Changing the paradigm of Programmatic Management of Drug-resistant TB

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Republic of Moldova Changing the paradigm of Programmatic Management of Drug-resistant TB Liliana Domente, Elena Romancenco GLI / GDI Partners Forum WHO Global TB Programme Geneva 27-30 April 2015

Republic of Moldova Country in transition in Eastern Europe Regained independence after breakdown of the Soviet Union in 1991 The territory 33.8 thousand km2 Population density 117 people/ 1km 2 Population 4.062.787(2014) GDP per capita USD 2,239(2013) Births, 12,2 The mortality rate 14 Migration - up to 30% of the population of working age TB is a serious issue of public health

TB epidemic breakdown Indicator Value Year Case notification rate, per 100 000 inhabitants 99 2014 TB Mortality, per 100 000 inhabitants 12 2014 Case detection, all form, % 81 2013 Treatment success (TB susceptible ), % 78 2013 Follow up (TB susceptible ), % 6 2013 MDR rate among new TB cases, % 24 2014 MDR rate among retreatment TB cases, % 62 2014 Treatment success (MDR TB), % 58 2012 Follow up (MDR TB), % 20 2012

TB incidence and mortality Institute of Phthisiopneumology Chiril Draganiuc

MDR TB, new cases, retreatment, 2006 2014, % The burden of MDR-TB is among the highest in the world.

Reasons of the high burden of MDR-TB Inadequate TB case finding High community transmission Inadequate detection (late detection) Inadequate access to (rapid) diagnostics Inadequate treatment Lack of availability of the right SLDs Inadequate patient adherence High nosocomial transmission Long hospitalization Inadequate IC measures

National strategy Improve access to TB and M/XDRdiagnosis and treatment Scaling up of use of rapid diagnostics (GeneExpert, other) Introduction of quality assurance systems for laboratories Strengthening drug supply management Reform the TB services towards patient- centered ambulatory care models Masterplan for optimal use of hospitals Revision of the financing mechanisms for hospital and ambulatory care Re-deployment of hospital staff and capacity development of PHC Improve integrated systems for infection control Application of administrative IC measures Redesign of physical infrastructure for better ventilation, IV light etc. Implementation of a protection system for - and screening of health workers

Achievements in TB diagnosis Well developed TB laboratory network 4 laboratories of 3 rd level, 59 microscopy centers, sputum collection points Microscopy, culture (LJ, MGIT), DST to FLD and SLD; LPA Specimen transportation system Internal and external quality assurance Universal coverage with culturing and DST ensured

Challenges in TB diagnosis Delays in full diagnosis were common Delays in initiation of correct treatment according to resistance profile contributed to : 1.further spread of DR 2. amplification of DR

Changing the paradigm The goal - laboratory strengthening Maintain full and universal coverage with TB and MDR-TB diagnosis Increase the speed of diagnosing resistance Improve the link between diagnosis and treatment Totally 30 Gene Xpert instruments 25 in the civilian TB services 3 in penitentiary institutions 2 in AIDS Centers.

Achievements and Challenges based on project implementation Achievements Increased the accessibility to rapid methods for all new suspect TB cases: Decreased the time for laboratory confirmation Increased the microbiological confirmation Improved the correct detection of TB according the susceptibility spectrum Universal access to rapid method decreased the time for initiation of correct treatment Improved Infection Control measures Challenges A key problem at the initial stages - slow uptake of the new technology by clinical staff (at all levels) To train clinicians in correct understanding and usage of laboratories results Universal access to rapid method contributed to enrolling a high number of patients, but treatment coverage was limited.

Achievements in TB treatment Universal access to treatment of I and II line Involvement of PHC in the TB control activities Introducing bonuses for PHC personnel Involvement of NGOs and Community TB centres in the TB control activities Social and teatment support to patients

Challenges in TB treatment Prolonged and unjustified hospitalisation. Higher costs of hospital care Significant risks of re-infection and nosocomial transmission of MDR TB Inadequate patient adherence Socio-economic impact related to patients long absence from the household

Changing the paradigm Alternatives to hospitalisation Enhance social and treatment support to patients Important role of NGOs and Community TB centres

Out-patient MDR-TB care in R. Moldova A study evaluated the impact of an innovative MDR- TB management model combining rapid diagnostics with OP-based MDR-TB treatment and intensified patient support from 2012 to 2014. 43 cases were managed as IP as per standard approach and 38 started OP with a standardized MDR-TB regimen provided by the district TB clinic and PHC facility in two districts Funded via unrestricted grant to the Centre for Health Policy Studies (PAS) by Otsuka.

Rezults of the study No major differences were found between IP and OP risk factors and clinical characteristics The median time to MDR-TB treatment initiation after Xpert test results was 10 days for IP vs 6 for OP Sputum smear conversion (median time IP vs OP) was 28 vs 42 days Culture conversion was 56 vs 56 days comparing IP vs OP Treatment outcomes (IP vs OP) were as follows: cured 25.6% vs 24% failed 0 vs 2 died 1 vs 1 lost to follow-up 3 vs 3 still on treatment 28 vs 23 No treatment was interrupted or modified because of adverse events Conclusion The study results demonstrate that OP MDR-TB care is feasible providing results not inferior to IP in Moldova, reducing the risk of nosocomial transmission and stigma. It can be expanded in other countries of the Region.

Achievements and Challenges based on project implementation Achievments OP MDR-TB care is feasible providing results not inferior to IP Sputum conversion within a month was almost the same of OP and those who were hospitalised Combining the use of rapid methods of diagnosis and treatment in OP lead to reducing the risk of nosocomial transmission. Treatment OP conditions allow the patient to receive family support, reduce stigma, patient stays in family and continues the housework Hospitalization criteria were reviewed in national protocols Challenges Resistance of medical personnel due to overburden and lack of proper incentives Initial fear of doctors to treat TB in OP conditions Lack of experience at PHC level in monitoring TB treatment Challenges in ensuring adequate nutrition and additional support in case of adverse effects (Insufficient assurance with compensated drugs) Frequent problem for a good treatment compliance is high alcohol consumption Conflict of interest related to hospitalization of patients.

OP treatment vs IP treatment, 2012-2014 Institute of Phthisiopneumology Chiril Draganiuc

Next steps development of a strategic plan Plan for out-patient TB care to improve treatment The objectives: compliance in the Republic of Moldova 1.To enhance out-patient TB care 2.To improve performance of service providers in TB control 3.To ensure an effective support in out-patient TB service provision through incentives and enablers 4.To offer education to patients and out-patient TB service providers

Thank you! Institute of Phthisiopneumology Chiril Draganiuc