What is the recommended drug regimen for the treatment of tuberculosis?

From the Guidelines

The recommended drug regimen for tuberculosis treatment is a 6-month treatment regimen composed of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) for multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) patients, including extensive pulmonary TB and extrapulmonary TB (except TB involving central nervous system, miliary TB, and osteoarticular TB) 1.

Key Considerations

• This regimen is recommended in place of the 9-month or longer (18-month) regimens for MDR/RR-TB patients.
• The use of the 9-month all-oral regimen rather than longer (18-months) regimen is suggested in patients with MDR/RR-TB and in whom resistance to fluoroquinolones has been excluded.
• Longer (18-month) treatments remain a valid option in all cases in which shorter regimens cannot be implemented due to intolerance, drug-drug interactions, extensively drug-resistant tuberculosis, extensive forms of extrapulmonary TB, or previous failure.

Rationale

• The new guidelines represent a milestone in MDR/RR-TB treatment landscape, setting the basis for a shorter, all-oral, more acceptable, equitable, and patient-centered model for MDR/RR-TB management.
• The BPaLM regimen is effective because each drug targets different aspects of Mycobacterium tuberculosis, preventing resistance development and improving treatment outcomes.

Important Notes

• Treatment adherence is crucial, and directly observed therapy (DOT) is often recommended to ensure patients complete the full course.
• Drug susceptibility testing should be performed before or early in treatment to adjust the regimen if resistance is detected, as multidrug-resistant TB requires longer treatment with second-line medications.
• The new guidelines may pose some challenges to be addressed to allow full implementation of the new recommendations, including intolerance, drug-drug interactions, and extensively drug-resistant tuberculosis.

From the FDA Drug Label

The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months. The recommended drug regimen for the treatment of tuberculosis is:

• Isoniazid
• Rifampin
• Pyrazinamide for the first 2 months Then,
• Isoniazid and
• Rifampin for the remaining 4 months 2

From the Research

Treatment Regimens for Tuberculosis

The recommended drug regimen for the treatment of tuberculosis (TB) typically involves a combination of medications.

• First-line therapy for active TB includes isoniazid, rifampin, pyrazinamide, and ethambutol for the initial two-month phase, followed by isoniazid and rifampin for 4 to 7 months, as standard treatment for people at low risk for drug-resistant disease 3.
• Directly-observed therapy (DOT) remains the standard of care for pulmonary TB, with virtual treatment monitoring using digital technologies becoming more common as a way to provide a more patient-centered approach to care 3.

Drug-Resistant Tuberculosis

For drug-resistant TB, recently approved medications are recommended, but novel agents in varying stages of development are being evaluated 3.

• One study found that a regimen of isoniazid, rifampin, pyrazinamide, and ethambutol given daily for 6 months produced successful outcomes for isoniazid-resistant tuberculosis 4.
• Another study evaluated an 8-month regimen based on ethambutol and isoniazid, but found that it was inferior to the standard 6-month regimen 5.

Latent TB Infection (LTBI)

Rifamycin-based regimens for LTBI have been successful in preventing progression to TB disease 3.

• One study found that once-weekly isoniazid and rifapentine for 12 weeks by DOT was safe and effective compared with 9 months of isoniazid 3.
• Newer studies are investigating even shorter LTBI treatment with durations of less than 2 months 3.

Factors Affecting Treatment Outcomes

Several factors can affect treatment outcomes, including patient compliance, drug resistance, and pharmacokinetic variation 6, 7.

• A study found that human immunodeficiency virus infection, formulation factors, and patient characteristics such as age and sex can influence antituberculosis drug concentrations 7.