CDST_LT: TB treatment initiation and Followup

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

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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

Adverse Drug Reactions(ADR) are unwanted or harmful reactions experienced following the use of a drug or combination of drugs and are suspected to be related to a drug. Severity of adverse effects varies from tolerable and mild ADRs to serious and life threatening ADRs.

Figure: Various Adverse Drug Reactions

Common ADR Symptoms:

• Pain in upper abdominal area, with loss of appetite
• Nausea – Uneasy feeling with inclination to vomit, after having the drugs
• Gastritis – Burning sensation in lower chest region, bloating sensation, sourness in mouth
• Diarrhoea - Loose stool(2-3 in a day)

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.”

Drug Susceptibility Testing (DST) refers to in-vitro testing using either of the phenotypic methods to determine susceptibility. Drug Resistance Testing (DRT) refers to in-vitro testing using genotypic methods (molecular techniques) to determine resistance.    

Universal Drug Susceptibility Testing (UDST) refers to universal access to rapid DST for at least Rifampicin (R), and further DST for at least Fluoroquinolones (FQs) among all TB patients with rifampicin-resistance.

• UDST is essential to identify patients who can be initiated on Drug-resistant TB (DR-TB) treatment instead of Drug-sensitive TB (DS-TB) treatment, especially in a situation where the drug-resistance level is high.
• It should be done preferably before initiation of treatment to a maximum within 15 days of diagnosis.
• UDST is a part of national policy under the National TB Elimination Programme (NTEP).
• NTEP has undertaken decentralization of quality assured diagnostics for scale up of UDST across the country which has helped in early detection of DR-TB treatment and reducing associated morbidity and mortality.

Drug-resistant TB (DR-TB) diagnosis is predominantly based on laboratory diagnosis. Presumptive-TB/ DR-TB is identified by the health facility doctor during passive screening or by health staff/ community volunteers during Active Case Finding (ACF). 

The vision of National TB Elimination Programme (NTEP) is to provide early diagnosis to all persons with any form of DR-TB through Universal Drug Susceptibility Testing (UDST).

All diagnosed TB patients are eligible for a NAAT test to know their Rifampicin sensitivity status. The integrated diagnostic algorithm for diagnosis of TB offers upfront Nucliec Acid Amplification Test (NAAT) for diagnosis of TB to vulnerable population. Among other eligible groups for NAAT are: non-responders to treatment and contacts of DR-TB patients are also offered upfront NAAT.

Rapid identification of DR-TB is achieved by using a combination of NAAT (CBNAAT/ Truenat) followed by sequential testing by first- and second-line Line Probe Assay (LPA) and Liquid Culture (LC) and Drug Susceptibility Testing (DST) for specific drugs as described below:

• When Rifampicin resistance is not detected by NAAT, the patient is offered First-line (FL) LPA.FL-LPA provides information on Isoniazid resistance.
• For Rif resistance/Inh resistance cases, SL-LPA  is done and it provides information on resistance to Levofloxacin, Moxifloxacin and Amikacin.
• For all Rif resistance cases, LC and DST is done for Pyrazinamid, Moxifloxacin (if resistance detected by LPA), Linezolid, Clofazimine*, Bedaquiline* and Delamanid*.

(* when available)

Resources

• Guidelines for PMDT in India, 2021.

Assessment