The suggested treatment regimen covering maximum non-Mycobacterium Tuberculosis (NTM) mainly Mycobacterium Avium Complex (MAC) is as follows:
Intensive Phase (IP) is for 3 months and can be extended to a maximum of 6 months with all four drugs.
The reconstitution of Bedaquiline (Bdq) bottle should be done at the State Drug Store (SDS).
In case of lost to follow-up/ death/ transferred-out/ treatment stopped patients, Bdq bottle shall be brought back from the treatment centre to the Health Facility (HF) to the TB Unit (TU) to the District TB Centre (DTC) within the shortest possible time.
Packaging of loose drugs into monthly patient-wise boxes should be done under the guidance of those in charge of drug logistics at the state and district levels.
Patient-wise drug box preparation should be done for the following Drug-resistant TB (DR-TB) regimens:
Tuberculosis (TB) unit (TU) is the sub-district level supervisory unit of National TB Elimination Program with the following organogram:
Figure: Organogram of a TB Unit
(PHI: Peripheral Health Institution)
TUs are based mainly on National Health Mission (NHM) health blocks with the aim of aligning with the NHM Block Programme Management Unit (BPMU) for optimum resource utilization and appropriate monitoring.
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)
The key level for the management of public health services is the district level. The District Tuberculosis Centre (DTC) is the nodal point for tuberculosis (TB) control activities in the district.
Functions of the DTC
The primary role of the DTC is a managerial one. The DTC is the central program management unit of the district responsible for all activities related to National TB Elimination Programme (NTEP) implementation such as:
he potential adverse drug events that can occur when using drugs in the H mono/ poly DR-TB regimen are tabulated below:
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.
|
ADVERSE DRUG EVENTS |
DRUGS |
|---|---|
|
QT prolongation |
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
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