Xpert MTB/RIF: early implementation experience Moldova (Republic - PowerPoint PPT Presentation

Xpert MTB/RIF: early implementation experience Moldova (Republic of) Dr. Andrei Mosneaga Director, Programs Management, Center for Health Policies and Studies (PAS Center) Dr. Liliana Domente NTP Manager / Director, Institute of Phtysiopneumology 5 th GLI meeting 1 Annecy, France, 16 April 2013

MDR-TB prevalence in new and re-treatment TB cases by WHO Regions, estimates based on latest available data (1994-2010), % 2 World: new – 3.4%, re-treatment – 19.8% Source: Zignol et al (2012)

MDR-TB prevalence in new and re-treatment TB cases by groups of countries of the WHO European Region (2008-2010), % 3 Source: Zignol et al (2012)

Republic of Moldova • ‘Country in transition’ in Eastern Europe • Regained independence after breakdown of the Soviet Union in 1991 • Territory: 33,846 sq.km • Population: 4.1 million • Including the separated region of Transnistria (0.52 million) • GNI per capita: USD 1,980 (2011) • Total number of notified TB cases, all forms (2012): 5,459 • Number of new TB cases (2012): 3,929 • Out of these, new SS+ cases: 1,380 • Case notification rate (new cases and relapses, 2012): 107 per 4 100,000 population • The burden of MDR-TB is among the highest in the world

Case notification rate (new cases and relapses), 1990-2012, per 100,000 5

MDR-TB prevalence among new and previously treated culture-positive cases, 2006-2011, % 6

Resistance profile among all TB cases (new and retreatment) with DST results in 2011, % 7

Full resistance pattern, 2011 New cases Retreatment Total Resistance profile Abs % Abs % Abs % Total number of patients with DST results 1,346 100.0 958 100.0 2,304 100.0 Sensitive to all 4 drugs 708 52.6 222 23.2 930 40.4 Any resistance: 638 47.4 736 76.8 1,374 59.6 Any resistance to H 494 36.7 676 70.6 1,170 50.8 97.6% of cases Any resistance to R 364 27.0 617 64.4 981 42.6 Any resistance to E 259 19.2 471 49.2 730 31.7 Any resistance to S 546 40.6 685 71.5 1,231 53.4 Mono-resistance: 184 13.7 61 6.4 245 10.6 H 51 3.8 15 1.6 66 2.9 with resistance to RIF R 8 0.6 5 0.5 13 0.6 E 17 1.3 6 0.6 23 1.0 S 108 8.0 35 3.7 143 6.2 H+R resistance (MDR-TB) 350 26.0 607 63.4 957 41.5 HR 10 0.7 16 1.7 26 1.1 (957 / 981) HRE 1 0.1 6 0.6 7 0.3 HRS 132 9.8 153 16.0 285 12.4 HRES 207 15.4 432 45.1 639 27.7 PDR H + other resistance 93 6.9 54 5.6 147 6.4 HS 65 4.8 39 4.1 104 4.5 are MDR HE 4 0.3 2 0.2 6 0.3 HES 24 1.8 13 1.4 37 1.6 PDR R + other resistance 6 0.4 5 0.5 11 0.5 RE 1 0.1 1 0.1 2 0.1 RS 5 0.4 2 0.2 7 0.3 RES 0 0.0 2 0.2 2 0.1 8 Other PDR 5 0.4 9 0.9 14 0.6 ES 5 0.4 9 0.9 14 0.6 Total PDR-TB 104 7.7 68 7.1 172 7.5 Total resistant to R but not MDR 14 1.0 10 1.0 24 1.0 Total MDR-TB 350 26.0 607 63.4 957 41.5

Challenges in TB (and DR-TB) diagnosis • Well developed TB laboratory network • 4 level III laboratories, >50 microscopy centers, sputum collection points • DSM, culture (LJ and automated MGIT), DST to FLD and SLD (conventional, MGIT, LPA), genotyping • Specimen transportation system • Internal and external quality assurance • Universal coverage with culturing and DST ensured • At the same time, substantial delays in full diagnosis are common • Delays in initiation of correct treatment according to resistance profile • It is considered that the above problems contribute to further spread and amplification of drug resistance • Therefore, the scope of laboratory strengthening is to: • Maintain full and universal coverage with TB and DR-TB diagnosis 9 • Increase the speed of diagnosis of resistance • Improve the link between diagnosis and treatmen t

Roadmap for rolling out Xpert MTB / RIF (WHO, December 2010) • The WHO evidence synthesis process confirmed a solid evidence base to support widespread use of Xpert MTB-RIF for detection of TB and rifampicin resistance. • Xpert MTB/RIF should be used as the initial diagnostic test in individuals suspected of MDR-TB or HIV-associated TB (strong recommendation) • Bridging these recommendations to the country situation, Moldova applied to TB REACH in Wave 2 for introduction of Xpert MTB/RIF technology (February 2011) • The project started in January 2012 (Year 1 budget USD 10 0.93 million)

Moldova TB REACH project • Focuses solely on Xpert MTB/RIF • The scope and objectives: • Rapid rollout of Xpert MTB/RIF to peripheral (district) level • Addressing the needs of populations at risk and with limited access to services: prisoners, PLHIV, Transnistria population • “ Additionality ” is seen primarily in increased bacteriological confirmation and rapid detection of RIF resistance (MDR), not in detecting more patients • 17,000 tests (cartridges) for Year 1; totally 25 Xpert instruments: • 20 in the civilian TB services • 3 in penitentiary institutions • 2 in AIDS Centers • Population coverage in Year 1: 56% (14 ‘Evaluation areas’) 11 • The instruments are placed at the level where the diagnosis of TB is established; no specimen transportation for Xpert testing

Location of Xpert instruments Year 1 12

Number of tests by quarter, all sites, abs. 13

Number of tests by month, all sites, abs. 14

Share of invalid tests by quarter, all sites, % of total tests 15

Xpert positivity rate by quarter, all sites (MTB+ results as % of total valid results) 16

Xpert added value (yield) to smear microscopy by quarter (ss- results as % of MTB+ GX results with valid microscopy results) 17

MDR-TB prevalence by quarter (% of RIF R results among total MTB+ GX results), ALL cases, % 18

Share of HIV+ results by quarter (% of HIV positive results among MTB+ GX results with valid HIV test results) 19

‘ Additionality ’ in bacteriological confirmation by Xpert in 14 project sites (2012 compared to 2011, by quarter) Overall ‘ additionality ’ in confirmation in 14 project areas: 333 cases, or 27.9% 20

Key conclusions based on early implementation experience • A precise and reliable technology, fully relevant to the country context • Substantial lead time was required to start (logistics), taking into account the number and specifics of project sites • A key problem at the initial stages had been slow uptake of the new technology by staff (at all levels) • Currently, there is full acceptance and use of the technology at all sites, and the productivity reaches the targets • In Moldova settings, Xpert MTB/RIF looks as a good trigger for system changes promoting patient-centered 21 approaches

Future plans • Reach 100% population coverage and 100% ‘productivity’ in 2015 • Ensure full observation of the new diagnostic algorithm • Align with treatment pathways at all levels and changes in care delivery model (i.e. outpatient treatment) • Ensure (at least through 2015) external funding for expansion and uninterrupted supply: • TB REACH Year 2 / UNITAID • EXPAND TB / TB EXPERT (?) • Global Fund (??) • Secure domestic funding for full coverage of the needs (negotiations with MOH and the National Health Insurance Fund underway, but will not feasible until 2015 at the 22 earliest)

An issue regarding (new) TB diagnostics • It looks like an idea of ‘stopping’ diagnosing more DR -TB patients is not a joke anymore! • Are we really serious… • from epidemiological point of view? • from ethical point of view? • from programmatic point of view? • IMPORTANT – in former Soviet Union countries with extremely high M/XDR-TB burden, consciousness about the very high (and probably intolerable in many instances) upcoming costs of treatment should motivate the decision makers to undertake real steps for preventing resistance (first of all regarding hospitalization practices ) • So, should we scale up our advocacy efforts to solidify 23 commitments and programs’ performance or ration the use of diagnostics to keep the indicators comfortable?..