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Ministry of HealthNational STD/AIDS Program
Universal Access toUniversal Access toAntiretroviralAntiretroviral Therapy:Therapy:
The Brazilian ExperienceThe Brazilian Experience
“universal and free of charge access to antiretroviral drugs”“treatment policy of AIDS”
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BRAZIL : Federative Republic
• POPULATION (2000): 169,500,000
• CUMULATIVE AIDS CASES NOTIFIDED (Dec/2000): 203,353
• CUMULATIVE PEDIATRIC AIDS CASES (Dec/2000): 7,086
• ESTIMATED NUMBER OF HIV+ INDIVIDUALS (1998): 536,000
• AIDS INCIDENCE RATE (1999): 14/100,000 in hab.
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Major Program Aspects
Universal access to antiretroviral (ARV) therapy throughout the Public Health System.
Treatment criteria established by an Advisory Committee, revised at least once a year or as frequently as needed, in order to reflect scientific developments and availability of new drugs.National ARV logistic control system Dispensary Laboratories
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Recommendations for beginning anti-retroviral therapy
Symptomatic patient
Asymptomatic patient with relevant findings
in laboratory tests (CD4+ viral load )
Pregnant HIV+ (reduction of vertical
transmission)
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Computerized System for the LogisticalControl of Antiretroviral Drugs.
• National patient register• Register linked to Aids drugs dispensing units • Checking register and drugs dispensing
according to MH criteria• Computerization of drugs dispensing units • Authenticate ARV requests via magnetic card• Information to patients• Daily data copying
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Computerized System for the Logistical Control of Drugs
Civil Rights
Quality of Life
magnetic card
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TOTAL = 424
Distribution of Dispensary Units of AntiretroviralDrugs in Brazil - February, 2001.
85
1
93
1
1 3
1
1 23
10
51
33
93
12923
30
9
3131
2
1095
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Viral Load = 63 Lab.CD4+ Lymphocyte = 70 Lab.
0101
01
02
06
03
17
04
03
01
0201
01
10
0101
01
01
01
01
01
01
01
03
0503
21
05
03
01
01
0101
0101
0101
0111
01
01
01
Networks of HIV Viral Load and CD4+
Lymphocytes Count - 2001
Source: Ministry of Health
01
01
01
01
0101
01
01
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Number of HIV-infected patients on ARV treatment in the Brazilian Public Health System (Jan/97 - Dec/00)
0
10.000
20.000
30.000
40.000
50.000
60.000
70.000
80.000
90.000
100.000
jan/97
mar/97
may/97
jul/97
sep/97
nov/97
jan/98
mar/98
may/98
jul/98
sep/98
nov/98
jan/99
mar/99
may/99
jul/99
sep/99
nov/99
jan/00
mar/00
may/00
jul/00
sep/00
nov/00
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ZIDOVUDINE (ZDV) 1993*DIDANOSINE (ddI) 1998*ZALCITABINE (ddC) 1997*LAMIVUDINE (3TC)1999*STAVUDINE (d4T) 1997*INDINAVIR 2000*
ARV distributed by Ministry of HealthARV distributed by Ministry of Health--Brazil (May/2001)Brazil (May/2001)
RITONAVIR SAQUINAVIR NELFINAVIRAMPRENAVIRNEVIRAPINE 2000*DELAVIRDINE EFAVIRENZ
* Generics manufactured in Brazil/year production commenced
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*Estimated data Source: Ministry of Health
Types of antiretroviral therapy receveid by patients in Brazil, by % (Jan1997 - Dec2000)
0%
20%
40%
60%
80%
100%
jan/
97
apr/9
7
jul/9
7
oct/9
7
jan/
98
apr/9
8
jul/9
8
oct/9
8
jan/
99
apr/9
9
jul/9
9
oct/9
9
jan/
00
apr/0
0
jul/0
0
oct/0
0
2N* 2N + PI 2N + NN 4 ARV
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Impact of Antiretroviral Therapy(1995 - 2000)
Reduced Mortality 40-70% 40-70%
Reduced Morbidity 60-80%
Reduced Hospitalization 4x reduction 234,000 avoided AIDS-related hospital admissons
Cost Savings U$ 677 million from 1997/2000
Tb 360 in 1996 and 82 in 2000
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*Estimated data
Price evolution (in US$) of ARV for adults use with domestic production. Brazil (1996 - 2001)
Source: Ministry of Health/Brazil
0
1
2
3
4
5
6
7
8
AZT cap100mg
AZT/3TC ddI tablet25mg
ddI tablet100mg
3TCtablet
150mg
d4T cap30mg
d4T cap40mg
NVPtablet
200mg
1996 1997 1998 1999 2000 2001*
Mean Reduction: 78%
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*Prelimanary data
Mean Cost (in US $) per Patient-year ofAntiretroviral Therapy. Brazil (1996 -2001)
Source: Ministry of Health/Brazil
3.320
2.530
4.860
3.810
4.540 4.240
1996 1997 1998 1999 2.000 2001*
Internal Produc.
1997 - 2001: 48% reduction
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Brazilian MH & Merck Agreement on ARV Price Reduction
(March, 2001)
64,8 % Price Reduction on Indinavir
U$ 1.33/capsule U$ 0.47/capsule
59,0 % Price Reduction on Efavirenz
U$ 2.05/capsule U$ 0.84/capsule
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Governamental Laboratories Manufacturing ARV in BrazilFar-Manguinhos/FIOCRUZ/Ministry of Health (45% of Total ARV National Production)FURP (SP)LAFEPE (PE)FUNED (MG)IQUEGO (GO)IVB (RJ)
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Far-Manguinhos
PharmaceuticalProduction
PharmaceuticalFormulation
Industrial Area400 people
Organic Synthesis Natural Products Pharmacology
R&D40 PhD
140 researchers
Direction
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Far-Manguinhos strategy for pharmaceutical production in AIDSR&D of formulation using acquired drugs in the international market by lower priceR&D of analytical methodology and standard referenceBio and pharmaceutical equivalence
Industrial capacity used capacity AIDS PU PU PU
tablets 1,2 billion 1 billion 51 million
capsules 149 million 110 million 80 million
creams 18 million 14 million -
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SaquinavirRitonavirNevirapine for children
Far-Manguinhos R&DTarget areas
TuberculosisTrypanosomosesAIDSMalaria
New developments in Far-Manguinhos for 2002
Far-Manguinhos R&DMain areas
Natural ProductsSynthesisPharmacology
2 research groups in new drugsProtease InhibitorsNNRTC inhibitors