SLIDE 1 Ministry of Health National STD/AIDS Program
Universal Access to Universal Access to Antiretroviral Antiretroviral Therapy: Therapy:
The Brazilian Experience The Brazilian Experience
“universal and free of charge access to antiretroviral drugs” “treatment policy of AIDS”
SLIDE 2 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.
SLIDE 3
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
SLIDE 4
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)
SLIDE 5 Computerized System for the Logistical Control 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
SLIDE 6
Computerized System for the Logistical Control of Drugs
Civil Rights Quality of Life
magnetic card
SLIDE 7 TOTAL = 424
Distribution of Dispensary Units of Antiretroviral Drugs in Brazil - February, 2001.
8
5 1 9 3 1 1 3 1 1 2 3 10 5 1 3 3 9 3 129 23 30 9 31 31 2 10 95
SLIDE 8 Viral Load = 63 Lab. CD4+ Lymphocyte = 70 Lab.
01 01 01 02 06 03 17 04 03 01 02 01 01 10 01 01 01 01 01 01 01 01 01 03 05 03 21 05 03 01 01 01 01 01 01 01 01 01 11 01 01 01
Networks of HIV Viral Load and CD4+ Lymphocytes Count - 2001
Source: Ministry of Health
01 01 01 01 01 01 01 01
SLIDE 9 Number of HIV-infected patients on ARV treatment in the Brazilian Public Health System (Jan/97 - Dec/00)
10.000 20.000 30.000 40.000 50.000 60.000 70.000 80.000 90.000 100.000 j a n / 9 7 m a r / 9 7 m a y / 9 7 j u l / 9 7 s e p / 9 7 n
/ 9 7 j a n / 9 8 m a r / 9 8 m a y / 9 8 j u l / 9 8 s e p / 9 8 n
/ 9 8 j a n / 9 9 m a r / 9 9 m a y / 9 9 j u l / 9 9 s e p / 9 9 n
/ 9 9 j a n / m a r / m a y / j u l / s e p / n
/
SLIDE 10 ZIDOVUDINE (ZDV) 1993* DIDANOSINE (ddI) 1998* ZALCITABINE (ddC) 1997* LAMIVUDINE (3TC)1999* STAVUDINE (d4T) 1997* INDINAVIR 2000*
ARV distributed by Ministry of Health ARV distributed by Ministry of Health-
Brazil (May/2001)
RITONAVIR SAQUINAVIR NELFINAVIR AMPRENAVIR NEVIRAPINE 2000* DELAVIRDINE EFAVIRENZ * Generics manufactured in Brazil/year production commenced
SLIDE 11 *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/97 jul/97
jan/98 apr/98 jul/98
jan/99 apr/99 jul/99
jan/00 apr/00 jul/00
2N* 2N + PI 2N + NN 4 ARV
SLIDE 12
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
SLIDE 13 *Estimated data
Price evolution (in US$) of ARV for adults use with domestic production. Brazil (1996 - 2001)
Source: Ministry of Health/Brazil
1 2 3 4 5 6 7 8
AZT cap 100mg AZT/3TC ddI tablet 25mg ddI tablet 100mg 3TC tablet 150mg d4T cap 30mg d4T cap 40mg NVP tablet 200mg
1996 1997 1998 1999 2000 2001* Mean Reduction: 78%
SLIDE 14 *Prelimanary data
Mean Cost (in US $) per Patient-year of Antiretroviral Therapy. Brazil (1996 -2001)
Source: Ministry of Health/Brazil
3.320 2.530 4.860 3.810 4.540 4.240
1996 1997 1998 1999 2.000 2001*
Internal Produc.
1997 - 2001: 48% reduction
SLIDE 15
Brazilian MH & Merck Agreement on ARV Price Reduction (March, 2001)
64,8 % Price Reduction on Indinavir U$ 1.33/capsule U$ 0.47/capsule 59,0 % Price Reduction on Efavirenz U$ 2.05/capsule U$ 0.84/capsule
SLIDE 16
Governamental Laboratories Manufacturing ARV in Brazil
Far-Manguinhos/FIOCRUZ/Ministry of Health (45% of Total ARV National Production)
FURP (SP) LAFEPE (PE) FUNED (MG) IQUEGO (GO) IVB (RJ)
SLIDE 17 Far-Manguinhos
Pharmaceutical Production Pharmaceutical Formulation Industrial Area
400 people
Organic Synthesis Natural Products Pharmacology R&D 40 PhD 140 researchers Direction
SLIDE 18
Far-Manguinhos strategy for pharmaceutical production in AIDS
R&D of formulation using acquired drugs in the international market by lower price R&D of analytical methodology and standard reference Bio 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 -
SLIDE 19
Saquinavir Ritonavir Nevirapine for children Far-Manguinhos R&D Target areas Tuberculosis Trypanosomoses AIDS Malaria New developments in Far-Manguinhos for 2002 Far-Manguinhos R&D Main areas Natural Products Synthesis Pharmacology
2 research groups in new drugs Protease Inhibitors NNRTC inhibitors
