Universal Access to Universal Access to Antiretroviral Therapy: - PowerPoint PPT Presentation

Universal Access to Universal Access to Antiretroviral Therapy: Therapy: Antiretroviral The Brazilian Experience The Brazilian Experience “universal and free of charge access to antiretroviral drugs” “treatment policy of AIDS” Ministry of Health National STD/AIDS Program

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.

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

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)

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

Computerized System for the Logistical Control of Drugs Civil Rights magnetic card Quality of Life

Distribution of Dispensary Units of Antiretroviral Drugs in Brazil - February, 2001. 1 1 1 2 3 5 3 1 1 5 3 2 8 9 3 9 9 3 3 1 30 10 TOTAL = 424 10 23 95 129 31 31

Networks of HIV Viral Load and CD4 + Lymphocytes Count - 2001 01 01 01 01 01 01 01 01 01 01 01 01 01 01 01 02 01 01 01 01 01 01 01 03 01 01 01 01 03 01 01 01 01 05 01 01 01 04 01 01 21 11 10 17 03 Viral Load = 63 Lab. 02 CD4 + Lymphocyte = 70 Lab. 03 03 05 06 Source: Ministry of Health

Number of HIV-infected patients on ARV treatment in the Brazilian Public Health System (Jan/97 - Dec/00) 100.000 90.000 80.000 70.000 60.000 50.000 40.000 30.000 20.000 10.000 0 7 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 9 0 0 0 0 0 0 9 9 9 9 9 9 0 0 9 9 9 9 9 9 9 9 9 9 9 9 0 0 0 0 / / / / / / / / / / / / / / / / / / / / / / / / l l l l n r y p v n r y p v n r y p v n r y p v u u u u a a a a a a e o a a e o a a e o a a e o j j j j m m m m m m m m j s n j s n j s n j s n

ARV distributed by Ministry of Health- - ARV distributed by Ministry of Health Brazil (May/2001) Brazil (May/2001) � ZIDOVUDINE (ZDV) 1993* � RITONAVIR � DIDANOSINE (ddI) 1998* � SAQUINAVIR � ZALCITABINE (ddC) 1997* � NELFINAVIR � LAMIVUDINE (3TC)1999* � AMPRENAVIR � STAVUDINE (d4T) 1997* � NEVIRAPINE 2000* � INDINAVIR 2000* � DELAVIRDINE � EFAVIRENZ * Generics manufactured in Brazil/year production commenced

Types of antiretroviral therapy receveid by patients in Brazil, by % (Jan1997 - Dec2000) 100% 80% 60% 40% 20% 0% jan/97 apr/97 jul/97 oct/97 jan/98 apr/98 jul/98 oct/98 jan/99 apr/99 jul/99 oct/99 jan/00 apr/00 jul/00 oct/00 2N* 2N + PI 2N + NN 4 ARV Source: Ministry of Health *Estimated data

Impact of Antiretroviral Therapy (1995 - 2000) � Reduced Mortality 40-70% 40-70% � Reduced Morbidity 60-80% Tb 360 in 1996 and 82 in 2000 � Reduced Hospitalization � 4x reduction � 234,000 avoided AIDS-related hospital admissons � Cost Savings U$ 677 million from 1997/2000

Price evolution (in US$) of ARV for adults use with domestic production. Brazil (1996 - 2001) 8 7 Mean Reduction: 78% 6 5 4 3 2 1 0 AZT cap AZT/3TC ddI tablet ddI tablet 3TC d4T cap d4T cap NVP 100mg 25mg 100mg tablet 30mg 40mg tablet 150mg 200mg 1996 1997 1998 1999 2000 2001* *Estimated data Source: Ministry of Health/Brazil

Mean Cost (in US $) per Patient-year of Antiretroviral Therapy. Brazil (1996 -2001) 4.860 4.540 4.240 3.810 Internal Produc. 3.320 2.530 1997 - 2001: 48% reduction 1996 1997 1998 1999 2.000 2001* Source: Ministry of Health/Brazil * Prelimanary data

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

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)

Far-Manguinhos Direction Industrial Area R&D 40 PhD 400 people 140 researchers Pharmaceutical Pharmaceutical Organic Synthesis Natural Products Pharmacology Production Formulation

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 -

New developments in Far-Manguinhos for 2002 � Saquinavir 2 research groups in new drugs � Protease Inhibitors � Ritonavir � NNRTC inhibitors � Nevirapine for children Far-Manguinhos R&D Far-Manguinhos R&D Target areas Main areas � Tuberculosis � Natural Products � Trypanosomoses � Synthesis � AIDS � Pharmacology � Malaria