a case study: hepatitis c treatment and severe anemia
DESCRIPTION
A case study: Hepatitis C treatment and severe anemia. Colina Yim RN(EC), MN Nurse Practitioner CAHN 2013. Objective. To illustrate the change of best practices in managing hepatitis C treatment related anemia. Mr. Number 1. 55 year old man first seen 2009 HCV G1, VL 1.30 x10E6 IU/ mL - PowerPoint PPT PresentationTRANSCRIPT
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UHN centre of excellence
A case study: Hepatitis C treatment
and severe anemia
Colina Yim RN(EC), MNNurse Practitioner
CAHN 2013
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Objective
To illustrate the change of best practices in managing hepatitis C treatment related anemia
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Mr. Number 1 55 year old man first seen 2009
HCV G1, VL 1.30 x10E6 IU/mL Cryoglobulins 2%: leg numbness, leg rashStopped alcohol age 53No co-morbidities Liver biopsy: A3 F3-4 Treated 2008
PegIFNα2a 180mcg/ RBV 1200 mg/day HCVRNA negative at wk 12 Stopped after 29 wks: anemia, neutropenia Relapsed !
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Mr. Number 1
2009 Treatment # 2 PegIFNα2a 180mcg/wk + RBV 1200 mg/day
What to do ? Treat again ?
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Treatment # 2Week HCV RNA ALT AST Hgb Lkc ANC Plts
0 1.04 E5 188 212 136 4.6 3.1 288
2 1.20 E5 78 109 111 2.2 1.4 176
4 4.52 E4 46 72 102 1.4 0.8 77
8 8.51 E2 28 55 93 1.7 0.9 221
12 4.52 E1 23 52 87 1.6 1.1 96
16 < 15 28 59 90 1.3 0.7 57
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Treatment # 2Week HCV RNA ALT AST Hgb Lkc ANC Plts
0 1.04 E5 188 212 136 4.6 3.1 288
2 1.20 E5 78 109 111 2.2 1.4 176
4 4.52 E4 46 72 102 1.4 0.8 77
8 8.51 E2 28 55 93 1.7 0.9 221
12 4.52 E1 23 52 87 1.6 1.1 96
16 < 15 28 59 90 1.3 0.7 57
24 23 43 83 1.2 0.6 83
48 28 51 89 1.0 0.6 55
72 < 15 24 52 78 1.4 0.9 56
Unfortunately Relapsed post treatment
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Mr. Number 1
Now May 2011 Cryos rebound from negative on treatment to 7% Skin lesions return Urinalysis now +ve for protein and blood Develops small ascites No varices
What to do now ?
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Mr. Number 1
May 2011 Treatment # 3 – SAP Boceprevir
PegIFNα2b 150mcg/wk + RBV 1200mg/day Plan to add Boceprevir after 4 wks lead-in
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Treatment # 3Wk HCV RNA ALT AST Hgb Retic Lkc ANC Plts
0 7.01 E4 90 118 132 6.0 4.5 372
2 36 74 110 163 3.3 2.3 456
4 Detected, < 15 23 56 92 181 2.0 1.2 228
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Treatment # 3Wk HCV RNA ALT AST Hgb Retic Lkc ANC Plts
0 7.01 E4 90 118 132 6.0 4.5 372
2 36 74 110 163 3.3 2.3 456
4 Detected, < 15 23 56 92 181 2.0 1.2 228
8 Not detected 23 45 64 111 2.5 1.7 105
10 52 1.5 0.8 105
Erythropoietin 40,000 IU/wk Blood transfusion q4w No RBV dose reduction
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Treatment # 3Wk HCV RNA ALT AST Hgb Retic Lkc ANC Plts
0 7.01 E4 90 118 132 6.0 4.5 372
2 36 74 110 163 3.3 2.3 456
4 Detected, < 15 23 56 92 181 2.0 1.2 228
8 Not detected 23 45 64 111 2.5 1.7 105
10 52 1.5 0.8 105
14 33 51 81 16 1.3 0.9 70
24 Not detected 29 41 74 1.1 0.8 17
Erythropoietin 40,000 IU/wk Blood transfusion q week Platelets transfusion Treatment stopped at 24 wks
SVR
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How should his anemia be best managed now ?
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Anemia Study: EPO vs Ribavirin Dose-Reduction
687 pts received boceprevir/ pegIFN/RBV 500 randomized at time of onset of anemia (Hgb < 10
g/dL) to RBV dose reduction (200-400mg) or Erythropoietin (40,000 IU/wk)
Response, % RBV Dose Reduction (n = 249)
Erythropoietin (n = 251)
End of treatment 82 82
SVR 71 71
Relapse 10 10
Poordad et al. EASL 2012 Abstract 1419.
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Timing of RBV Dose Reduction Does Not Impact SVR
< 4 wks > 4- 8 wks > 8-12 wks > 12-16 wks > 16 wks0
102030405060708090
100
7064
79 82
7171 68 70
88
71
RBV dose reduction Erythropoietin
SVR %
Poordad F, et al. AASLD 2012. Abstract 154.
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Degree of RBV Dose Reduction Does Not Impact SVR
67
7680
64
7769
83
0
10
20
30
40
50
60
70
80
90
1 2 3 4 5 6 7
SVR %
Poordad F, et al. AASLD 2012. Abstract 154.
Number of RBV dose reduction steps*
* step= 200 mg RBV/day decrease for > 3 days
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Lower SVR Rate if < 50% RBV Received
< 50 50 to <60 60 to < 70 70 to < 80 > 800
10
20
30
40
50
60
70
80
90
100
18
74 77
89 92
SVR %
Poordad F, et al. AASLD 2012. Abstract 154.
% of total RBV dose received
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SVR Rates with RBV Dose Reduction or Erythropoietin in Cirrhotics
Non cirrhotic Cirrhotic0
10
20
30
40
50
60
70
80 73
57
7264
RBV dose reduction Erythropoietin
SVR %
Lawitz E et al. AASLD 2012. Abstract 50.
n = 438 n = 48
** Cirrhotics more likely to receive secondary intervention than non cirrhotics
P=0.59
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Telaprevir Clinical Trials Pooled Data: RBV Dose Reduction Does Not Impact SVR
RBV dose reduction No RBV dose reduction0
10
20
30
40
50
60
70
80 7672
54
41
T/P/R P/R
SVR %
Sulkowski et al. EASL 2011. Abstract .
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Take Home Messages
Close monitoring for anemia
RBV dose reduction is the first strategy for managing anemia Can reduce dose aggressively i.e. to 600 mg Maintain > 50 % of total RBV dose Can dose reduce cirrhotics Cirrhotics may need secondary intervention
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Higher SVR Rates if RBV Dose Reduced when HCV RNA was
Undetectable
Undetectable Detectable 0
102030405060708090
10086
56
86
56
RBV dose reduction Erythropoietin
SVR %
Poordad F, et al. AASLD 2012. Abstract 154.
HCV RNA