1. Washington D.C., USA, 22-27 July 2012www.aids2012.org Access to HCV treatment for people with HIV/HCV Professor Gregory Dore Viral Hepatitis Clinical Research Program, Kirby Institute, The University of New South Wales & St Vincent’s Hospital, Sydney

2. Washington D.C., USA, 22-27 July 2012www.aids2012.org Disclosures RocheMSDJanssenBMSGilead Research GrantsYes Advisory BoardYes Travel SponsorshipYes NoYes StocksNo ConsultancyNoYes NoYes

3. Washington D.C., USA, 22-27 July 2012www.aids2012.org Burden of HIV and HCV HIV HCV MSM PWID HCV HIV

4. Washington D.C., USA, 22-27 July 2012www.aids2012.org Without effective HIV management, including adherence to antiretroviral therapy, consideration of HCV treatment is problematic

5. Washington D.C., USA, 22-27 July 2012www.aids2012.org HIV mortality by CD4 cell count DAD Arch Intern Med 2006 /100 py

6. Washington D.C., USA, 22-27 July 2012www.aids2012.org Directly observed ART in opiate pharmacotherapy setting Berg KM. CID 2011;153:936-943

7. Washington D.C., USA, 22-27 July 2012www.aids2012.org Directly observed ART in opiate pharmacotherapy setting Berg KM. CID 2011;153:936-943

8. Washington D.C., USA, 22-27 July 2012www.aids2012.org The complexity and lack of tolerability of IFN- based therapy mean that a major impact on HCV disease burden among PWID populations will not be achieved

9. Washington D.C., USA, 22-27 July 2012www.aids2012.org HCV treatment uptake in HIV/HCV ESLD = 19 Advanced HIV = 16 Psych co-morb = 6 Drug/alcohol = 6 HCV RNA –ve = 9 F0/1 = 30 Patient refusal = 10 Mehta SH et al, AIDS 2006;20:2361-2369

10. Washington D.C., USA, 22-27 July 2012www.aids2012.org The advent of IFN-free direct acting antiviral therapy will provide the feasibility to rapidly scale- up HCV treatment programs for PWID

11. Washington D.C., USA, 22-27 July 2012www.aids2012.org DAA development timeline 201220102014201120152013 DAA combination PEG-IFN + RBV PEG-IFN + RBV + DAA Treatment complexity Dore GJ. Med J Aust 2012;196:629-632

12. Washington D.C., USA, 22-27 July 2012www.aids2012.org IFN-free DAA therapy: genotype 1, treatment naïve EASL 2012 SVR 4-12 %

13. Washington D.C., USA, 22-27 July 2012www.aids2012.org HCV treatment strategies Phase I (IFN-based therapy, 2012-2014): Treat primarily as liver disease Target treatment to F2-4 Increase disease staging (i.e. Fibroscan assessment) Community-based disease staging (i.e. Portable Fibroscan) Expand treatment access: Prisons, Methadone clinics, Rural & Regional, Nurse Practitioners/Consultants, GPs, ID specialists Phase II (IFN-free therapy, 2014 and beyond): Treat primarily as infectious disease Treat all stages of disease Major involvement of infectious disease and primary care clinics, with advanced disease in liver clinics Strategies to optimize adherence ? Treatment as prevention

14. Washington D.C., USA, 22-27 July 2012www.aids2012.org Hepatic elastography Vergniol J et al. Gastroenterology 2011:140:1970-1979.

15. Washington D.C., USA, 22-27 July 2012www.aids2012.org Progression to ESLD, HCC, liver-mortality /1,000 py Johns Hopkins HIV/HCV Clinic (n=631) Baseline liver biopsy 1993-2009; Median follow-up = 5.4 years Sulkowski M et al, CROI 2010

16. Washington D.C., USA, 22-27 July 2012www.aids2012.org Community-based HCV treatment Arora S E et al. Hepatology 2010; 52:1124-1133

17. Washington D.C., USA, 22-27 July 2012www.aids2012.org Without removal of barriers to treatment access, including DAA treatment price reform, the impact of improving therapy on HCV disease burden will be modest

18. Washington D.C., USA, 22-27 July 2012www.aids2012.org Removing barriers to treatment access Patient directed: Improved education and counseling Evaluation of peer-based support Management of co-morbidities, particularly psych and drug and alcohol Provider directed: Improved education and training Expansion of practitioner base: addiction medicine, ID, primary care Incentives for involvement in HCV treatment and care Infrastructure based: Improved HCV screening and assessment Development of multidisciplinary teams Community based programs, including telehealth/telemedicine

19. Washington D.C., USA, 22-27 July 2012www.aids2012.org Price of first generation ART

20. Washington D.C., USA, 22-27 July 2012www.aids2012.org Impact of improving HCV treatment Thomas DL. Lancet 2010;376:1441-1442