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Alessio Aghemo First Division of Gastroenterology

5 th Paris Hepatitis C Conference. Paris, 30 January 2012. Luncheon: How to optimize treatment of G2 and G3 patients. Alessio Aghemo First Division of Gastroenterology Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico Università degli Studi di Milano. S.G. 57 yr Housewife.

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Alessio Aghemo First Division of Gastroenterology

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  1. 5th Paris Hepatitis C Conference Paris, 30 January 2012 Luncheon: How to optimize treatment of G2 and G3 patients Alessio Aghemo First Division of Gastroenterology Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico Università degli Studi di Milano

  2. S.G. 57 yr Housewife HCV infection (genotype 2a/c) known since 1998 No risk factors for HCV ALT values 2 x ULN since 1998 Comorbidities: overweight (BMI 28) September 2008: Fibroscan 10.2 KPa, SR 96%, IQR 1.1 Enlarged liver at US, no splenomegaly Refuses PegIFN plus Rbv Continues Follow-up visits at our center

  3. Liver Function Tests Liver Function Sep 2008 Sep 2009 Sep 2010 112 5.62 1.0 3.9 1.11 196 9.8 78 3.62 1.0 4.0 1.16 184 11.4 • ALT IU/L 61 • HCV-RNA 105/IU/mL 2.68 • Total Bilirubin mg/dL 1.2 • Albumin g/dL 4.1 • Prothrombin ratio 1.12 • Platelets 103/mmc 195 • Fibroscan KPa 10.2 Liver biopsy: 24 mm specimen Chronic hepatitis with septae (Ishak G7, S4)

  4. Liver Function Tests During PegIFNalfa2a 180 mcg + Rbv 800 mg/day Liver Function Baseline Week 2 Week 4 33 <12 1.0 3.9 1.11 127 12.5 4130 1630 39 ND 0.9 3.9 1.16 118 11.8 3500 1450 • ALT IU/L 78 • HCV-RNA 105/IU/mL 3.68 • Total Bilirubin mg/dL 1.0 • Albumin g/dL 4.1 • Prothrombin ratio 1.12 • Platelets 103/mmc 195 • Hb 14 • WBC 5500 • Neutrophils 2900 What is the optimal treatment duration?

  5. HCV RNA Kinetics During PegIFN + Rbv to Predict Treatment Outcome and Individualize Treatment Duration PegIFNalfa + RBV 800/day PegIFNalfa + RBV 800 mg/day HCV-2/3 Patients Weeks 0 12-16 24

  6. SVR Rates Following Abbreviated Therapy in HCV-2 and HCV-3 HCV-2 only Abbreviated (12-16 weeks) Standard (24 weeks) RVR (+) RVR (+) RVR (-) 91% 87% 95% 93% - 89% 95% 97% 50% 67% - 75%

  7. The ACCELERATE Study: SVR Rates by Genotype 86% 76% 70% 70% 77% 66% 60% 60% SVR (%) P= <.0001 P= 0.1565 N=346 N=303 N=333 N=327 Standard population; VR = HCV RNA < 50 IU/mL White lines represent 95% confidence intervals Shiffman ML et al NEJM 2007 Jul 12;357(2):124-34.

  8. The ACCELERATE Study: sub-analysis of SVR in Patients with RVR 16 weeks Pegasys 180 ug + Copegus 800 mg 24 weeks Pegasys 180 ug + Copegus 800 mg N=243 81% p=0.0012 Genotype 2 92% N=212 N=215 84% p=0.1046 Genotype 3 N=193 90% 0% 20% 40% 60% 80% 100% SVR Shiffman ML et al NEJM 2007 Jul 12;357(2):124-34.

  9. Identifying HCV-2/3 Patients Who Can Receive a 16-wk Abbreviated Course of PegIFNalfa2a and Ribavirin Similar SVR rates 87% vs 88% in patients with at least 2 positive predictors LVL, <40 yrs, <65 Kg and absence of cirrhosis Diago M et al, Hepatology 2010 ; 51(6):1897-903

  10. Efficacy of PegIFNalfa2a plus Rbv in 818 HCV-2 & HCV-3 Patients with Advanced Fibrosis and Cirrhosis Without advanced fibrosis Cirrhosis Bridging fibrosis (no cirrhosis) 100 89 86 84 76 80 61 57 60 Response rates (%) 32 40 28 15 20 0 EOT SVR Rel Bruno S et al, Hepatology 2010, 51(2):388-97

  11. High Rates of Post-treatment Relapse in HCV-2 and 3 Patients with Advanced Fibrosis PegIFNalfa2a + Rbv 800 mg PegIFNalfa2b + Rbv 800-1200 mg Prati GM et al, J Hepatology 2012, 56:341-347

  12. High Rates of Post-treatment Relapse in HCV-2 and 3 Patients with Advanced Fibrosis Prati GM et al, J Hepatology 2012, 56:341-347

  13. Liver Function Tests During PegIFNalfa2a 180 mcg + Rbv 800 mg/day anf Follow-up Liver Function Week 4 Week 24 (EOT) Week 4 fup 55 ND 1.0 3.9 1.11 147 11.5 4130 1630 57 3.62 0.9 3.9 1.16 198 13.8 5500 2450 • ALT IU/L 39 • HCV-RNA 105/IU/mL ND • Total Bilirubin mg/dL 0.9 • Albumin g/dL 3.9 • Prothrombin ratio 1.16 • Platelets 103/mmc 118 • Hb 11.8 • WBC 3500 • Neutrophils 1450

  14. What Now??? • Retreat with PegIFN plus Rbv? • Retreat using high dose Rbv? (Off Label) • Retreat using Telaprevir? (Off Label) • Wait for new drugs? (2014-2015)

  15. Telaprevir Alone or in Combination With PegIFN/Rbv For HCV-2 Patients Phase II study on 23 HCV-2 and 26 HCV-3 patients Foster GR et al, Gastroenterology 2011, 141:881-889

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