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Follow-up Evaluation of Patients on Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen
Learning ObjectivesFollow-up Evaluation of Patients on Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen
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.
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) |
|
Culture |
|
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:
|
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 3rd 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
- 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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