From the Guidelines
The most effective treatment for multidrug-resistant tuberculosis (MDR TB) is the 6-month treatment regimen composed of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM), as recommended by the 2022 WHO DR-TB treatment update 1. This treatment regimen has been shown to be more effective than the traditional 9-month or longer regimens, with a higher success rate and lower mortality risk.
- The BPaLM regimen is a significant improvement over previous treatment options, offering a shorter treatment duration and improved outcomes for patients with MDR TB.
- The use of bedaquiline, a diarylquinoline, has been approved by the FDA for the treatment of MDR TB, and its effectiveness has been demonstrated in clinical trials 1.
- The 2022 WHO DR-TB treatment update also emphasizes the importance of monitoring patient response to treatment, the timing of starting antiretroviral therapy in MDR/RR-TB patients living with HIV, and the use of surgery for patients on MDR/RR-TB treatment 1.
- It is essential to note that the treatment of MDR TB requires a comprehensive approach, including the use of effective treatment regimens, monitoring of patient response, and management of adverse reactions.
- The International Standards for Tuberculosis Care (ISTC) provide a framework for the diagnosis and treatment of TB, including MDR TB, and emphasize the importance of prompt and accurate diagnosis, effective treatment, and patient-centered care 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Tuberculous Meningitis (TBM) Overview
- TBM is the most common form of central nervous system tuberculosis (TB) and has very high morbidity and mortality 2
- Characteristic cerebrospinal fluid (CSF) findings of TBM include a lymphocytic-predominant pleiocytosis, elevated protein, and low glucose 2
Diagnosis and Treatment
- CSF acid-fast smear and culture have relatively low sensitivity but yield is increased with multiple, large volume samples 2
- Nucleic acid amplification of the CSF by PCR is highly specific but suboptimal sensitivity precludes ruling out TBM with a negative test 2
- Treatment for TBM should be initiated as soon as clinical suspicion is supported by initial CSF studies 2
- Empiric treatment should include at least four first-line drugs, preferably isoniazid, rifampin, pyrazinamide, and streptomycin or ethambutol 2
First-Line Drugs and Treatment Regimens
- The World Health Organization recommends the directly observed therapy short-course (DOTS) regimen, a combination of four first-line antibiotics (isoniazid, rifampicin, pyrazinamide and ethambutol), for the treatment of active pulmonary tuberculosis (TB) 3
- A regimen of isoniazid, rifampin, pyrazinamide, and ethambutol given daily for 6 months produced successful outcomes when used in a public health tuberculosis clinic as routine therapy for isoniazid-resistant tuberculosis 4
- Fixed-dose combination (FDC) formulation, where a single tablet contains the active ingredients of four aforementioned drugs, is gaining popularity due to its ease of administration 5
Pharmacokinetics and Determinants
- Evaluation of sources of pharmacokinetic variation can facilitate optimization of tuberculosis treatment regimens by identification of avoidable sources of variation and of risk factors for low or high drug concentrations in patients 6
- Several factors independently associated with variations in antituberculosis drug concentrations were identified, including human immunodeficiency virus infection, formulation factors, gender, age, and dose per kilogram of body weight 6