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”

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 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

Computerized System for the Logistical Control of Drugs

Civil Rights

Quality of Life

magnetic card

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

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

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

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

*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

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

*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%

*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

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 BrazilFar-Manguinhos/FIOCRUZ/Ministry of Health (45% of Total ARV National Production)FURP (SP)LAFEPE (PE)FUNED (MG)IQUEGO (GO)IVB (RJ)

Far-Manguinhos

PharmaceuticalProduction

PharmaceuticalFormulation

Industrial Area400 people

Organic Synthesis Natural Products Pharmacology

R&D40 PhD

140 researchers

Direction

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 -

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