Brazil - Stop TB Partnership

Brazilian Ministry of Health
Secretariat of Health Surveillance
National Tuberculosis Program
From Data to Scale-Up: Building on the
Evidence Base for New TB Diagnostics
Draurio Barreira, MD
National Coordinator - NTP/MoH – Brazil
Annecy, April 16th 2013
Brazil: factsheets
Surface: 8,514,877 km² (5th largest country)
States: 27
Borders: Argentina, Bolivia, Colombia, French
Guyana, Guyana, Paraguay, Peru, Suriname,
Uruguay and Venezuela
Population (2011): 192,376,496 inhab. (5th largest
population)
Urban population: 83,8%
GNP (2011):
- Total: US$ 2,421 trillons USD (6th)
- Per capita: US$ 12,422 USD (63rd)
Social indicators
- HDI (2011): 0,718 (84th)
- Life expectancy: 73,5 year (92nd)
- Child mortality: 19,3/thousand (106th)
- Literacy: 90,4% (94th)
Brazilian Health System – universal access, free of
charge
Brazil: factsheets
Surface: 8,514,877 km² (5th largest country)
States: 27
Borders: Argentina, Bolivia, Colombia, French
Guyana, Guyana, Paraguay, Peru, Suriname,
Uruguay and Venezuela
Population (2011): 192,376,496 inhab. (5th largest
population)
Urban population: 83,8%
GNP (2011):
- Total: US$ 2,421 trillons USD (6th)
- Per capita: US$ 12,422 USD (63rd)
Social indicators
- HDI (2011): 0,718 (84th)
- Life expectancy: 73,5 year (92nd)
- Child mortality: 19,3/thousand (106th)
- Literacy: 90,4% (94th)
Brazilian Health System – universal access, free of
charge
Tuberculosis in Brazil
Overview – 2011
• 70 thousands new cases reported in 2012
• Incidence rate 36,1 per 100,000 inhab.
• 17th country in the WHO high burden list (111th country in
world list)
• 4,600 deaths per year
• MDR prevalence among new cases 1.4% (survey 2008/09)
• TB-HIV co-infection in new cases 9.7%
• 4th leading cause of death between infectious diseases
• 1st cause of death in patients with HIV/AIDS
TB incidence Rate
Brazil 1990-2012
By 100.000 inhabitants
70
60
51,8
50
40
36,1
30
20
10
0
Incidência
Cumulative number of Gene Xpert instrument modules and Xpert
MTB/RIF cartridges procured under concessional pricing
Country
Xpert MTB/RIF
Cartridges
South Africa
Kenya
India
Brazil
590,000
40,000
36,000
33,000 (~45,000)
Xpert MTBRIF Global
Purchase
~1,9 million cartridges
966 GeneXpert Systems
5,017 modules
77 countries (among 145 eligible
for concessional pricing)
IMPACT STUDY
PI: Betina Durovni
Rio de Janeiro Health Department, Brazil
Study sites
Rio de Janeiro and Manaus
* MoH data, Brazil, 2011, per 100.000 inhabitants
Objectives
To estimate, in the routine of public health facilities
of two municipalities in Brazil, the impact of the
implementation of the Xpert MTB/Rif assay on:
• the case detection of pulmonary TB
• the detection of MDR-TB
Study Design
Randomized stepped-wedge
Feb 2012
Feb 2012
Sept 2012
Sept 2012
Control / Intervention
• Control data: collected on routine smear
microscopy performed during baseline
• Intervention: introduction of the Xpert MTB/Rif
assay as replacement of sputum smear
microscopy in routine health care settings.
• Start date: February 4th 2012
• End date: October 4th 2012
Study Population
Coverage
• Rio de Janeiro: 100% coverage of
the population
The Xpert MTB/Rif assay was introduced at each of
the 11 district laboratories that provide sputum smear
microscopy in the city.
• Manaus: approx. 70% coverage of
the population
The Xpert MTB/Rif assay was introduced at 3 laboratories
linked to Municipal and State level governments.
Intervention algorithm
Data Sources
Study used routine public health
data systems
 GAL (National lab-based register database)
– Primary source for this analysis
 SINAN (National Disease Surveillance
Reporting System) – Preliminary results,
SINAN still being analyzed
IEC materials and training
Preliminary Findings
Number of samples contributing
to the analysis
14
Labs Participating in
the Study
Total Samples in
Control Period
(n=16,436)
Samples
cont ribut ing to
control phase
(n=11,705 )
Total Samples in
Intervention
(n=18,322)
Samples NOT
contributing to
control phase (n=
4,731)
Samples
contributing to
Intervention phase
(n=12,522)
Samples NOT
cont ribut ing t o
intervention phase
(n=5,800)
Follow-up samples
(n-2,621)
Follow-up samples
(n=1,124)
Smears only
(n=2,170)
Not residents (n=76)
Duplicates (n=3,177)
Missing age (n=354)
- < 1 ml - 1.151 (7.5%)
- Inadequate – 200 (1.3%)
- Others – 819 (5.3%)
Not residents (n=156)
Duplicates (n=736)
Missing age (n=117)
Preliminary Findings
Incidence Rate Ratio
Incidence Rate Ratio of positive pulmonary TB diagnosis per 100,000
person/years, comparing control and intervention phases, crude and
random effects models.
Source: GAL, RJC and Manaus
Secondary Findings
Resistance data
Operational Findings
 Human resources: no changes in required
work force
 Training: short learning curve in lab
 Equipment capacity limitations: addressed
by adjustments in working process
 Gaps in technical support: delayed
replacement of defective modules
 Samples: unexpected number of insufficient
samples
COST-EFFECTIVENESS STUDY
Preliminary findings
Cost summary by category (US$/2012)
Cost category
Health care facility I
(Rio de Janeiro)
Health care facility II
(Rio de Janeiro)
Health care facility III
(Manaus)
Smear
Xpert
Smear
Xpert
Smear
Xpert
Overhead
1,22
2,04
1,37
1,97
1,04
0,99
Building space
0,88
1,46
0,15
0,22
0,07
0,06
Equipments
0,61
1,86
0,39
1,85
0,33
1,00
Staff
2,53
1,81
1,83
1,47
7,74
6,47
Reagents, Chemicals
and Consumables
1,15
10,74
1,15
10,74
1,15
10,74
Total cost
6,38
17,90
4,89
16,24
10,32
19,26
Cost-Effectiveness Study
Preliminary findings
Test
Mean Cost in US$
Smear
7,20 (14,40)
Xpert
17,80
ACCEPTABILITY STUDY
Qualitative methodology
• Patients reported a marked reduction in the interval
between initial clinical diagnosis and laboratory
confirmation (with smear most cases approx. 2 weeks,
now approx. 3 days).
• Clinical diagnoses tended to lead to treatment before
confirmatory results, even after implementation of
the new technology.
• There was no identifiable resistance to the new
technology among lab technicians, possibly because
they are still in charge, despite changes in workflow.
Summary of findings
• Preliminary results indicate Xpert MTB/Rif increases
detection of TB cases in this routine setting by 34%,
compared to smear microscopy
• Accepted by lab staff despite changes to routine
• Detection of resistance to Rif was valuable TB control tool
• Impact on time to treatment start and case reporting still
pending for analysis
• Operational challenges remain, but are not barriers to
implementation
• Xpert MTB/Rif likely to be cost-effective in Brazilian
context
• Improved detection is key to addressing the realities of our
TB epidemic
Challenges
Smear microscopy
• We perform smear microscopy from 87,1% of pulmonary TB
• From which we got positive results for 66,4%
• It means positive bacteriological confirmation for 57,8% of all
TB pulmonary cases (42,2% with no evidence of BK+)
• Besides that, in Rio e Manaus we would lost 34% of TB
cases as false negative!
Sputum culture
• We perform sputum culture of 36,5% of retreatment TB
cases
• Only 23,5% of total pulmonary TB cases
• And 24,3% of people living with HIV
Percentage of sputum microscopy performed and
positive among new pulmonary TB cases. Brazil,
2001-2011*.
%
100
90
85,1
86,2
87,1
83,2
84,6
87,1
83,0
86,2
82,7
86,1
82,6
62,7
62,6
65,2
65,6
65,5
65,0
66,4
62,7
63,7
66,3
62,4
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
80
70
60
50
40
30
20
10
0
% Achieved
% Positive
Year
Source: MS / SINAN. * Preliminary data, subject to revision. Achieved= positive + negative
Percentage of culture held among
retreatment cases of TB. Brazil, 2001-2011*.
%
50
45
40
34,1
35
30
22,9
25
26,8
20,1
20
15
24,6
36,5
12,5
12,8
14,2
2001
2002
2003
15,0
2004
16,9
10
5
0
2005
2006
2007
2008
Year
Source: MS / SINAN. * Preliminary data, subject to revision. Achieved= positive + negative
2009
2010
2011
Percentage of culture held among
TB pulmonary cases. Brazil, 2001-2011*.
%
50
45
40
35
30
25
20
15
10
9,0
9,4
10,3
10,9
2001
2002
2003
2004
12,5
14,0
15,9
16,8
2007
2008
22,5
23,5
2010
2011
18,8
5
0
2005
2006
2009
Year
Source: MS / SINAN. * Preliminary data, subject to revision. Achieved= positive + negative
Percentage of culture conducted among
TB-HIV cases. Brazil, 2001-2011*.
%
50
45
40
35
30
25
20
19,2
15,8
16,9
2001
2002
15,7
16,6
16,9
17,0
2003
2004
2005
2006
20,4
21,3
2008
2009
22,8
24,3
15
10
5
0
2007
Year
Source: MS / SINAN. * Preliminary data, subject to revision. Achieved= positive + negative
2010
2011
Plans…
• Replace all diagnostic smear microscopy in Brazil
by Xpert MTB Rif
• Create a network of sentinel surveillance for
TBMR
• Monitor the pattern of resistance of TB/HIV
• Implement national lab-based register database
everywhere with Xpert MTB Rif
• Expand the liquid culture to accelerate access the
results
• Expand culture to support implementation of
Xpert MTB Rif
Strategy for Rapid Test Roll Out - Brazil
CRITERIA (Technical Group)
o All the Brazilian Capitals and cities with more than 200 new TB cases
notified in 2011
o Cities that have prisons with laboratory infrastructure which have a high
demand of smear sputum (around 2,000 per year)
o Cities at the border and/or with indigenous population (> 50 new TB cases
in 2011)
o Central Public Health Laboratories (LACEN) with significant demand of
smear sputum
 Total of cities identified = 66
 These cities account for more than 60% of the TB burden in Brazil
 We estimate around 120 GX machines and 400,000 cartridges for
implementation
Diagnosis through TB Rapid Test in Adults and Teenagers
(over 10 years old)
Acknowledgements
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Alexandre Menezes
Anete Trajman
Betina Durovni
Carla Ribeiro Guedes
Cristiane Thiago
Frank Cobelens
Kenneth Camargo
Larissa de Siqueira Fernan
Márcia Pinto
Michael Kimmerling and the support of the Gates
Foundation
Raphaella Fagundes Daros
Ricardo Steffen
Rosângela Caetano
Susan van der Hoff
Valeria Saraceni
Xpert Rollout team
Visit our website for further information:
www.saude.gov.br/tuberculose
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draurio.barreira@saude.gov.br
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