Is it important to detect drug resistance at the time of TB diagnosis?

Lessons from multi-centric study in India

Dr K S Sachdeva Additional Deputy Director General

Central TB Division

Ministry of Health & Family Welfare

Government of India

Global and India TB Situation

Global India

Estimated

Incidence

2013

Estimated

Number of deaths

2013

Estimated

Incidence 2013

Estimated

Number of

deaths 2013

Notification

under RNTCP

-2014 #

All forms of TB 90 lakh 11 lakh * 21 lakh 2.4 lakh * 14,43,942

HIV Associated

TB11 lakh 3.6 Lakh 1.2 lakh 38,000 44171

Multi Drug

Resistant TB480,000 210,000 61,000

amongst

notified cases

24,073

Source: WHO Global Tuberculosis Report 2014Excluding deaths attributed to HIV/TB,

# (Annual TB Report-2015)

Introduction

Globally, India is the highest TB burden country, accounting for1/5th of TB incidence

50% of global MDR-TB cases are estimated to be from China and India

Estimated number of DR-TB cases amongst cases notified under RNTCP in2014: 61000

Approx. another 30000 DR-TB cases expected in the private sector

Globally, DST is offered to cases with high risk of resistant

This approach we could at best detect 2/3rd of estimates amongst notifiedcases

Issues of operational losses in cases being tracked & specimen sent for DST

Decentralized deployment of GeneXpert could possibly, helpRNTCP achieving:o and detection of all TB and DR-TB cases

Project Design

Project Coverage Project sites

o 18 decentralized Xpert labs established at existing public sector microscopy centers

o Xpert: default Dx test for all presumptive TB cases; Each lab covered 0.5 million pop

Project implementation

Baseline PhaseNo active intervention

o TB & Rif resistant TB diagnosis as per RNTCP diagnostic algorithm

Overall data capturedo Total 44.9 programme months data captured

(2.1- 5.1 months/site)

o Total 11,064 presumptive pulmonary TB & DR-TB cases tested o 10,832 TB o 232 DR-TB

o 4 sites excluded from baseline & direct roll out of intervention for early feasibility assessment

Intervention Phase Upfront Xpert MTB/RIF testing for all pulmonary TB & DR- TB suspects

o Parallel smear microscopy for internal comparison

Intervention

o Same day sputum specimen transportation to Xpert lab

o Rx based on Xpert test results

Overall data captured

o Total 350.1 months data (16.4- 21.6 months/site)o Total, 1,04,276 presumptive pulmonary TB & DR-

TB cases tested on CBNAATo 1,01,700 TBo 2,576 DR-TB

Key Research questions: Impact assessment of upfront Xpert MTB/RIF testing on TB and Rif

resistant TB detection

Project Intervention: Upfront Xpert MTB/RIF testing of TB suspects

Xpert MTB/RIFadditional

contribution of bacteriologically-

confirmed cases and Rifampicin

resistant -TB cases

Xpert Positivity 20.3%

Smear Positivity 14.4%

Rif Resistant - 2301 (11.2%)6

TB case detection: Baseline Vs Intervention phase

With upfront Xpert MTB/RIF test bacteriological TB case notification increased by:

11% for all forms of pulmonary TB

33% for Bacteriological TB cases

Xpert MTB/RIF performance among paediatric population

30-06-2015 8

Xpert MTB/RIF performance among HIV infected population

9

Rifampicin Resistant TB case detection

Category

Confirmed

PTB

Cases on

Xpert

Number

Detected

with

additional

Rifampici

n

resistanc

e

Xpert RIF

resistance

prevalenc

e

%

Presumptive TB patients 20587 2301 11.2

New 14539 841 5.8

Xpert Positive ; Smear-positive 9308 474 5.1

Xpert positive; smear-neg/NA 5231 367 7.0

Previously treated 6048 1460 24.1

Xpert positive; Smear-positive 3837 979 25.5

Xpert positive; smear-neg/NA 2211 481 21.8

TB patients who are DR-TB suspects 2099 464 22.1

Increased detection of DR-TB cases with upfront Xpert testing of TB suspects

Summary

This was a large scale demonstration at public health facilities

99.1% patients got valid test results on Xpert MTB/RIF

With upfront Xpert MTB/RIF testing, study demonstrated 33% increase in proportion of bacteriologically confirmed TB cases diagnosed

> Two fold increase in detection rates in PLHA & Pediatric population

Upfront Xpert testing lead to five fold increase in Rifampicin resistant TB case detection

Cost effectiveness assessment underway

Acknowledgment

FIND - Implementing partner

USAID Funding

WHO-India Country Office and technical support network

State TB officers, District TB officers, Medical Officers and respective RNTCP staff from 18 study TUs.

National Reference Laboratories (NRL) and Intermediate reference Laboratories (IRL) from all states participating in the study

AIGHD team