Peg-IFN and ribavirin: what sustained virologic response can be achieved by using HCV genotyping and viral kinetics?

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1 Peg-IFN and ribavirin: what sustained virologic response can be achieved by using HCV genotyping and viral kinetics? Prof. I. Bakulin Gastroenterology Department

2 Key Questions

3 Background Worldwide prevalence Rising cirrhosis, HCC, OLT High costs of chronic hepatitis C $ Billion $100 $80 $60 $40 $20 Projected Costs of Hepatitis C (US) $ Pyenson B et al. Consequences of hepatitis C virus (HCV): costs of a baby boomer epidemic of liver disease. May 2009; Milliman, Inc.

4 Key Questions

5 HCV Clinical Practice Guidelines Panel What are the goals and endpoints of treatment? What are the results of current therapies and the predictors of response? How should patients be assessed before therapy? What are the contra-indications to therapy? Who should be treated? What first-line treatment should be prescribed? How should treatment be managed? How should treatment be tailored to the virological response? How can success rates of SoC be improved? EASL Clinical Practice Guidelines: Management of hepatitis C virus infection, 2011

6 EASL Clinical Practice Guidelines: Management of hepatitis C virus infection (1) The goal of therapy is to eradicate HCV infection (A1). (2) The endpoint of therapy is sustained virological response (A1). Once obtained, SVR usually equates to cure of infection in more than 99% of patients (A1).

7 EASL Clinical Practice Guidelines: Management of hepatitis C virus infection (1) All treatment-naïve patients with compensated disease due to HCV should be considered for therapy (A2). (2) Treatment should be initiated promptly in patients with advanced fibrosis (METAVIR score F3 F4), and strongly considered in patients with moderate fibrosis (METAVIR score F2) (B2). (3) In patients with less severe disease, indication for therapy is individual (C2).

8 Diagnostic algorithm for patients with HCV Hematology; Clinical Chemistry (ALT, AST, insulin + glucose, Fe + ferritin); Immunology (HBsAg, anti-hcv, anti-hiv, ANA, ASMA, anti- LKM1, AMA, ceruloplasmin, a1-antitrypsin); Virology (HCV RNA titer, HCV genotype ); TSH; Abdominal Ultrasound; Fibrosis and histological activity (liver biopsy; non-invasive methods serum markers, elastography). Determination of IL28B polymorphisms (CC, CT, TT).

9 Higher SVR rates are achieved in patients without cirrhosis Patients without bridging fibrosis/cirrhosis Patients with bridging fibrosis/cirrhosis p=0.011 p= p= SVR (%) n= Genotype 1/4 48 weeks Genotype 2/3 24 weeks Genotype 2/3 16 weeks Bruno S, et al. 43rd EASL 2008; Abstract 774

10 Younger age and low viral load are predictive of achieving an SVR in patients with cirrhosis Genotype 1/4 patients with bridging fibrosis/cirrhosis treated with Peg-IFN 2a SVR (%) g/wk plus ribavirin 1000/1200 mg/day for 48 weeks n= 59 Age <40yrs Age 40yrs Viral load < IU/mL 40 Viral load IU/mL Bruno S, et al. 43rd EASL 2008; Abstract 774

11 Key Questions of

12 What are the choices when treating CHC today? The approved Standard-ofcare (SoC) for CHC Peg-INFα + Ribavirin

13 IDEAL (n=3070): efficacy of combination therapy (PegIFNа2а / PegIFNа2b + Ribavirin) Р=0,57 % patients

14 Key Questions of

15 HOW LONG TO TREAT CHRONIC HEPATITIS C? Genotype 1 Treatment duration 48 weeks Genotype 2/3 Treatment duration 24 weeks

16 Genotypes 1, 2, 3: SVR in 5 largest trials (PegIFNа2b + Ribavirin) SVR, % Genotype 1 (n=4792) 42% 44% 40% 39% 39% SVR, % Genotype 2/3 (n=1659) 82% 81% 76% 72% 67% Manns 2001 WitthoeftMcHutchison Cooper 2009 Jacobson 2007 Manns 2001 Zeuzem 2004 MangiaJacobson Manns Manns MP et al. Lancet. 2001;358: Witthoeft T et al. J Viral Hepat. 2010;17: McHutchison JG et al. N Engl J Med. 2009;361: Cooper C et al. Poster presented at: 60th Annual AASLD; October 30-November 3, 2009; Boston, MA. No Jacobson IM et al. Hepatology. 2007;46: ; 6. Zeuzem S et al. J Hepatol. 2004;40: Mangia A et al. N Engl J Med. 2005;352: Data on File, MSD

17 EASL Clinical Practice Guidelines: Management of hepatitis C virus infection (1) Treatment duration should be tailored to the on-treatment virological response at weeks 4 and 12, and eventually week 24. The likelihood of SVR is directly proportional to the time of HCV RNA disappearance (B1).

18 Virologic responses HCV treatment HCV RNA (log 10 IU/mL) RVR ~ 90% SVR EVR DVR ~? SVR SVR Weeks

19 SVR in Patients Who Achieved an RVR SVR (%) 100 RVR: HCV RNA negative (< 50 IU/mL) at Wk n= n= n= n= 257 GT 1 GT 2 GT 3 GT 4 Patients With an RVR Fried MW, et al. EASL Abstract 7.

20

21 Response-guided therapy (RGT) - Genotype 2/3 Week 4 RVR Low viral level, mild fibrosis High viral level weeks 24 weeks

22 Response-guided therapy(rgt) - Genotype 2/3 Week 4 Week 12 RVR Low viral level, mild fibrosis High viral level EVR or HCV RNA > 2log 10 decline DVR HCV RNA < 2log 10 decline weeks weeks 24 weeks 48 weeks Discontinuation

23

24 Response-guided therapy(rgt) - Genotype 1 Week 4 RVR Low viral level, mild fibrosis High viral level 24 weeks 48 weeks

25 Response-guided therapy(rgt) - Genotype 1 Week 4 Week 12 Low viral level, mild fibrosis RVR EVR = HCV RNA (-) High viral level 24 weeks 48 weeks 48 weeks

26 Response-guided therapy(rgt) - Genotype 1 Week 4 Week 12 Low viral level, mild fibrosis RVR High viral level EVR = HCV RNA (-) HCV RNA < 2log 10 decline or >30.000UI/ml Discontinuation 24 weeks 48 weeks 48 weeks

27 Response-guided therapy(rgt) - Genotype 1 Week 4 Week 12 RVR Low viral level, mild fibrosis High viral level 24 weeks 48 weeks HCV RNA(-) 48 weeks HCV RNA < 2log 10 or >30.000UI/ml 72 weeks DVR = HCV RNA(-) Discontinuation Discontinuation Week 24 HCV RNA (+)

28 Slow-to-Respond Patients: Extending Therapy weeks 72 weeks SVR (%) RBV dose (mg/day) = 0 Berg 800 Sanchez-Tapias 800 Ferenci Berg T, et al. Gastroenterology. 2006;130: Sanchez-Tapias JM, et al. Gastroenterology. 2006;131: Ferenci P, et al. AASLD Abstract 390.

29 Summary The likelihood of SVR is directly proportional to the time of HCV RNA disappearance; In patients with RVR and low viral load (<400, ,000 IU/ml) treatment duration for genotype 1 and genotypes 2/3 can be considered 24 and weeks respectively;

30 Summary Patients who have EVR should be treated for 48 weeks regardless of the HCV genotype and baseline viral load; Patients with DVR can be treated for 72 weeks regardless of the HCV genotype. Endpoints W12 and W24 should be considered for treatment discontinuation because of non-respond for all HCV genotypes.

31 Thank you for your attention!

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