Xpert/Rif country rollout in the Philippines: impact and lessons learned

Transcription

1 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

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

3 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

4 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

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

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

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

8 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)

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

10 Number of MDR - TB patients PhilPACT Performance Target as of June 2012 PhilPACT target cases to detect and treat Cases detected Enrolled PhilPACT target cases to detect and treat Cases Cumulative detected cases detected Enrolled Cumulative Enrolled

11 Monthly cartridge consumption Total monthly consumption per cartridge

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13 Sub Total 1,543 2,903 8,441 12,887 DSSM RESULT POSITIVE NEGATIV E Number of DR-TB suspect tested GeneXpert results, 2012 RESULT NOT AVAILAB LE GRAND TOTAL ,890 Mtb Detected Rif Resistant 679 (44%) 142(4.8%) ,084 (16%) Rif Susceptible ,229 (25%) Indetermina te (0.37%) Mtb not Detected ,262 (56%) Error (2%) Invalid (0.09%)

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

15 MDG TARGETS: Prevalence rate of 502/100,000; death rate of 24/100,

16 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

17 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

18 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 hrs; results to be released by followed by a hard copy Training and Supervision: - to develop a monitoring plan for sites outside Metro Manila

19 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 costeffective tests Implementing treatment of MDR-TB only to confirmed MDR-TB cases

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

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

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

24 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

25 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

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