Brazil - Stop TB Partnership
Transcription
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 • • • • • • • • • • • • • • • • 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 1 4 [email protected] 5