HCV in 2020: Any cases left? Rafael Esteban Hospital General Universitario Valle Hebron Barcelona. Spain

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1 HCV in 2020: Any cases left? Rafael Esteban Hospital General Universitario Valle Hebron Barcelona. Spain

2 Yes, still too many

3 Measures to eradicate an Infectious Disease Prevention: Vaccination Screening Treatment: Diagnosis Treatment for all stages of the disease Access to treatment

4 Prevention No HCV Vaccine in 2012 Do we need a prophylactic vaccine to prevent HCV?

5 Natural History of HCV Incidence : 1-10 / / year Acute Infection > 80 % Asymptomatic Resolved < 10 % / > 50 % Size and source of infection Age / sex HLA Chronicity Clinical phenotype > 90 % / < 50 % Normal ALT Mild / Moderate CH Severe CH ~ 0 % ~ 0 % ~ 20 % 1-22 % 20-0 % % Compensated Cirrhosis 1-88 % / year HCC Decompensation Death

6 Large global burden of the infection Hepatitis C: A Worldwide Epidemic Estimated ~ 170 million (3.1%) globally (2003) The Americas 13.1 million (1.7%) 1, 2, 3 1 Europe 8.9 million (1.03%) 1 Africa 31.9 million (5.3%),5 3 Eastern Mediterranean 21.3 million (.6%) 3 Asia: 6 1,3 1, 3 Southeast Asia 32.3 million (2.15%) Western Pacific 62.2 million (3.9%) Common Genotype Worldwide: 6 World Health Organization. Hepatitis C: global prevalence: update Farci P, et al. Semin Liver Dis. 2000;20: Wasley A, et al. Semin Liver Dis. 2000;20:1-16.

7 Despite decline in the incidence HCV infection continues Cases per 100,000 Surrogate testing of blood donors 20 Anti-HCV test 18 (1st generation) 16 licensed 1 12 Anti-HCV test 10 (2nd generation) 8 licensed 6 Decline among Decline among transfusion recipients 2 injection drug users Year Centers for Disease Control and Prevention. Available at: Accessed April 10, 2007.

8 Reported HCV Cases in the United States by Risk Factor 100 Percentage of Cases Injection drug use 0 Sexual 20 Health-related work 0 Transfusion Year * based on non-a, non-b hepatitis. Centers for Disease Control and Prevention. Available at: Accessed April 10, 2007.

9 Burden of Hepatitis C Virus Infection Will Increase in The Near Future Anti-HCV Positive (%) *Associated with more sever liver damage, requiring more medical attention if untreated. Armstrong GL, et al. Hepatology. 2000;31: All patients Infection for > 20 years* Year

10 Prevention HCV Vaccine could be an option in 2020? Pros Pre-exposure protection Protect large populations with low but significant risk Integrated with other vaccines Limitations Challenges in vaccinated high risk populations Possibility of vaccine escape mutants Few promising candidates (only 1 in phase I/II)

11 Measures to eradicate an Infectious Disease Prevention: Vaccination Screening Treatment: Diagnosis Treatment for all stages of the disease Access to treatment

12 The Evolution of HCV Therapy Virologic Eradication is the Goal SVR (%) IFN 6m IFN 12m IFN/ RBV PEG-IFN RBV PEG-IFN /RBV/PI

13 Impact of SVR on Progression in Patients with Cirrhosis ***p<0.001 Bruno et al, Hepatology 2007; 5:

14

15 HCV treatment: future perspectives 201/2015? 2016/2017? PI: protease inhibitor; PR: peginterferon + ribavirin; DAA: direct-acting antiviral; DCV: daclatasvir

16 SOUND-C2 (BI /BI ): SVR according to HCV subtype GT1a GT1b Patients (%) * * BI dosing Duration (weeks) RBV +/ TID 16 + TID 28 + TID 0 + BID 28 + TID 28 TID 16 + TID 28 + TID 0 + BID 28 + TID 28 *Data for 0 week group are SVR rates SVR: HCV RNA undetectable at weeks (SVR) and 12 weeks (SVR12) after treatment completion Zeuzem S, et al. EASL 2012: Abstract 101

17 AI-00 (DCV + GS-7977): SVR GT1 GT2/3 Patients with HCV RNA <LOD (%) * ** N=1 5 N=1 N=1 5 *1 patient required addition of peg-ifn/rbv, 1 patient with relapse at Week **2 patients lost to follow-up (following Week 12 and 2 visits); LLOQ=lower limit of quantification N=1 6 N=1 = < LLOQ and detectable N=1 Zeuzem S, et al. J Hepatol 2012;56 (Suppl 2):S5

18 Sofosbuvir Phase 2 results Gt 1 Gt 2/ ATOMIC ELECTRON (Gt 1, naïve) (Gt 1,2,3; naïve, NR) Gt 1, naïve) EASL 2012 and Gilead Press releases; NEUTRINO: Single arm 7977/P/R x 12 weeks in genotype 1 in phase 3.

19 Gaps in the achievement of effectiveness of HCV treatment in national VA practice Kramer et al Journal of Hepatology 2012; 56: (DOI: /j.jhep )

20 Access to Hepatitis C treatment The Americas 13.1 million (1.7%) 1, 2, 3 1 Europe 8.9 million (1.03%) 1 Africa 31.9 million (5.3%),5 3 Eastern Mediterranean 21.3 million (.6%) 3 Asia: 6 1,3 1, 3 Southeast Asia 32.3 million (2.15%) Western Pacific 62.2 million (3.9%) Common Genotype Worldwide: 6 World Health Organization. Hepatitis C: global prevalence: update Farci P, et al. Semin Liver Dis. 2000;20: Wasley A, et al. Semin Liver Dis. 2000;20:1-16.

21 Access to Hepatitis C treatment The Americas 13.1 million (1.7%) 1, 2, 3 BAD Common Genotype GOOD Europe 8.9 million (1.03%) 1 Africa million LIMITED(5.3%) BAD,5 Worldwide: 6 LIMITED 3 Eastern Mediterranean 21.3 million (.6%) 3 Asia: 6 1,3 1, 3 Southeast Asia 32.3 million (2.15%) GOOD Western Pacific 62.2 million (3.9%) World Health Organization. Hepatitis C: global prevalence: update Farci P, et al. Semin Liver Dis. 2000;20: Wasley A, et al. Semin Liver Dis. 2000;20:1-16.

22 SUPPORTED BY AN EDUCATIONAL GRANT FROM GILEAD HEPATIC HEALTH

23 Accessibility to Peg-IFN antiviral therapy in different European countries HCV prevalence rate (%) HCV prevalence* Treatment levels Patients treated per 100 prevalent cases 0 Belgium France Germany Italy Spain UK 0 There are substantial differences between European countries in terms of HCV prevalence and access to antiviral therapy *Observed prevalence was obtained from national studies during a specific period. Deuffic-Burban S, et al. Gastroenterology 2012 [Epub ahead of print]

24 Results: reduction in cumulative incidence of genotype 1 HCV-related cirrhosis, Reduction in cumulative incidence (%) % % +% +3% Dual therapy PI-based triple therapy +3% +1% 0 Belgium France Germany Italy Spain UK Greater reduction in HCV-related cirrhosis with PI-based triple therapy than with dual therapy Deuffic-Burban S, et al. Gastroenterology 2012 [Epub ahead of print]

25 Reinforcing screening and treatment access: incidence of genotype 1 HCV-related cirrhosis, % Dual therapy PI-based triple therapy PI-based triple therapy with increased screening and treatment access* Reduction in cumulative incidence (%) % +6% +158% +17% +265% 0 Belgium France Germany Italy Spain UK Dramatic reduction in HCV-related cirrhosis with PIbased triple therapy + reinforced screening and treatment access *Assumes 75% of HCV-infected patients will be screened by 2015 and one G1-infected patient in two will be treated in 2015 with PI-based triple therapy Deuffic-Burban S, et al. Gastroenterology 2012 [Epub ahead of print]

26 Reduction in cumulative incidence of genotype 1 HCV-related deaths, Dual therapy % PI-based triple therapy Reduction in cumulative incidence (%) % +2% +27% +28% +37% 0 Belgium France Germany Italy Spain UK Greater reduction in HCV-related deaths with PI-based triple therapy than with dual therapy Deuffic-Burban S, et al. Gastroenterology 2012 [Epub ahead of print]

27 Reinforcing screening and treatment access: cumulative incidence of genotype 1 HCV-related deaths, % Dual therapy PI-based triple therapy PI-based triple therapy with increased screening and treatment access* Reduction in cumulative incidence (%) % +58% +150% +128% +26% 0 Belgium France Germany Italy Spain UK Dramatic reduction in HCV-related deaths with PI-based triple therapy + reinforced screening and treatment access *Assumes 75% of HCV-infected patients will be screened by 2015 and one G1-infected patient in two will be treated in 2015 with PI-based triple therapy Deuffic-Burban S, et al. Gastroenterology 2012 [Epub ahead of print]

28 In summary in 2020 Hepatitis C will be still a problem Advanced Liver Disease and HCC Oral free IFN regimen and Triple and Quad therapy would likely have a considerable impact on HCV-related cirrhosis and deaths Need for reinforcing HCV screening and access to therapy to amplify the control of the disease

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