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

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

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

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

PEG + Interferon

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

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

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

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 : Getz Pharmaceuticals announces peginterferon production & price cut from 15,000 to 8,000 Pakistani rupees June : Cyplasin Biomedical and Minapharm announce distribution/marketing agreement for C-Pegferon

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)