STS: TB Treatment and care

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

​

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

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Treatment of Tuberculosis Disease, CDC, 2006.
• Guide on Tuberculosis Control for Primary Health Care Providers, WHO, 2015.
• Treatment of Tuberculosis: Guidelines for National Programmes, WHO, 2003.

Assessment

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:

1. Early bactericidal activity: Killing of actively growing bacilli (in the phase of rapid multiplication and uninhibited metabolic activity).
2. Sterilizing activity of persisting bacilli, i.e., metabolically inhibited organisms in a quasi-dormant state.
3. 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

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

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Tuberculosis Case-finding and Chemotherapy: Questions and Answers, K. Toman.

 Assessment

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)

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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

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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)

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

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

Image

Figure: Flowchart-Treatment Initiation

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2021.
• Training Modules (1-4) for Programme Managers and Medical Officers, CTD, MoHFW, India.

Assessment

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.

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

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

Video:

Closing Cases and Assigning Treatment Outcomes (Web)

Video:

Closing Cases and Assigning Treatment Outcomes (Mobile)

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

1. Counsel and reassure the patient as the common occurring adverse effects usually resolve with time.
2. Advise the patient to take all the drugs together.
3. Advise patient to take light meal (biscuits, bread, rice etc.) before taking drugs.
4. Inform patients that they may take drugs embedded in banana or at the bedtime to reduce their associated side effects.
5. Encourage patients to keep themselves hydrated by increasing fluid intake.
6. 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

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After completion of TB treatment, all patients should be followed up at the end of

• 6 months,
• 12 months,
• 18 months &
• 24 months

TB patients at the follow up should be screened for any clinical symptoms and/or cough. If found positive on screening, then sputum microscopy and/or culture should be considered. This is important in detecting the recurrence of TB at the earliest.

After completion of TB treatment, if the patient has not developed any clinical symptoms and/or cough and also if the microscopy remains negative during their follow up, then the patient is considered as “Relapse Free Cure from TB.”

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:

1. Documenting administered drugs with their dosages
2. Documenting follow-up investigation results
3. Monitoring adherence to treatment
4. Recording adverse events
5. Recording treatment outcomes

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

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.

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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.

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

Resources

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

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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

• Nikshay Zendesk, Nikshay Knowledge Base, Advanced Transfer in Web.
• Guidelines for PMDT in India, 2021.

Assessment

Pharmacovigilance is defined by the World Health Organisation (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

• It is a fundamental public health surveillance activity to ensure patient safety measures in healthcare.
• Good pharmacovigilance will identify the risks within the shortest possible time after medicines have been marketed and help establish or identify risk factors.

Importance of Pharmacovigilance

Pharmacovigilance allows for intelligent, evidence-based prescribing with the potential for preventing many Adverse Drug Reactions (ADRs). Pharmacovigilance will help in:

• Improving patient care by assessing both the harms and benefits received from drugs (anti-tubercular treatment).
• Strengthening patient safety, safeguarding the patient’s interests and ensuring adherence to prescribed drug regimens.
• Preventing antimicrobial resistance.

Pharmacovigilance ultimately helps each patient in receiving optimum therapy at a lower cost to the health system.

Conducting Pharmacovigilance under the National TB Elimination Programme (NTEP)

The Pharmacovigilance Programme of India (PvPI) was set up by the Ministry of Health and Family Welfare, Govt. of India, in July 2010. PvPI is India’s national programme for surveillance of ADR-related information.

NTEP in collaboration with PvPI, and with support from WHO India, developed the comprehensive active Drug Safety Monitoring and Management (aDSM) system for ADR monitoring. Pharmacovigilance is prioritised in Drug-resistant TB (DR-TB) centres for drug-resistant cases.

Adverse events reporting for pharmacovigilance is done as follows:

1. DR-TB centres are linked with ADR Monitoring Centres (AMC) established in medical colleges to initiate reporting of ADR in a systematic manner.
2. Serious adverse events are reported to AMCs and Central TB Division (CTD) within 24 hours. This is done via a standardized suspected ADR reporting form (Annexure-11) which is filled by the treating doctor.
3. The data is entered in Nikshay on a regular basis by statistical assistants at the nodal DR-TB centre and senior DR-TB TB-HIV supervisors at the district DR-TB centre.
4. From Nikshay, the information is directly communicated to PvPI through a connecting bridge called Vigiflow.
5. The ADR data submitted to Vigifloware is analysed by PvPI and shared with CTD on a regular basis.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• 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.
• Practical Handbook on the Pharmacovigilance of Medicines used in the Treatment of Tuberculosis, WHO, 2012.

Assessment

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.

Assessment

​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

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Index TB Guidelines on Extra-pulmonary Tuberculosis for India, Central TB Division, 2016.

Assessment

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

There are five principal ways to prevent Drug-resistant Tuberculosis (DR-TB), as given in the figure below.

Image

 Figure: Five Principal Ways to Prevent DR-TB; Source: Guideline for PMDT in India, 2021.

• Drug resistance cannot be prevented by mere diagnosis and treatment of DR-TB.
• Basic TB diagnostic and treatment services should receive priority for the prevention of drug resistance.
• Systems for early detection and treatment of DR-TB should be integrated into the existing TB services and the general health system.
• Healthcare facilities and congregate settings should be provided with proper infection control measures.
• Transmission should be prevented by addressing non-specific determinants like access to care, comorbidities and awareness.

Resources

• Guidelines for PMDT in India, 2021.
• Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-resistant Tuberculosis.

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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

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

• Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India, CTD, MoHFW, India, 2021.
• Training Modules (1-4) for Programme Managers and Medical Officers, CTD, MoHFW, India.

Assessment

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

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• A Guide to Conducting TB Patient Mortality Audits using a Patient-centered Approach, KNCV, USAID and MSH, 2012.
• Operational Guide for Facility-based Audit and Review of Paediatric Mortality, WHO, 2018.

Assessment

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.

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

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.
 

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

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

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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

All patients diagnosed with TB should have universal access to rapid DST for at least Rifampicin and further DST for at least Fluoroquinolones among all TB patients with rifampicin resistance, i.e. UDST. 

UDST tests are offered preferably before treatment initiation to a maximum within 15 days from diagnosis. Based on the UDST test result, if Rifampicin resistance is detected, the patient is shifted to DR-TB Treatment Regimen. If Rifampicin resistance is not detected, then first-line anti TB treatment is continued, and the patient is screened further on their follow-ups. If tested positive in sputum examination during any patient follow up, then sputum is sent for further drug resistance testing, and the patient is referred to PHI for follow-up.

Figure: Screening of patient for initiating DRTB Treatment from DSTB 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

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)

• 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.

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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.

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Common Adverse events to second line treatment are as below

Figure: Adverse Drug Reaction to Second line drugs

Adverse events should be identified, monitored and be referred to

• Nearest treating doctor for minor symptoms or
• District DR-TB Centres for major symptoms

If required, hospitalization can be done at the District DR-TB Centers where inpatient facility is available or referred to a Nodal DRTB Centre for admission

• TB Infection (or previously known as Latent TB infection) is a stage in between uninfected and having active TB. In this stage the person has no symptoms and can only be identified using laboratory tests.

• The vast majority of infected people may never develop TB disease. However, to achieve TB elimination, it is important to treat TB infection in people at risk of developing active TB disease.

• It is a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens with no evidence of clinically manifested active TB.

• There is no single acceptable/reliable test for direct identification of Mycobacterium tuberculosis infection in humans. Tuberculin Skin Test (TST) and Interferon-gamma release assay (IGRA) are commonly used tests for identifying TB infection.

Resources:

• Latent Tuberculosis Infection Guideline

• Guideline for Programmatic Management of Tuberculosis Preventive Treatment in India

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

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The NTEP has prioritized the target population for TPT based on elevated risk of progression from infection to TB disease or increased likelihood of exposure to TB disease. 

The target populations have been divided into two groups:

1. Household contacts of bacteriologically confirmed pulmonary TB patients notified in Nikshay from public and private sector.

#Chest X Ray (CXR) and TBI testing would be offered wherever available, but TPT must not be deferred in their absence

*Bacteriologically confirmed pulmonary TB patients to be prioritized for enumeration of the target population for TPT

2. Expanded to other risk groups

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.

Image

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

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. 

*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

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

• Guidelines for Programmatic Management of Tuberculosis Preventive Treatment in India, CTD, MoHFW, India, 2021.
• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, CTD, MoHFW, India, 2021.

Assessment

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.

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

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/#/ 

Resources:

• Guidelines for Programmatic Management of Tuberculosis Preventive Treatment.
• Prevent TB Dashboard.
• Prevent TB India Mobile App.

Assessment

Several medical conditions are risk factors for TB and poor TB treatment outcomes. Similarly, TB can complicate the course of some diseases. Therefore, it is important to identify these comorbidities in people diagnosed with TB to ensure early diagnosis and improved outcomes. When these conditions are highly prevalent in the general population, they can significantly contribute to the TB burden. Consequently, reducing the prevalence of these conditions can help prevent TB.

TB shares underlying social determinants with many of these conditions. Addressing the social determinants of health is a shared responsibility across disease programmes and other stakeholders within and beyond the health sector. 

Figure: Various comorbid and special situation related with tuberculosis

The primary impact of HIV on TB is that the risk of developing TB becomes higher in patients with HIV. Overall, HIV-infected persons have an approximately 8-times greater risk of TB than persons without HIV infection. 

Screen TB PLHIV patients for symptoms of TB and HIV

Figure: Screening steps for TB - HIV patients

Treatment for TB HIV Patients​

• All TB patients who have been diagnosed and registered under NTEP should be referred for screening for HIV.
• Referral of TB patients for screening for HIV and its recording & reporting is the responsibility of the Peripheral Health Institutions(PHI) where TB treatment is initiated.
• TB patients diagnosed with HIV will receive the same duration of TB treatment with daily regimen as non-HIV TB patients.
• TB patients must be referred to the nearest ART(Anti - Retroviral Treatment) centre for management of HIV.

As a consequence of urbanization as well as social and economic development, there has been a rapidly growing epidemic of Diabetes Mellitus(DM). India has the second largest number of diabetic people in the world.

Screen TB patients for symptoms of diabetes

Figure: Screening steps for TB - Diabetic Patients

Treatment for TB Diabetes Patients​

• All TB patients who have been diagnosed and registered under NTEP will be referred for screening for Diabetes.
• Referral of TB patients for screening for DM and its recording & reporting is the responsibility of the Peripheral Health Institutions(PHI) where TB treatment is initiated.
• TB patients diagnosed with diabetes will receive the same duration of TB treatment with daily regimen as non-diabetic TB patients.
• TB patients must be referred to the nearest healthcare facility for management of DM.
• Regular monitoring of blood sugar levels is advised.

Malnutrition refers to deficiencies, excesses or imbalances in a person’s intake of energy and/or nutrients. The term malnutrition covers 2 broad groups of conditions.

• One is ‘undernutrition’—which includes stunting(low height for age), wasting(low weight for height), underweight(low weight for age) and micronutrient deficiencies or insufficiencies(a lack of important vitamins and minerals).
• The other is overweight, obesity and diet-related non communicable diseases (such as heart disease, stroke, diabetes, and cancer).

Screen TB Malnutrition patients for nutritional needs

Figure: Screening Steps for TB - Malnutrition patients

Treatment for TB Malnutrition Patients

Cases of TB with SAM and moderate undernutrition should be referred to the nearest health facility of NTEP for further management. Special focus should be given to the following categories:

• Children below five years
• School-age children and adolescents(Up to age 18 years)
• Adults, including pregnant and lactating women, with active TB and SAM

About 10% TB deaths globally have been attributed to alcohol as a risk factor(WHO, Global TB Report 2017). Alcohol abuse is associated with threefold increase in risk of contracting tuberculosis.

Side effects of anti TB drugs in this situation might get aggravated.

Figure: Impact of Alcoholism on TB patients

Treatment for Alcoholic TB Patients:

• Patients with TB and a history of alcohol use should be referred to the nearest health facility of NTEP to manage TB and alcoholism.
• While registering as a TB case, the status of alcohol use should be recorded in the patient records. If the TB patient is an alcohol user, he/she should be counselled to quit it. If the patient doesn't quit alcohol, s/he may be referred to the nearest alcohol de-addiction facility.
• The patient should be assessed at every follow-up visit for TB and the status of use of alcohol.
• At the end of treatment, his/her status of alcohol use should be recorded on the treatment card. If the patient has not quit alcohol, he/she should be referred to the nearest alcohol de-addiction facility and Alcohol Anonymous wherever available.

Almost 38% of TB deaths are associated with the use of tobacco. The prevalence of TB is three times higher among ever-smokers as compared to that of never-smokers. Mortality from TB is three to four times higher among ever-smokers as compared to never-smokers. Smoking contributes to 50% of male deaths in the 25-69 age group from TB in India.

Figure: Impact of Tobacco on TB patients

Treatment for TB - Tobacco Patients:

• While registering as a TB case, the status of tobacco use is recorded on the TB treatment card.
• If the TB patient is a smoker or tobacco user, he/she is counselled to quit tobacco use. The patient is assessed at every visit for follow up for TB and the status of tobacco use.
• At the end of treatment, his/her status of tobacco use is recorded in the treatment card. If the patient has not quit tobacco use, he/she will be referred to the nearest Tobacco Cessation Clinic(TCC) or Quit Line or M-Cessation Initiative.

Silicosis is a progressive and disabling interstitial lung disease caused by inhalation and deposition in the lungs of particles of free silica.

Mutual Risk of TB and Silicosis

• TB is a clinical complication of silicosis, called silico-tuberculosis. Silica-exposed workers with or without silicosis are at increased risk for TB. There is also an increased risk of extrapulmonary TB in individuals exposed to silica.
• The risk of a patient with silicosis developing TB is 2.8 – 3.9 times higher than a healthy individual.
• The risk of TB relapse in patients with silicosis is approximately 1.5 times higher than in patients without silicosis.

The presence of silica particles in the lung and silicosis may:

• Facilitate initiation of TB infection and progression to active TB
• Exacerbate the course and outcome of TB, including prognosis and survival

Diagnosis

The diagnosis of silicosis is made based on a history of exposure to silica accompanied by a clinical and radiological profile consistent with the disease.

Under the Integrated Management Algorithm for TB disease and TB infection released by the National TB Elimination Programme (NTEP), patients with silicosis are first screened according to the four-symptom complex to rule out/in active TB and tested for TB accordingly. 

If active TB is ruled out >> Refer for Tuberculin Skin Test (TST)/ Interferon Gamma Release Assay (IGRA) >> Positive test >> Evaluate with Chest X-ray (CXR) >> Commence TB Preventive Therapy (TPT) irrespective of CXR results.

CXR often indicates TB in silicosis patients earlier than the clinical symptoms, and regular radiographic screening is required for early TB detection. Radiographic comparison of serial films is done with particular attention to:

• Rapid appearance of new opacities, symmetric nodules or consolidation and the finding of pleural effusion or excavations.
• Cavitation is the strongest indicator of probable silico-tuberculosis.

Other diagnostic tools that can help in diagnosis are:

• Chest Computed Tomography (CT) scan
• Bronchoscopy with bronchoalveolar lavage in conjunction with transbronchial biopsy
• Spirometry

Treatment and Follow-up

To keep the disease from getting worse, all silicosis patients need to eliminate any more exposure to silica. Supportive measures include the use of cough medicines, bronchodilators, oxygen therapy and pulmonary rehabilitation.

TB treatment in patients with silicosis is challenging, perhaps due to impairment of macrophage function by free silica and/or poor drug penetration into fibrotic nodules. Usual anti-TB drugs with directly observed therapy are recommended but for an extended duration of at least 8 months, to reduce the chances of relapse.

Follow-up of patients with silicosis and TB follow the same schedule as is in prevailing guidelines.

Prevention

TB prevention in silicosis patients is essential and includes:

• Active surveillance of vulnerable groups including workers
• Adoption of measures to reduce exposure to silica dust
• Patients with silicosis are eligible for TPT after ruling out active TB

NTEP is in the process of engaging with the Ministry of Labour and Mining to identify high priority districts with stone crushing units/ mining industry. Specific guidelines will be developed to support persons with an occupational risk for TB and provide access, diagnosis and treatment services from the programme.

Resources

• NTEP at a Glance; Comprehensive Clinical Management Protocol of Tuberculosis, 2022.
• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Silico-tuberculosis, Silicosis and Other Respiratory Morbidities Among Sandstone Mine-workers in Rajasthan - A Cross-sectional Study, Saranya Rajavel et al., 2020.
• Mini-review: Silico-tuberculosis; Massimiliano Lanzafame et al, 2021.
• Immunity to the Dual Threat of Silica Exposure and Mycobacterium tuberculosis, Petr Konečný et al., 2019.

Assessment

​

Relationship between Cancer and Tuberculosis (TB)

TB and malignancy may be related in the following four ways:

1. TB as a marker for occult cancer: Occult cancer may lead to locally-reduced infection barriers and/or generalised immunosuppression, rendering a cancer patient susceptible to TB infection/ reactivation.
2. TB as a risk factor for cancer: TB may increase the risk of cancer locally and systemically through chronic inflammation, fibrosis and production of carcinogenic molecules.
3. Shared risk factors for TB and some cancers: Shared risk factors such as smoking, alcoholism, Chronic Obstructive Pulmonary Disease (COPD) and immunosuppression, including HIV, may lead to both TB and cancer, affecting both prevalent and subsequent cancer risk.
4. Treatment of cancer-fueling TB: Many cancers are treated with immunosuppressants or steroids. These drugs might induce immunosuppression in the patients undergoing treatment for cancer and hence, a flare-up of TB.

Mutual Risk of Cancer and TB

• TB patients are 2-11 times more likely than non-TB patients to develop lung cancer, according to studies.
• After cancer diagnosis, the incidence of TB also increases, both in the short term and long-term.
• All types of cancer increase the risk of the development of active TB, but with varying degrees. Haematologic cancer patients had the highest rates of active TB, followed by head and neck cancers, lung cancer and breast cancer patients.

There is intrinsic immunosuppression due to the cancer itself, immunosuppressive effects of chemotherapy, or other host factors (e.g., smoking, malnutrition) that may increase the susceptibility to both cancer and TB. Thus, there is increased incidence of TB in cancer patients, and vice-versa.

Diagnosis of TB in Cancer Patients: Under the Integrated Management Algorithm for TB disease and TB infection released by the National TB Elimination Programme (NTEP), cancer patients are first screened according to the four-symptom complex to rule out/in active TB and all presumptive TB cases need to undergo testing for TB.

Co-existence of TB and cancer poses a diagnostic challenge since clinical and radiological presentations between TB and cancers are similar, hence the need for bidirectional screening. E.g., if biopsy specimens reveal infiltration by malignant cells, still send sample for microbiological confirmation of M. tuberculosis. Thus, allowing for accurate diagnosis and initiation of anti-TB treatment instead of attributing clinical deterioration to chemotherapy complications and progression of underlying malignancy.

Diagnosis of lung cancer in TB patients is usually done in consultation with a clinical specialist and can include examination of induced sputum specimens for malignant cells, as well as use of other diagnostic tools such as Computed Tomography (CT) scans, bronchoscopy, Positron Emission Tomography (PET) scans, Magnetic Resonance Imaging (MRI), histopathology and the use of biological markers.

Treatment

TB treatment in cancer patients uses the standard DS-TB/DR-TB regimens and course, except that the treating physician should assess the drug interactions between anti-TB and anti-cancer drugs. For cancer treatment, drugs may have to be modified to accommodate anti-TB treatment and to aid better prognosis of the TB outcome. However, all decisions must be taken by a competent specialist after examining the individual case.

Curative resection, chemotherapy and radiation therapy are the mainstay treatment options for cancer in TB patients. Co-existence of TB in cancer patients necessitates anti-TB treatment with extended duration, if required. Follow-up during and after treatment also follows prevailing guidelines.

Prevention

Under the NTEP, TB prevention in cancer patients is essential and includes:

• Regular screening for signs and symptoms of TB infection among all patients on immunosuppressive therapy and anti-Tumour Necrosis Factor (TNF) medicines.
• Education and referral of patients who do not have TB symptoms for TB infection testing/assessment of their eligibility for TPT.

Resources

• NTEP at a Glance; Comprehensive Clinical Management Protocol of Tuberculosis, 2022.
• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Tuberculosis and Risk of Cancer: A Danish Nationwide Cohort Study, D. F. Simonsen et al., International Journal of Tuberculosis and Lung Diseases, The Union, 2014.
• Increased Risk of Active Tuberculosis after Cancer Diagnosis, Dennis F. Simonsen et al., Journal of Infection, 2017.
• Pulmonary Tuberculosis as Differential Diagnosis of Lung Cancer; MLB Bhatt et al., South Asian Journal of Cancer, 2012.

Assessment

The presence of tuberculosis disease during pregnancy, delivery, and postpartum is known to result in unfavourable outcomes for both pregnant women and their infants. These outcomes include a roughly two-fold increased risk of preterm birth, low birth weight, intrauterine growth restriction, and a six-fold increase in perinatal death.

Screen TB patients in Pregnancy & Lactating Patients

Figure: Screening Steps in special situation - Pregnancy and Lactating TB Patients

Treatment for TB - Pregnant & Lactating Patients

• Cases of pregnant/lactating women with active TB should be referred to the nearest health facility of NTEP for further management.
• They should be continued on iron and folic acid and other vitamins and minerals to complement their maternal micronutrient needs.
• In situations when calcium intake is low, calcium supplementation is recommended as part of antenatal care.

Tuberculosis and COVID-19 are infectious diseases which primarily attack the lungs. They present with similar symptoms of cough, fever and difficulty in breathing, although TB disease has a longer incubation period and a slower onset of disease.

Screen patients for symptoms of TB and COVID-19

Figure: Screening steps for TB - COVID 19 Patients

Management of TB & COVID-19 Patients

People with TB are likely to be at increased risk of COVID-19 infection, illness and death. So, TB patients should take precautions as advised by health authorities to be protected from COVID-19 and continue their TB treatment as prescribed.

Prevention: While both TB and COVID-19 are spread by close contact between people, the exact mode of transmission differs. Thus, the patient should be explained the following measures to control disease spread.

• Apart from that keeping rooms well ventilated, avoiding crowds and Respiratory precautions are thus important in the control of COVID-19 and TB Disease