M 02: Treatment Support and Monitoring of TB Patient

What is Drug-Sensitive Tuberculosis (DS-TB)?

• DSTB is a case where a person is infected with TB bacteria that are susceptible to all first line anti-TB drugs. It means that all of the first line TB drugs will be effective as long as they are taken properly and regularly.

• This type of TB has the best prognosis and the shortest treatment duration.

• Patients diagnosed with TB are considered to be DS-TB case, till such time s/he detected with resistance to any anti-TB drugs.

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DSTB Treatment duration is of 6–9-month course of antibiotics. The duration and drug dosage used may vary according to a patient’s age, type of TB infection, and whether s/he has been treated before.

The standard 6-month course of treatment consists of two phases. 

*Extension of CP: Depending upon response to treatment or type of disease, physician may decide to extend the treatment by 3 months.

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.
 

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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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.

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.”

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

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

The following TPT treatment options are recommended under NTEP once active TB has been ruled out:

Post-treatment TPT for PLHIV: In patients previously treated for TB, post-treatment TPT has been considered in view of the 5-7 times higher risk of recurrence of TB among PLHIV and nearly 90% of these due to re-infection. Thus, all CLHIV/PLHIV who had successfully completed treatment for TB disease earlier should receive a course of TPT after completing treatment of TB.

Resources 

• Guideline for Programmatic Management of Tuberculosis Preventive Treatment in India

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

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

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Tuberculosis(TB) is curable if patients are treated with effective, uninterrupted anti-tuberculous treatment. Treatment adherence is critical for curing individual patients, controlling the spread of infection in the community, and minimizing the development of drug resistance.

Adherence to treatment means that a patient follows the recommended course of treatment by taking all the prescribed medications for the entire length of time, as necessary. In other words, “right dose for the right duration”.

In Drug Sensitive Tuberculosis(DSTB), a TB patient completes 168 doses of TB treatment and adheres to TB treatment.

Adherence to tuberculosis(TB) treatment is important for promoting individual and public health. Poor adherence to TB treatment results in:

• More individual suffering and death,
• Costly treatment as treatment regimens lengthen and
• Increases the risk for Drug Resistant Tuberculosis

Proper treatment of all forms of TB is critical to reducing individual morbidity and mortality and to interrupting transmission among family and community members.

Recording of Treatment Adherence can be done as

• Manually by DOT/Health Care Provider in TB Treatment Card of a patient.
• Self-reported by Patient using digital tools for reporting adherence using 99 DOTS and MERM technologies.

Monitoring Treatment Adherence:

All TB patients should be monitored to assess their response to TB treatment. Nikshay Adherence calendar has a colour legend for various doses taken by a patient

Figure: Sample Nikshay Adherence Calendar in web and Mobile App

Image

Figure: DSTB Treatment Card (Paper)
 

99DOTS is a low-cost digital adherence technology built-in Nikshay that uses inexpensive packaging(envelopes or stickers) with medication that enables people taking medication to engage with their treatment daily. This packaging, distributed to TB patients taking medications, has a hidden number behind perforated flaps on the external envelope; in some cases, the number may be fixed outside the medication blister or pill bottle. This number can be a toll-free number that can be called to register daily adherence or a code sent by SMS, USSD, or other communication channels. Calling or messaging the number is free!

Figure: 99 DOTS Envelope

MERM: The Medication Event Reminder Monitor(MERM) is a digital pillbox that provides daily pill-taking reminders and facilitates remote monitoring of medication adherence. This system provides visual and audible reminders for both daily dosing and refill,.transmits this data to a server so that healthcare providers can remotely visualize patients’ dosing histories to support enhanced adherence counselling. 

Figure: MERM Box

Manual recording of Adherence in Nikshay:

in Nikshay, Adherence can only be recorded only if there is corresponding dispensation being issued to a Patient 

Figure: Steps to record manual dose in Nikshay

Recording in Patient Treatment Card:

Figure: Filled Treatment card for TB Patient

Missed Dose recording in Nikshay:

For recording missed doses in Nikshay, following steps should be followed:

Administration of drugs and adherence to therapy

Community Health Volunteers should ensure supply and regular consumption of TB drugs by a patient, so that TB patients adhere to their treatment.

Monitoring of Adverse Drug Reactions

Community Health Volunteers should be able to do an early identification and referral for Adverse Drug Reactions(ADRs) to the nearest health facility of NTEP Programme.

Referral for Clinical & Lab Follow up of Patient as per TB Treatment schedule

Community Health Volunteers should ensure that the patient adheres to the regular monthly follow up and sputum test at the end of each treatment phase as per the TB Treatment guideline.

Community Health Volunteers should also help in recording of TB recurrence in a patient on Nikshay platform(i.e., old details with new episodes)

Maintaining records of TB patients and linkages with health systems

Community Health Volunteers should ensure that the necessary TB patient records are maintained at the nearest health facility, which in turn should be linked with the health systems.

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