DR-TB HIV Coordinator: TB Treatment and Care

Fullscreen

DR-TB HIV Coordinator: General concepts in TB Treatment

Fullscreen

Goals of treatment

Content

The goals of tuberculosis treatment are:

Rendering the patient non-infectious, breaking the chain of transmission and decreasing the infection pool
Decreasing case fatality and morbidity by ensuring relapse-free cure
Minimising and preventing the development of drug resistance.

To meet the goals of treatment, the regimens should be:

Safe, easy to administer and aid treatment adherence
Long enough to achieve the long-term cure of the disease, and short enough to increase patient compliance.

Any treatment regimen which reduces the pill count but increases the overall treatment success is an ideal regimen to meet the goals of tuberculosis treatment.

Resources

Training Modules (1-4) for Programme Managers and Medical Officers, 2020.

Assessment

Question

Answer 1

Answer 2

Answer 3

Answer 4

Correct answer

Correct explanation

Page id

Part of Pre-test

Part of Post-test

In what scenarios is a TB treatment regimen considered efficient?

High sputum conversion

High treatment success

Low emergence of drug resistance

All of the above

The goal of TB treatment ties in with how we consider a regimen efficient, and this occurs when the regimen results in high sputum conversion and treatment success, and low relapse rates and emergence of drug resistance.

Strategies for TB Treatment

Content

Under the National TB Elimination Programme (NTEP), strategies adopted in the treatment of TB are based on the available scientific and operational researches. These strategies are combined to ensure better treatment outcomes for the TB patients. The main strategies include:

Domiciliary Treatment

This is a strategy that allows for the treatment of TB in a patient’s home.
Domiciliary chemotherapy proved to be as effective as sanatoria treatment (which was the historical way of treating TB) and achieved higher cure rates.
The patients having the social benefits of being at home.

Short Course Chemotherapy (SCC)

Chemotherapy of TB underwent revolutionary changes in the 70s owing to the availability of two well-tolerated and highly effective drugs – rifampicin and pyrazinamide.
These drugs allowed for SCC and made it possible to simplify treatment and reduce its duration without reducing the therapeutic effect.
Now with SCC regimens, it is possible to treat and cure TB patients in 6 months.
When given daily, these regimens are effective, achieve high cure rates, prevent the emergence of drug resistance and minimize relapses.
The shorter duration also contributes to improvement in treatment adherence.

Directly Observed Treatment (DOT)

DOT is a method whereby a trained healthcare worker or another trained designated person (treatment supporter) watches a patient swallow each dose of anti-TB drugs and document it.

DOT can reduce the development of drug resistance, treatment failure, or relapse after the end of treatment.
Many patients who do not receive directly observed treatment stop taking drugs once they feel better.
Hence, by providing DOT, the NTEP ensures that patients receive the right drugs, in the right doses, at the right intervals and for the right duration.

The modern treatment strategy is based on standardized short-course chemotherapy regimens largely administered on a domiciliary basis, utilising the DOTS strategy and proper case management to ensure completion of treatment and cure.

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which of these treatment strategies are adopted by NTEP?	Domiciliary treatment	Use of short-course chemotherapy	Directly observed treatment	All of the above	4	Strategies utilized by NTEP in TB treatment are domiciliary, short-course chemotherapeutic short-course regimens that are directly observed.

Pharmacological Basis of treatment

Content

Tuberculosis treatment and its different regimens have scientific backgrounds for their formulations. To understand this, we need to know about the mode of action of each anti-TB drug first.

Mode of Action of Anti-TB Drugs

Anti-TB drugs have the following three actions:

Early bactericidal activity: Killing of actively growing bacilli (in the phase of rapid multiplication and uninhibited metabolic activity).
Sterilizing activity of persisting bacilli, i.e., metabolically inhibited organisms in a quasi-dormant state.
Ability to prevent the emergence of drug resistance.

The ranking of first-line drugs with respect to their type of activity is indicated in Table 1 below.

Table 1: Ranking of first-line anti-TB drugs used in the treatment of drug-sensitive TB, based on the mode of action and activity

First-line Drugs	Early Bactericidal	Sterilizing	Prevention of emergence of drug resistance
Isoniazid (H)	++++	++	++++
Rifampicin (R)	+++	++++	+++
Pyrazinamide (Z)	++	+++	+
Ethambutol (E)	+	Nil	++

Thus, each drug has unique characteristics and drug combinations will make the regimen more effective.

Need for Long Duration of Treatment of TB

Anti-TB drugs mostly kill actively multiplying tubercle bacilli.
When bacilli have low metabolic activity, i.e., when bacterial growth has almost come to a standstill and the organisms are “dormant”, they are not killed by otherwise bactericidal drugs. Such organisms are referred to as persisters*.
Though they may survive in the presence of drugs, behaving as if they were drug-resistant, they are in fact susceptible to the drugs.
Thus, if for some reason these organisms regain their ability to multiply freely, they would be killed by the very drugs that had not harmed them before.
When dormant bacilli again become metabolically active and start multiplying during effective chemotherapy, they are soon killed.
Once chemotherapy has been completed, the revived bacilli may continue to multiply and thus cause relapse.
This explains why conventional chemotherapy needs to be of long duration.

Resources

Assessment

Question

Answer 1

Answer 2

Answer 3

Answer 4

Correct answer

Correct explanation

Page id

Part of Pre-test

Part of Post-test

What is the role of the intensive phase of anti-TB treatment?

To reduce adverse drug reactions in patients

To achieve rapid killing of actively multiplying bacillary population

To prevent the emergence of drug-resistance

Options 2 and 3

The role of IP is to achieve rapid killing of actively multiplying bacillary population and eliminate naturally occurring drug-resistant mutants and prevent the further emergence of drug resistance.

Yes

Which of the following drugs is bacteriostatic?

Isoniazid

Ethambutol

Pyrazinamide

Rifampicin

Ethambutol is an effective bacteriostatic drug, helpful in preventing the emergence of resistance to other companion drugs.

Yes

Treatment Phases
Content
Standard TB Treatment is divided into two phases

Intensive Phase(IP): In this phase,
Kills most of the TB bacteria during the first 8 weeks of treatment, but some bacteria can survive longer

Therefore, more drugs are administered to kill the bacteria and reduce the severity of disease.

Treatment in this phase usually is of short duration(2 to 6 Months or more) in comparison to Continuation Phase(CP)

Continuation Phase(CP): In this phase,
All the remaining TB bacteria are in the dormant stage i.e., stage when growth and development of bacteria are temporarily stopped.

Therefore, fewer but powerful antibiotics are administered to kill those bacteria.

Treatment in this phase usually lasts longer than Intensive Phase(IP)(4 to 18 Months or more)

Kindly provide your valuable feedback on the page to the link provided HERE
Fixed Dose Combinations [FDC]s
Content
Fixed-dose combinations (FDCs) are drug formulations where two or more drugs are combined physically into one formulation such as a tablet or pill.

This is more convenient to the patients taking medicines and it also simplifies the supply chain.

Resources:

Technical and Operational Guidelines for TB Control in India 2016

Kindly provide your valuable feedback on the page to the link provided HERE
Advantages of FDCs

Content

Fixed-Dose Combination(FDC) provides a simple approach to deliver the correct number of drugs at the right dosage as all the necessary drugs are combined in a single tablet. By altering the number of pills according to the patient’s body weight, complete treatment is delivered without the need for calculation of dose

Figure: Advantages of Fixed Dose Combination(FDC)
FDCs used in NTEP

Content

Image
TB Drug Regimen
Content
A regimen means a prescribed systematic form of treatment for a course of drug(s). For TB treatment, Multi drug combination of regimen is followed.

All TB drug regimens have an initial intensive phase(IP) followed by a continuation phase(CP).

Following are some of the main TB drug regimens used based on the drug resistance pattern detected for TB patients.

First-Line Anti TB Drugs(Prescribed for Drug Sensitive TB DS-TB)
Daily weight band wise FDC

Second-Line Anti TB Drugs (Prescribed for Drug Resistance TB - DR-TB)
H Mono Poly Regimen

Shorter oral Bedaquiline containing MDR-TB regimen

Longer oral Bedaquiline containing regimen

Shorter injectable containing MDR-TB regimen

TB Treatment Initiation

Content

It is extremely important for any type of TB patient to be initiated on the right treatment at the earliest in order to have better treatment outcomes. Therefore as soon as the patient is diagnosed, s/he should immediately be traced with the help of the Community Health Officer (CHO) of the Health and Wellness Centres (HWC), TB Health Visitors (TBHV) / Senior Treatment Supervisor(STS) and the health facility doctors and initiated on the appropriate treatment regimen.

Steps in TB Treatment Initiation

Figure: Flowchart-Treatment Initiation

Resources

Assessment

Question

Answer 1

Answer 2

Answer 3

Answer 4

Correct answer

Correct explanation

Page id

Part of Pre-test

Part of Post-test

The ultimate goal of the initial counselling session should be to empower the patient and their caregiver to make informed decisions regarding the treatment initiation.

True

False

The ultimate goal of the initial counselling session should be to empower the patient and their caregiver to make informed decisions regarding the treatment initiation.

Yes

As soon as the patient is diagnosed, s/he should immediately be traced with the help of the Community Health Officer (CHO) of the Health and Wellness Centres (HWC), TB Health Visitors (TBHV) / Senior Treatment Supervisor(STS) and the health facility doctors and initiated on the appropriate treatment regimen

True

False

Soon after identification pre treatment counselling is given to patient and caregivers followed by pre treatment evaluation and treatment initiation.

Yes

Follow-up of TB patient
Content
To know the TB treatment response and to determine that if patient is cured, TB patients are clinically evaluated at the end of every four weeks of treatment, and they are also followed up by performing sputum test at end of each treatment phase (i.e. Intensive phase and Continuation phase)

TB patients during clinical evaluations are assessed to

Identify possible adverse reactions to medications;

Check for any comorbid conditions;

Weight change;

monitor adherence; and determine treatment efficacy by observing their symptoms

Although each patient responds to treatment at a different pace, all TB symptoms should gradually improve and eventually go away.

Patients whose symptoms do not improve during the first 2 months of treatment, or whose symptoms worsen after improving initially, should be re-evaluated for adherence issues and development of drug resistance.

TB Treatment Outcome

Content

When a TB patient consumes all the doses under the prescribed regimen, then Treatment Outcome is declared for a Patient.

Treatment Outcome	Description
Cured	A TB patient who was microbiologically confirmed for TB at the beginning of treatment but who is smear or culture negative at the end of complete treatment
Treatment Complete	A TB patient who completed treatment without evidence of failure or clinical deterioration BUT with no record to show that the smear or culture results of biological specimen in the last month of treatment was negative, either because the test was not done or because the result is unavailable
Treatment Failure	A TB patient whose biological specimen is positive by smear or culture at the end of treatment A case of paediatric TB who fails to have microbiological conversion to negative status or fails to respond clinically/or deteriorates after 4 weeks of compliant intensive phase shall be deemed to have failed response provided alternative diagnoses/reasons for non-response have been ruled out.
Loss to Follow up	A TB patient whose treatment was interrupted continuously for one month or more
Not Evaluated	A TB patient for whom no treatment outcome is assigned
Treatment Regimen Changed	A TB patient who is on first line regimen and has been diagnosed as having TB(DR-TB) and switched to DR-TB regimen prior to being declared as failed
Died	A patient who has died during anti-TB treatment(due to any reason)

Treatment success is considered when a TB patient either Cured or Treatment completed is accounted in treatment success

Adverse Event Definitions and Classifications

Content

Adverse Drug Reaction (ADR): An unwanted or harmful reaction experienced following the administration of a drug or a combination of drugs, under normal conditions of use, and is suspected to be related to the drug.

Adverse Event (AE): Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease that presents in a patient during the course of treatment or the procedure, regardless of whether it is considered related to the medical treatment or procedure.

An AE does not necessarily have a causal relationship with the treatment.
Suspected ADR and actual ADRs are a subset of AEs, as can be seen in the figure below.

Figure: Relationship between adverse events, suspected adverse reactions and adverse reactions

The table below highlights the difference between an ADR and an AE.

Table: Difference between an adverse drug reaction and an adverse event
ADVERSE DRUG REACTION (ADR)	ADVERSE EVENT
World Health Organization (WHO) defines an ADR as “Any response to a drug which is noxious, unintended and occurs at doses used in man for prophylaxis, diagnosis or therapy.” i.e it necessarily has a causal relationship.	Any untoward medical occurrence during treatment, which does not necessarily have a causal relationship with this treatment.

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

Classification of Adverse Drug Events
Content
Adverse Drug Events are classified on the basis of severity:

1. Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

Results in death

Is life-threatening (subject was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it is more severe)

Requires inpatient hospitalization or prolongation of existing hospitalization

Results in persistent or significant disability/incapacity

Results in a congenital anomaly/birth defect

Results in suspected transmission of any infectious agent via the medicinal product

Is medically important

2. Non-serious Adverse Drug Reaction (ADR) Associated with the Use of Drugs: Any adverse drug reaction that does not meet the above criteria to be a serious AE and is considered associated with the use of the drug .

4. Life-threatening: Any event in which the patient was at risk of death at the time of the event; but does not refer to an event, which hypothetically might have caused death if it were more severe.

5. Associated with Use of the Drug: An adverse event is considered associated with use of the drug if the attribution is possible, probable or very likely.

Resources

Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, March 2021

Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019

WHO - A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis, 2012

Technical and Operational Guidelines for TB in India, 2016

Kindly provide your valuable feedback on the page to the link provided HERE

Types of ADR of TB Treatment

Content

Adverse Drug Reactions(ADR) are classified into serious and non-serious ADR depending upon the intensity of symptoms experienced by the patient. Below is the brief overview

Common ADRs	Non-serious ADR	Serious ADR (Refer to the nearest health facility)
Nausea and Vomiting	Symptoms of dehydration like thirst, dizziness, tiredness, dry mouth and eyes	Extreme vomiting, Signs and symptoms of severe dehydration Blood in vomit Electrolyte imbalance and Altered level of consciousness
Gastritis and Pain in abdomen	Occasional Discomfort Sour taste in mouth with acid reflux Burning sensation in upper abdominal region	Severe pain in abdomen Acidity, Burping, Flatulence, Vomiting Blood in vomit Electrolyte imbalance and Altered level of consciousness.
Diarrhoea	2-3 /3-10 loose liquid stools with signs and symptoms of dehydration.	More than 10 watery stools Signs and symptoms of dehydration Blood in stool Fever Intense abdominal pain Electrolyte imbalance and Altered level of consciousness
Tingling, Burning, Numbness in hands and feet	Mild numbness and weakness in hands and feet. Prickling, stabbing, burning or tingling along with gradual increase in severity of numbness and weakness.	Signs and symptoms of moderate neuropathy Extreme sensitivity to touch, Lack of coordination and balance Muscle Weakness Poor control of bowel and bladder
Pain in Joints	Pain on touching joints Pain on walking, swelling and redness Warmth in and around joints	Stiffness and signs of increased tenderness Severe weakness and restricted joint movement
Skin rashes, itchiness, and allergic reactions	•Itching and skin rashes with tingling and burning sensations	Itching with increased size and raised wheels Swelling of lips and tongue Severe allergic reactions /Serious disorder of the skin with painful rashes /Shredding of skin.

Management of Adverse Drug Reactions(ADRs) of TB Treatment
Content
Counsel and reassure the patient as the common occurring adverse effects usually resolve with time.

Advise the patient to take all the drugs together.

Advise patient to take light meal (biscuits, bread, rice etc.) before taking drugs.

Inform patients that they may take drugs embedded in banana or at the bedtime to reduce their associated side effects.

Encourage patients to keep themselves hydrated by increasing fluid intake.

Provide ORS (Oral Rehydration Solution) to counter dehydration due to loose motion and vomiting.

Figure: Referral to PHI for ADR

Resources:

Training Guide for Peripheral Health Workers on Adverse Drug Reactions

Kindly provide your valuable feedback on the page to the link provided HERE

Follow up sputum examination

Content

Follow-up Sputum Examination is useful for the clinical follow-up which helps in assessing the response to treatment, and to establish cure or failure at the end of treatment.

Significance:

The most important tool in the diagnosis of tuberculosis is direct microscopic examination of appropriately stained sputum specimens for acid-fast bacilli (AFB). The technique is simple and inexpensive, and used in the detection of tuberculosis. Sputum microscopy is also useful for the clinical follow up which helps in assessing the response to treatment, and to establish cure or failure at the end of treatment.

Schedule

In case of Drug-sensitive Tuberculosis (DS-TB), the follow-up is done at the end of Intensive Phase (IP) and at the end of Continuation Phase (CP).

In case of Drug-resistant Tuberculosis (DR-TB), the follow up schedule is different for all the three regimen described below:

Isoniazid (H) mono/ poly DR-TB regimen

Monthly from month 3 onwards, till the end of treatment
Conduct sputum microscopy within 7 days, if the smear at month 4 or later is positive to rapidly ascertain bacteriological conversion/ reversion.

Shorter oral Bedaquiline-containing Multidrug-Resistant (MDR)/ Rifampicin-Resistant (RR)-TB regimen

Monthly from 3^rd month onwards, till end of IP
Monthly in extended IP, only if previous month S+ve
Conduct sputum microscopy within 7 days, if the smear at 6 months is positive to rapidly ascertain bacteriological conversion/ reversion.

Longer oral M/ XDR-TB regimen

With culture at Culture and Drug Susceptibility (C&DST) lab
Conduct sputum microscopy within 7 days if any smear at 6 month or later is positive to rapidly ascertain bacteriological conversion/ reversion.

Post Treatment Follow-Up

After completion of treatment, the patients should be followed-up at the end of 6, 12, 18 & 24 months for detecting recurrence of TB at the earliest. In presence of any clinical symptoms and/or cough, sputum microscopy and/or culture should be considered. This is important in detecting recurrence of TB at the earliest.

Implications

The sputum follow-up examination is a quick and reliable method which helps in monitoring the progress of the treatment and gives an early indication of any recurrence.

Resources

Assessment

Question 1

Answer 1

Answer 2

Answer 3

Answer 4

Correct Answer

Correct Explanation

Page id

Part of Pre-Test

Part of Post-Test

The follow-up in all oral longer regimen should be done with culture at C&DST Lab

True

False

The follow-up of sputum is done with culture at C&DST lab

Yes

TB Treatment Card

Content

The Tuberculosis Treatment Card is a paper-based recording form that is kept in the institution treating the TB patient under the National TB Elimination Programme (NTEP). It is a pre-requisite documentation related to treatment services offered to TB patients under NTEP.

Uses of the TB Treatment Card

The TB treatment card is primarily used for:

Documenting administered drugs with their dosages
Documenting follow-up investigation results
Monitoring adherence to treatment
Recording adverse events
Recording treatment outcomes

There are two pages in the TB treatment card and details in each page is delineated in the table below.

Table: Parts of the Treatment Card; *Source: NTEP Training Module 2 for Programme Managers & Medical Officers, p. 105*
PAGE	DETAILS CONTAINED IN PAGE
The First Page	Patient details such as name, age, sex and address of the patient
	Type of disease
	History of anti-TB treatment
	Regimen prescribed and duration of treatment
	Results of investigation before and during treatment
	Comorbidity-related information
	Contact tracing and chemoprophylaxis details
	Social habits such as tobacco and alcohol use
The Back Page	Details of intensive and continuation phases of treatment including drug details and adherence monitoring
	Retrieval actions for missing doses
	Adverse events
	Post treatment follow-up, nutritional support details and remarks
	Treatment outcome

Important Points to Note

The TB treatment card is filled at the Peripheral Health Institution (PHI) when a patient is initiated on treatment.
The original TB treatment card is kept at the PHI and updated fortnightly.
A duplicate treatment card is to be given to the treatment supporter for documentation of daily events.
The treatment supporter should be trained on how to record the treatment card.
Details on the patient’s HIV status are not included in the treatment supporter’s copy to maintain confidentiality.

The figure below shows the 1^st page of the TB treatment card. Click here to access the full form in the NTEP Training Modules 1-4 for Programme Managers & Medical Officers, p. 223.

Figure: First Page of the TB Treatment Card; Source: NTEP Training Modules 1-4 for Programme Managers & Medical Officers, p. 223

Resources

NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE

NTEP TB ID Card

Content

In the National TB Elimination Programme (NTEP), the ‘NTEP TB identity card’ is provided for their identification and record of clinical follow-ups.

The identity card is completed for each patient who has a Tuberculosis (TB) Treatment Card, and it is kept with the patient. Information from the TB Treatment Card is used to complete the identity card.

There are 3 parts in the NTEP TB identity card and details in each part is delineated in Table 1.

Table 1: Parts of the NTEP TB identity card; Source: NTEP Training Module 2 for Programme Managers & Medical Officers, p. 105
PART	DETAILS CONTAINED IN THE SECTION
The First and Second Part	Patient information
Name and address of the TB unit/ district
Treatment details of the patient including: Disease classification Type of patient Treatment provider Case definition Weight bands Dosage Sputum results Culture results Results of follow-up smear examinations Results of follow-up cultures Information on the date of treatment initiation Treatment outcome
The Back Part	Appointment dates for visits to NTEP facilities
Contact details of NTEP staff in case of side events/queries

The information contained in this card will help to continue treatment in case the patient is transferred or admitted to any other health facility any time during the treatment period. The TB identity card is shown in Figure 1.

Figure 1: NTEP TB Identity Card; Source: NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

Figure 2: Sample of a patient’s TB identity card

Resources

NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

Kindly provide your valuable feedback on the page to the link provided HERE

PMDT Treatment Book

Content

The Programmatic Management of Drug-resistant Tuberculosis (PMDT) treatment book is a document that is issued to all patients who are diagnosed with DR-TB and are placed on a regimen for DR-TB. It is given in annexure 31 under the PMDT guidelines 2021.

The PMDT treatment book is to be kept with the patient and should be brought along whenever s/he comes to Drug-resistant TB Centre (DR-TBC) or District TB Centre (DTC) or Health Facility (HF) for clinical follow-up or for Adverse Drug Reaction (ADR) management and should be filled out by the healthcare provider.

The PMDT treatment book contains the following sections:

Details about the patient, treatment supporter, TB unit from where the patient is availing treatment
Reason for testing, previous TB treatment history, type of TB, current TB treatment regimen with the date of diagnosis and treatment initiation
Information on an initial home visit, Drug Susceptibility Test (DST) results for different anti-TB drugs, contact investigation, DR-TB committee meetings
Information about weight and height of the patient, different weight bands for DR-TB regimen, different types of anti-TB drugs prescribed to patients and their dosages, eligibility and consent of patient if a new drug has been prescribed
Information on investigations, follow-up results, details about monthly administration of drugs with the weight of patient for the full duration of treatment
Information on retrieval action taken for a patient who has missed doses, any ADR reported and their management
Detailed clinical notes written by the treating physician during each visit
Information about treatment outcome and post-treatment periodic follow-up
General information about the TB disease, mode of transmission, treatment, drugs in the regimen, side effects of drugs, and a few important do’s and don’ts for the patient.

Figure: PMDT Treatment Book; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, 2021, CTD, MoHFW, India.

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
When is the PMDT treatment book issued to a patient?	When a patient is diagnosed with DR-TB	When a patient is transferred out	When a patient is lost to follow-up	When a patient has completed treatment	1	The Programmatic Management of Drug-resistant Tuberculosis (PMDT) treatment book is a document that is issued to all patients who are diagnosed with DR-TB and are placed on a regimen for DR-TB.		Yes	Yes

DRTB Treatment Register
Content
This is a line list of confirmed DRTB cases on treatment based on current health facilities.

Description: This register gives details about the tests and final interpretation based on the treatment start date and notification date:

Health Facility ( Diagnosing & current facility details, ie.. State/District/ TU/PHI).

Date of diagnosis and basis of diagnosis.

Date of TB treatment initiation and regimen type.

CBNAAT and Truenat Details - CBNAAT MTB Result, Rif Resistance, final interpretation and date reported.

F line LPA and S line LPA Final interpretation.

Video file

Video: DRTB Treatment Register

Transfer of TB Patient

Content

TB patients may not stay in one place throughout the treatment duration. When they move from one place to other, there should be a mechanism to hand over the responsibility of continuing the patient's treatment in a facility near the new place of the patient. This is the concept of patient transfer and can be easily managed in Nikshay portal.

The transfer module in Nikshay enables transfer requests of patients between Health Facilities (HFs) across the country.
Provision of shifting of patient from one HF to another is possible if the patient changes his/her residence for the purpose of treatment.
The requests are of two types: “Transfer In” and “Transfer Out”.
All transfer requests needs to be accepted by the “District/ TB Unit (TU)/ Peripheral Health Institute (PHI)” where the transfer request is made in order for it to take effect.
Transfer requests can be made to even the District/ TU level. However, it can be completed only once the “Transferred to PHI” has been assigned.

Figure: Transfer Management in Nikshay; Source: Nikshay Zendesk, Nikshay Knowledge Base, Advanced Transfer in Web.

Steps in Transfer of TB Patient

1. In Nikshay, the referring HF updates details from the current HF of patient to the HF where patient is being transferred.

2. The receiving HF gets the intimation about the transfer.

The patient transfer module also provides the provision to pull the patient belonging to another HF to the recipient HF. The accountability of the transferred patients is now with the receiving HF and the treatment initiating facility.

A separate transfer register is also available to get details about various transfers from and to a given district, which can be downloaded from Nikshay reports.

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Transfer requests include "Transfer In" and "Transfer Out".	True	False			1	Transfer requests include "Transfer In" and "Transfer Out".		Yes	Yes

Treatment Support Plan

Content

In order to achieve TB treatment success, a good treatment support plan for the patients is essential. The National TB Elimination Programme (NTEP) recommends developing a treatment support plan for each patient at the time of treatment initiation. A holistic Treatment Support Plan (TSP) must include the following:

1) Treatment Supporter (TS) for each patient

A Treatment Supporter (TS) who is acceptable and accessible to the patient and accountable to the health system (healthcare worker/ community volunteer/ private practitioner/ family member) identified in mutual consultation with the patient and provider during pre-treatment evaluation.
The assigned TS should be able to receive training on drug administration, adherence monitoring, Adverse Drug Reaction (ADR) referrals etc., and perform these functions.

2) Periodic review of patient’s treatment

Treatment Initiation counselling and monthly or need-based (in high TB burden areas) follow-up counselling to all TB patients and their family members must be included through staff who have expertise in the same, to address both bio-medical and psycho-social issues that could impact treatment.
The TSP must also include a protocol for the field monitoring staff to capture each instance of treatment interruption and Adverse Drug Reactions, so that they can be effectively addressed before the patient turns lost to follow-up.

3) Psychosocial Support to TB patients and their families

Counselling to the patients experiencing stigma, discrimination, marital/family discords, substance users etc. by the trained staff, and appropriate referrals for psychiatric ,de-addiction support etc. should be offered whenever required.
The focus should be on observing, identifying and capturing above mentioned factors during treatment initiation as well as in each follow up visit.
Home visit follow ups with consent from the patients must also be included in the TSP which may allow for better understanding and management of psycho-social issues.
As an extension of TSP, community engagement activities which includes key persons such as politicians, religious leaders, self-help groups, TB champions etc by the TB staff is recommended to raise awareness and sensitise the communities about TB and also articulate a whole-of-society approach to ending TB.

4) Referral linkages for needy TB patients - to central and state government’s various social welfare and protection schemes and additional nutrition support services

With the aim to eliminate catastrophic expenditure due to TB, the Government of India (GoI) has insisted on linking TB patients and households to the applicable government social welfare and protection schemes.
The treatment supporters and the health systems staff who are in regular contact with the patients (Senior Treatment Supervisors, TB Health Visitors, District Programme Supervisors) should be trained in referral linkages so as to enable further support to the patients and their family members to avail the benefits under schemes.
The GoI has rolled out a Direct Beneficiary Transfer (DBT) mechanism to support TB patients' nutrition (Ni-kshay Poshan Yojana) and travel during treatment whereas several state governments have also initiated certain state-specific schemes for TB patients across the country.
Further as a part of patients treatment support, the GoI has initiated the ‘Nikshay Mitra’ campaign under the ‘Pradhan Mantri TB Mukth Bharat Abhiyan’ where in persons/companies/societies can adopt an entire block/ward to provide nutrition support to TB patients for a specific treatment period.

5) Treatment Completion Counselling

The TSP must include an end of treatment counselling for all patients, on the importance of post treatment follow ups and holistic self-care approach for leading an overall healthy life and also the ability to focus on life after TB treatment completion.

Resource

Assessment

Question

Answer 1

Answer 2

Answer3

Answer 4

Correct Answer

Correct explanation

Only health workers can become treatment supporters for a TB patient.

True

False

Factors like acceptability, accessibility to the patient, and accountability to the health are taken into consideration when a treatment supporter is identified, and family members can also be treatment supporters and provided training by a health worker.

Referral linkages for needy TB patients - to central and state government’s various social welfare and protection schemes and additional nutrition support services is part of holistic Treatment Support Plan (TSP)

True

False

With the aim to eliminate catastrophic expenditure due to TB, the Government of India (GoI) has insisted on linking TB patients and households to the applicable government social welfare and protection schemes.

Management of EPTB

Content

The management principles of Extrapulmonary Tuberculosis (EPTB) are shown in the figure below.

Figure: Ten principles about what every EPTB patient in India needs as a basic standard of care

Abbr: CBNAAT:Cartridge-based Nucleic Acid AMplification Test; PTB: Pulmonary TB; NTEP: National TB Elimination Programme

Diagnosis of EP-TB

All efforts need to be made to get a microbiological confirmation whenever a sample is available.
Clinical diagnosis can be made by treating physician based on the clinical features, lab investigations, imaging studies and by ruling out other causes

Treatment Regimen and Duration for EPTB

The treatment regimen and schedule for EPTB cases will remain the same as for pulmonary TB (2HRZE/ 4HRE). However, the duration of the continuation phase in EPTB may be extended in special situations such as TB Meningitis, bone and spine TB etc.

Role of Surgery in EPTB Cases

Surgery is sometimes required for the diagnosis of EPTB. It is reserved for management of late complications of the disease.

Monitoring Treatment Response

Response to treatment in EPTB may be best assessed clinically. Clinical follow-up is the most important criterion for the follow-up of EPTB patients. The clinician can assess the patient’s condition by checking weight gain and a decrease/ increase in presenting clinical symptoms.
Investigations such as Acid-fast Bacilli (AFB) microscopy, chest X-ray, liver function tests, serum creatinine, and USG-abdomen can be used to monitor the treatment status.

The treatment support and other monitoring activities remain the same as for pulmonary TB.

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
What is the standard treatment duration for most EPTB cases?	2 weeks	1 month	6 months	3 years	3	The treatment regimen and schedule for EPTB cases will remain the same as for pulmonary TB (2HRZE/ 4HRE).		Yes	Yes
In which cases can the treatment duration exceed 6 months in EPTB?	TB meningitis	TB of the bone and joint	Depending on the clinician’s decision	All of the above	4	EPTB treatment duration can be extended beyond 6 months in TB meningitis, TB of bone and joint (including TB otitis media), and if recommended by the clinician.		Yes	Yes

Management of Patients with Treatment Interruptions

Content

Treatment interruption is defined as a patient-initiated episode in which the patient discontinues TB treatment. All efforts must be made to ensure that TB patients do not interrupt treatment or are not lost to follow-up. Action should be taken to promptly retrieve patients who fail to come for their daily dose by the treatment supporter

The management of treatment interruptions is made based on the following criteria:

i. Type of case: Whether new, relapse or failure

ii. Duration of treatment taken: Less than one month/ more than one month. This helps in assessing the risk of the presence of drug resistance.

iii. Duration of Interruption: Less than one month/ more than a month.

If treatment interruption is more than one month, the outcome is declared as ‘lost to follow up’.

If a patient returns to the health facility after interrupting treatment for more than one month, the patient sample needs to be subjected to Drug Susceptibility Testing (DST) to determine resistance/ sensitivity status to anti-TB drugs.

In case the interruption is for less than one month, the same treatment regimen is completed to complete all doses.

Modes of Retrieval

TB treatment is supervised by a trained treatment supporter (a health worker, family member or community volunteer). The residential address is verified for all TB patients by home visits. However, in case of treatment interruption, patient retrieval action is required.

Retrieval can be done by the following modes:

1. Retrieval of patients interrupting treatment within 24 hours of discontinuation is done by the Treatment Supporter (TS) or Accredited Social Health Activist (ASHA)/ Auxilliary Nurse Midwife (ANM)/ Multipurpose Worker (MPW). The reason for interruptions should be reviewed carefully and efforts made to counsel and bring the patient back for treatment.

2. If the TS is not successful in retrieving such patients, it should be reported to the next higher level of supervisors, like Senior Treatment Supervisor (STS), and they should take all efforts to counsel and retrieve the patient.

3. If the patient interrupts treatment on more than one occasion, the Medical Officer of the Peripheral Health Institute (MO-PHI) should visit the patient’s home. The MO-PHI should give intensive counselling to the patient and may provide additional support to continue the treatment without interruption.

4. Innovative use of information and communication technologies for treatment adherence monitoring through 99 DOTS, Medication Event Reminder Monitor (MERM), etc. are also beneficial in finding missed doses and initiating retrieval action by the health staff.

Resources

1. Training Modules (1-4) for Programme Managers and Medical Officers.

2. Guidelines for PMDT in India, 2021.

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
If treatment interruption is more than one month, the outcome is declared as ‘lost to follow-up'.	True	False			1	If treatment interruption is more than one month, the outcome is declared as ‘lost to follow-up'.		Yes	Yes

Management of TB in special situations

Content

The treatment for TB is demanding in terms of duration of treatment, adverse drug reactions, the requirement of prolonged adherence by patients and catastrophic expenditures. The presence of a special condition added on by a TB diagnosis makes it even more challenging.

To improve the outcomes for such challenging situations, the programme recommends certain modifications in the regimen, which are listed in the table below.

Table: Management of TB in Special Situations

Pregnancy and lactation	Pregnant women with TB should be jointly managed by an obstetrician/ gynaecologist and pulmonologist/ physician.
	The shorter oral Bedaquiline-containing Multidrug-resistant (MDR)/Rifampicin-resistant (RR)-TB regimen should not be administered in pregnant women before 32 weeks due to Ethionamide (Eto) led to potential teratogenicity in first trimester and risk of hypothyroidism in the infant in second trimester.
	Beyond 32 weeks, the choice of regimen needs to be a consultative decision between the obstetrician and physician at the Nodal/District Drug-resistant TB Centre (N/DDR-TBC).
	In pregnant women diagnosed with DR-TB, if the duration of pregnancy is <20 weeks*, the patient should be advised to opt for Medical Termination of Pregnancy (MTP) in view of the potential severe risk to both mother and foetus.
	Bedaquiline (Bdq) and Delamanid (Dlm) both should not be recommended during the lactating period unless the mother is willing to replace breastfeeding with formula feed.
	Breastfeeding must be continued and after ruling out active TB, the baby should be given 6 months of isoniazid preventive therapy, The mother should be advised about cough hygiene measures such as covering the nose and mouth while coughing, sneezing or any act which can produce sputum droplets.
	Mothers receiving INH and their breastfed infants should be supplemented with vitamin B6 (pyridoxine), recommended dose of Pyridoxine in infants is 5 mg/day and for mother is 10mg/day.
Renal impairment	In the presence of mild to moderate renal impairment dosage of Ethambutol (E) and Levofloxacin (Lfx) should be adjusted.
	In the presence of severe renal impairment, Lfx can be replaced with a normal dose of Moxifloxacin (Mfx) (200/400 mg based on the patients’ weight).
	In case of patients undergoing dialysis, medicine should be given either 4-6 hours before dialysis or immediately after dialysis
Pre-existing liver disease	MDR/ RR-TB patients having deranged Liver Function Test (LFT) during pre-treatment evaluation should be strictly monitored as clinically indicated while on treatment.
	In patients with pre-existing liver disease with persistently abnormal liver function tests, a shorter oral MDR/ RR-TB regimen should be avoided due to presence of High-dose Isoniazid (H(h)), Eto and Pyrazinamide (Z).
	If the serum alanine aminotransferase level is more than 3 times normal before the initiation of treatment, the following regimens should be considered: – Containing two hepatotoxic drugs: - 9 months of isoniazid and rifampicin, plus ethambutol (until or unless isoniazid susceptibility is documented) - 9HRE - 2 months of isoniazid, rifampicin, streptomycin and ethambutol, followed by 7 months of isoniazid and rifampicin-2SHR/ 7HR - 6–9 months of rifampicin, pyrazinamide and ethambutol-(6-9 RZE) Containing one hepatotoxic drug: 2 months of isoniazid, ethambutol and streptomycin, followed by 10 months of isoniazid and ethambutol (2SHE/10 HE) Containing no hepatotoxic drugs: 18–24 months of streptomycin, ethambutol and fluoroquinolone. (18-24 SLE)
Seizure disorders	Patients should be evaluated to check if seizures are under control and verify if the patient is taking anti-seizure medication.
	Since Eto, Fluoroquinolones (FQ), and high dose Isoniazid are associated with seizures they should be used carefully/ avoided amongst MDR/RR-TB patients with a history of seizures.
	Though the seizure is not common with Bdq, it should also be considered while assessing the causality assessment.
	The prophylactic use of oral pyridoxine (vitamin B6) up to 5-25 mg/day can be used in patients with seizure disorders to protect against the neurological adverse effects of isoniazid or cycloserine.
	Serum levels of anti-epileptic drugs should be monitored closely to identify any drug interactions.

Management of Adverse Drug Reactions (ADRs) in Special Situations

The actual management of ADR begins during the treatment initiation counselling, where the patient should be instructed in detail about potential adverse effects due to the prescribed drug regimen and when they occur, to notify a healthcare provider.
Treatment Supporter (TS) should be trained to closely monitor the patient for any signs of ADR (especially, since drug-drug interaction could happen) daily so that they can be recognized and managed quickly.
The TS should also be trained to identify ADR as major and minor.
A symptom-based approach should be followed to manage minor ADR where the patient is usually able to tolerate anti-TB drugs and continue medication with symptomatic treatment. Appropriate referrals should be made for all major ADRs that may require hospitalization of the patient.
If the adverse effect is mild and not serious the treatment regimen must be continued with the help of ancillary drugs, if needed.
For most second-line drugs related ADR, reducing the dosage/ terminating the offending drug can be considered and should be decided by the Nodal/District Drug-resistant TB Centre (N/DD- TBC) committee.
Psychosocial support, patient education and motivation through TS and other patient support groups are also effective ways to manage the ADRs.

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
The shorter oral Bdq-containing regimen should not be administered to pregnant women until how many weeks?	20	22	30	32	4	The shorter oral Bedaquiline-containing MDR/RR-TB regimen should not be administered in pregnant women before 32 weeks as it can cause Ethionamide (Eto)-led potential teratogenicity in the first trimester and risk of hypothyroidism in infants in the second trimester.		Yes	Yes

Death Audit

Content

A death review or mortality audit is a means of documenting the causes of death and the factors that contributed to it, identifying factors that could be modified and actions that could prevent future deaths, putting the actions into place and reviewing the outcomes.

The aims of the audit or review of deaths in hospitals and health services are to:

Ensure that all deaths are identified and discussed, and confidentiality is maintained.
Assign a cause or causes to each death.
Determine whether the care given was consistent with evidence-based clinical practice, standards of care or the care desired by professionals.
Determine the social, environmental and nutritional risk factors for any death.
Determine possible modifiable factors in the care of each person who dies.
Change modifiable factors to improve the quality of care and avoid similar deaths in the future.
Improve the quality and completeness of patient documentation.
Provide an opportunity for reflection and support to HCWs.
Let families know that their relative’s life was valued, the death is being taken seriously and HCWs are committed to learning and improving their practice.

Under the National TB Elimination Programme (NTEP), death audits provide insights into the chain of social, economic and clinical events leading to TB deaths and guide the programme in taking appropriate actions to prevent them.

Process for Undertaking Death Audits

An overview of the process for undertaking a TB death audit is shown in the figure below. Under NTEP, the following stakeholders are involved in the process:

The medical officer should conduct an in-depth audit of all the deaths occurring amongst TB patients irrespective of initiation of treatment.
Similarly, the District TB Officer (DTO) should conduct the death review of all Multidrug-resistant TB (MDR-TB) patients who died.

Figure: Overview of the process for undertaking a TB death audit

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which of the following is true about death audits?	A death audit is a means of documenting the causes of death and the factors that contributed to it.	It helps in identifying factors that could be modified and actions that could prevent future deaths.	It can be conducted via a community-based death review	All of the above	4	A death review or mortality audit is a means of documenting the causes of death and the factors that contributed to it, identifying factors that could be modified and actions that could prevent future deaths, putting the actions into place and reviewing the outcomes. It is conducted via two main methods: Community-based Death Review and Facility-based Mortality Audit.		Yes	Yes
Which of the following stakeholders are responsible for conducting death reviews under NTEP?	Treatment supporters	Medical officers	State TB officers	None of the above	2	The medical officer should conduct an in-depth audit of all the deaths occurring amongst TB patients irrespective of initiation of treatment.		Yes	Yes

DR-TB HIV Coordinator: TB and Comorbidities

DR-TB HIV Coordinator: DS-TB Treatment and care

Fullscreen

Categorization of DSTB Treatment Regimen
Content
Daily Regimen is prescribed for Drug Sensitive TB patients (DSTB), where the patient needs to consume the FDC formulation daily.

Daily Regimen comprises the first line Anti TB drugs based on

Age: Adult/ Pediatric

Weight of the patient: Weight Bands

Age: Based on age, patients are categorized into

Adults: The patient's age should be greater than 19 years

Paediatrics: Patient's age up to 19 years and weight less than 39 Kgs

Weight Bands:

Treatment dosages are based on TB patients’ weight.

A weight band category is defined for Adults and Pediatric patients separately, and FDC are issued based on that weight category.

Treatment Regimen for DSTB – Adult

Content

Intensive Phase(IP): Consists of eight weeks (56 doses) of HRZE in daily dosages as per weight of patient.

Continuation Phase(CP): Consists of 16 weeks (112 doses) of HRE in daily dosages as per weight of patient.

For adults, there are five weight bands, as shown in the table below. The table also indicates the number of FDC tablets that have to be consumed in each weight band

Weight band category	Intensive phase(IP) (HRZE - 75/150/400/275)	Continuation phase(CP) (HRE - 75/150/275)
25–34 kgs	2	2
35–49 kgs	3	3
50–64 kgs	4	4
65–75 kgs	5	5
>=75 kgs	6	6

Regular monthly follow up of the patient needs to be done and if patient loses or gains approx. 5 kg weight and if weight band changes during the treatment, then the dose of the patient needs to be recalculated.

Treatment Regimen for DSTB - Pediatrics

Content

Intensive Phase (IP)

Consists of eight weeks (56 doses) of HRZ in daily dosages as per weight of patient.

Ethambutol (E) is given separately for children to monitor ophthalmic side effects.

Continuous Phase (CP)

Consists of 16 weeks (112 doses) of HRE in daily dosages as per the weight of the patient.

In Pediatric, there are six weight bands’s as shown in the table below. The table also indicates the number of FDC tablets that has to be consumed in each weight band

Weight Band category	Fixed-Dose Combinations (FDCs)
	Intensive phase (IP) (HRZE - 75/150/400/275)	Continuation phase (CP) (HRE - 75/150/275)
4-7 kgs	1	1
8-11 kgs	2	2
12-15 kgs	3	3
16-24 Kgs	4	4
25-29 Kgs	3 + 1A	3 + 1A
30-39 Kgs	2 + 2A	2 + 2A

Regular monthly follow-up of the paediatric patient needs to be done and if the patient weight crosses the range of the weight band during the treatment, then the weight band of the patient should be changed immediately.

Children above 39 kg shall usually be adolescents, the drug dosage requirement for them would be similar to adults

Resources:

Technical and Operational Guidelines for TB Control in India 2016

Kindly provide your valuable feedback on the page to the link provided HERE

DS-TB Treatment – Patient Flow

Content

Community Health Volunteers(CHVs) have to refer the presumptive cases identified based on the r symptom screening to the nearest NTEP health facility for further investigation. Once Diagnosed with TB, the TB patients are initiated on the first-line TB treatment. Patients are also offered NAAT within a maximum of 15 days to rule out any drug resistance. If no drug resistance is detected, then the patient continues on the first-line TB treatment. TB patients are then clinically evaluated every month to check the progress of TB treatment.

The treatment duration of TB is divided into two phases - The Intensive Phase(IP) and the Continuation Phase(CP). Post-treatment completion, patients are then evaluated at intervals of 6,12,18 and 24 Months to ensure a relapse-free TB cure for the patient.

Figure: DSTB Treatment Flow

Adverse Drug Reactions(ADRs) to First Line Treatment

Content

Symptoms	Drug Responsible	Action to be taken by Community Health Volunteers
Gastrointestinal Symptoms	Any Oral Medications	Reassure patient. Give TB Drugs with less water at a longer interval. If symptom persists, refer to the nearest health facility
Itching/Rashes	Isoniazid	Reassure patient. In case of severe itching, refer the patient to the nearest health facility
Tingling/ burning/ numbness in the hands & feet	Isoniazid	Refer the patient to the nearest health facility
Joint Pains	Pyrazinamide	Reassure patient. Increase intake of liquids. If severe, refer the patient to the nearest health facility
Impaired Vision	Ethambutol	Refer the patient to the nearest health facility
Ringing in the ears, Loss of hearing, Dizziness and loss of balance	Isoniazid, Rifampicin or Pyrazinamide	Refer the patient to the nearest health facility
Hepatitis: Anorexia/ nausea/ vomiting/ jaundice	Isoniazid, Ethambutol, Rifampicin or Pyrazinamide	If patient detected with signs of jaundice, refer the patient to the nearest health facility

DR-TB HIV Coordinator: DR-TB Treatment and care

Fullscreen

Drug-Resistant Tuberculosis(DR-TB)
Content
What is Drug-Resistant Tuberculosis?

Drug-Resistant TB occurs when bacteria become resistant to the drugs used to treat TB. This means that the drug can no longer kill the TB bacteria.

Multidrug-resistant TB (MDR TB) is a type of DR-TB where TB bacteria is resistant to both Isoniazid and Rifampicin, the two most potent anti-TB drugs.

Figure: High Risk for Drug-Resistant Tuberculosis (DRTB)

Resources:

Guidelines for Programmatic Management of Drug-Resistant Tuberculosis in India, March 2021

WHO Consolidated Guidelines on Tuberculosis: Module 4-Treatment: Drug resistant TB Treatment, 2020

Types of Drug Resistance Tuberculosis -DRTB

Content

Resistant

Sensitive

Unknown / Sensitive

Types of Drug Resistance TB (DR TB)	Resistance to Isoniazid (H)	Resistance to Rifampicin (R)	Resistance to Fluroquinolone (FQ) Ofloxacin, Levofloxacin, Moxifloxacin	Resistance to Group A Drugs Bedaquiline or Linezolid
H Mono / Poly Drug Resistance Resistant to Isoniazid (H) Sensitive to Rifampicin (R) Unknown / Sensitive to Fluoroquinolone (FQ) or Group A Drugs - Bedaquiline or Linezolid
Rifampicin Resistance (RR) Resistant to Rifampicin (R) Unknown / Sensitive to other drugs
Multi Drug Resistance TB (MDR TB) Resistant to Isoniazid (H) and Rifampicin (R) Unknown / Sensitive to Fluoroquinolone (FQ) or Group A Drugs - Bedaquiline or Linezolid
Pre-Extensive Drug Resistance (Pre -XDR) Resistant to Isoniazid (H), Rifampicin (R) and any Fluroquinolone (FQ) Sensitive/ Unknown to Group A Drugs - Bedaquiline or Linezolid
Extensive Drug Resistance (XDR) Resistant to Isoniazid (H) , Rifampicin (R) and any Fluoroquinolone (FQ) and at least one additional Group A Drugs - (presently to either Bedaquiline or linezolid [or both])

Resources:

Goals of DR-TB Treatment
Content
Goals of Drug-resistant Tuberculosis (DR-TB) treatment under the National Tuberculosis Elimination Program (NTEP) are as follows:

Image

Figure: Goals of DR-TB Treatment; Source: Guidelines for PMDT in India, March 2021, p41.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

Technical and Operational Guidelines for TB in India, 2016.

Kindly provide your valuable feedback on the page to the link provided HERE

Newer Anti-TB Drugs

Content

Figure: Sirturo 100 mg Bedaquiline Tablets

Newer anti-TB drugs are needed to improve the treatment outcomes of DR-TB, shorten the duration of treatment, address the problem of drug resistance, and have less toxic drugs.
Five decades after the discovery of Rifampicin, two newer drugs with anti-TB effects were approved for the treatment of multidrug-resistant tuberculosis (MDR-TB) by the Central Drugs Standard Control Organization (CDSCO). These are:

Bedaquiline (Bdq)
Delamanid (Dlm)

In July 2020, the Drug Controller General of India (DCGI) also approved a third newer drug - Pretomanid (Pa) to use under the Conditional Access Programme (CAP) under the National Tuberculosis Elimination Program (NTEP).

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

Weight Band-wise Dosages of DR-TB Drugs for Adults

Content

The dosage for Drug-resistant TB (DR-TB) drugs used in the regimen by weight bands for adults are enumerated in the table below.

Table: Weight Band-wise Drug Dosage of DR-TB Drugs for Adults; *Source: Guidelines for PMDT, India 2021, pp.51,64.*
SR NO	DRUGS	16-29 KG	30-45 KG	46-70 KG	>70 KG
1	Levofloxacin (Lfx)	250 mg	750 mg	1000 mg	1000 mg
2	Moxifloxacin (Mfx)	200 mg	400 mg	400 mg	400 mg
3	High dose Mfx (Mfx^h)	400 mg	600 mg	600 mg	600 mg
4	Bedaquiline (Bdq)	Week 0–2: Bdq 400 mg daily Week 3–24: Bdq 200 mg 3 times per week
5	Clofazimine (Cfz)	50 mg	100 mg	100 mg	200 mg
6	Cycloserine (Cs)³	250 mg	500 mg	750 mg	1000 mg
7	Linezolid (Lzd)	300 mg	600 mg	600 mg	600 mg
8	Delamanid (Dlm)	50 mg twice daily (100 mg) for 24 weeks in 6-11 years of age 100 mg twice daily (200 mg) for 24 weeks for ≥12 years of age
9	Amikacin (Am)¹	500 m	750 mg	750 mg	1000 mg
10	Pyrazinamide (Z)	750 mg	1250 mg	1750 mg	2000 mg
11	Ethionamide (Eto)³	375 mg	500 mg	750 mg	1000 mg
12	Na - PAS (60% weight/ vol)^2,3	10 gm	14 gm	16 gm	22 gm
13	Ethambutol (E)	400 mg	800 mg	1200 mg	1600 mg
14	Imipenem - Cilastatin (Imp-Cln)³	2 vials (1 g + 1 g) bd (to be used with Clavulanic acid)
15	Meropenems (Mpm)³	1000 mg three times daily (alternative dosing is 2000 mg twice daily
16	Amoxicillin-Clavulanate (Amx-Clv) (to be given with Carbapenems only)	875/125 mg bd	875/125 mg bd	875/125 mg bd	875/125 mg bd
17	High-dose H (H^h)	300 mg	600 mg	900 mg	900 mg
18	Rifampicin (R)	300 mg	450 mg	600 mg	750 mg
19	Pyridoxine (Pdx)	50 mg	100 mg	100 mg	100 mg
¹For adults more than 60 yrs of age, dose of Second Line Injectable (SLI) should be reduced to 10 mg/kg (max up to 750 mg) ²In patients on Para-aminosalicylic Acid (PAS) with 80% weight/volume the dose will be changed to 7.5 gm (16-29 kg); 10 gm (30- 45 kg); 12 gm (46-70 kg) and 16 gm (>70 kg) ³Drugs can be given in divided doses in a day in the event of intolerance

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

Treatment of DR-TB in Children
Content
The principles of designing Drug-resistant TB (DR-TB) treatment regimens (Shorter or longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB), and H mono/ poly DR-TB regimens in children are similar to adults:

Children, aged 5 years to less than 18 years of age and weighing at least 15 kg, are eligible for both longer oral and shorter oral Bedaquiline-containing Multidrug-resistant (MDR)/ Rifampicin-resistant TB (RR-TB) regimens.

Management of H mono/ poly DR-TB in children will be the same as in adults and child-friendly formulations can be used.

The drug doses should be used as per paediatric weight bands.

Bedaquiline (Bdq) tablets suspended in water have been shown to have the same bioavailability as tablets swallowed whole and therefore, should be used to treat DR-TB in children until a child-friendly formulation becomes available.

Delamanid (Dlm) is already approved for treating M/XDR-TB under the National TB Elimination Programme (NTEP) for children from 6 years onwards.

As in adults, the extension of Bdq beyond 6 months and concomitant use of Bdq and Dlm in special situations will apply to children as well.

Treatment can be directly extended to 9 months in certain conditions like extensive disease, extrapulmonary TB, uncontrolled comorbidity, smear-positive cases at the end of the 4th month and when the regimen is modified.

Shortening the total treatment duration to less than 18 months may be considered in children without the extensive disease.

For children under 5 years of age, where neither Bdq nor Dlm is approved yet, the longer oral M/XDR-TB regimen should be suitably modified as per the replacement drug. A suitable regimen can be designed considering child-friendly formulations where Bdq can be replaced with Amikacin (Am), Pyrazinamide (Z) or Ethionamide (Eto) in the initial phase.

Children below 5 years are not excluded from short-course regimens, instead receive short course injectables till further evidence on the use of Bdq is available.

The use of injectable agents in children should be exceptional and limited to salvage treatment and be monitored for early detection of ototoxicity.

Meropenem is the preferred drug over imipenem in TB meningitis considering the risk of seizures in children due to Imipenem.

Additional Information

Achieving an appropriate dose in children aged 3-5 years will be easier when the special formulation dispersible 25 mg tablet used in trials in these age groups becomes available.

The recent data review for the World Health Organization (WHO) guidelines suggested that there are no additional safety concerns for concurrent use of Dlm with Bdq.

For treatment and management of adverse drug reactions in children, there should be provision for treatment in consultation with a specialist.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

Consolidated Guidelines on Tuberculosis: Module 4 - Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE
DR-TB Treatment Care Cascade
Content
The Drug-resistant TB (DR-TB) treatment process for all DR-TB patients follows a care cascade.

DR-TB patient tracing by health staff
Referral for treatment initiation to health facility/ district or nodal DR-TB site
Pre-treatment evaluation

Decision on patient’s treatment regimen by DR-TB committee
DR-TB treatment initiation*
Counselling of patient and his/her family
Treatment supporter identification in consultation with the patient
Active Drug Safety Monitoring (aDSM) form filling
Adverse Drug Reaction (ADR) Management (as and when needed)
Follow up visits to the nearest Health Facility (HF)

*(H Mono/ Poly DR-TB Patient - Any health facility; Multidrug/ Extensively DR-TB (M/ XDR-TB) Patient - Nodal/ District DR-TB Centre (N/DDR-TBC); Contact of MDR/ DD-TB with FQ-susceptibility - TB Preventive Therapy after ruling out active disease)

HFs are responsible for updating the information of DR-TB patients in Nikshay on a real-time basis.

This entire care cascade needs to be monitored by the Medical Officer of the TB Unit (MO-TU) and the senior DR-TB TB-HIV supervisor. The figure below elaborates on these processes that should be followed in the DR-TB treatment care cascade.

Figure: Processes for all DR-TB Patients in the Treatment Care Cascade; Source: PMDT Guidelines India, 2021, p43.

Abbr: PTE: Pre-treatment Evaluation; ADR: Adverse Drug Reaction; aDSM: Active Drug Safety Monitoring

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-resistant Tuberculosis, 2014.

WHO Consolidated Guidelines on Tuberculosis, Module 4 - Treatment: Drug-resistant TB Treatment.

Kindly provide your valuable feedback on the page to the link provided HERE

Pre-treatment Counselling of DR-TB Patients

Content

Pre-treatment counselling must serve as an informed decision-making process that enables patients to make a duly informed decision regarding the use of all anti-TB drugs and regimen, including newer drugs.

Written consent is not needed for any treatment regimen under National TB Elimination Programme (NTEP).

Figure: Key points to be covered during pre-treatment counselling; Source: PMDT Guidelines India, 2021, p45.

Abbr: TPT: TB Preventive Treatment

Training of counsellor:

All key points depicted in the figure here should be covered.
A counselling register must be maintained for all patients.

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

Pre treatment evaluation of a DRTB cases
Content
Let us understand the objective and importance of Pre-treatment Evaluation (PTE) of Drug-resistant TB (DR-TB) patients.

PTE Objective

Drugs used for the treatment of drug-resistant TB have significant adverse effects. Hence, there is a need for PTE to rule out any underlying condition at the baseline, like co-morbid conditions, radiological abnormalities, Electrocardiogram (ECG) changes, or biochemical derangements.

PTE is essential to identify:

The patient's eligibility for initiation of a particular regimen

Patients who require special attention during treatment

Regimen modifications from the beginning of treatment

Important Points

In the majority of Multidrug-resistant (MDR)/ Rifampicin-resistant Tuberculosis (RR-TB) patients, PTE can be done on an outpatient basis.

The District TB Officer (DTO) and Medical Officer of the TB Unit (MO-TU) can arrange for PTE at the Nodal and District DR-TB Centre (N/DDR-TBC) or at the sub-district level health facility, wherever feasible.

No additional investigations are required for H Mono/ Poly DR-TB patients unless clinically indicated.

The PTE carried out at the time of treatment initiation can be considered valid for 1 month from the date of the test result and the patient can be re-initiated on a subsequent regimen considering the previously conducted PTEs.

Active Drug Safety Management and Monitoring (aDSM) treatment initiation forms are required to be completed for all DR-TB patients at the time of initiation of each new episode of treatment.

PTE should include a thorough clinical evaluation by a physician and expert consultation as per the need.

Laboratory-based tests should be performed based on the drugs used in the treatment regimen.

Pre-treatment evaluation should be made available free of charge to the patient.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4 -Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE
DR-TB Treatment – Patient Flow

Content

After getting diagnosed with Drug-Resistant TB(DR-TB), the patient is referred to District DRTB Centre(DDR-TBC) for initiation of treatment. Few clinically complicated cases are referred to the Nodal DRTB Centre(NDR TBC). Since the drugs used for the treatment of DR-TB have significant adverse effects and to rule out any underlying comorbid conditions or radiological or ECG, or biochemical derangements, a Pre-treatment evaluation is done to check eligibility of patients for DR-TB regimen and to identify those patients requiring special attention and regimen modifications before initiating patients on TB treatment.

After initiation of treatment, patients are monitored every month. If the sputum test is positive during the follow-up, then the sputum sample is sent for further testing, and if needed, the regimen is changed. And if the sputum sample turns out to be negative during follow up sputum test, then the same treatment regimen is continued till treatment completion.

Post-treatment completion, patients are evaluated at the interval of 6, 12, 18 and 24 months, screened for any clinical signs and symptoms, and, if found suspected, then referred for sputum microscopy and /or culture test.

Figure: TB patient flow after being diagnosed with Multi Drug Resistance TB(MDR/RR TB)
Second Line anti TB drugs
Content
The anti-TB drugs recommended for treatment of Multi- and Extensively Drug-resistant (M/XDR) TB patients are grouped into three groups – A, B and C (Figure below).

Figure: Groups A, B and C of Anti-TB Drugs used in Treatment of M/XDR-TB Patients

Grouping of drugs is done based on their efficacy, experience of use and drug class. This grouping is intended to guide the design of individualized, longer M/XDR-TB regimens (the composition of the recommended shorter MDR/RR-TB regimen is largely standardized).

Resources

Guidelines for Programmatic Management of Tuberculosis in India, 2021.

WHO Consolidated Guidelines on Tuberculosis, Module 4 - Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE
DR-TB Treatment Regimens
Content
Depending upon type of drug resistance, there are four broad DRTB Treatment regimen.

H Mono/Poly Treatment Regimen(6-9 months)

Shorter oral Bedaquiline containing MDR/RR-TB regimen(9-11 months)

Shorter injectable containing regimen(9-11 months)

Longer oral M/XDR-TB regimen(18-20 months)

Drugs administered for DRTB Regimen:

Drugs are decided based on the drug resistance detected for a patient and will be informed by the medical officer.

Injections might also be administered to the admitted patient.

H Mono/Poly Regimen can be initiated at any health facility, while the other two regimen need to be initiated at N/DDR-TB Centre

Figure: Patient wise boxes(PWB) for DRTB Treatment
Treatment Algorithm for MDR/RR-TB
Content
The treatment algorithm for Multidrug-resistant/ Rifampicin-resistant TB (MDR/ RR-TB) patients is a part of an integrated diagnostic and treatment algorithm under Programmatic Management of Drug-resistant Tuberculosis (PMDT).

A shorter oral Bedaquiline (Bdq)-containing MDR/ RR-TB regimen is recommended for those MDR/ RR-TB patients in whom resistance to the component drugs has been excluded or those who have not been previously treated for more than one month with second-line drugs used in shorter oral Bdq - containing MDR/ RR-TB regimen and have no other exclusion criteria.

All those MDR/ RR-TB patients who are not eligible for a shorter Bdq - containing regimen, after careful evaluation, are considered for a longer M/ XDR-TB regimen.

The treatment algorithm for MDR/ RR-TB patients is shown below.

Figure: Treatment Algorithm for MDR/RR-TB; Source: PMDT Guidelines India, March 2021, p46.

Footnotes for the Algorithm

⁴ As per mutation pattern, includes resistance inferred.

⁵ Discordance in RR results between Nucleic Acid Amplification Tests (NAAT) & First-line Line Probe Assay (FL-LPA) to be resolved with a repeat NAAT at Culture and Drug Susceptibility Testing (C&DST) lab and microbiologists will provide the final decision. InhA mutation is associated with Eto resistance. Use other exclusion criteria to decide regimen if FL-LPA is done on culture isolates for patients with smear-negative specimens.

⁶ To assess Levofloxacin (Lfx), Moxifloxacin (Mfx) and Amikacin (Am) resistance.

⁷ Start treatment based on Line Probe Assay (LPA) results and modify based on Liquid Culture (LC) and DST results later.

⁸ Whenever DST is available.

⁹ Other exclusion criteria for shorter oral Bdq-containing MDR/ RR-TB regimen includes:

History of exposure for > 1 month to Bdq, Lfx, Ethionamide (Eto), or Clofazimine (Cfz), if the result for DST (Bdq, Fluoroquinolone (FQ), Inh A mutation, Cfz & Pyrazinamide (Z)) is not available.

Intolerance to any drug or risk of toxicity from a drug in the shorter oral Bdq-containing MDR/ RR-TB regimen (e.g. drug-drug interactions).

Extensive TB disease – the presence of bilateral cavitary disease or extensive parenchymal damage on chest radiography. In children aged under 15 years, presence of cavities or bilateral disease on chest radiography.

Severe Extrapulmonary TB (EP-TB) disease - the presence of miliary TB or TB meningitis or Central Nervous System (CNS) TB. In children aged under 15 years, extra-pulmonary forms of disease other than lymphadenopathy (peripheral nodes or isolated mediastinal mass without compression).

Pregnant and lactating women (with conditional exceptions).

Children below 5 years.

¹⁰ This portion applies as states move to a shorter oral Bdq-containing MDR/ RR-TB regimen under the guidance of the National TB Elimination Programme (NTEP).

¹¹ Patients who were on a longer oral M/ XDR-TB regimen based on the history of exposure for >1 month and in whom resistance is not detected to Isoniazid (H) or FQ may be switched to shorter oral Bedaquiline containing MDR/ RR-TB regimen based on the FL and Second-line LPA (SL-LPA) results if the duration of longer oral M/ XDR-TB regimen drugs consumed is <1 month.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE

Management of M/XDR-TB Treatment During Pregnancy

Content

In pregnant women diagnosed with multi-drug resistant (MDR)/rifampicin-resistant TB (RR-TB), if the duration of pregnancy is <20 weeks*, the patient should be advised to opt for medical termination of pregnancy (MTP) in view of the potential severe risk to both the mother and the fetus. Figure 1 shows the management algorithm for pregnant patients based on their gestational age.

Figure 1: Management of M/XDR-TB patients during pregnancy based on gestation age; Source: Guidelines for PMDT, India 2021, p.71

* 24 weeks will apply wherever the bill is passed.
# Regimen: 4-6 Bdq (6m) Lfx, Cfz, Eto, Hh, Z, E / 5 Lfx, Cfz, Z, E. No modifications allowed.
@ Regimen:18-20 Lfx, Bdq(6m or longer) Lzd#, Cfz, Cs. Lzd dose to be tapered to half after 6-8 months based
on bacteriological response. Modify regimen if one or more drug cannot be used due to reasons of resistance,
tolerability, contraindication, availability etc.
• in the order of Z E PAS.
• Eto may be considered after 32 weeks’ gestation.
• Am may be considered in post-partum period only. Am will not be started in the final 12 months of treatment.

If the pregnancy is ≤ 20 weeks* and the patient is willing to opt for MTP, she should be referred to a gynecologist or obstetrician for MTP after which shorter oral Bedaquiline-containing MDR/RR-TB regimen can be initiated (if the patient has not started treatment) or continued (if the patient is already on treatment) by the DR-TB Centre committee.

If she does not opt for MTP or has a pregnancy >20 weeks* duration, she will be shifted to a longer oral M/XDR-TB regimen.

For patients who are unwilling for MTP or have a pregnancy of >20 weeks* (making them ineligible for MTP), the risk to the mother and the fetus should be explained clearly and the pregnant DR-TB patients need to be monitored carefully, both in relation to the treatment and progress of the pregnancy.

Shorter oral Bedaquiline-containing MDR/RR-TB regimen cannot be administered in pregnant women before 32 weeks due to Ethionamide (Eto)-led potential teratogenicity in the first trimester and risk of hypothyroidism in the infant in the second trimester.

Beyond 32 weeks, the choice of regimen (shorter/longer) needs to be a consultative decision between the obstetrician and physician at the nodal (N)/district DR-TB Centre (DDR-TBC). More compelling evidence on toxicity causes attributed to the use of specific anti-TB drugs during pregnancy and lactation is needed.

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

DR-TB Treatment in Pregnancy: Recommendation for the Use of Contraception
Content
All women of childbearing age who are awaiting results of the Culture and Drug Susceptibility Test (C&DST), as well as those receiving Drug-resistant TB (DR-TB) treatment, should be advised and counselled intensively to use birth control measures because of the potential risk to both the mother and the foetus.

It should be noted that oral contraceptives might have decreased efficacy due to vomiting and drug interactions with DR-TB drugs (use of Rifampicin in mono/poly resistant TB).

Contraception methods that can be used during DR-TB treatment, based on individual preference and eligibility are:
Barrier methods (e.g., condoms/ diaphragms), intrauterine devices (e.g., CuT), Depot medroxyprogesterone (Depo-provera).

In women, the Isoniazid (H) mono/poly DR-TB regimen may be started or continued safely, except that care should be taken while using oral contraceptives.

A woman on oral contraception, while receiving rifampicin treatment may choose between two options following consultation with a physician:
Use of an oral contraceptive pill containing a higher dose of oestrogen (50 μg)

Use of another form of contraception.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

Consolidated Guidelines on Tuberculosis: Module 4 - Treatment: Drug-resistant TB Treatment, 2020.

Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-resistant Tuberculosis, 2014.

Collaborative Framework for Management of Tuberculosis in Pregnant Women, 2021.

Kindly provide your valuable feedback on the page to the link provided HERE
Follow-up Monitoring of DR-TB Patients
Content
The following points should be covered in follow-up monitoring of Drug-resistant TB (DR-TB) patients:

Monitor DR-TB treatment progress and disease response.

Monitor bacteriological and radiological improvements in DR-TB treatment.

Identify derangements in bio-chemical results and on Electrocardiogram (ECG) which are indicative of systemic disorders that could result in drug-induced adverse events, or comorbidities that may require timely interventions to address and improve the probability of treatment success, survival and quality of life.

Follow-up monitoring to be done periodically based on the type of TB/ severity of disease/ type of regimen used, etc.

Components of Follow-up Monitoring

Clinical monitoring

Follow-up evaluations

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4 - Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE

Rehabilitation service to TB patients

Content

The holistic management of Tuberculosis (TB) patients can improve their life expectancy. The importance of addressing malnutrition, adverse drug reactions, psycho-social well-being, and catastrophic expenses correctly and in a timely fashion is essential in reducing morbidity and mortality.

Table: Rehabilitation services for TB patients
Rehabilitation Services for TB Patients	Care Providers	Key Components
Nutritional Rehabilitation	1. Senior Treatment Supervisor 2. TB Health Visitors 3. Accredited Social Health Activists (ASHAs) 4. Auxiliary Nurse Midwife (ANM) 5. TB treatment supporter 6. Medical officers at Peripheral Health Centre (PHC), Community Health Centre (CHC) level	Supporting nutritional needs of TB patients through Ni-kshay Poshan Yojana Management of undernutrition in nutrition rehabilitation centres (NRCs) Linkages for extra nutritional support for TB patients like the public distribution system (PDS) or food security act.
Pulmonary Rehabilitation	1.Physiotherapists (preferable one male and one female) 2. Nurses 3. Attendant	Management of physical and psychological impairment due to the disease to lower the handicap.
Physical Rehabilitation	therapists (preferable one male and one female) Nurse Doctors Surgeons Physio Attendant	Management of post-treatment sequelae by early identification and periodic assessment. Comorbidity management
Social Rehabilitation	1. TB Health Visitors 2. Accredited Social 3. Health Activists (ASHAs) 4. Auxiliary Nurse Midwife (ANM) 5. TB treatment supporter 6. Medical officers at PHC, CHC level 7. Ni-kshay Mitra	Linkage for vocational rehabilitation e.g., Skill India Synergy between social welfare support systems like: Rashtriya Swasthya Bima Yojana (RSBY) TB pension schemes National rural employment guarantee scheme National Health Protection Scheme (NHPS) for palliative care and rehabilitation
Mental Rehabilitation	1. Psychiatrist 2. Psychologists / Counsellors 3. TB Health Visitors 4. Accredited Social 5. Health Activists (ASHAs) 6. Auxiliary Nurse Midwife (ANM) 7. TB treatment supporter 8. Medical officers at PHC, CHC level	Psychological counselling to the patient and caregivers. Assisting patients in the planning of decisions related to the end-of-life stage.

Patient rehabilitation is ensured by:

1. IT-based monitoring via Ni-kshay platform

2. Community-based monitoring

3. Surveillance: A comprehensive surveillance system for TB patients and their providers built into eNikshay. This is supported by a call centre for user-friendly private reporting and patient monitoring.

Resource

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation
Rehabilitation services to TB patients comprise Nutritional, Physical, Pulmonary, Social and Mental Rehabilitation.	False	True			2	The holistic management of tuberculosis (TB) patients can improve life expectancy. The importance of addressing malnutrition, adverse drug reactions, psycho-social well-being, and catastrophic expenses correctly and in a timely fashion is essential in reducing morbidity and mortality.

Palliative Care in DR-TB
Content
The World Health Organization (WHO) defines palliative care as an approach that improves the quality of life of patients and their families facing the problems associated with life-threatening illnesses, through prevention and relief of suffering by means of early identification, impeccable assessment, and treatment of pain and other physical, psychosocial and spiritual problems.

The goal of such treatment is to improve the quality of life for both the patient and their family.

Drug-resistant TB (DR-TB) remains a life-threatening condition with high mortality and poor cure rates, considering this palliative care is more relevant in DR-TB patients. Palliative care is being considered under the National TB Elimination Programme (NTEP) for DR-TB patients who have advanced disease and reduced lung functions. The approach involves systematically engaging institutes with expertise in palliative care (public as well as private facilities) for providing such care to needy TB patients.

The benefits of DR-TB patients receiving palliative care are as follows:

Provides relief from respiratory distress, pain and other symptoms.

Affirms life and regards dying as a normal process and intends neither to hasten nor postpone death.

Integrates the psychological and spiritual aspects of patient care.

Offers a support system to help patients live as actively as possible until death.

Offers a support system to help the family cope during the patient’s illness and in their bereavement.

Enhances quality of life and may also positively influence the course of illness.

Resources

Companion Handbook to the WHO Guidelines for the Programmatic Management Of Drug-resistant Tuberculosis, 2014.

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, 2021.

Kindly provide your valuable feedback on the page to the link provided HERE
Need for Palliative Care in DR-TB Patients
Content
The current TB treatment strategy is based on a patient-centred approach to treatment and alleviation of patients' suffering that has been restricted mostly to its physical aspects. However, difficulties faced by patients and families affected by life-threatening diseases span across physical, psychological, social and spiritual aspects. Therefore, a more holistic approach to patient treatment requires broadening to a patient-centric care approach with palliative care services.

Palliative care would be necessary for the care of:

Patients who are chronically ill with extensive drug resistance and extensive fibro-cavitary or disseminated bilateral lung disease

Patients who have failed regimen for Extensively Drug-resistant Tuberculosis (XDR-TB) or mixed pattern resistance

Patients for whom the World Health Organization (WHO)-recommended regimen cannot be designed even with new drugs.

There is significant suffering associated with Drug-resistant TB (DR-TB) illness and its treatment. This kind of burden increases the possibility of TB patients not being able to adhere to treatment which many times results in the treatment failing to cure them.

Delivering palliative care to alleviate the suffering of patients during Multidrug-resistant TB (MDR-TB) treatment, especially when all possibilities of treatment have failed, is an ethical imperative.

Thus, the need for palliative and end-of-life care is being increasingly recognized as an important part of the continuum of care for DR-TB patients.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, 2021.

Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-resistant Tuberculosis, 2014.

Kindly provide your valuable feedback on the page to the link provided HERE
Interim Treatment Outcomes of DR-TB Cases
Content
There are two main interim treatment outcomes that can occur during Drug-resistant TB (DR-TB) treatment. These are:

Bacteriological Conversion: This occurs after bacteriological confirmation of TB in at least two consecutive cultures (applicable for DR-TB and Drug-sensitive (DS-TB)) or smears (applicable for DS-TB only), taken on different occasions, at least 7 days apart, are found to be negative.

Bacteriological Reversion: This occurs when at least two consecutive cultures (applicable for DR-TB and DS-TB) or smears (applicable for DS-TB only), taken on different occasions, at least 7 days apart, are found to be positive, either after the initial conversion or for patients without bacteriological confirmation of TB.

For defining treatment failed, bacteriological reversion is considered only when it occurs in the continuation phase.

Time-to-culture conversion is calculated as the interval between the date of DR-TB treatment initiation and the date of the first of these two negative consecutive cultures taken 7 days apart (date of sputum specimens collected for culture should be used).

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE

Final Treatment Outcomes of DR-TB Cases

Content

Under the National TB Elimination Programme (NTEP), the treatment outcome definitions of Drug-susceptible TB (DS-TB) and Drug-resistant TB (DR-TB) have been aligned in recent times. However, the treatment outcome is declared at different time points for certain outcomes (e.g., cured/ treatment completed) since the duration of DR-TB treatment is longer when compared to DS-TB treatment.

Table: Final DR-TB Treatment Outcomes
TREATMENT OUTCOMES	DEFINITION	REMARKS
Treatment failed	A patient whose treatment regimen needs to be terminated or permanently changed to a new regimen option or treatment strategy.	Reasons for the change include: No clinical and/or bacteriological response (a bacteriological conversion with no reversion) Adverse Drug Reactions (ADRs) Evidence of additional drug resistance to medicines in the regimen
Cured	A pulmonary TB patient with bacteriologically confirmed TB at the beginning of treatment who completed the treatment as recommended by the national policy with evidence of bacteriological response and no evidence of treatment failed.	Bacteriological response - bacteriological conversion with no reversion.
Treatment completed	A patient who completed the treatment as recommended by the national policy whose outcome does not meet the definition for cured or treatment failed.	---
Died	A patient who died before starting or during the course of treatment.	Patient died of any reason.
Lost to follow-up	A patient who did not start the treatment or whose treatment was interrupted for 2 consecutive months or more.	---
Not evaluated	A patient for whom no treatment outcome was assigned.	This includes cases “transferred out” to another treatment unit and whose treatment outcome is unknown and excludes patients who lost to follow-up.

Points to Note

In case of a change in the regimen within the scope of the guidelines, from shorter to longer or vice-versa in the initial months before any definitive treatment outcome applies, the outcome of only the changed regimen needs to be reported. The patient needs to be moved out of the denominator of the previous regimen.
Patients who are still on treatment due to frequent short interruptions (less than 2 consecutive months) due to patient or provider requirements can be reported as not evaluated as an outcome is not assigned at the time of reporting, but the data can be cleaned and updated later when the outcome is available.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

Kindly provide your valuable feedback on the page to the link provided HERE

Interim reports of DR-TB Treatment

Content

As Drug-resistant TB (DR-TB) treatment is of relatively long duration, the interim treatment reports are prepared in Ni-kshay to assess the interim treatment outcomes in the programme.

Criteria

The interim report assessment period is six calendar months, usually counted from January to the end of June and July to the end of December.
All patients registered and starting treatment during the assessment period are included in the calculation.

Interpretation

Interim results of DR-TB patients who started treatment during the first semester of a year (1 January to 30 June), should be calculated at the beginning of April of the following year.
The interim report form should be completed 9 months after the closing day of the cohort so as to allow culture information at 6 months of treatment to be included for all patients in the cohort.

Sl. No.	DR-TB Regimen	Time point for interim reporting	Cohort for interim evaluation, reporting and monitoring (Here ‘X’ is the reporting month)	If reporting month is X= April 2023, following are the corresponding cohort for interim report evaluation
1	Isoniazid (H) - mono/ poly DR-TB regimen	4th month of treatment	X - 6 months	Cohort of October 2022 and previous
2	Shorter oral Bedaquiline-containing Multidrug-resistant (MDR)/ Rifampicin-resistant (RR)-TB regimen	4th month of treatment	X - 6 months	Cohort of October 2022 and previous
3	Longer oral Multidrug-resistant/ Extensively Drug-resistant TB (M/XDR-TB) regimen	6th month of treatment	X - 10 months	Cohort of June 2022 and previous
4	BPal (Bedaquiline, Pretomanid, Linezolid) regimen	4th month of treatment	X - 6 months	Cohort of October 2022 and previous
5	Prior longer M/XDR-TB regimen (Drug Susceptibility Testing (DST) guided regimen)	6th month of treatment	X - 10 months	Cohort of June 2022 and previous

Importance

Culture conversion (for confirmed DR-TB cases) and death by six months are important predictors of final outcomes.
It also provides early information on the number of patients initiated on second-line drugs for MDR-TB that turned out not to be XDR.
Information on treatment interruption at the end of six months is important for programme review and implementing corrective actions.
Overall interim reports are important for supervision, monitoring and evaluation at all programmatic levels.

Resources

Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, 2021, CTD, MoHFW, India.

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
What is the duration of the assessment of the interim report in NTEP?	2 Calendar months	3 Calendar months	6 Calendar months	12 Calendar months	3	The interim report assessment period is six calendar months, usually counted from January to the end of June and July to the end of December.		Yes	Yes

PMDT Report

Content

Video file

Video: PMDT Report

DR-TB HIV Coordinator: Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen

Fullscreen

Shorter oral Bedaquiline-containing MDR/RR-TB regimen
Content
Based on the World Health Organization (WHO) treatment guidelines, 2020 recommendations, the National TB Elimination Programme (NTEP) have decided to transition from the current shorter injectable-containing Multi-drug Resistant (MDR)/ Rifampicin-resistant TB (RR-TB) regimen to the shorter oral bedaquiline-containing MDR/RR-TB regimen in the year 2021.

Salient Features of the Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen

This regimen will be used in patients >5 years of age weighing 15 kg or more.

The regimen will be expanded in a phased manner starting with selected states to gain programmatic experience to guide future expansion within 2021.

The regimen consists of an initial phase of 4 months that may be extended up to 6 months and a continuation phase of 5 months, giving a total duration of 9-11 months. Bdq is used for a duration of 6 months.

Figure 1: Regimen and duration of shorter oral Bdq-containing MDR/RR-TB regimen

Abbr: Bdq - Bedaquiline, Lfx- Levofloxacin, Cfz- Clofazamine, Z- Pyrazinamide, E- Ethambutol, H^h- High-dose Isoniazid, Eto- Ethionamide

Points to Note

From the start to the end of 4 months these drugs are used: Bedaquiline, Levofloxacine, Clofazamine, Pyrazinamide, Ethambutol, high-dose Isoniazid, Ethionamide

From the start of 5 months to the end of 6 months (If IP not extended): Bdq, Lfx, Cfz, Z, E

From the start of 7 months to the end of 9 months: Lfx, Cfz, Z, E

If the IP is extended up to 6 months, then all 3 drugs Bdq, Hh and Eto are stopped together

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis, Module 4 - Treatment: Drug Resistant TB Treatment.

Kindly provide your valuable feedback on the page to the link provided HERE
Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen: Pre-treatment Evaluation [PTE]
Content
There are two main evaluations that must be conducted during pre-treatment evaluation to initiate patients on a shorter oral bedaquiline-containing MDR/RR-TB regimen. These evaluations are:

Clinical Evaluation

History and physical examination

Height check

Weight check

Psychiatric evaluation, if required

Laboratory-based Evaluation

Random Blood Sugar (RBS)

HIV testing following counselling

Complete blood count (Haemoglobin (Hb), Total Leucocyte Count (TLC), Differential Leucocyte Count (DLC), platelet count)

Liver function tests (including serum proteins Thyroid-stimulating Hormone (TSH) levels)

Urine examination – routine and microscopic

Serum electrolytes (Sodium (Na), Potassium (K), Magnesium (Mg), Calcium (Ca))

Urine pregnancy test (in women of reproductive age)

Chest X-ray

Electrocardiogram (ECG)

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4-Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE
Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen: Treatment Extension
Content
The total duration of treatment in this regimen is 9-11 months with Intensive Phase (IP) at least 4 months and Continuation Phase (CP) for 5 months. Treatment extension of IP is done up to 2 months based on follow-up results and is indicated in the algorithm presented in the figure below.

Figure: Treatment Extension/ Regimen Change Based on Follow up Smear/ Culture/ DST Results

Abbr: FL & SL- LPA- First Line & Second Line- Line Probe Assay, C&DST- Culture and Drug Susceptibility Test, Z- Pyrazinamide, Cfz- Clofazimine, FQ- Fluoroquinolone, N/DDR-TBC- Nodal/ District DR-TB Centre

Resources

Guidelines for Programmatic Management of Tuberculosis in India, 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.
Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen: Drug Dose Administration
Content
Drug dose administration for shorter/ longer oral Bedaquiline (Bdq)-containing Multidrug-resistant (MDR)/ Rifampicin-resistant (RR)-TB regimen depends on the factors described below.

The dosage of second-line anti-TB drugs would vary as per the weight of the Drug-resistant TB (DR-TB) patients. There are five weight bands in adult patients (≥ 18 years): <16 kg, 16-29 kg, 30-45 kg, 46-70 kg and >70 kg. The weight bands of adult patients for Drug-sensitive TB (DS-TB) patients are different compared to DR-TB patients.

All morning doses should be supervised by the treatment supporter via Directly Observed Treatment, Short-course (DOTS).

In patients with drug intolerance, Cycloserine (Cs), Ethionamide (Eto) and Sodium (Na) Para Aminosalicylic Acid (PAS), can be given in two divided doses. Pyridoxine should be provided as part of the regimen till the end of treatment for all patients.

Change in Weight Bands during Treatment

For adult DR-TB patients whose weight increases or decreases by 5 kg or more compared to baseline weight and crosses the current weight band during the course of the treatment, the weight band must be changed at the time of issuing next month's box to the treatment supporter of the patient.

For paediatric patients, the drug dosage should be adjusted immediately once the weight of the patient crosses the range of the weight band. Counsel the patient about the change in dose.

Key Considerations for Newer Drugs 

Avoid milk-containing products with drugs: The calcium in the milk can decrease the absorption of Fluoroquinolones (FQs).

Avoid large fatty meals: Fat impairs the absorption of anti-TB drugs (Cs, Isoniazid (H), etc.).

Resources

Guidelines for Programmatic Management of Tuberculosis in India, 2021.

The Use of Bedaquiline in the Treatment of Multidrug-resistant Tuberculosis: Interim Policy Guidance, 2013

Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen: Dosage of Drugs for Adults

Content

In adults, the dosage of drugs for a shorter oral Bedaquiline (Bdq) - containing Multi-drug Resistant (MDR)/ Rifampicin-resistant Tuberculosis (RR-TB) regimen, varies according to their weight.

The table below provides drug dosages for adult patients, according to their weight bands, in a shorter oral Bedaquiline-containing MDR/RR-TB regimen.

Table: Weight-bandwise Dosages for Adult Patients on Shorter Oral Bdq-containing MDR/ RR-TB Regimen
Sr No	Drugs	16-29 kg	30-45 kg	46-70 kg	>70 kg
1	High dose H (H^h)	300 mg	600 mg	900 mg	900 mg
2	Ethambutol (E)	400 mg	800 mg	1200 mg	1600 mg
3	Pyrazinamide (Z)	750 mg	1250 mg	1750 mg	2000 mg
4	Levofloxacin (Lfx)	250 mg	750 mg	1000 mg	1000 mg
5	Bedaquiline (Bdq)	Week 0–2: Bdq 400 mg daily Week 3–24: Bdq 200 mg 3 times per week
6	Clofazimine (Cfz)	50 mg	100 mg	100 mg	200 mg
7	Ethionamide (Eto)*	375 mg	500 mg	750 mg	1000 mg
8	Pyridoxine (Pdx)	50 mg	100 mg	100 mg	100 mg
*Drugs can be given in divided doses in a day in the event of intolerance.

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

Possible Adverse Events Due to Drugs in Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen

Content

Drugs that are part of the shorter Bedaquiline (Bdq)-containing regimen have some typical side effects which need close monitoring of Drug Resistant-TB (DR-TB) patients while providing the treatment.

Table: Possible adverse events due to drugs in the shorter oral Bedaquiline-containing MDR/RR-TB regimen; Source: Guidelines for PMDT in India, 2021.
Adverse Drug Events	Causative Drugs
QT prolongation	Bdq, Fluoroquinolone (FQ), Clofazimine (Cfz)
Rash, allergic reaction and anaphylaxis	Any drug
Gastrointestinal symptoms	Ethionamide (Eto), Pyrazinamid (Z), Ethambutol (E), Bdq, Cfz, FQs, Isoniazid(H)
Diarrhoea and/or flatulence	Eto
Hepatitis	Z, H, Eto, Bdq
Giddiness	Eto, FQ, Z
Hypothyroidism	Eto
Arthralgia	Z, FQ, Bdq
Peripheral neuropathy	H, FQ, rarely Eto, E
Headache	Bdq
Depression	FQ, H, Eto
Psychotic symptoms	Isoniazid (H), FQ
Suicidal ideation	H, Eto
Seizures	H, FQ
Tendonitis and tendon rupture	FQ
Vestibular toxicity (tinnitus and dizziness)	FQs, H, Eto
Optic neuritis	E, Lzd, Eto, Cfz, H
Metallic taste	Eto, FQs
Gynaecomastia	Eto
Alopecia	H, Eto
Superficial fungal Infection and thrush	FQ
Dysglycaemia and Hyperglycaemia	Eto

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

Kindly provide your valuable feedback on the page to the link provided HERE

Follow-up Evaluation of Patients on Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen

Content

Apart from clinical evaluation, the patients need to be closely assessed by various laboratory parameters to monitor the improvement on treatment, drug-induced adverse events or co-morbidities to enable timely interventions to address these and improve the probability of treatment success, survival and quality of life.

Table: Laboratory evaluations and follow-up schedule for patients on shorter oral Bdq containing Multidrug-resistant (MDR)/ Rifampicin-resistant (RR) TB regimen; *Source: Guidelines for PMDT in India 2021, p54.*
EVALUATION TEST	FOLLOW-UP SCHEDULE
Clinical + Weight (Wt.)	Monthly in Intensive Phase (IP) or extended IP if the previous month shows Smear-positive (S+ve), quarterly in Continuation Phase (CP)
Smear Microscopy (SM)	Monthly from 3rd month onwards till end of IP Monthly in extended IP only if the previous month S+ve (IP extension up to a maximum of 6 months) Conduct SM within 7 days, if the smear at 6 months is positive to rapidly ascertain bacteriological conversion/ reversion.
Culture	At the end of month 3, end of month 6 and/or end of treatment If the culture result of month 6 is positive, collect one repeat sample immediately to rapidly ascertain the bacteriological conversion/ reversion. If the repeat sample is culture-negative, then end of treatment specimen collection should be done.
Drug Susceptibility Testing (DST)	First-line and Second-line Line Probe Assay (FL-SL LPA) (Levofloxacin (Lfx), Moxifloxacin (Mfx), Ethionamide (Eto)) and Liquid Culture and Drug Susceptibility Testing (LC&DST) (Pyrazinamide (Z), Bedaquiline (Bdq), Clofazimine (Cfz), Mfx, Linezolid (Lzd), Delamanid (Dlm)*) if any of the following: Culture +ve (end of month 3 or later and end of treatment) Smear +ve at end of IP, end of extended IP and end of treatment
Urine Pregnancy Test (UPT)	As and when clinically indicated
Complete Blood Count (CBC)	As and when clinically indicated
Thyroid Stimulating Hormone (TSH) and Liver Function Test (LFT)^#	At end of IP, then as and when clinically indicated
Chest X-ray (CXR)	At end of IP, then as and when clinically indicated, end of treatment
Electrocardiogram (ECG)^$	At 2 weeks, then monthly in the first 6 months, then as and when clinically indicated
Serum Electrolytes (Na, K, Mg, Ca)	As and when indicated and in case of any QTcF prolongation
Specialist consultation	As and when clinically indicated
Colour vision test	Once in two months (in children)
^# HBsAG and other viral markers (Hepatitis A, C & E) to be done in case of Jaundice. ^$ In case of baseline ECG abnormality or QTcF ≥450ms with a shorter oral Bedaquiline-containing MDR/RR-TB regimen that contains Bdq and Cfz, ECG must be done on daily basis for initial 3 days or as suggested by a cardiologist. Repeat ECG with long II lead after an hour to reconfirm abnormal ECG. DST whenever available.

Important Points

The most important evidence of response to DR-TB treatment is the conversion of sputum smear and culture to negative.
If no additional resistance is detected on follow-up after 3^rd month, the IP will be extended on monthly basis up to a maximum of 6 months.

If bacteriological reversion is ascertained or if any resistance is detected by FL-LPA or SL-LPA or if found to be smear/ culture positive at the end of 6 months or later, the patient will be declared as ‘treatment failed’.

The patient is then re-evaluated for a longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimen with appropriate modification if required.
A patient once treated with the shorter oral Bedaquiline-containing MDR/RR-TB regimen for more than one month will never be reinitiated on it again.

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

DR-TB HIV Coordinator: Shorter injectable containing regimen

Fullscreen

Shorter Injectable-containing MDR/RR-TB Regimen: Pre-treatment evaluation and follow-up

Content

The table below provides the details about the clinical evaluation and laboratory tests that need to be done during Pre-treatment Evaluation (PTE) to initiate patients on shorter injectable-containing Multidrug-resistant (MDR)/ Rifampicin-resistant Tuberculosis (RR-TB) regimens.

Table: Clinical evaluation and laboratory tests to be done during PTE for initiation of shorter injectable-containing MDR/ RR-TB regimen; *Source: Guidelines for PMDT in India-2021, p48 and 50.*
CLINICAL EVALUATION	LABORATORY-BASED EVALUATION
History and physical examination	Random Blood Sugar (RBS)
Height check	HIV testing following counselling
Weight check	Complete blood count (haemoglobin (Hb), Total Leucocyte Count (TLC), Differential Leucocyte Count (DLC), platelet count)
Psychiatric evaluation, if required	Liver function tests (including serum proteins)
	Thyroid-stimulating Hormone (TSH) levels
	Urine examination – routine and microscopic
	Serum creatinine
	Audiometry
	Urine pregnancy test (in women of reproductive age)
	Chest X-ray
	Electrocardiogram (ECG)

Follow-up Investigations

Audiometry: Baseline and then every 2 months till Second-line Injectable (SLI) (Kanamycin (Km)/ Amikacin (Am)) course is completed and then, as and when clinically indicated
Serum creatinine: Baseline and then monthly till SLI course is completed.

The rest of the management would be the same as for shorter all oral Bedaquiline (Bdq) - containing MDR/ RR-TB regimen.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

Kindly provide your valuable feedback on the page to the link provided HERE

DR-TB HIV Coordinator: Longer Oral M/XDR-TB Regimen

Fullscreen

Longer Oral M/XDR-TB: Regimen and Duration
Content
Longer oral Multi (M)/ Extensive Drug-resistant (XDR) -TB treatment is specified with a definite regime and duration.

Regimen: (18-20) Levofloxacin (Lfx), Bedaquiline (Bdq) (6 months or longer), Linezolid^#(Lzd), Clofazimine (Cfz), Cycloserine (Cs) (^#dose of Lzd will be tapered to 300 mg after the initial 6–8 months of treatment)

Duration: 18-20 months

No separate Intensive Phase (IP) and Continuation Phase (CP).

Bdq will be given for 6 months and extended beyond 6 months as an exception.

Pyridoxine should be given to all Drug-resistant TB (DR-TB) patients as per the weight bands.

For Extensively Drug-resistant TB (XDR-TB) patients, the duration of a longer oral XDR-TB regimen would be for 20 months.

Resources

Guidelines for Programmatic Management of Drug-Resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE
Pre-treatment Evaluation [PTE] in Longer Oral M/XDR-TB Regimen
Content
Pre-treatment evaluation for patients on a longer oral Multi/ Extensively Drug-resistant TB (M/XDR-TB) regimen requires both clinical evaluation and laboratory-based evaluation as given below.

Clinical Evaluation

Physical examination

Height

Weight

Psychiatric evaluation if required

Ophthalmologist opinion (for Linezolid)

Surgical evaluation for consideration after culture conversion is achieved

Laboratory-based Evaluation

Random Blood Sugar (RBS)

HIV-testing following counselling

Complete blood count (Hb, TLC, DLC, platelet count)

Liver function tests (including serum proteins)

Thyroid Stimulating Hormone (TSH) levels

BUN and Sr Creatinine- If Amikacin needs to be added

Urine examination- routine and microscopic

Serum electrolytes (Na, K, Mg, Ca)

Urine pregnancy test (in women of reproductive age)

Chest X-ray

Electrocardiogram (ECG)

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE
Treatment Extension in Longer Oral M/XDR-TB Regimen
Content
The total duration of a longer oral Multidrug/ Extensively drug-resistant TB (M/XDR-TB) regimen is 18–20 months.

Image

Figure: Protocol for Treatment Extension in Longer Oral M/XDR-TB Treatment Regimen

Extension of Bedaquiline (Bdq) beyond 6 months is to be considered in patients in whom an effective regimen cannot otherwise be designed.

If any additional resistance to Group A, B or C drugs in use is detected, the patient needs to be reassessed at the Nodal/ District Drug-resistant Tuberculosis Centre (N/DDR-TBC) for modification of a longer oral M/XDR-TB regimen immediately on receiving the report.

A treatment duration of 15–17 months after culture conversion is suggested for most patients. The duration may be modified according to the patient’s response to treatment.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE

Dosages of M/XDR-TB Drugs for Adult in Longer Oral M/XDR-TB Regimen

Content

It is important to know the dosages of Multi (M)/ Extensively Drug-resistant TB (XDR-TB) drugs for adults on a longer oral M/XDR-TB regimen.

The table below shows the M/XDR-TB regimen drugs for adults weight band-wise, used in longer oral M/XDR-TB regimen customized for India by national experts.

Table: Dosages of M/XDR-TB Drugs for Adults in Longer Oral M/XDR-TB Regimen
Sr.No	Drugs	16-29 kg	30-45 kg	46-70 kg	>70 kg
1	Levofloxacin (Lfx)	250 mg	750 mg	1000 mg	1000 mg
2	Moxifloxacin (Mfx)	200 mg	400 mg	400 mg	400 mg
3	High dose Mfx (Mfx^h)	400 mg	600 mg	600 mg	600 mg
4	Bedaquiline (Bdq)	Week 0–2: Bdq 400 mg daily Week 3–24: Bdq 200 mg 3 times per week
5	Clofazimine (Cfz)	50 mg	100 mg	100 mg	200 mg
6	Cycloserine (Cs)³	250 mg	500 mg	750 mg	1000 mg
7	Linezolid (Lzd)	300 mg	600 mg	600 mg	600 mg
8	Delamanid (Dlm)	50 mg twice daily (100 mg) for 24 weeks in 6-11 years of age 100 mg twice daily (200 mg) for 24 weeks for ≥12 years of age
9	Amikacin (Am)¹	500 mg	750 mg	750 mg	1000 mg
10	Pyrazinamide (Z)	750 mg	1250 mg	1750 mg	2000 mg
11	Ethionamide (Eto)³	375 mg	500 mg	750 mg	1000 mg
12	Na - PAS (60% weight/ vol)^2,3	10 gm	14 gm	16 gm	22 gm
13	Ethambutol (E)	400 mg	800 mg	1200 mg	1600 mg
14	Imipenem-Cilastatin (Imp-Cln)³	2 vials (1g + 1g) bd (to be used with Clavulanic acid)
15	Meropenems (Mpm)³	1000 mg three times daily (alternative dosing is 2000 mg twice daily) (to be used with Clavulanic acid)
16	Amoxicillin-Clavulanate (Amx-Clv) (to be given with Carbapenems only)	875/125 mg bd	875/125 mg bd	875/125 mg bd	875/125 mg bd
17	Pyridoxine (Pdx)	50 mg	100 mg	100 mg	100 mg
¹For adults more than 60 years of age, the dose of Second-line Injectable (SLI) should be reduced to 10 mg/kg (max up to 750 mg). ²In patients of Para Amino Salicylic Acid (PAS) with 80% weight/ volume the dose will be changed to 7.5 gm (16-29 kg); 10 gm (30-45 Kg); 12 gm (46-70 kg) and 16 gm (>70 kg). ³Drugs can be given in divided doses in a day in the event of intolerance.

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

Adverse Drug Reactions due to Longer oral M/XDR-TB Regimen

Content

The table below showcases the adverse drug events that may be caused by drugs used for longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimen. In these situations, replacement drugs are used instead of these drugs.

Table: Possible Adverse Drug Events in the Longer Oral M/XDR-TB Regimen
ADVERSE DRUG EVENTS	DRUGS
QT prolongation	Bedaquiline (Bdq), Fluoroquinolone (FQ), Clofazimine (Cfz)
Rash, allergic reaction and anaphylaxis	Any drug
Gastrointestinal symptoms	Ethionamide (Eto), P-Aminosalicylic Acid (PAS), Pyrazinamide (Z), Ethambutol (E), Bdq, Cfz, Linezolid (Lzd), FQs
Diarrhoea and/or flatulence	PAS, Eto
Hepatitis	Z, Eto, PAS, Bdq
Giddiness	Amikacin (Am), Eto, FQ and/or Z
Haematological abnormalities	Lzd
Hypothyroidism	Eto, PAS
Arthralgia	Z, FQ, Bdq
Peripheral neuropathy	Lzd, Cycloserine (Cs), Am, FQ, rarely Eto, E
Headache	Bdq, Cs
Depression	Cs, FQ, Eto
Psychotic symptoms	Cs, Isoniazid (H), FQ
Suicidal ideation	Cs, Eto
Seizures	Cs, H, FQ
Tendonitis and tendon rupture	FQ
Nephrotoxicity (renal toxicity)	Am
Vestibular toxicity (tinnitus and dizziness	Am, Cs, FQs, Eto, Lzd
Hearing loss	Am
Optic neuritis	E, Lzd, Eto, Cfz
Metallic taste	Eto, FQs
Electrolyte disturbances (Hypokalaemia and Hypomagnesaemia	Am
Gynaecomastia	Eto
Alopecia	Eto
Superficial fungal infection and thrush	FQ
Lactic acidosis	Lzd
Dysglycaemia and Hyperglycaemia	Eto

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

Details of Replacement Sequence of Drugs in Longer Oral M/XDR-TB Regimen
Content
Replacement of component(s) drug(s) is required in conditions like adverse drug reaction, poor tolerance, contraindication and resistance detected on baseline Liquid Culture (LC) Drug Susceptibility Testing (DST).

The replacement sequence of drugs is prepared according to their efficacy, no demonstrable resistance, prior use, side-effect profile and background resistance to replacement drug in the country.

In case of the need for replacement of any of the component(s) in the longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimen, the following broad principles apply:

The regimen should preferably be fully oral. However, in certain circumstances, injectables may have to be used.

At least 4-5 drugs are to be used in the initial 6 to 8 months and at least 3-4 drugs in the last 12 months.

Replacement sequence of Group C drugs for longer oral M/XDR-TB regimen was recommended in the order of – Delamanid (Dlm), Amikacin (Am), Pyrazinamide (Z), Ethionamide (Eto), P-aminosalicylic acid (PAS), Ethambutol (E), Penems.

The combined use of Bedaquiline (Bdq) and Dlm in the regimen is recommended in whom an appropriate regimen cannot be designed using all 5 drugs from Group A and B.

Dlm and Am will not be initiated in the final 12 months of treatment.

The duration of new drugs (Bdq or Dlm) is limited to 6 months. Extension beyond 6 months to be considered in patients with whom an effective regimen cannot be otherwise designed

Imipenem-Cilastatin (Imp-Cln) will only be used as a last resort.

In individual patients for whom the design of an effective regimen is not possible as per recommendations, BPaL regimen (Bedaquiline, Pretomanid, Linezolid regimen) can be considered as a last resort under prevailing ethical standards.

To modify the regimen, the Nodal and District Drug-resistant TB Centre (N/DDR-TBC) physician must review DST and patient profile and then suitable regimen to be designed based on the replacement sequence table given in the Programmatic Management of Drug-resistant TB (PMDT) guideline.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE

DR-TB HIV Coordinator: Isoniazid (H) Mono/Poly DR-TB Regimen

Fullscreen

Regimen, Duration and Dosage for Isoniazid [H] Mono/Poly DR-TB Regimen

Content

Isoniazid (H) mono/ poly Drug-resistant TB (DR-TB) regimen has the following regimen, duration and dosage of drugs.

Regimen: (6 or 9) Lfx R E Z

Dosage

The dosage of drugs would vary as per the weight of the patients.
Adult patients (≥ 18 years) would be classified in weight bands of <16 kg, 16-29 kg, 30-45 kg, 46-70 kg and 70 kg. The drug dosages by these weight bands are shown in the table below.
All drugs in the regimen are to be given on a daily basis under observation.

Table: Drugs used in H Mono/ Poly DR-TB Regimen by Weight bands for Adults. *Source: Guidelines for PMDT, India, 2021, p79.*
SR. NO	DRUGS	16-29 KG	30-45 KG	46-70 KG	>70 KG
1	Rifampicin (R)	300 mg	450 mg	600 mg	750 mg
2	Ethambutol (E)	400 mg	800 mg	1200 mg	1600 mg
3	Pyrazinamide (Z)	750 mg	1250 mg	1750 mg	2000 mg
4	Levofloxacin (Lfx)	250 mg	750 mg	1000 mg	1000 mg

Duration

H mono/ poly DR-TB regimen is for 6 or 9 months with no separate Intensive Phase (IP)/ Continuation Phase (CP).
In exceptional situations of unavailability of loose drug R or E or Z, the use of 4 FDC (HREZ) with Levofloxacin (Lfx) loose tablets may be considered as an option rather than not starting the H mono/ poly DR-TB patients on treatment.

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

Isoniazid [H] Mono/Poly DR-TB Regimen: Pre-treatment Evaluation
Content
Pre-treatment evaluation for any TB patient must include a thorough clinical evaluation by a doctor with:

History and physical examination

Height/ weight check

Random Blood Sugar (RBS)

Chest X-ray

HIV test

No additional investigations (except the basic evaluations mentioned above) are required for Isoniazid (H) mono/ poly Drug-resistant TB (DR-TB) patients unless clinically indicated.

The pre-treatment evaluation carried out at the time of treatment initiation can be considered valid for 1 month from the date of the test result and the patient can be reinitiated on a subsequent regimen considering the previously conducted pre-treatment tests.

Active Drug Safety Management and Monitoring (aDSM) treatment initiation form needs to be completed for all DR-TB patients at the time of initiation of each new episode of the treatment.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 4 - Treatment: Drug-resistant TB Treatment, 2020.

Kindly provide your valuable feedback on the page to the link provided HERE

Adverse Drug Events: H Mono/Poly DR-TB Regimen

Content

he potential adverse drug events that can occur when using drugs in the H mono/ poly DR-TB regimen are tabulated below:

Table: Possible Adverse Events due to Drugs in H Mono/ Poly DR-TB Regimen; *Source: Guidelines for PMDT, India, 2021, p83.*
ADVERSE DRUG EVENTS	SUSPECTED DRUG(S)
Hepatitis	Rifampicin (R), Pyrazinamide (Z)
QT prolongation	Fluoroquinolone (FQ), Clofazimine (Cfz)
Rash, allergic reaction and anaphylaxis	Any drug
Gastrointestinal symptoms	Z, Ethambutol (E), Cfz, FQs
Giddiness	FQ, Z
Arthralgia	Z, FQ
Peripheral neuropathy	FQ, E
Depression	FQ
Psychotic symptoms	FQ
Seizures	FQ
Tendonitis and tendon rupture	FQ
Vestibular toxicity (tinnitus and dizziness)	FQ
Optic neuritis	E, Linezolid (Lzd), Cfz
Metallic taste	FQ
Superficial fungal infection and thrush	FQ

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

Replacement Sequence in the H Mono/Poly DR-TB and Shorter Oral Bdq-containing MDR/RR-TB Regimens

Content

Different conditions may demand the replacement of Isoniazid (H) mono/ poly Drug-resistant TB (DR-TB) and shorter oral Bedaquiline (Bdq)-containing Multidrug-resistant (MDR)/ Rifampicin-resistant (RR) -TB regimens.

Replacement Sequence of Drugs in H Mono/ Poly DR-TB Regimen

Drugs of the H mono/ poly DR-TB regimen will be replaced in case of:

Additional resistance to one of the drugs in the regimen
Intolerance to any of the drug/s used in the regimen
Unavailability of one of the drug
Contraindication of the component drugs of the regimen

In such situations, modification of H mono/ poly DR-TB regimen may be done using the sequence of using replacement drugs as delineated in the table below.

Table: Replacement Sequence of Drugs to Modify the H mono/ poly DR-TB Regimen
SITUATION	SEQUENCE OF USING REPLACEMENT DRUGS
If Levofloxacin (Lfx) can’t be used	Replace with High dose Moxifloxacin (Mfx^h) if second line-line probe assay pattern suggests. Do liquid culture drug susceptibility testing for detection of resistance to Mfx^h, Pyrazinamide (Z), Linezolid (Lzd) and Clofazimine (Cfz)
If Mfx^h or Z can’t be used	Replace with Lzd. If Lzd also cannot be given, replace it with Cfz* + Cycloserine (Cs).
If both Mfx^h and Z can’t be used	Add 2 drugs of the 3 – Lzd, Cfz*, Cs in order of preference based on resistance, tolerability & availability.
If Rifampicin (R)-resistance exists	Switch to an appropriate shorter or longer regimen.
*whenever Drug Susceptibility Test (DST) is available.

In the first three situations above, treatment will continue for a total duration of 9 months.
Treatment duration of H mono/ poly DR-TB regimen can be longer in extensive pulmonary TB diseases up to 9 months.
The use of new drugs is not yet recommended in the treatment of H mono/ poly DR-TB cases due to lack of evidence.

Replacement Sequence of Drugs in Shorter Oral Bdq-containing MDR/RR-TB Regimen

If there is a need for stopping/ replacing any drug in the shorter oral Bedaquiline-containing multi-drug resistant (MDR)/rifampicin-resistant tuberculosis (RR-TB) regimen then this regimen needs to be stopped.
Evaluate the patient to switch to a longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimen.
Replacement/ stopping any of the drugs in the regimen is not recommended.

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

DR-TB HIV Coordinator: ADR Management

DR-TB HIV Coordinator: TB Infection treatment and care

Fullscreen

Testing for TB Infection
Content
For TB infection, there are two recommended tests which can be used to identify such patients.

Tuberculin Skin Test (TST)

The skin test is done by injecting a small amount (0.5 ml) of TB antigens into the top layer of skin on your inner forearm. If one has ever been exposed to TB bacteria (Mycobacterium tuberculosis), there will be a reaction indicated by the development of a firm red bump (induration) >= 10 mm at the site within 2 days.

Image

Figure: Tuberculin Skin Test

Interferon-gamma release assay (IGRA)

IGRA is a Blood test. If one has been exposed to TB bacteria, the white blood cell in the blood will release a substance called gamma interferon when the cells are exposed to specific TB antigens.

Image

Figure: Interferon-gamma release assay (IGRA)

Resources:

Latent Tuberculosis Infection Guideline

Guideline for Programmatic Management of Tuberculosis Preventive Treatment in India

Kindly provide your valuable feedback on the page to the link provided HERE

TB Preventive Therapy

Content

TPT treatment options recommended under NTEP include:

3-month weekly Isoniazid and Rifapentine (3HP)
6-months daily isoniazid (6H)

Table 1: TPT Options for Target Population; Source: (Guidelines for Programmatic Management of Tuberculosis Preventive Treatment)

Table 2: TPT dosage based on age and weight band recommended by NTEP; Source: Guidelines for Programmatic Management of Tuberculosis Preventive Treatment

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
TPT options recommended under NTEP include which of the following?	3-month weekly Isoniazid and Rifapentine (3HP)	Rifampicin	6-months daily isoniazid (6H)	1 and 3	4	TPT options recommended under NTEP include 3-month weekly Isoniazid and Rifapentine (3HP) and 6-months daily isoniazid (6H).		Yes	Yes

Eligibility for TPT

Content

The eligibility for TB Preventive Treatment (TPT) relies on ruling out active TB among individuals and groups who are known to have a high risk of acquiring TB.

Prioritization of the target population for TPT is based on elevated risk of progression from infection to TB disease or increased likelihood of exposure to TB disease: At-risk populations include:

1. Expanded eligible group including children >5 years, adolescents and adult Household Contacts (HHC) of pulmonary* TB patients notified in Nikshay from public and private sector (*bacteriologically confirmed pulmonary TB patients will be prioritized for enumeration of the target population for TPT)

Table 1: Target Population (Expanded Eligible Groups); Source: Guidelines for Programmatic Management of Tuberculosis Preventive Treatment.

(*bacteriologically confirmed pulmonary TB patients will be prioritized for enumeration of the target population for TPT)

TPT reduces the overall risk for TB by 60-90% among People Living with HIV (PLHIV). Adults and children (>12 months) living with PLHIV should be screened for TB using a four-symptom complex and TPT can be provided to those without symptoms or after ruling out active TB in those with TB symptoms.

All HHC of pulmonary TB patients is at substantially higher risk for progression to active TB than the general population. Hence, all HHC of pulmonary TB patients, regardless of their age, should be given TPT after ruling out TB. In children HHC under 5 years of age, TPT will be offered after ruling out active TB, without testing for TB infection. In children, HHC >5 years and adults, chest X-rays and testing for TB infection would be offered wherever available.

Expanded to other risk groups

Individuals in other risk groups include those on immunosuppressive therapy, having silicosis, on anti-TNF treatment, on dialysis, and preparing for organ or haematologic transplantation.

Systematic TB infection testing and treatment are not recommended for people with diabetes mellitus, malnutrition, smoking, or harmful alcohol abuse unless they have other risk factors for TB, such as HIV infection or a history of contact with TB patients within their household.

Table 2: Target Population (Other Risk Groups); Source: Guidelines for Programmatic Management of Tuberculosis Preventive Treatment.

Resource

Guidelines for Programmatic Management of Tuberculosis Preventive Treatment.

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
TPT reduces the overall risk for TB by 60-90% among People Living with HIV (PLHIV).	True	False			1	TPT reduces the overall risk for TB by 60-90% among People Living with HIV (PLHIV).

Cascade of Care for TPT

Content

In the cascade of care approach, all target populations (People Living with HIV (PLHIV), Household Contacts (HHCs) and other such groups) who are at risk of developing TB disease are systematically reached out, screened for TB disease and after ruling out active TB disease, provided TB Preventive Treatment (TPT) as a part of the continuum of care.

The cascade of care approach among TPT target populations is shown in Figure 1.

Figure 1: Cascade of TB Preventive Treatment; Source: Guidelines for Programmatic Management of Tuberculosis Preventive Treatment, p3.

Resources:

Guidelines for Programmatic Management of Tuberculosis Preventive Treatment in India.

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which of the following is the correct TPT cascade of care?	Offer upfront CBNAAT to all at-risk populations, then offer TPT based on the results.	Identify at-risk populations, then offer TPT to all the people that have been identified.	Identify target populations at risk of developing TB, screen them, rule-out active TB disease, and provide TPT to eligible populations.	None of the above	3	The TPT cascade of care is: Identify target populations at risk of developing TB disease, screen them for TB disease, rule-out active TB disease, and provide TPT to eligible populations.

Approaches for TPT implementation

Content

There are two programmatic approaches for Tuberculosis Preventive Therapy (TPT) implementation:

1. Test-and-treat approach – This approach aims to detect TB infection among key groups for implementing TPT.

After ruling out active TB, the beneficiary is tested for TB infection.
TPT is offered only to those with a positive test (Interferon Gamma Release Assay (IGRA)/ Tuberculin Skin Test (TST)/ Cutaneous TB (C-TB))

2. Treat-only approach – For certain groups, like People Living with HIV (PLHIV) and House Hold Contacts (HHC) < 5 years old, detecting TB infection is not required. Hence, this approach is given.

After ruling out active TB, TPT is offered without testing for TB infection.

Test and treat approach*	HHC of sputum positive Pulmonary TB >/= 5 years old Individuals on: Immunosuppressive therapy Having silicosis On anti-TumourTNF treatment On dialysis Preparing for solid organ or haematopoietic stem cell transplantation
Treat-only approach	HHC of sputum positive Pulmonary TB (PTB) < 5 years old PLHIV^#

*All efforts should be made to make IGRA available. However, TPT should not be withheld in case of non-availability of IGRA.

^#PLHIV < 1 year old are offered TPT only if they are a household contact of an active TB case.

Resources

Guidelines for Programmatic Management of TB Preventive Treatment in India, 2021.

Assessment

Question

Answer 1

Answer 2

Answer 3

Answer 4

Correct answer

Correct explanation

Page id

Part of Pre-test

Part of Post-test

Which of the following category of TPT beneficiaries is offered TPT without IGRA testing?

Household contacts of sputum positive PTB >/= 5 years old

PLHIV

Patient on dialysis

Silicosis patient

PLHIV and HHC of sputum positive PTB < 5 years old are offered TPT without testing for IGRA. This is called Treat-only approach.

Yes

Counselling for IGRA/TST

Content

Interferon Gamma Release Assay (IGRA) and Tuberculin Skin Tests (TST) are performed on individuals who are ruled out for active TB disease.

However, positive and negative tests in IGRA and TST do not necessarily mean the patient does or does not have Tuberculosis Infection (TBI) as the possibility of false positives and false negatives cannot be ruled out in these tests.

Importance of Counselling in IGRA/ TST

All patients who undergo IGRA/ TST are already aware that they do not have an active TB disease and hence counselling is important to help them make informed decisions about undergoing IGRA/ TST for detecting TBI.
Additionally, at the time of receiving positive IGRA/ TST results, they may be symptom-free or otherwise healthy. In such cases, resistance/denial to receive a prophylactic treatment like TB Preventive Therapy (TPT) is higher as its treatment course duration also is relatively longer.
Counselling in IGRA/ TST is of utmost importance when the respective person belongs to the high-risk population and needs to be necessarily initiated on TPT and thus needs to be counselled for the same.

Components of Counselling in IGRA/ TST

Information on TBI
Need for undergoing IGRA/ TST
Importance of initiating TPT post-IGRA/ TST tests
If initiated on treatment, then schedule of medication
Medication adherence support
Follow-up
Importance of completing the TPT course, adverse events

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Counselling for IGRA/ TST should necessarily include which of the following?	Counselling on DR-TB	Counselling on TB Infection (TBI)	Counselling on DBT	None of the above	2	Counselling for IGRA/ TST should necessarily include ‘Counselling on TB infection (TBI)’.		Yes	Yes

Counselling for TPT

Content

Counselling is of paramount importance for TB Preventive Treatment (TPT) initiation and completion as most of the target population screened and found eligible would know that they do not have TB disease, would be symptom-free or otherwise healthy and would not feel the need to take any treatment, especially Household Contacts (HHC).

Stakeholders Involved in Counselling for TPT (Figure below)

Figure: Stakeholders involved in counselling for TPT

Abbr: HWCs: Health and Wellness Centres; PHC: Primary Health Centre; ICTC: Integrated Counselling and Testing Centres; ART: Anti-retroviral Therapy; PLHIV: People Living with HIV

Components of Counselling for TPT

While counselling the person and family members, the treating doctors/ staff must follow the steps outlined in the table below for an effective counselling session.

Component	Actions to be taken
Confidentiality	Ensure confidentiality when seeking a person’s commitment to complete the course before initiating TPT.
Information	Provide information on: TB infection Need for TPT and protective benefits to the individual, household and wider community TPT is available free of charge under National Tuberculosis Elimination Programme (NTEP) TPT regimen prescribed, including duration, schedule of medication collection, and directions on how to take the medications Potential side-effects and adverse events involved and what to do in the event of various side-effects. People treated with rifamycins should be alerted in advance about the pink discolouration of secretions due to this medicine Importance of completing the full course of TPT Reasons and schedule of regular clinical and laboratory follow-up for treatment and monitoring Signs and symptoms of TB and advise on steps if they develop them
Medication adherence support	Agree on the best way to support treatment adherence, including the most suitable location for drug intake and the need for a treatment supporter, if required.
Family support	Involve family members and caregivers in health education when possible.
Openness	Invite clarification questions and provide clear and simple answers.
Information, Education and Communication materials	Provide information materials in the local language and at the appropriate literacy level of the person concerned. Reinforce supportive educational messages at each contact during treatment.
Call support (in case of emergencies)	Provide a telephone number of the HCW staff/ TB Health Visitors and Senior Treatment Supervisors concerned to call for other queries or a need to contact health services for advice.

The National TB Elimination Programme (NTEP) national call centre (NIKSHAY SAMPARK – Toll-free number 1800116666) may be provided to index TB patients, those initiated on TPT and family members to serve as a resource for information, counselling and troubleshooting as required to enable TPT initiation, follow-up monitoring and completion.

Resources:

Guidelines for Programmatic Management of Tuberculosis Preventive Treatment in India.

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which of the following people are involved when counselling for TPT?	Index TB patients	Caregivers	Family members	All of the above	4	When counselling persons eligible for TPT, it is best to involve the index TB patients, their families and caregivers.		Yes	Yes

Monitoring adherence to TPT

Content

To achieve high treatment completion rates and the desired epidemiological impact of the TB Preventive Treatment (TPT), monitoring TPT treatment adherence, including management of missed doses and Adverse Drug Reactions (ADRs), is of paramount importance under the National TB Elimination Programme (NTEP).

Significance of Monitoring Adherence to TPT

Adherence to the TPT course and treatment completion are important determinants of clinical benefit, both at the individual and population levels as:

Irregular or inadequate treatment reduces the protective efficacy of the TPT regimen.
Poor adherence or early cessation of TPT can potentially increase the risk of the individual developing TB, including drug-resistant TB.
Efficacy of TPT is greatest if at least 80% of the doses are taken within the duration of the regimen. The total number of doses taken is also a key determinant of the extent of TB prevention.

Figure: Strategies to Promote Adherence

Prevent TB India App and Integration with Nikshay as a Monitoring Tool

Currently, under the NTEP, the person’s lifecycle approach and TB treatment episode level are recorded in Nikshay.
TPT information management is integrated with this existing Nikshay approach. This includes information on screening, testing, eligibility assessment, TPT initiation, adherence monitoring and follow-up till treatment completion.
The NTEP has adapted the World Health Organisation (WHO) Prevent TB India app and hosted it on Nikshay as an interim solution till the Nikshay TPT module is developed and fully functional.
Health workers or treatment supporters will make entries directly into the app.
The TPT monitoring dashboard can be accessed by various levels of supervisors using their respective Nikshay login ids using a link provided in the Nikshay Reports section on TPT Reports.
A web-based comprehensive dashboard for Prevent TB initiative is also available at https://ltbi.nikshay.in/ltbi-generic-new/#/

Table: Roles of Stakeholders in Monitoring Adherence to TPT
Role	Stakeholder
Treatment support and adherence monitoring including entry of daily doses taken in the Prevent TB India app/ Nikshay TPT module.	Community volunteers (TB survivors/ champions, Accredited Social Health Activists (ASHAs) and Anganwadi Workers)
Regularly undertake home visits or tele/ video calls to monitor TPT adherence. Identify treatment interruptions at the earliest (Dashboards of Prevent TB India app/ Nikshay TPT module may be checked every week along with pill counting).	HWCs/ sub-centre/ urban health posts (Community Health Officers (CHOs), Auxillary Nurse Midwives (ANMs), multipurpose workers and other field staff) Primary Health Centres (PHCs)/ Urban PHCs/ Private clinic (Medical Officers (MO), staff nurse)
Adherence support and clinical monitoring through the concerned PHC/ sub-centre. Supportive supervision and handholding support to field level facilities and frontline workers, ASHAs and community volunteers on digital recording, using Prevent TB India app and monitoring TPT and follow-up examinations.	TB Unit (MO, Laboratory Technicians (LTs), staff nurse, pharmacist, counsellor (if available), Senior Treatment Supervisors (STS), Senior TB Laboroary Supervisors (STLS), TB Health Visitors (TBHV))
Ensuring adherence support for People Living with HIV (PLHIV) on TPT through mechanisms such as outreach workers, PLHIV networks, peer support groups, etc.	Anti Retroviral Therapy (ART) centre/ Link ART centre (MO, pharmacist, (institutional) staff nurse, counsellor, care coordinator)
Monitor and support adherence to TPT.	Tertiary care/ Medical colleges/ Corporate hospitals/ District hospitals/ Dialysis/ Cancer facilities (doctors, staff nurses)
Review data updating in Prevent TB India app/ Nikshay TPT module wherever available, check the quality of data regularly and provide feedback to TPT treatment supporters and for retrieval of TPT interrupters.	Supervisory staff at all health facilities including the State/ District TB cell (State TB Officers (STO), District TB Officers (DTO), State/ District Programme Coordinators)

Resources:

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which tools are used to monitor TPT adherence under the NTEP?	Video calls	Counting empty blisters	Directly asking the patient	Options 1 and 2	4	TPT adherence monitoring tools include direct observation of drug intake, 99DOTS/ MERM, counting empty blisters, tele/ video calls and refill monitoring.
Which of the following apps are currently used by NTEP to monitor TPT adherence?	TB Aarogya Sathi	Prevent TB India App	TPT app for NTEP	None of the above	2	NTEP has adapted the WHO Prevent TB India app and hosted it on Nikshay to monitor the entire TPT care cascade, including TPT adherence.

Preventive Treatment for Contacts of DR-TB Patients: WHO Recommendations

Content

The World Health Organisation (WHO) recommends Tuberculosis Preventive Treatment (TPT) among contacts exposed to Multidrug-resistant TB (MDR-TB) with Fluoroquinolone (FQ)-sensitive, or Isoniazid (H)-resistant with Rifampicin (R) sensitive DR-TB patients.

Points to be Considered Before TPT Initiation

The preventive treatment should be individualized after a careful assessment of the intensity of exposure of contact with the index case.
Confirm the source patient and her/his drug resistance pattern bacteriologically.
Ascertain Latent TB Infection (LTBI) using Interferon Gamma Release Assay (IGRA) or Tuberculin Skin Tests (TST).

Table: WHO's TPT Regimen Recommendation
TPT REGIMEN	ELIGIBLE POPULATION
6Lfx (six-month Levofloxacin)	Among contacts exposed to patients with known MDR and FQ-sensitive TB
6H (six-month Isoniazid)	Among contacts of H-susceptible TB in confirmed R-resistant TB index patient
4R (four-month Rifampicin)	Among contacts with known H-resistant and R-sensitive TB

Regardless of whether treatment is given or not, clinical follow-up should be done for two years.

Any emergent signs and symptoms suggestive of TB should be actively investigated and curative regimens started, as needed.

Resources

Kindly provide your valuable feedback on the page to the link provided HERE

Screening among Household Contacts of DR-TB Patients
Content
The National TB Elimination Programme (NTEP) follows an integrated algorithm for screening and ruling out active Tuberculosis (TB) among Household Contacts (HHCs) of Drug-resistant Tuberculosis (DR-TB) patients.

Figure: Integrated Algorithm for Screening and Ruling out Active TB among HHCs of DR-TB Patients; Source: Guidelines for PMDT in India, 2021, p118.

Abbr: MDR/RR-TB: Multidrug-resistant/ Rifampicin-resistant TB; FQ: Fluoroquinolone; h: Isoniazid; R: Rifampicin; DR-TB: Drug-resistant TB; DS-TB: Drug-susceptible TB; TPT: TB Preventive Treatment; CXR: Chest X-ray; TST: Tuberculin Skin Tests; IGRA: Interferon Gamma Release Assay.

Salient Features of the Screening Algorithm

Once a DR-TB patient is identified, all HHCs are counselled, screened and evaluated to rule out active TB.

Nucleic Acid Amplification Test (NAAT) will be used up front among contacts with symptoms or abnormal Chest X-ray (CXR) to diagnose TB.

If the result is Mycobacterium tuberculosis (MTB) detected with no resistance, the treatment for Drug-sensitive TB (DS-TB) is initiated.

If the result is MTB detected with Isoniazid (H) and/or Rifampicin (R) resistance, manage as per DR-TB guidelines.

If the result is MTB not detected, in HHC <5 years of age, assess for TB Preventive Treatment (TPT) and check for any contraindications.

If the result is MTB not detected, in HHC >5 years of age with Latent TB Infection (LTBI) test positive or unavailable and CXR is normal or unavailable, check for any contraindications.

If contraindications to TPT drugs exist, defer TPT and if no contraindication exists, offer TPT regimen as appropriate based on the Drug Susceptibility Testing (DST) pattern of the index patient

Follow-up for active TB as necessary, even for patients who have completed preventive treatment irrespective of TPT offer.

Footnotes

HIV-positive contact: If <10 years of age, any one of current cough, fever, history of contact with TB, reported weight loss, confirmed weight loss >5% since last visit or growth curve flattening or weight for age <-2 Z-scores. Asymptomatic infants, <1 year, with HIV are only treated for LTBI if they are household contacts of a TB patient. TPT or Interferon Gamma Release Assay (IGRA) may identify People Living with HIV (PLHIV) who will benefit most from preventive treatment. CXR may be used in PLHIV on Anti-retroviral Treatment (ART), before starting TPT.

Symptomatic HHC: Any one of cough or fever or night sweats or haemoptysis or weight loss or chest pain or shortness of breath or fatigue. Children <5 years should also be free of anorexia, failure to thrive, not eating well, decreased activity or playfulness to be considered asymptomatic.

Other high-risk groups: Includes silicosis, dialysis, anti-TNF agent treatment, preparation for transplantation or other vulnerable risk groups where testing must precede TPT.

Contraindication to TPT: Include acute or chronic hepatitis; peripheral neuropathy (if Isoniazid is used); regular and heavy alcohol consumption. Pregnancy or a previous history of TB are not contraindications.

Selection of TPT regimen: Regimen is chosen based on considerations of age, strain (drug-susceptible or otherwise), risk of toxicity, availability and preferences.

CXR may have been carried out early on as part of intensified case finding.

Resources

Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

WHO Consolidated Guidelines on Tuberculosis: Module 1: Prevention: Tuberculosis Preventive Treatment, 2020.

Latent TB Infection: Updated and Consolidated Guidelines for Programmatic Management, WHO, 2018.

Kindly provide your valuable feedback on the page to the link provided HERE

TCC	Meeting Frequency	Stakeholders
National	Biannual	Deputy Director General TB (DDG TB, Head) and DDG's of all other comorbidity programmes, Addl. DDG TB and other programmes, World Health Organisation (WHO) representatives from TB and the comorbidity programmes, Representatives from national TB institutes, Experts from academic and research institutions, Representatives from civil society organisations, Programme managers, and TB patients.
State	Quarterly	Managing Director National Health Mission (NHM-Head), State TB Officer (STO), State nodal officers for the comorbidity programmes, Research and academic experts in TB and comorbidities, representatives from civil society organisations, programme officers from state cells, and TB patients.
District	Quarterly	District Collector-NHM (Head), District TB Officer, District Nodal Officers for the comorbidity programmes, Experts from research and academic institutes, Representatives from civil societies, professional bodies, and TB patients.