]

Don't know what this means but my baseline HGB was 16.1, I was UND at 2 weeks, HBG 15.9. My HGB has trended downward to stand at 11.9 @12weeks. Just wondering if they found a conection between RVR and anemia?

[Deb_c430]

what is the HGB based on? What is the ratio? Range is 11.5-15.00

Sorry some one explain it to me simply please head is spinning today

[portann]

Is that the same study that put me into a tailspin?  I've been yapping away since yesterday that I failed tx because my hemoglobin never dropped below 10!  Help. I thought hovering just above death was enough but apparently it wasn't.

xxoo

[jmjm530]

I don't think that would affect the conclusions, but it is curious.

Perhaps the Scheing trials used to draw data from used a different dose scheme (1.5 mg/kg) as opposed to a more tiered scheme (800, 1000, 1200) with Roche?

[FlGuy]

I'd have to study the results a little closer, but it's interesting to see that those who used PegIntron had a riba max dose of 1400 and those using Pegasys had a max riba dose of 1200. And, it was sponsored by Schering (PegIntron),  Hmmmm

[jmjm530]

The table didn't copy and paste correctly. Unless someone wants to straigten it out, you can just go to the AASLD web and plug the ID number (1851) into the search screen per instructions in first post of this thread:

http://www.medhelp.org/posts/show/673797