edited by morris sherman md bch phd frcp(c) associate professor of medicine
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Edited by Morris Sherman MD BCh PhD FRCP(C) Associate Professor of Medicine University of Toronto. Protease Inhibitors in Chronic Hepatitis C: An Update Chapter 4 – Case Study: Treatment Naive. November 2012. Case Study: Treatment Naive. Edward Tam MD FRCPC Medical Director - PowerPoint PPT PresentationTRANSCRIPT
Edited byMorris Sherman MD BCh PhD FRCP(C)
Associate Professor of MedicineUniversity of Toronto
Protease Inhibitors in Chronic Hepatitis C:An Update
Chapter 4 – Case Study: Treatment Naive
November 2012
Case Study:
Treatment Naive
Edward Tam MD FRCPCMedical Director
LAIR Centre
Ms. MH
31 year old female
Diagnosed in 2004 with genotype 1a HCV
Previous IVDU
Otherwise healthy
Meds: Milk thistle
No Biopsy
ALT 1-2 x ULN on serial monitoring
Ms. MH
Followed periodically with monitoring of liver biochemistry
FibroScan December 9, 2010: 4.9 kPa What evidence supports the use of Milk Thistle? Is FibroScan a reliable and accurate tool for fibrosis
assessment? Does it represent a viable alternative to liver biopsy?
FibroScan versus Liver Biopsy
Myers RP et al. Can J Gastroenterol. 2010 Nov;24(11):661-70
1.00
0.75
0.50
0.25
0.000.250.00 0.50 0.75 1.00
Sen
sitiv
ity
1-Specificity
AUROC (95% CI)≥ F2: 0.74 (0.68-0.80)≥ F3: 0.89 (0.84-0.94) F4: 0.94 (0.90-0.97)
Ms. MH
FibroScan December 9, 2010: 4.9 kPa (consistent with stage 0 – 1 fibrosis)
Discussions with patient throughout 2011 regarding therapy
Although no medical urgency, very keen to pursue therapy for personal reasons
Ms. MH
January 6, 2012, treatment initiated with pegylated interferon alpha-2b (120mcg) plus ribavirin (500mg BID), as planned lead-in to boceprevir-based treatment.
Week 0
HCV RNA 5.29 logs
ALT 106
Hb 144
Plts 295
Neutrophils 6.0
Ms. MH: Week 4 Results
Week 0 Wk 2 Wk 4
HCV RNA 5.29 logs -- Undetectable
ALT 106 53 33
Hb 144 120 108
Plts 295 236 214
Neutrophils 6.0 2.0 2.0
Given the undetectable HCV RNA at the end of WK4 lead-in (dual therapy), is adding Boceprevir necessary?
Significance of Lead-in Response
Vierling et al. EASL 2011.
SPRINT-2: SVR based on degree of early interferon response(log decline in HCV RNA at week 4 of P/R in all patients (cohort 1 + cohort 2)
30
43
60
72 74
89 90 90
<0.5
0.5-
<1.0
1.0-
<1.5
1.5-
<2.0
2.0-
<3.0
3.0-
<4.0
≥4.0
Unde
tect
able
28 28
7065
8089 89 89
<0.5
0.5-
<1.0
1.0-
<1.5
1.5-
<2.0
2.0-
<3.0
3.0-
<4.0
≥4.0
Unde
tect
able
05
21
33
45
58
7997
0
20
40
60
80
100
<0.5
0.5-
<1.0
1.0-
<1.5
1.5-
<2.0
2.0-
<3.0
3.0-
<4.0
≥4.0
Unde
tect
able
PR48 BOC RGT BOC/PR48
Log10 viral load decrease after weeks of P/R lead-in
% o
f pat
ient
s w
ith S
VR
Results Through Week 12
Wk 4 Wk 6 Wk 8 Wk 10 Wk 12HCV RNA Undetectable -- Undetectable -- Undetectable
ALT 33 27 26 22 28
Hb 108 107 101 91 94
Plts 214 179 177 175 174
Neutrophils 2.0 1.3 1.6 1.2 1.2
Boceprevir added with 5th interferon injection HCV RNA remains undetectable Due to worsening anemia and fatigue, RBV dose
reduced to 600mg total daily dose after wk 10 results
Results Through Week 24
Wk 12 Wk 16 Wk 20 Wk 24HCV RNA Undetectable -- -- Undetectable
ALT 28 32 25 24
Hb 94 105 101 103
Plts 174 171 164 169
Neutrophils 1.2 1.4 1.0 1.0
HCV RNA remained undetectable through week 24, and patient qualifies for shortened duration therapy (to D/C at week 28)
The Canadian Liver Foundation (CLF) was the first organization in the world devoted to providing support for research and education into the causes, diagnoses, prevention and treatment of all liver disease. Through its chapters across the country, the CLF strives to promote liver health, improve public awareness and understanding of liver disease,
raise funds for research and provide support to individuals affected by liver disease.
For more information visit www.liver.ca or call 1-800-563-5483.
This project made possible through the financial support of Merck Canada Inc. The views, information and opinions contained herein are those of the authors and do not necessarily reflect the views and opinions of Merck Canada Inc.
The Canadian Liver Foundation gratefully acknowledges the participating health care professionals for their contributions to this project and for their commitment to the liver health of Canadians.