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Explore the global landscape of Hepatitis C treatment, including the challenges, impact on populations, treatment options, and barriers to access. Learn about the importance of advocacy, awareness, pricing strategies, and civil society involvement in improving treatment accessibility. Discover key priorities and opportunities for action in addressing Hepatitis C treatment access worldwide.
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Hepatitis C Treatment Access Needs Karyn Kaplan, TTAG (channeling Tracy Swan/TAG) December 13, 2011
TAG’s Hepatitis C Pipeline Report http://www.treatmentactiongroup.org/hcv/publications/2011/hcvpipeline2011?id=4416
Situation • HCV : 3% of world’s population (170 million) • Chronic HCV: 130 million • 39 million: serious liver disease/cirrhosis if untreated/unsuccessfully treated • 3-4 million new infections/year • 365,000 die of HCV complications • 10 million PWID HCV+ (6-15 million), or 67% of the global IDU population (Lancet/77 countries) • PLWHA - HIV greatly accelerates HCV progression; coinfection doubles risk of OIs • Lack of harm reduction coverage = more HCV
HCV can be treated and cured • Curative for half who undergo it • Less effective for HIV/HCV, people with cirrhosis, African-Americans, etc. • Genotype 1 most common/harder to treat (<40%) • Current SOC (PEG-IFN/ribavirin) “unlikely to have a significant impact on reducing domestic or global rates of HCV-related illness and death”(TAG HCV Pipeline 2011)
Biologics • (PegIFN, Herceptin, Humira, HPV vax) -- grown inside living cells rather than put together chemically like ordinary drugs -- cost 22x ordinary drugs --need generic drug-makers to compete --need to encourage generic development and approval
Treatment Situation • SOC = Pegylated interferon + ribavirin • SOC for genotype 1 = Protease inhibitors + PegIFN/ribavirin Telapravir (PI) + SOC (better) Bocepravir (PI) + SOC (cheaper) (PI+SOC = higher cure rates, but higher cost: 49,500 USD) • Next = Oral antivirals without interferon, once-a-day dosing, shorter therapy (DAAs)
Why so little political will? • US 3 million HCV+, 50-35% undiagnosed; most untreated • 350 Thai PWID (MSCRP, 2009): 66% never heard of HCV • Few advocacy groups • Nature of disease: “silent killer,” effects manifest over decades • Cost of meds and diagnostics, and complexity -- 40% chronic HCV living in countries that don’t provide funding for treatment -- 80% low-income countries want assistance with treatment access
Why so little consumer demand? • Lack of awareness • Harsh treatment side effects • Exorbitant cost (diagnostics, treatment) • Doctor lack of knowledge/commitment to treat • Policymakers apathetic about funding • Insurance reimbursement inadequate • Overly strict eligibility criteria • Medical contraindications
Why is the treatment so expensive? “I had to use all my savings and borrow heavily to pay over 700,000 rupees for my 48-wk treatment…The Indian Government’s silence on this issue is more like telling us ‘I am sorry you will die because treating you is not cost-effective.’”(Nanao Haobam, coinfected activist) • US Example: US patent protection • 2016 (PegIntron)/Merck • 2017 (Pegasys)/Roche 48-week course 30,000 USD + physician/nurse time + lab monitoring + additional medication • Lack of generic alternatives
Desired strategies to address pricing (Drug companies) • High-volume, low-profit strategy for low- and middle-income countries • Register HCV treatments in all countries • Grant voluntary licenses to generic manufacturers supplying low- and middle-income countries (TAG HCV Pipeline Report 2011)
What can civil society do? • Develop our own capacity (info, materials) • Raise awareness and desire to treat among key stakeholders • Mobilize funding for community education/advocacy • Identify lead organizations; clarify roles • Develop local, regional, global advocacy strategies • Examine patent validity in country (India), push govts to issue CLs, identify biosimilar producers, get drugs on EDLs
2012: Priorities for Action • Research/Information • Movement-building- Build a coordinated movement of informed, educated activists particularly from directly-affected populations • Access through trials? And work with local trial researchers • Price negotiation • Generic clarification - sources, GMP audit • Generate interest in key allied organizations such as MSF, OSF, donors, GFATM, UN, others • Develop coordinated source of relevant, accurate, updated info available in various languages • Create networks at country, regional, global level to advocate • Integrate issue into existing networks, bring to forefront (harm reduction) • Generate government interest and buy-in
Opportunities OSF AEM - dedicated program including funding for exploring issues, supporting activism WHO resolution GFATM funding treatment? MSF funding treatment? Activism: US, Europe, CEE/FSU, Asia Country interest: Thailand, Indonesia, etc. Address patent protections/monopoly, pricing and access for trials: Global Activist Meeting