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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
(the one who discovered HCV), Prof.Barone and me.
THE HEPATITIS C CHALLENGE
1989
The burden of HCV infection
• 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
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.
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 BASSETTE
da Folha de S.Paulo
www.uol.com.br, access 08/25/2005.
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.
Brazil: GDPs & HCV care: it is the
Economy “stupid”...
“HCV Belt”
GDP ($Reais) -2007 São Paulo State ~ 70% of all HCV production!
(from darker to lighter) (care &therapy)
+ 500,000
+ 100,000
+ 50,000
+ 10,000
+ 5,000
+ 1,000
Source: IBGE 2009/ DATASUS.
Human DeveIopment Index:
1990 (“HCV First Year”)-2006.
(darker color= higher HDI)
IMPROVING HDI
IMPROVING SCIENCE ($$)
IMPROVING DISEASE BURDEN
HCV vs Brazilian response
HCV Field & Brazil
• Before 1989 – NANB hepatitis • Forced by LAW: PegIFN&RBV
• Universities and HIV units • 2002 – PCR without quotes/limits
• 1989 – HCV • 2004 – Isention of Federal Tax for
• Viral Hepatitis academic units liver diseases patients
• 1990-1999 – Serologic tests, PCR, IFN&RBV • 2005 – Protocol update (Peg); Federal
• HAART, Blood Banks control, IFN, 90`s- Law reconizes viral hepatitis as an
NGO`s issue
• Cities,States Hepatitis Programs • 2006 – Health Ministry established
the central trade of PegIFN
• 2000-RBV distribution, social care
• 2007- Protocol update
• 2001 Cities Laws for prevention
• 2008 – Patients with a representant
• 2002 – PegIFN in the Advisory Board at Health
• March 2002 – First National NGOs (11) Ministry
Meeting – Letter from Santos • 2009 – Hepatitis Program joins Aids
• 2002 – National Hepatitis Program & first Program
National Guideline • More than 70 NGOs; 2 National
Moviments, WHA representative.
Timeline of actions (Summary)
2009 & Beyond
Before HCV 1989 1990`s 2002-PegIFN (DAAs)
Brazilian Constitution
-Law!
Academic Academic Institutions National
Institutions HIV assistance Net Policies Government
Social Mobilizations (NGOs) &
Local laws on awareness NGOs
and assistance
WHY US ?
Maybe because an example of
partnership. But, what about results ?
Epidemiology of HCV infection in Brazil.
** Blood supply safe since 90’s &
NAT recently approved.
* poverty, unsafe injections,
dental care, health associated, tattoo, etc.
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
%
2,5 20 a 69 years
2 1,89 1,94
1,79
1,61
Prevalence
1,5
1,05 1,08 1,10
1 0,81
0,69
0,5 0,32
0
North: pending data.
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.
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.
Brazil: Liver Disease by Age Group
2.500 Pro-activity: intervention before the problem increase !
2.000
1.500
1.000
500
0
Menor 1 1a4 5 a 14 15 a 24 25 a 34 35 a 44 45 a 54 55 a 64 65 a 74 75 anos
ano anos anos anos anos anos anos anos anos e mais
... 022 Hepatite viral
Viral Hepatitis
. 036 Neopl malig do fígado e vias bil intrahepát
Liver Cancer
... 080.2 Fibrose e cirrose do fígado
Liver Cirrhosis * Alcohol excluded
Source: MS/SVS/DASIS - Sistema de Informações sobre Mortalidade – SIM (2006).
Brazil: Deaths by determined causes(CID10) & liver diseases
associated : 2000-2006.
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
Viral Hepatitis
... 022 Hepatite viral
Liver Cancer
. 036 Neopl malig do fígado e vias bil intrahepát
... 080.2 Fibrose e cirrose do fígado
Liver Cirrhosis * Alcohol excluded
Source: MS/SVS/DASIS - Sistema de Informações sobre Mortalidade – SIM (2006).
Brazil: Inpatients Impacts of Liver Disease vs
ALL others diseases (2007)
9,16
Length of stay Liver disease stay longer & spent too much !
(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) Liver disease associated (Mean)
(other than liver disease)
Source: Ministério da Saúde - Sistema de Informações Hospitalares do SUS (SIH/SUS) .
Liver Transplantation from cadaveric
donor (2002- june 2007)
Number of Procedures
* 2007 374
2006 804
2005 759
2004 757
2003 644
2002 525
0 100 200 300 400 500 600 700 800 900
Source: Sistema Nacional de Transplantes / MS.
Wa i t i n g l i st fo r l i ve r t ra n s p l a ntat i o n -
H C F M U S P/ S ã o Pa u l o / 2 0 0 9 .
1%
2% 1% 1%
7%
HCV
10% ALCOHOL
HBV
CRIPTOGENETIC
HCV AUTOIMMUNE
10% 51% PBC
HBV+HCV (1%)
HBV+HDV (1%)
SBC
17%
Anti-Rejection drugs expenses (2000-2007).
Millions (R$)
100,00
89,38
90,00
80,00
70,00 62,49 63,99
61,52
60,00 54,47
43,21
50,00
35,35
40,00 32,99
30,00
20,13 29,60 31,32 29,63
28,56 27,20
20,00
11,16
10,00 2,22
0,50 1,64 0,80
0,00 0,16 0,54
0,00 0,00
0,00
2000 2001 2002 2003 2004 2005 2006 2007
Tacrolimus 1/5 mg cápsula
Ciclosporin 100mg sol.oral-10/25/50/100 mg por cápsula
Anti-Hep B Immunoglobulin - 100/1000 UI inj
Source: Ministério da Saúde - Sistema de Informações Ambulatoriais do SUS (SIA/SUS)
HEALTH ASSISTANCE & THERAPY
Sistema Único de Saúde - SUS
SVR among pivotal trials and real-
life at HC-FMUSP*
*Stanislau Affonso de Araújo,E et al (2007) Pegylated Interferon for chronic HCV infection:is it that good for “real real-life”?
14th International Symposium on Hepatitis C Virus & Related Viruses, p P284.
Why so huge
difference ????
Manns M, et al. Lancet. 2001;358:958-965.
Fried MW, et al. N Engl J Med. 2002;347:975-982. *HCFMUSP: 91% GT 1.
Real Life – HCFMUSP 2003-2006.
Multivariate analysis.
Aim compliance: interdisciplinar approach !
Stanislau Affonso de Araújo,E et al (2007) Pegylated Interferon for chronic HCV infection:is it that good for “real real-life”?
14th International Symposium on Hepatitis C Virus & Related Viruses, p P284.
PegIFN by region in SUS (2002-2007*)
*jan-may
Estimated therapies with PegINF by region//Brazil
2002-2007 (may).
2010 update ~15,000 therapies
Estimativa de terapias Peg
População Estimativa de HCV(1,4%) 2002 2003 2004 2005 2006 2007(até maio) Total
Norte 15.022.000 210.308 0 80 143 45 33 287 587 "0,28%"
Nordeste 51.609.000 722.526 20 269 441 163 50 617 1.561 "0,22%"
Sudeste 79.561.000 1.113.854 95 753 1.728 820 692 6.075 10.163 "0,91%"
Sul 27.308.000 382.312 13 127 317 121 79 711 1.366 "0,36%"
Centro-Oeste 13.269.000 185.766 4 93 168 70 55 293 682 "0,37%"
Total 186.769.000 2.614.766 132 1.322 2.796 1.219 909 7.983 14.360
"0,55%"
"30%"= 784.430 "1,83%"
R$ 275.712.000,00/ ~ 140,000,000,00 US dollars (PegINF)
But only 0,5 a 1,8% of the patients needing care...and what is the SVR ?
PROBLEMS
• Personal expectatives ?
• How many ?
• Myths
–HCV is always complex
–HCV is always expensive
Imbalance....
Knowledge evolution
Patients needs (the best, now!)
Disease burden
System organization:
Assistance net
Financing
Personal expectatives...different angles...
Solution ?
To manage !
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...
HCV: predictable disease!
Inclusion:
Basic assistance:
Time to organize !
Advisory/ Non-pharmacological approach/ Harm
reduction/ Serological testing. !
Time to stratify risk
Time to Harm Reduction (avoid coinfections)!
TIME!
Clinical & Laboratory
Time to non-pharmacologic therapies!
evaluation.
Time in HCV Natural History= YEARS !
Avoid traps:ex.liver biopsy !*
*use of new non-invasive markers
Therapy (including the simple and inexpensive
PLATELET COUNT!!!!)
Possible paths to follow.
1.Recognize the
problem: impacts &
prevalence.
2. Define as a
priority issue.
3. Make a plan.
3.1Consider Natural History as an allied
and Harm Reductions policies
3.2 Join Medical and Patients societies
3.3 Establish a broad Therapeutic Protocol
3.3.1 – Non pharmacological
3.3.2 - Pharmacologic
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!
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
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.
HCV Prevention, Screening, Diagnosis and Treatment – a Practical Country
Case Study: Brazil.
• Prevention • Diagnosis
– HBV vaccination, – Strengthen official laboratories.
educational activities – Centralized offer of Biomolecular
(ex.cosmetic clinics, laws, Tests.
days and weeks of – Liver biopsies – a big concern.
prevention)
– Harm reduction policies: • Treatment
still weak. – Official rules.
– Avoid co-infections ! – Treat who needs to be treated
• Screening – Central buying medicines.
– Serologic and Campaigns – Use of Aids net
(NGOs) with point-of-care – Direct observation therapies
tests (thousands of tests – Multidisciplinary approach
and counseling!!!) – OBTAIN compliance !
Brazilian proposition to WHO.
Facts & Faces to remember:
Harvey Alter & Qui-Lim Choo Jeová Fragoso and Carlos Varaldo two cornerstone
at the 20th HCV Anniversary Leadership in the NGOs moviment at the 20th HCV
Symposia in Brazil (2009). Anniversary Symposia in Brazil (2009).
The first step The more advanced step The necessary step
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).
Thanks for your attention !
contact: evaldostanislau@uol.com.br
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