1. Uniting Forces for Access to Hepatitis C Treatment Global Epidemiology Global Epidemiology & Treatment Access Issues & Treatment Access Issues Tracy Swan Treatment Action Group

2. HCV: a “Viral Time Bomb” 170 million people have been infected 5 million people are HIV/HCV coinfected

4. HCV Testing & TX Access HCV testing: not universally available/accessible –Multiple diagnostic tests needed HCV TX: > 40% of the world’s population in countries with no gov’t funding for HCV TX –Additional barriers -- even when TX is funded Data from a World Hepatitis Alliance/ WHO Report: Viral Hepatitis: Global Policy http://www.worldhepatitisalliance.org/Libraries/Campaign_Materials/Viral_Hepatitis_Global_Policy.sflb.ashx

5. HCV: Current SOC Ribavirin: a pill or capsule, generic versions available in many countries; cheap to make Peginterferon: a weekly injection, branded versions produced by two companies (Merck & Roche) – It is prohibitively expensive – Patented until 2016/2017

6. PEG + Interferon

7. What Can Be Done to Increase HCV Treatment Access? Governments Regulatory Agencies Pharmaceutical Companies Civil Society

8. Role of Governments Allocate adequate funding for HCV surveillance, education, prevention, diagnostic/care and treatment programs Negotiate better prices for HCV diagnostics & TX Consider HCV treatment essential: issue compulsory licenses for HCV drugs and support patent challenges if necessary Develop HCV treatment guidelines

9. Regulatory Agencies Can…. Harmonize global requirements for biosimliar approval October 2009: WHO Guidelines on Evaluation of Similar Biotherapeutic Products EMA Guideline on Similar Biologic Medicinal Products (2006) FDA Guidance forthcoming in late 2010

10. Pharmaceutical Companies Can… Cut prices for low-and middle income countries (high-volume, low profit) Register products in all countries Produce cheaper biosimilars/generics June 18 2010: Getz Pharmaceuticals announces peginterferon production & price cut from 15,000 to 8,000 Pakistani rupees June 28 2010: Cyplasin Biomedical and Minapharm announce distribution/marketing agreement for C-Pegferon

11. Civil Society & HCV TX Access Mobilize to raise awareness & demand access to HCV prevention tools, diagnostics, care and treatment! Pressure governments, pharmaceutical companies, and keep HCV on donor agendas Integrate HCV into HIV programming when feasible Use the legal system to gain access through challenging/ blocking patents Look to successful HIV strategies, and at countries that have increased HCV TX access (Georgia, Brazil)