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Hepatitis C Treatment Access Needs

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. The “viral time bomb”. Situation.

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Hepatitis C Treatment Access Needs

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  1. Hepatitis C Treatment Access Needs Karyn Kaplan, TTAG (channeling Tracy Swan/TAG) December 13, 2011

  2. TAG’s Hepatitis C Pipeline Report http://www.treatmentactiongroup.org/hcv/publications/2011/hcvpipeline2011?id=4416

  3. The “viral time bomb”

  4. 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

  5. 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)

  6. 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

  7. 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)

  8. 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

  9. 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

  10. 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

  11. 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)

  12. 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

  13. 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

  14. 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

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