Multidrug-Resistant TB Diagnosis Treatment Linking Diagnosis and Treatment Charles L. Daley, M.D. National Jewish Health University of Colorado Denver
Disclosures Chair, Data Monitoring Committee for delamanid trials in adults (Otsuka) Member, Data Monitoring Committee for delamanid trials in children (Otsuka)
MDR-TB Linking Diagnosis and Treatment Gaps in Global TB Control The Gap Between Diagnosis and Treatment Exploring the Gap Closing the Gap
Gaps in Global MDR-TB Control Reporting Gap Diagnosis Gap Treatment Gap Outcome Gap Success Gap 480,000 estimated new cases 300,000 (63%) estimated cases among notified TB patients 136,000 (45%) notified MDR-TB patients 97,000 (71%) started on treatment 52,206 had outcomes reported (2011) (84%) 48% treatment success 25% lost or no data Includes: Notified cases Diagnosed but not notified Not yet diagnosed with TB 39,000 on waiting lists Only 6% of estimated MDR- TB among notified cases were treated successfully
RR-/MDR-TB notification and enrolment MDR-TB cases and additional rifampicin-resistant TB cases detected (orange) compared with TB cases enrolled on MDR-TB treatment (turquoise), global trend and trend in 27 high MDR-TB burden countries, 2009 2013
DST Coverage Among New Bacteriologically Confirmed Cases Target Actual Global Tuberculosis Report 2014
DST Coverage in Previously Treated Cases Global Tuberculosis Report 2014
Evolution of Testing for MDR-TB Decentralization Phenotyping: Solid Culture Phenotyping: Liquid Culture Genotyping: Line Probe Genotyping: Xpert MTB/RIF 2006 2007 2008 2010 2012
Xpert MTB/RIF Cartridges and Modules Procured
Enrolment on MDR-TB Treatment Target Actual Global Tuberculosis Report 2014
Enroled on MDR-TB Treatment/Estimated MDR-TB Among Notified Pulmonary TB Falzon D, et al. Lancet 2013;13:690
Why the Gap? A Gap Analysis Lab Diagnosis Treatment Technology used for testing Diagnostic and treatment facilities are separate Poor communication Lack of diagnostic/treatment algorithms Physicians do not "trust" rapid test results MDR-TB Treatment Committee Review Unavailability of second-line drugs Treatment capacity is limited (requires hospitalization) Patient delays and refusing therapy Patient
Many Causes for the Gap Beyond the Labaratory Laboratory delays Technology Communication of results Provider delays Lack of algorithms Distrust of results Patients delays Delay in returning Refusal of treatment Program delays Lack of electronic recording and reporting Centralized treatment Lack of availability of second-line drugs
Time from Sputum Collection to Treatment Decision, Lima Peru 5 months Yagui M, et al. Int J Tuberc Lung Dis 2006:10:838
Time to Detection of Rifampicin Resistance with MTB/RIF, LPA, Phenotypic DST >7000 patients screened at: Primary health care clinics South Africa, Peru, India Drug resistant TB screening facilities Azerbaijan, Philippines Emergency room Uganda Boehme CC, et al. Lancet 2011:377:1495
Proportion and Time of Results Reported to Clinics from Date of First Sputum Boehme CC, et al. Lancet 2011:377:1495
MDR-TB Treatment Commencement Time (sample taken to treatment initiated) 10/29 high burden primary health facilities, Capetown Initiation of MDR-TB Treatment LPA Median (95% CI): 43 (40-46) Xpert Median (95% CI): 17 (13-22) Naidoo P, et al. PLoS ONE 2014:e103328
Median Time Delay by Drug Susceptibility Testing Methods, Days Jacobson KR, et al. CID 2013;56:503
Barrier Poor Communication Algorithms Distrust of results from rapid test Closing the Gap Beyond the Laboratory Possible Intervention Electronic reporting of results to provider and program (and patient?) Development and validation of protocols in different epidemiologic and clinical settings Provider education Lack of availability of QA SLD Government commitment, Global Drug Facility Limited treatment capacity Patients delays Government commitment, Decentralization of services Patient/family education, Patient-centered care
Linking Diagnosis and Treatment Diagnosis Treatment GLI GDI Earlier treatment means: Less patients will be lost to follow-up Less transmission to others Less morbidity Less mortality
Global Laboratory Initiative (GLI) Priority activities for 2013-2014 are to: strengthen laboratory capacity and infrastructure in resource-limited areas support the global scale-up of rapid diagnostics and improve quality of individual laboratories and laboratory networks
GDI - Global Drug-resistant TB Initiative
GDI - Global Drug-resistant TB Initiative Facilitate integration and coordination of efforts to align diagnostic services for patients with access to high-quality care Develop targeted advocacy strategies and resource mobilization for DR- TB management scale-up Build global consensus on the management of DR-TB for patient-centred care delivery ("care for cure") Promote strategies to facilitate patient access to high-quality DR-TB care through a long-term, in-country capacity building approach Facilitate effective knowledge sharing among partners and harmonise coordination with existing technical assistance mechanisms Support prioritization of research to generate evidence for PMDT
GDI - Global Drug-resistant TB Initiative Facilitate integration and coordination of efforts to align diagnostic services for patients with access to high-quality care Develop tool to standardize the evaluation of the diagnostic and treatment GAP at country level Pilot the tool in 5 high burden MDR-TB countries Use tool to evaluate all high burden countries Develop country specific interventions to close the gap Goal: Get all detected MDR-TB cases on QA regimens
Global MDR-TB Treatment Outcomes, 2011 Cohort Global Tuberculosis Report 2014
GLI and GDI Newsletters
MDR-TB Linking Diagnosis and Treatment GLI and GDI Joint Partners Forum For Strengthening And Aligning TB Diagnosis And Treatment April 27-30 Geneva, Switzerland