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 16 th 2013
Brazil: factsheets Surface: 8,514,877 km² (5 th largest country) States : 27 Borders: Argentina, Bolivia, Colombia, French Guyana, Guyana, Paraguay, Peru, Suriname, Uruguay and Venezuela Population (2011): 192,376,496 inhab. (5 th largest population) Urban population : 83,8% GNP (2011): - Total: US$ 2,421 trillons USD (6 th ) - Per capita: US$ 12,422 USD (63 rd ) Social indicators - HDI (2011): 0,718 (84 th ) - Life expectancy: 73,5 year (92 nd ) - Child mortality: 19,3/thousand (106 th ) - Literacy: 90,4% (94 th ) Brazilian Health System – universal access, free of charge
Brazil: factsheets Surface: 8,514,877 km² (5 th largest country) States : 27 Borders: Argentina, Bolivia, Colombia, French Guyana, Guyana, Paraguay, Peru, Suriname, Uruguay and Venezuela Population (2011): 192,376,496 inhab. (5 th largest population) Urban population : 83,8% GNP (2011): - Total: US$ 2,421 trillons USD (6 th ) - Per capita: US$ 12,422 USD (63 rd ) Social indicators - HDI (2011): 0,718 (84 th ) - Life expectancy: 73,5 year (92 nd ) - Child mortality: 19,3/thousand (106 th ) - Literacy: 90,4% (94 th ) 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. • 17 th country in the WHO high burden list (111 th 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% • 4 th leading cause of death between infectious diseases • 1 st 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 Xpert MTBRIF Global Xpert MTB/RIF Country Purchase Cartridges ~1,9 million cartridges South Africa 590,000 Kenya 40,000 966 GeneXpert Systems India 36,000 5,017 modules Brazil 33,000 (~45,000) 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 Sept 2012 Feb 2012 Sept 2012 Feb 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 4 th 2012 • End date: October 4 th 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 Total Samples in Control Period Intervention (n=16,436) (n=18,322) Samples Samples NOT Samples Samples NOT contributing to contributing to contributing to contributing to control phase control phase (n= Intervention phase intervention phase ( n=11,705 ) 4,731 ) ( n=12,522 ) (n=5,800) Follow-up samples (n-2,621) Follow-up samples (n=1,124) Smears only (n=2,170) Not residents (n=76) Not residents (n=156) - < 1 ml - 1.151 (7.5%) Duplicates (n=3,177) - Inadequate – 200 (1.3%) Duplicates (n=736) Missing age (n=354) - Others – 819 (5.3%) 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$/2012) Cost category Health care facility I Health care facility II Health care facility III (Rio de Janeiro) (Rio de Janeiro) (Manaus) Smear Xpert Smear Xpert Smear Xpert 1,22 2,04 1,37 1,97 1,04 0,99 Overhead 0,88 1,46 0,15 0,22 0,07 0,06 Building space 0,61 1,86 0,39 1,85 0,33 1,00 Equipments 2,53 1,81 1,83 1,47 7,74 6,47 Staff 1,15 10,74 1,15 10,74 1,15 10,74 Reagents, Chemicals and Consumables 6,38 17,90 4,89 16,24 10,32 19,26 Total cost
Cost-Effectiveness Study Preliminary findings Test Mean Cost in US$ 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 result s, 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 87,1 87,1 86,1 86,2 86,2 90 85,1 84,6 83,0 83,2 82,6 82,7 80 70 60 66,3 66,4 65,6 65,5 65,2 65,0 63,7 62,7 62,7 62,6 62,4 50 40 30 20 10 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 % 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 36,5 34,1 35 26,8 30 24,6 22,9 25 20,1 16,9 20 15,0 14,2 12,8 12,5 15 10 5 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 Year Source: MS / SINAN. * Preliminary data, subject to revision. Achieved= positive + negative
Percentage of culture held among TB pulmonary cases. Brazil, 2001-2011*. % 50 45 40 35 30 23,5 22,5 25 18,8 20 16,8 15,9 14,0 12,5 15 10,9 10,3 9,4 9,0 10 5 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 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 24,3 22,8 25 21,3 20,4 19,2 20 17,0 16,9 16,9 16,6 15,8 15,7 15 10 5 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 Year Source: MS / SINAN. * Preliminary data, subject to revision. Achieved= positive + negative
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
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