Manila, Dec.2014

NEW DRUGS INTRODUCTION IN VIETNAM – SHORT PROGRESS UPDATE

Summary

Process and activities done by steps

acording to implementation plan

Challenges and obstacles encountered

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

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

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)

PV methods in NTP

Spontaneous reporting

CohortEvent Monitoring

Since

1994

Since 2013

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.

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

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

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)

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

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

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

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)

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)

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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