Xpert MTB/RIF Roll Out in Indonesia Interim ReportInterim Report

Bachti Alisjahbana, Sanne van Kampen, Santo Nugroho, Shinta, Sumanto Simon, Diah E. Mustikawati

TORG Indonesian National TB Program

KNCV / TB CARE IC / C

Indonesia

TB Situation in Indonesia

• 4th Highest TB case load world wide? MDR TB • ? MDR TB,

• Very few MDR-TB on treatment

• HIV concentrated epidemic• Very few confirmed TB (~ 4% in HIV cohort)• Very few confirmed TB ( 4% in HIV cohort)

TB CARE I GeneXpert Core Project Indonesia:Indonesia:1. Intensified introduction of Xpert MTB/RIF in 3 selected

countries: Nigeria Vietnam Indonesiacountries: Nigeria, Vietnam, Indonesia2. Document lessons learnt and collect evidence for further

planning and scaling up of Xpert MTB/RIF

Input▫ Xpert machines , 1,700 cartridges ▫ TA for roll out in coordination with NTP incl site▫ TA for roll-out in coordination with NTP, incl. site▫ Assessments, training, supervision, M&E ▫ Op. Research Monitoring implementation and collecting evidence for further scale-

up of Xpert in collaboration with local research group (TORG)

Operational research objective

Key research question & outcomes

Operational research objectiveBased on the WHO ‘Rapid Implementation’ (March 2011)

Key research question & outcomes

What is the impact of Xpert on programmatic outcomes related to TB & MDR TB diagnosis and

Expected key outcomes:

outcomes related to TB & MDR-TB diagnosis and treatment among high risk groups?

Expected key outcomes:1. Increased TB and MDR-TB case notification2. Increased TB and MDR-TB treatment initiation3 R d ti i h lth t d l3. Reduction in health system delays4. Additional yield of Xpert over smear microscopy5. Reliability of Xpert as marker for MDR-TB

Methodology• Pre-Post comparative analysis• Outcome 1-3: Comparing retrospective to prospective▫ Retrospectve: March – August 2011 data (no Xpert)

P i M h A 2012 ( i h X )▫ Prospective: March - August 2012 (with Xpert)▫ # diagnosed ▫ # starting on treatment

• Comparative analysis• Outcomes 4-5: Comparing Xpert with conventional

TB HIV X t Zi hl N l▫ TB HIV: Xpert vs. Ziehl Neelsen▫ MDR TB: xpert vs. Culture (MGIT & LJ)▫ # additional yield by Xpert▫ # sens-spec for MDR detection▫ # sens-spec for MDR detection

Algorythm of the MDR TB CategoryAlgorythm of the MDR TB Category

MDR TB suspecMDR TB suspec(AFB pos)

Sputum microscopy (morning & spot)Xpert Mtb/Rif

TB Pos (R Sen) TB Pos (R Res) Negative/ No TB

1st line Tx 2nd line Tx

M tuberculosis positive M tuberculosis negative

Culture M.tuberculosis

M.tuberculosis positive M.tuberculosis negative

DST FLD

Algorythm of the HIV TB categoryAlgorythm of the HIV-TB categoryHIV Patients

Screen for symptoms & history of TB and CXR if

available

TB Suspect Not Suspect

Xpert Mtb/Rif

AFB Microscopy

TB Pos TB NegTB Pos TB Pos TB Neg(Rif Res)

(Rif Sen)

* Repeated if high clinical suspicion

Sites & periodSites & period

1. Mikro UI & RSCM (Jakarta) 1. Mikro UI & RSCM (Jakarta) 2. RS Persahabatan (Jakarta)3. RS Soetomo & BLK (Surabaya)( y )4. RS Moewardi (Solo)5. RSHS and BLK (Bandung)( g)

Data gathered from routine registersData analysis using stataAim for final analysis after in Mar 2013

ResultsP ti d t 1073Prospective data n=1073• Excluded 117 (reg date, double entries,

treatment before test)treatment before test)• Included in prospective data: n=956▫ MDR-TB Suspect n= 673MDR TB Suspect n 673▫ HIV-TB n= 283

Retrospective data: pTotal year 2011 n = 989Included n=507

MDR TB suspects:number of patient tested and detected R resistant / MDR?

Site Total suspects

Xpert tests done

MTB positive

RIF Resistant (Culture & DST)p p

1 275 226 (82%) 184 (81%) 89 (46%) 42/45 (93%)

3 151 145 (96%) 112 (77%) 39 (35%) 10/12 (83%)

4 140 117 (84%) 101 (86%) 46 (46%) 28/31 (90%)

5 107 102 (95%) 71 (70%) 38 (54%) 22/25 (88%)5 107 102 (95%) 71 (70%) 38 (54%) 22/25 (88%)

Total 673 590 (88%) 468 (79%) 212 (45%) 102/113 (90%)

MDR TB suspects:Does suspect criteria 1 3 6 has higher Rif Resistant?Does suspect criteria 1,3,6 has higher Rif Resistant?

Total Xpert tests RIF Total suspects

Xpert tests done

RIF resistant

With suspect criteria 1,3,6 322 281 (87%) 125 (44%)

With other suspect criteria 292 256 (88%) 72 (28%)

All MDR suspects 614 537 (88%) 197(37%)

Out of 673 MDR-TB suspects, 614 (91%) have a suspect criteria (1-9) appointed to them.

HIV TB tHIV TB suspects:Number of suspect tested by xpert and Rif resistant?

Site Total suspects Xpert tests done

MTB positive

RIF resistant

1 25 25 (100%) 3 (12%) 0 (0%)

2 127 123 (97%) 36 (29%) 4 (11%)

3 12 12 (100%) 2 (17%) 0 (0%)

4 39 35 (90%) 7 (20%) 1 (14%)

5 80 64 (80% 12 (19%) 0 (0%)

Total 283 259/283 (92%) 60/259 (23%) 5 (8%)

Outc1: MDR TB case notificationOutc1: MDR TB case notificationComparing pre to post Xpert introduction

600

500

600

) MDR suspects

300

400

uspe

cts

(#

MDR suspects

Tested

RIF resistant

100

200

MD

R s

0

100

RSP (R ) RSP (P) Moewardi (R )

Moewardi (P) Soetomo (R ) Soetomo (P) Total (R ) Total (P)(R) (P) (R) (P) (R) (P) (R) (P)Hosp 1 Hosp 3 Hosp 4 Total

(R): Retrospective tested with culture (P): Prospective tested with xpert and culture

Hosp 1 Hosp 3 Hosp 4 Total

Obj.2: MDR TB treatment initiationjComparing pre to post Xpert introduction

600

500

#)

MDR suspects

300

400

susp

ects

(#

Tested

RIF resistant

100

200MD

R s

MDR treatment

0

100

RSP (R ) RSP (P) Moewardi (R )Moewardi (P)Soetomo (R ) Soetomo (P) Total (R ) Total (P)(R) (P) (R) (P) (R) (P) (R) (P)Hosp 1 Hosp 3 Hosp 4 Total

(R): Retrospective tested with culture (P): Prospective tested with xpert and culture

O tc 2: MDR TB treatment initiationOutc.2: MDR TB treatment initiationComparing pre to post Xpert introduction

14

16

MD

R

3 PMDT sites

8

10

12

s st

arti

ng

Mm

ent

4

6

8

DR

su

spec

tstr

eat

0

2

MD

M '11 A '11 M '11 J '11 J '11 A '11 S '11 M '12 A '12 M '12 J '12 J '12 A '12 S '12

Outc 3: MDR TB suspects Outc.3: MDR TB suspects Reduction in treatment initiation

DAYS P i X P X i d iDAYS Prior to Xpertintroduction

Post Xpert introduction

Site Median Min-Max Median Min-Max

RSP 68.3 (n=33) 3-228 8.9 (n=10) 0-29

Moewardi 65.3 (n=19) 40-101 20.7 (n=19) 5-58

Soetomo 100 (n=28) 3-249 22.6 (n=29) 1-106

RSHS 45 7 ( 13) 1 84RSHS - - 45.7 (n=13) 1-84

Total 78.7(n=80)

22.7 (n= 71) ( ) ( )

Outc.4: Additional yield of Xpert over smear microscopy in HIV TB suspectsPost Xpert introduction

Xpert Total

MTBpositive

MTB negative

Error/ invalid

SmearPositive 15 (88%) 2 (12%) * 0 17

Negative 9 (8%) 106 (91%) 2 (2%) 117

Total 24 108 2 134

* 2 showed MOTT in culture 2 showed MOTT in culture

Outc.5: Comparing Xpert with culture on detection of MTB

Only suspects included with culture result after Xpert result : +14 days for MGIT / +30 days for LJ. (144 MGIT / 96 LJ cultures)

Culture

TotalPositive Negative Non-TB

Xpert MTB positive 168 (70%) 43 (18%) 2 (1%) 213

MTB negative 3* (1%) 23 (10%) 1 (0%) 27

* 3 from RSP all MDR SS-

MTB negative 3 (1%) 23 (10%) 1 (0%) 27

Total171 66 3 240

3 from RSP, all MDR, SS-

Outc.5: Comparing Xpert with C/DST on detection of Rif Resistant / MDR

O l i l d d i h l i i l f X l d

C/DST

Only suspects included with culture positive result after Xpert result : +14 daysfor MGIT / +30 days for LJ. (90 MGIT / 77 LJ)

MDR Mono-RIF

Mono-INH

Suscep. Total

MTB RIF 8 ( %) ( %) ( %) ( %)

Xpert

MTB pos. RIF resistant

89 (53%) 5 (3%) 4 (2%) 2 (1%) 100

MTB pos. RIF susceptible

11 (6%) 0 16 (10%) 37 (22%) 64Xpert susceptible

MTB neg. 3 (2%) 0 0 0 3

Total 103 5 20 39 167

C l iConclusionsPromising results of Xpert • Promising results of Xpert

• High % of MDR TB supports need for rapid diagnosis

• Implication on clinical care?

▫ Confirmatory test needs improvement (culture/DST)

▫ Hesitation of clinicians

▫ Lack of experience and resources

• Expansion?

▫ Capacity vs. coveragep y g

• Indonesian National TB Programg• Lab WG/PMDT/TORG, • BPPM mikro, WHO, FHI, MSH, • Coordinating partner: PMU TB CARE I• Coordinating partner: PMU TB CARE I• Collaborating partners: KNCV, WHO• Facilitation: TB CARE Country Office• USAID Jakarta