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Edited by Morris Sherman MD BCh PhD FRCP(C) Associate Professor of Medicine

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

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Edited by Morris Sherman MD BCh PhD FRCP(C) Associate Professor of Medicine

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  1. 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

  2. Case Study:Treatment Naive Edward Tam MD FRCPC Medical Director LAIR Centre

  3. 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

  4. 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?

  5. FibroScan versus Liver Biopsy 1.00 0.75 0.50 Sensitivity AUROC (95% CI) ≥ F2: 0.74 (0.68-0.80) ≥ F3: 0.89 (0.84-0.94) F4: 0.94 (0.90-0.97) 0.25 0.00 0.00 0.25 0.50 0.75 1.00 1-Specificity Myers RP et al. Can J Gastroenterol. 2010 Nov;24(11):661-70

  6. 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

  7. 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.

  8. Ms. MH: Week 4 Results Given the undetectable HCV RNA at the end of WK4 lead-in (dual therapy), is adding Boceprevir necessary?

  9. Significance of Lead-in Response 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) PR48 BOC RGT BOC/PR48 100 90 90 89 89 89 89 97 80 79 80 74 72 70 65 60 58 60 45 % of patients with SVR 43 40 33 30 28 28 21 20 5 0 0 <0.5 <0.5 <0.5 ≥4.0 ≥4.0 ≥4.0 1.0-<1.5 1.5-<2.0 0.5-<1.0 2.0-<3.0 3.0-<4.0 3.0-<4.0 0.5-<1.0 1.0-<1.5 1.5-<2.0 2.0-<3.0 3.0-<4.0 1.0-<1.5 1.5-<2.0 0.5-<1.0 2.0-<3.0 Undetectable Undetectable Undetectable Log10 viral load decrease after weeks of P/R lead-in Vierling et al. EASL 2011.

  10. Results Through Week 12 • 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

  11. Results Through Week 24 • HCV RNA remained undetectable through week 24, and patient qualifies for shortened duration therapy (to D/C at week 28)

  12. 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.

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