Manila, Dec.2014 NEW DRUGS INTRODUCTION IN VIETNAM – SHORT PROGRESS UPDATE.
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Transcript of Manila, Dec.2014 NEW DRUGS INTRODUCTION IN VIETNAM – SHORT PROGRESS UPDATE.
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Manila, Dec.2014
NEW DRUGS INTRODUCTION IN VIETNAM – SHORT PROGRESS UPDATE
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Summary
Process and activities done by steps
acording to implementation plan
Challenges and obstacles encountered
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BDQ introduction/ Implementation planStep 1. Country’s readiness assessmentStep 2. Identification of partners involved (MOH, KNCV, WHO,
NI&ADR centers, CHAI)Step 3. Establishment of National Task Force and BDQ technical
working group Step 4: Development of national treatment plan for introduction of
BDQStep 5: Bedaquiline implementationStep 6: Generating evidence for scale up
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Step 1. country’s readiness assessment-Done
Country level Ha Noi Ho Chi Minh
Can Tho
Laboratory capacity x x x x
Clinical Review Committee
X (Nat, Tx Unit) x x x
Case management x x x x
Recording & reporting x x x x
Monitoring & Evaluation X (periodically, all levels, checklist)
x x x
Pharmacovigilance x x x x
Technical assistance X x x x
DRS X (4 times) x x x
Budget X (GF) x x x
Drug supply system x x x x
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Reporting and recordingPapers based R-R according to WHO’s report formsElectronic reporting system
VITIMES (DS-TB)e-TB manager (DR-TB): has piloted in HCM City and
expanded (at district level in HCMC and provincial level in other PMDT provinces)
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PV methods in NTP
Spontaneous reporting
CohortEvent Monitoring
Since
1994
Since 2013
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CEM in MDR-TB treatment
Timeline:
Activities 20132014 2015 2016
1 2 3 4 5 6 7 8 9 101112 1 2 3 4 5 6 7 8 9 101112 1 2 3 4 5 6 7 8 9 101112
Protocol and tools
Protocol approval
Training
Enrolment
Data collection, data input & patient management
Surveillance and supporting
Data analysis
Report
End up
Now
Study B6.1: AEs of anti-TB drugs in the treatment of MDR-TB in Vietnam.
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Step 2-3 (Done)
Step 2. Identification of partners involved (MOH, KNCV, WHO, NI&ADR centers, CHAI)
Step 3. Establishment of :National Task Force (Vice Minister,
representatives of MOH related departments, NTP)
BDQ technical working group
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Step 4: Development of national treatment plan for introduction of BDQ-Done
Selection of pilot sites (Hanoi, HCMC, Can Tho)
Update the treatment guidelines and training materials
Timeline developmentBudget: GF approval for the first 100
patients in 2015
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Update treatment guideline
Target group for BDQ introductionFQ resistance in MDR-TB patientsSecond line injectable resistance in MDR-TB
patientsXDR-TB patientsOthers:
Intolerate with SLDs in standard cat 4 regimenResistant to at least 2 group 4 drugs
(Cs,Pto/Eto,PAS)Use on top of treatment regiment per WHO
guidelines (companion handbook 2014)
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Timeline development
Actitities Q1 2014
Q2 2014
Q3 2014
Q4 2014
Q1 2015
Q2 2015 onwards
TWG meeting X X X X X XTask Force meeting X X XImplementation plan X XSubmission to MOH for approval X XDrugs order XUpdate the treatment guidelines and training materials
X X
Training for pilot sites XUpdate e-TB manager for BDQ X XDev. Of R-R and PV for BDQ X X XBudget X XPatients screening for treatment X X XTreatment initiation XTA Supervision X X X
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BDQ introduction process-Activities done
April 2013: 1st introduction workshop of new TB drug Bedaquiline (WHO – Viet Nam MOH – NTP)
February 2014: 2nd workshop about BDQ (WHO – MOH – NTP): country’s readiness assessment for BDQ implementing
April 2014: establishment and 1st meeting of Vietnam BDQ technical working group, 1st draft of National Implementation plan
June 2014: Global Fund approved budget for treatment with BDQ for the first 100 patients
June 2014: 1st draft of Clinical guidelines of using BDQ in MDR/pre-XDR and XDR-TB treatment
July 2014: MOH officially established the National Task force for implementing new TB drug (heading by Vice Minister and representatives from related departments of MOH, NTP)
August 2014: NTP in collaboration with Pharmacovigilance dept. of Hanoi Pharmacy University to prepare the CEM for ADRs of BDQ (B5.16)
September 2014: 3rd meeting of BDQ TWG: revise and finalize required document.
November 2014: Join the meeting on preparing for the introduction of new TB drugs & Inter-
regional workshop on PV 1st Task Force meeting: ways to prepare supporting documents to submit for
approval
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Step 5: Bedaquiline implementation
Hold advocacy and initiation workshops in 3 pilot provinces among NTP – Provincial People Committee – Department of health – Provincial TB hospital (Dec 2014)
Preparing 3 pilot sites: materials, equipment and trainings (patient screening, clinical management, active pharmacovigilance …- Jan 2015)
Place the order of drugs (Jan 2015)Patient screening and initiation: 1st patient
enrolled in BDQ treatment (2nd Q/2015)Monitoring treatment response Detection, management and reporting of adverse
events
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Step 6: Generating evidence for scale up
Minimum basic data set (compared with control groups)
Adverse events (harms) in individuals exposed to new drug% of patients treated with bedaquiline who experienced severe
adverse events (heart, liver)% of patients whose regimen need to be changed due to AE
Response to treatment (effectiveness)% of success rateTime to culture convertion% of patients who resistant to bedaquiline
Adhearance to treatment:% Default% interrupt using BDQ during 6 monthsPatient’s experience of using BDQ
KEY DATA FOR ASSESSMENT OF Bedaquiline IMPLEMENTATION (No screened, eligible, enrolled, Tx outcome, etc)
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AdvantagesStrong commitment of NTP leaders and pilot sites in
BDQ implementation in Vietnam. Establishment of National TF with representatives from MOH (powerful advocacy)
• Great technical support from partners, especially WHO (both head quarter and country office): experts, technical documents
• Budget for 1st 100 patients (including drugs, examinations and PV) has already been approved by the Global Fund
• Good collaboration with HN Pharmacy university in implementing pharmacovigilance activities for BDQ in the same time (also funded by the GF)
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Main challenges• BDQ is still in the phase III clinical trial
May delay in administrative procedures require stronger advocacy effort
• GF mainly supports drugs and examinations, still lack of funding for program cost and health system cost
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