B (HBV-LC) C (HCV-LC)

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1 B (HBV-LC) C (HCV-LC)

2 Histologic Scoring Systems for Fibrosis Fibrosis METAVIR Ishak None 0 0 Portal fibrosis (some) 1 1 Portal fibrosis (most) 1 2 Bridging fibrosis (occasional) 2 3 Bridging fibrosis (marked) 3 4 Incomplete cirrhosis 4 5 Cirrhosis 4 6 B (HBV-LC)

3 Goals of chronic hepatitis B therapy Su TH & Kao JH. Expert Rev Gastroenterol Hepatol 2015;9: B (lamivudine, Zeffix) (adefovir, Hepsera) (entecavir, Baraclude) (telbivudine, Sebivo) (tenofovir, Viread)

4 B B C HBsAg(+) (1) HBsAg (+) HBV DNA 2,000IU/mL + (2) Metavir F4 Ishak F5 ) or or Zeffix(100mg) / Sebivo(600mg) Baraclude(0.5mg) / Viread (300mg)

5 B? B Child-Pugh scores in HBV-LC

ETV-048: Improvement in MELD/CTP Scores Parameter Mean MELD score change from BL (SE) CTP score improvement or no worsening,* n/n (%) CTP score 2 point reduction,* n/n (%) CTP class improvement, n/n

6 ETV-048: Improvement in MELD/CTP Scores Parameter Mean MELD score change from BL (SE) CTP score improvement or no worsening,* n/n (%) CTP score 2 point reduction,* n/n (%) CTP class improvement, n/n (%) *Noncompleter = failure. CTP class C/B to A only. Wk 24 Wk 48 ETV ADV ETV ADV -2.0 (0.45) -0.9 (0.46) -2.6 (0.62) -1.7 (0.50) 66/100 (66) 32/100 (32) 25/93 (27) 65/91 (71) 22/91 (24) 22/81 (27) 61/100 (61) 35/100 (35) 35/93 (38) 61/91 (67) 25/91 (27) 29/81 (36) Liaw YF, et al. Hepatology. 2011;54: retrospective study from 2005 HBV-associated cirrhosis 18 centers in Turkey 227 patients

7 Changes in CTP scores KÖKLÜ S et al., CGH 2013;11:88 94 B

ETV Long term treatment Distribution of Ishak fibrosis scores at baseline, Year 1 and Years 3 7 60

Long-term* n=57 * Median time of long-term biopsy: 280 weeks (range: 144 316 weeks). Chang TT et al.

8 ETV Long term treatment Distribution of Ishak fibrosis scores at baseline, Year 1 and Years Patients (n) Ishak fibrosis score Missing 0 Baseline Week 48 Long-term* n=57 * Median time of long-term biopsy: 280 weeks (range: weeks). Chang TT et al., HEPATOLOGY 2010;52: Improvement of hepatic fibrosis after 5-year TDF Baseline cirrhosis: N=96 N=384

9 Tenofovir for Chronic Hepatitis B Tsai NC et al., Dig Dis Sci 2015;60:260-8 Yun-Fan Liaw. Clin Liver Dis 2013;17:413-23

10 B NA increases survival rate in HBV-LC NA Historical control Kim et al. JGH 2012;27:

11 NA increases survival rate in HBV-LC Kim et al. JGH 2012;27: Cumulative probability of liver-related mortality in cirrhotic patients Liver-related mortality: death related to cirrhosis complications and/or HCC Wong GL et al. HEPATOLOGY 2013;58:

12 B 50 ETV reduced HCC incidence compared with control Cumulative HCC rate (%) Log-rank test: P < % 13.7% Control ETV therapy reduced the 5-year HCC risk by > 60% compared with control group Multivariate Cox regression analysis:* HR 0.37 (95% CI ) P = % 3.7% ETV Treatment duration (years) No. at risk ETV Control * Adjusted for age, sex, alcohol, smoking, cirrhosis, HBV genotype, HBeAg status, HBV DNA, ALT, albumin, γgtp, total bilirubin and platelet count. CI, confidence interval; HR, hazard ratio. Hosaka T et al. Hepatology 2013;58:98-107

13 Reduction in HCC incidence with ETV greater among cirrhotic patients Cirrhosis No Cirrhosis Cumulative HCC rate (%) Log-rank test: P < % 4.3% 38.9% 7.0% Control ETV Cumulative HCC rate (%) Log-rank test: P = % 3.6% Control 0 0 0% 2.5% ETV Treatment duration (years) Treatment duration (years) No. at risk ETV Control No. at risk ETV Control Hosaka T et al. Hepatology 2013;58: Cumulative probability of HCC in cirrhotic patients Wong GL et al. HEPATOLOGY 2013;58:

14 Cumulative incidences of HCC 22.7% 7.32% Chun-Ying Wu et al. Gastroenterology 2014;147: B

15 Wu CY et al. JAMA 2012;308(18):

16 C (HCV-LC) C + ribavirin

17 Peg-Intron Pegasys Rebetol Robetrol C

18 B C ALT Anti-HCV HCV RNA C?

19 IFN treatment regress HCV-related fibrosis Comparison of Liver Fibrosis Stage in patients of CHC reaching SVR Fibrosis improved in 56%, stable in 32%, Deteriorated in 12% Regression of cirrhosis in 9/14 patients Maylin S. et al., GASTROENTEROLOGY 2008;135:

20 Post-SVR Cirrhosis Regression Rates According to the METAVIR Score D Ambrosio & Aghemo. Hepat Mon 2012;12: IFN treatment decreases mortality in patients with CHC

Design, Setting, and Patients An international, multicenter, long-term follow-up study from 5 large

an interferon-based treatment regimen between 1990 and 2003, following histological proof of

Complete followup ranged between January 2010 and October 2011.

21 Design, Setting, and Patients An international, multicenter, long-term follow-up study from 5 large tertiary care hospitals in Europe and Canada of 530 patients with chronic HCV infection who started an interferon-based treatment regimen between 1990 and 2003, following histological proof of advanced hepatic fibrosis or cirrhosis (Ishak score 4-6). Complete followup ranged between January 2010 and October (The Ishak fibrosis score was 4 in 143 patients (27%), 5 in 101 patients (19%), and 6 in 286 patients (54%).) SVR and Liver-related mortality Van der Meer AJ et al., JAMA 2012-;308:

22 SVR and Liver failure Van der Meer AJ et al., JAMA 2012-;308: C

23 HCC in HCV-related liver cirrhosis (SVR vs no SVR) Singal et al. CGH 2010;8:

24 HCC in HCV-related liver cirrhosis (treated vs untreated) Singal et al. CGH 2010;8: Cumulative incidence of HCC in HALT-C Trial Lok AS et al., GASTROENTEROLOGY 2011;140:

25 SVR and HCC Van der Meer AJ et al., JAMA 2012;308: Japanese Chronic hepatitis C (non-cirrhosis, n = 863, cirrhosis, n = 150) SVR (sustained virological response) TVR (transient virological response): ETVR+, no SVR NVR (non-virological response): decrease in the HCV RNA < 2 log10 IU/ml at week 12 Ogawa E et al., JH 2013;58:

26 Cumulative incidence of HCC after PegIFNa2b and RBV treatment Ogawa E et al., JH 2013;58: Free from HCC and any liver-related complication 351 patients with HCV-related cirrhosis Soo Aleman et al. Clinical Infectious Diseases 2013;57(2):230 6

27 Eradication of HCV Infection and the Development of HCC Rebecca L. Morgan et al. Ann Intern Med 2013;158: C

28 Recurrence of resected HCC in chronic hepatitis C Yao-Chun Hsu et al. HEPATOLOGY 2013;58: Postoperative Peg-Interferon Plus Ribavirin Is Associated With Reduced Recurrence of HCV-Related HCC? Yao-Chun Hsu et al. HEPATOLOGY 2013;58:

29 Direct antiviral agent for HCV-related liver cirrhosis Long-term? Mission impossible? Tom Cruise Mission possible

30 Thanks

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