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HCV & Brazil: lessons learned.

HCV & Brazil: lessons learned. Evaldo Stanislau Affonso de Araújo,MD, PhD. Hospital das Clínicas FMUSP ( presented by Dr. Fábio Mesquita). Who am I? Why I am not here ?. Who I am. Why I am not here?. Left to right: Prof.Mendonça, Qui-Lim Choo

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HCV & Brazil: lessons learned.

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  1. HCV & Brazil: lessons learned. Evaldo Stanislau Affonso de Araújo,MD, PhD. Hospital das Clínicas FMUSP (presentedbyDr.Fábio Mesquita)

  2. Who am I? Why I am not here ? Who I am... Why I am not here? Left to right: Prof.Mendonça, Qui-Lim Choo (the one who discovered HCV), Prof.Barone and me.

  3. Thehepatitis c challenge

  4. 1989

  5. Aproximately 3.9 million infected in USA 35.000 estimated new cases per year 85% became chronic 10.000-20.000 deaths per year associated to HCV Estimated to become 3 times larger in the next 10-20 years Principal cause of Chronic liver disease Cirrhosis Liver cancer Liver Transplantation The burden of HCV infection CDC. MMWR Morb Mortal Wkly Rep. 1998;47;1-39. NIH Consensus Conference Statement. Avaiable at: http://consensus.nih.gov/2002/ 2002HepatitisC2002116html.htm. Acesso 19 de Agosto, 2008. Rustgi VK. J Gastroenterol. 2007;42:513-521.

  6. Brazil headline: HCV associated mortality in Brazil is growing at the fastest rate among all other causes. 14/08/2005 - 09h51 Mortalidade por hepatite C é a que mais cresce no país. FERNANDA BASSETTEda Folha de S.Paulo www.uol.com.br, access 08/25/2005.

  7. Health Ministry Death Report: 11/2008: Cirrhosis and Liver diseases 8th cause of death among men. http://189.28.128.100/portal/arquivos/pdf/coletiva_saude_061008.pdf, acesso em 11/11/08.

  8. Brazil: GDPs & HCV care: it is theEconomy “stupid”... “HCV Belt” São Paulo State ~ 70% of all HCV production! (care &therapy) GDP ($Reais) -2007     (from darker to lighter)  + 500,000    + 100,000 + 50,000 + 10,000 + 5,000 + 1,000 Source: IBGE 2009/ DATASUS.

  9. Human DeveIopment Index: 1990 (“HCV First Year”)-2006. (darker color= higher HDI) IMPROVING HDI IMPROVING SCIENCE ($$) IMPROVING DISEASE BURDEN

  10. HCV vs Brazilian response HCV Field & Brazil Forced by LAW: PegIFN&RBV 2002 – PCR without quotes/limits 2004 – Isention of Federal Tax for liver diseases patients 2005 – Protocol update (Peg); Federal Law reconizes viral hepatitis as an issue 2006 – Health Ministry established the central trade of PegIFN 2007- Protocol update 2008 – Patients with a representant in the Advisory Board at Health Ministry 2009 – Hepatitis Program joins Aids Program More than 70 NGOs; 2 National Moviments, WHA representative. • Before 1989 – NANB hepatitis • Universities and HIV units • 1989 – HCV • Viral Hepatitis academic units • 1990-1999 – Serologic tests, PCR, IFN&RBV • HAART, Blood Banks control, IFN, 90`s-NGO`s • Cities,States Hepatitis Programs • 2000-RBV distribution, social care • 2001 Cities Laws for prevention • 2002 – PegIFN • March 2002 – First National NGOs (11) Meeting – Letter from Santos • 2002 – National Hepatitis Program & first National Guideline

  11. Timeline of actions (Summary) 2009 & Beyond (DAAs) 1989 Before HCV 1990`s 2002-PegIFN Brazilian Constitution -Law! Academic Institutions National Policies Academic Institutions HIV assistance Net Social Mobilizations (NGOs) Local laws on awareness and assistance Government & NGOs

  12. Why us ?

  13. Maybe because an example of partnership. But, what about results ?

  14. Epidemiology of HCV infection in Brazil. ** Blood supply safe since 90’s & NAT recently approved. * poverty, unsafe injections, dental care, health associated, tattoo, etc.

  15. Capitals National household survey– 2004-2005. Brazilian Health Ministry/ PAHO. Anti-HCV prevalence ~ 1,5%/ 189,000,000 = 2,7 mi with Anti-HCV + ! 10 a 19 years % 20 a 69 years 2,5 1,94 1,89 2 1,79 1,61 1,5 1,10 1,08 Prevalence 1,05 1 0,81 0,69 0,5 0,32 0 South Southeast North-East Center-West Federal District North: pending data.

  16. Prevalence of HCV genotypes during 1990-1997 and 1999-2007 in a cohort of patients from São Paulo, Brazil.Cavalheiro NP, Melo CE, Tengan F, Araujo ESA, Barone AA.HCV 2008 Conference, San Antonio, USA. 2,155 samples 1990-2007 Gt 1: 1538 (71,4%) Gt 2: 114 (5,3%) Gt 3: 478 (22,2%) Gt 4: 12 (0,6%) Gt 5: 13 (0,6%) Gt 6: zero.

  17. Age is an issue ! • São Paulo city: • overall prevalence of Anti-HCV: 1,4 %. • 50-59 years: 3,8%. Poynard T et al. Lancet, 1997: 825.

  18. Brazil: Liver Disease by Age Group Pro-activity: intervention before the problem increase ! Viral Hepatitis Liver Cancer Liver Cirrhosis * Alcohol excluded Source: MS/SVS/DASIS - Sistema de Informações sobre Mortalidade – SIM (2006).

  19. 10.000 9.000 8.000 7.000 6.000 5.000 4.000 3.000 2.000 1.000 0 2000 2001 2002 2003 2004 2005 2006 ... 022 Hepatite viral . 036 Neopl malig do fígado e vias bil intrahepát ... 080.2 Fibrose e cirrose do fígado Brazil: Deaths by determined causes(CID10) & liver diseases associated : 2000-2006. Viral Hepatitis Liver Cancer Liver Cirrhosis * Alcohol excluded Source: MS/SVS/DASIS - Sistema de Informações sobre Mortalidade – SIM (2006).

  20. 9,16 Length of stay (mean) 5,8 576,63 Mean value by Episode (R$) 672,35 576,63 Mean AIH Value (R$) 648,91 0 100 200 300 400 500 600 700 800 Brasil (Mean) (other than liver disease) Liver disease associated (Mean) Brazil: Inpatients Impacts of Liver Disease vs ALL others diseases (2007) Liver disease stay longer & spent too much ! Source: Ministério da Saúde - Sistema de Informações Hospitalares do SUS (SIH/SUS).

  21. Number of Procedures * 2007 374 2006 804 759 2005 2004 757 2003 644 525 2002 0 100 200 300 400 500 600 700 800 900 Liver Transplantation from cadaveric donor (2002- june 2007) Source: Sistema Nacional de Transplantes / MS.

  22. Waiting list for liver transplantation-HCFMUSP/São Paulo/2009. 1% 1% 1% 2% 7% HCV HCV ALCOHOL 10% HBV CRIPTOGENETIC AUTOIMMUNE PBC 51% 10% HBV+HCV (1%) HBV+HDV (1%) SBC 17%

  23. Millions (R$) 100,00 89,38 90,00 80,00 63,99 62,49 70,00 61,52 54,47 60,00 43,21 50,00 35,35 32,99 40,00 30,00 31,32 29,63 20,13 29,60 28,56 27,20 20,00 11,16 2,22 10,00 0,50 1,64 0,80 0,16 0,54 0,00 0,00 0,00 0,00 2000 2001 2002 2003 2004 2005 2006 2007 Tacrolimus 1/5 mg cápsula Ciclosporin 100mg sol.oral-10/25/50/100 mg por cápsula Anti-Hep B Immunoglobulin - 100/1000 UI inj Anti-Rejection drugs expenses (2000-2007). Source: Ministério da Saúde - Sistema de Informações Ambulatoriais do SUS (SIA/SUS)

  24. Health assistance & therapy

  25. Sistema Único de Saúde - SUS

  26. SVR among pivotal trials and real-life at HC-FMUSP* *Stanislau Affonso de Araújo,E et al (2007) Pegylated Interferon for chronic HCV infection:is it that good for “real real-life”? 14th International Symposium on Hepatitis C Virus & Related Viruses, p P284. Why so huge difference ???? Manns M, et al. Lancet. 2001;358:958-965. Fried MW, et al. N Engl J Med. 2002;347:975-982. *HCFMUSP: 91% GT 1.

  27. Real Life – HCFMUSP 2003-2006. Multivariate analysis. Aim compliance: interdisciplinar approach ! Stanislau Affonso de Araújo,E et al (2007) Pegylated Interferon for chronic HCV infection:is it that good for “real real-life”? 14th International Symposium on Hepatitis C Virus & Related Viruses, p P284.

  28. PegIFN by region in SUS (2002-2007*)*jan-may

  29. EstimatedtherapieswithPegINFbyregion//Brazil 2002-2007 (may). 2010 update ~15,000 therapies R$ 275.712.000,00/ ~ 140,000,000,00 US dollars (PegINF) Butonly 0,5 a 1,8% ofthepatientsneedingcare...andwhat is the SVR ?

  30. PROBLEMS • Personal expectatives ? • How many ? • Myths • HCV is always complex • HCV is always expensive

  31. Imbalance.... Knowledge evolution Patients needs (the best, now!) Disease burden System organization: Assistance net Financing

  32. Personal expectatives...different angles...

  33. Solution ? To manage !

  34. Local organization. • Training on disease management and estabilish routines; • Spread of assistance; • Fight miths: • It is expensive... • It is complex... • Every patients take medicines... • I do not have what offer...

  35. HCV: predictable disease! TIME! Time to organize ! Time to stratify risk ! Time to Harm Reduction (avoid coinfections)! Time to non-pharmacologic therapies! Time in HCV Natural History= YEARS ! Avoid traps:ex.liver biopsy !* *use of new non-invasive markers (including the simple and inexpensive PLATELET COUNT!!!!)

  36. Possible paths to follow. 1.Recognizetheproblem: impacts & prevalence. 2. Define as a priorityissue. 3. Make a plan. 3.1Consider Natural History as analliedandHarmReductions policies 3.2 Join Medical andPatientssocieties 3.3 Establish a broadTherapeuticProtocol 3.3.1 – Nonpharmacological 3.3.2 - Pharmacologic

  37. Conclusions • Magnitude and virologic aspects similar to developed countries, p.ex. USA. • Liver disease (HCV related) is an important and increasing cause of death in Brazil • Despite efforts, assistance still far from ideal • Access • Lack of exams • Southeast/South axis • Free Rx but how to expand assistance ? • Economic impact: raising costs (Rx, Tx, Post-Tx Rx…) • Future burden of retreatment (increase # of NR) & DAAs (costs, resistance, compliance…) • Poor real-life results • Compliance issues ? • Genetic/racial issues ? • To be evaluated – IL28B polymorphism!

  38. Among the universe of HCV carriers in the USA for each 100 tested, only 49 were refered, 27 went to a medical consultation, 17 did a liver biopsy and only 10 were treated. What about us? Irving et al J Viral Hep 13, 2006

  39. Effectiveness of Hepatitis C Treatment with Pegylated Interferon and Ribavirin in Urban Minority Patients. (HEPATOLOGY 2010;51:1137-1143. Paul Feuerstadt,1 Ari L. Bunim,1 Heriberto Garcia,2 Jordan J. Karlitz,3 Hatef Massoumi,4 Amar J. Thosani,4 Andrew Pellecchia,1 Allan W. Wolkoff,4 Paul J. Gaglio,4 and John F. Reinus4. Intention-to-treat analysis (ITT) showed SVR in 14% of genotype 1 patients and 37% in genotype 2/3 patients (P < 0.001). SVR was significantly higher in faculty practice (27%) than in clinic patients (15%) by intention-to-treat (P 0.01) but not per-protocol analysis (46% faculty practice, 34% clinic). 3.3% of 1,656 treatment-naïve, HIV antibody–negative individuals ultimately achieved SVR. Current hepatitis C therapies may sometimes be unavailable to, inappropriate for, and ineffective in United States urban patients. Treatment with pegylated interferon and ribavirin was less effective in this population than is implied by multinational phase III controlled trials. New strategies are needed to care for such patients.

  40. HCV Prevention, Screening, Diagnosis and Treatment – a Practical Country Case Study: Brazil. • Prevention • HBV vaccination, educational activities (ex.cosmetic clinics, laws, days and weeks of prevention) • Harm reduction policies: still weak. • Avoid co-infections ! • Screening • Serologic and Campaigns (NGOs) with point-of-care tests (thousands of tests and counseling!!!) • Diagnosis • Strengthen official laboratories. • Centralized offer of Biomolecular Tests. • Liver biopsies – a big concern. • Treatment • Official rules. • Treat who needs to be treated • Central buying medicines. • Use of Aids net • Direct observation therapies • Multidisciplinary approach • OBTAIN compliance !

  41. Brazilian proposition to WHO.

  42. Facts & Faces to remember: Harvey Alter & Qui-Lim Choo at the 20th HCV Anniversary Symposia in Brazil (2009). Jeová Fragoso and Carlos Varaldo two cornerstone Leadership in the NGOs moviment at the 20th HCV Anniversary Symposia in Brazil (2009).

  43. Thenecessarystep The first step The more advanced step

  44. The ultimate step: union to win ! Working together against HCV: physicians, researchers, government and NGOs/ patients (picture took at the end of the HCV 20 years Symposia, Brazil2009).

  45. Thanks for your attention ! contact: evaldostanislau@uol.com.br

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