Draurio Barreira, MD National Coordinator - NTP/MoH Brazil Annecy, - - PowerPoint PPT Presentation

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 51,8 36,1

10 20 30 40 50 60 70

Incidência

Cumulative number of Gene Xpert instrument modules and Xpert MTB/RIF cartridges procured under concessional pricing

Country Xpert MTB/RIF Cartridges South Africa 590,000 Kenya 40,000 India 36,000 Brazil 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)

PI: Betina Durovni Rio de Janeiro Health Department, Brazil

IMPACT STUDY

Study sites Rio de Janeiro and Manaus

* MoH data, Brazil, 2011, per 100.000 inhabitants

To estimate, in the routine of public health facilities

• f 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

Objectives

Study Design Randomized stepped-wedge

Feb 2012 Sept 2012 Feb 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

• 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.

Study Population Coverage

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 contributing to control phase (n=11,705 ) Samples NOT contributing to control phase (n= 4,731) Follow-up samples (n=1,124) Not residents (n=76) Duplicates (n=3,177) Missing age (n=354) Total Samples in Intervention (n=18,322) Samples contributing to Intervention phase (n=12,522) Samples NOT contributing to intervention phase (n=5,800) Follow-up samples (n-2,621) Smears only (n=2,170) Not residents (n=156) Duplicates (n=736) Missing age (n=117)

• < 1 ml - 1.151 (7.5%)
• Inadequate – 200 (1.3%)
• Others – 819 (5.3%)

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

Preliminary Findings Incidence Rate Ratio

Secondary Findings Resistance data

• 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 Operational Findings

Preliminary findings

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 summary by category (US$/2012)

COST-EFFECTIVENESS STUDY

Cost-Effectiveness Study Preliminary findings

Test Mean Cost in US$

Smear 7,20 (14,40) Xpert 17,80

• 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.

Qualitative methodology

ACCEPTABILITY STUDY

• 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

Summary of findings

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

Challenges

%

Year

Percentage of sputum microscopy performed and positive among new pulmonary TB cases. Brazil, 2001-2011*.

Source: MS / SINAN. * Preliminary data, subject to revision. Achieved= positive + negative

82,6 82,7 83,0 83,2 84,6 85,1 86,1 86,2 86,2 87,1 87,1 62,4 62,7 62,7 62,6 63,7 65,2 65,6 65,5 65,0 66,3 66,4

10 20 30 40 50 60 70 80 90 100

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 % Achieved % Positive

%

Year

Percentage of culture held among retreatment cases of TB. Brazil, 2001-2011*.

Source: MS / SINAN. * Preliminary data, subject to revision. Achieved= positive + negative 12,5 12,8 14,2 15,0 16,9 20,1 22,9 24,6 26,8 34,1 36,5

5 10 15 20 25 30 35 40 45 50

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

%

Year

Percentage of culture held among TB pulmonary cases. Brazil, 2001-2011*.

Source: MS / SINAN. * Preliminary data, subject to revision. Achieved= positive + negative

9,0 9,4 10,3 10,9 12,5 14,0 15,9 16,8 18,8 22,5 23,5

5 10 15 20 25 30 35 40 45 50

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

%

Percentage of culture conducted among TB-HIV cases. Brazil, 2001-2011*.

Source: MS / SINAN. * Preliminary data, subject to revision. Achieved= positive + negative

Year

15,8 16,9 15,7 16,6 16,9 17,0 19,2 20,4 21,3 22,8 24,3

5 10 15 20 25 30 35 40 45 50

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

• 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

Plans…

Strategy for Rapid Test Roll Out - Brazil

CRITERIA (Technical Group)

• All the Brazilian Capitals and cities with more than 200 new TB cases

notified in 2011

• Cities that have prisons with laboratory infrastructure which have a high

demand of smear sputum (around 2,000 per year)

• Cities at the border and/or with indigenous population (> 50 new TB cases

in 2011)

• 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)

• 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

Acknowledgements

1 4 5

draurio.barreira@saude.gov.br

Visit our website for further information: www.saude.gov.br/tuberculose