Xpert/Rif country rollout in the Philippines: impact and lessons - PowerPoint PPT Presentation

Xpert/Rif country rollout in the Philippines: impact and lessons learned Celia Carlos, MD Chief, Laboratory Research Division Research Institute for Tropical Medicine In behalf of the National TB Reference Laboratory

Outline  Strategy and algorithms used  Achievements and evidence of impact  Challenges encountered  Future plans

National GeneXpert Strategy  Rapid roll-out of GX from Metro Manila to regions (within the last Q of 2011)  GX positioned with or close to existing PMDT treatment and culture centers  National and sub-national/regional levels

Suspects, diagnostic algorithms  Suspect Selection Criteria: - all DR-TB patients:  retreatment cases with (+) DSSM results from quality assured MC  retreatment cases with (-) DSSM results from quality assured MC and active TB dx by RHU MD or TB dxtic committee  HIV TB suspect – newly started and only in 2 centers (RITM and SLH)*  symptomatic household contacts of any of the above 3 cases *HIV prevalence in Philippines = 1% of population

Suspects, diagnostic algorithms  Guidelines and SOPs developed  Revision of request, results forms, laboratory registers (NTRL revised the lab request forms and registers to include Gx results)

Diagnostic Algorithm with Xpert for MDR- TB (old) DOTS or MDR-TB suspects Private Sector (Sm + or X-ray +) Smear (-), Smear + but X-ray (+) Xpert MTB/RIF TB, RIF (+) TB, RIF (-) No TB (+ or -) S-ReTx for Retest/Further Tx for TB MDR-TB clinical Obs (Cat II) DST for FLD & SLD Individualized Tx Slide courtesy of Dr. WJ Lew

Case Finding Strategy in the Philippines National Gx Strategy Treatment Center or Satellite Treatment Treatment centers Quality Center Assured Laboratory R-res GX/Confirmed DRTB Identification and referral Category IV of suspects treatment GeneXpert, Screening, DSSM, TB Govt. DOTS facilities • assessment, Culture, DST Pvt. facilities/ referring • sputum health providers collection Hospitals • Treatment Sites (Peripheral • Health Centers)

Site selection for GeneXpert placement  Based on existing network of treatment and culture centers  At or near point-of-care  Treatment Center or Culture Center with:  adequate space: secure, ambient temperature  stable electrical power supply  continuous water supply  storage space for the cartridges  available staff (either organic or contractual)

Nationwide Distribution of Gx for PMDT  16 Gx centers all over the country (20 machines)  44 Treatment Centers/STC

PhilPACT Performance Target as of June 2012 PhilPACT target cases to detect and treat Cases detected Enrolled 18000 16000 Number of MDR - TB patients 14000 12000 10000 8000 6000 4000 2000 0 2010 2011 2012 2013 2014 2015 2016 PhilPACT target cases to detect 1174 3546 5918 8290 10662 13034 15406 and treat Cumulative cases detected Cases detected 522 1670 2694 Cumulative Enrolled Enrolled 601 1786 2690

2011-2012 Monthly cartridge consumption 1400 1200 Total monthly consumption 1000 per cartridge 800 600 400 200 0

GeneXpert results, 2012 DSSM RESULT POSITIVE NEGATIV RESULT GRAND E NOT TOTAL AVAILAB LE Number of DR-TB 1544 2905 8441 12,890 suspect tested Rif Resistant 679 (44%) 142(4.8%) 1263 2,084 Mtb (16%) Detected Rif 759 339 2131 3,229 Susceptible (25%) Indetermina 2 16 30 48 te (0.37%) Mtb not Detected 75 2371 4816 7,262 (56%) Error 28 32 192 252 (2%) Invalid 0 3 9 12(0.09%) Sub Total 1,543 2,903 8,441 12,887

Number of DR-TB suspect tested (N=12,890), 2012 Number of DR-TB suspect tested, 2012 (N=12,890) 252 12 (1.96%) (0.09%) 48 (0.37%)

484 29 2012 MDG TARGETS: Prevalence rate of 502/100,000; death rate of 24/100,000

Lessons learned  Using old algorithm, too many patients (26%) were started unnecessarily on Cat IV treatments without confirmation of drug resistance due to wide use of empiric treatment regimen  Using old algorithm resulted in too many backlogs for DST; -> molecular triaging to determine whether FL-DST only is required or FL and SL-DST needs to be implemented urgently  With Xpert, treatment delays decreased  Need to provide recalculations of PMDT enrolment targets according to 2 nd DRS results, existing epidemiological data, results of current experience in PMDT case finding data  importance of results of QA microscopy and GX in clinical decision-making

Challenges  National GeneXpert Strategy – bringing GX closer to patients (point-of-care) – sustaining the financial costs (courier) – High cost of calibration & annual calibration overdue – It is taking a long time for the coordination of the calibration between Cepheid and the local service provider – Macare  Clinical & Laboratory Algorithm: – need continuous review and analysis of data  Site Selection criteria for geographical expansion being developed through ─ planned operational research on cost-effective diagnostic tests  Human Resources - 80% of staff working in NTRL, culture centers, and GeneXpert sites are supported via Global Fund  Procurement, importation & registration – Currently no problem & being done by GF principal recipient but DOH needs to be able to carry out its own supply & logistics plan prior to end of GF funding

Challenges cont’d.  Infrastructure and quality of laboratories - cost of transport system - optimum procedure for quality assurance  Linking of diagnostic and clinical services - improving TAT to 24-48 hrs; results to be released by email followed by a hard copy  Training and Supervision: - to develop a monitoring plan for sites outside Metro Manila

Next Steps  Clinical & Laboratory Algorithm: – revise testing algorithm based on data gathered – establish molecular ‘triaging’ with only rifampicin-resistant isolates to receive SL-DST – operational research planned on cost- effective tests – Implementing treatment of MDR-TB only to confirmed MDR-TB cases

Xpert Test Results (January to December 2012) (44.0%) (4.8%)

Diagnostic Algorithm with Xpert for MDR- TB (New) DOTS MDR-TB suspects Private Sector (Sm+ or X-ray +) Smear (-), Smear + Re test but X-ray (+) RIF+ Xpert MTB/RIF TB, RIF (+) TB, RIF (-) No TB S-ReTx for Further Tx for TB MDR-TB clinical Obs (Cat II) DST for FLD & SLD Individualized Slide courtesy of Dr. WJ Lew Tx

Diagnostic Algorithm with Xpert for MDR- TB (old) DOTS or MDR-TB suspects Private Sector (Sm + or X-ray +) Smear (-), Smear + but X-ray (+) Xpert MTB/RIF TB, RIF (+) TB, RIF (-) No TB (+ or -) S-ReTx for Retest/Further Tx for TB MDR-TB clinical Obs (Cat II) DST for FLD & SLD Individualized Tx Slide courtesy of Dr. WJ Lew

Next Steps  Implement new diagnostic algorithm with Xpert for MDR-TB starting April 2013  Rollout: 1) around 10 Xpert machines for diagnosis of TB in pedia patients & extrapulmonary TB and other special situations (UNITAID) 2) 50 sites under NTP (external to PMDT program) in provinces and districts  Site Performance – review reason for low workload and potential for increasing workload in a sustained manner  Procurement, importation & registration – logistics for module replacement will need to be in place – need to strengthen supplies management to avoid stock out

Next Steps cont’d  Infrastructure and quality of laboratories - ensuring proper transport of specimens  Linking of diagnostic and clinical services – evaluate reasons for long TAT and how to reduce this – ensure quality of microscopy  Training and Supervision: – Integrate monitoring & evaluation in the Lab Subplan – Continuous proficiency of lab workers

Acknowledgments  NTRL: Dr. Noel Macalalad, Dr. Cecilia Ama  WHO: Dr. Woojin Lew  NTP: Dr. Rosalind Vianzon, Dr. Anna Celina Garfin