Uniting Forces for Access to Hepatitis C Treatment

Global Epidemiology & 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 http://www.worldhepatitisalliance.org/Libraries/Campaign_Materials/Viral_Hepatitis_Global_Policy.sflb.ashx

HCV: Current SOCRibavirin: a pill or capsule, generic versions available in many countries; cheap to make

Peginterferon: a weekly injection, branded versionsproduced 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 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

Civil Society & HCV TX AccessMobilize 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 countriesthat have increased HCV TX access (Georgia, Brazil)