The latest clinical practice guidelines advocate for four- and six-month all-oral regimens for eligible children and adults with drug-susceptible or drug-resistant tuberculosis.
RT’s Three Key Takeaways:
- Shortened TB Regimens Recommended: New clinical guidelines recommend four-month regimens for drug-susceptible TB in eligible children and adults, and six-month regimens for rifampin-resistant TB, significantly reducing treatment duration compared to traditional therapies.
- Adherence and Monitoring are Critical: Experts stress the importance of directly observed treatment, safety monitoring, and drug-susceptibility testing to ensure regimen effectiveness and prevent the emergence of drug resistance.
- Guidelines Backed by Evidence: Using the GRADE framework, the guidelines offer evidence-based recommendations, balancing efficacy and safety for both drug-susceptible and drug-resistant tuberculosis cases.
In the latest clinical practice guidelines from the American Thoracic Society, the Centers for Disease Control and Prevention, European Respiratory Society, and Infectious Diseases Society of America, an expert panel shared new recommendations for all-oral, shorter treatment regimens for tuberculosis (TB) in eligible children and adults.
The guidelines were published online in the American Journal of Respiratory and Critical Care Medicine.
“There has been a quest and concerted effort to develop shorter treatments for TB, after decades of little drug development,” says Jussi Saukkonen, MD, ATSF, one of the lead authors of the guidelines, in a release. “With recent studies, we have been able to shorten the regimen durations for both drug-susceptible and drug-resistant TB for most patients, down to four and six months, respectively.”
However, the panel notes that “for those who are not eligible for these shorter regimens, the 2016 and 2019 recommendations should be consulted.”
Using the thorough, evidence-based Grading of Recommendations, Assessment, Development, and Evaluation framework, the expert panel made the following recommendations for patients with tuberculosis.
Q&A on New Recommendations
Question: In adolescents and adults with drug-susceptible pulmonary tuberculosis, is a four-month regimen composed of two months of isoniazid, rifapentine, pyrazinamide, and moxifloxacin followed by two months of isoniazid, rifapentine, and moxifloxacin (2HPZM/2HPM) as efficacious and safe as the standard six-month drug-susceptible TB regimen of two months of isoniazid, rifampin, pyrazinamide, and ethambutol (2HRZE) followed by four months of isoniazid, and rifampin (4HR)?
Answer: In people aged 12 years or older with drug-susceptible pulmonary tuberculosis, we conditionally recommend the use of a four-month regimen of isoniazid, rifapentine, moxifloxacin, and pyrazinamide (conditional recommendation, moderate certainty of evidence).
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Question: In children and adolescents with non-severe, drug-susceptible pulmonary TB, is a four-month regimen composed of standard-dose two months of isoniazid, rifampin, pyrazinamide, and ethambutol followed by two months of isoniazid and rifampin (2HRZE/2HR) as efficacious and safe as the standard 6-month drug-susceptible TB regimen of two months of isoniazid, rifampin, pyrazinamide, and ethambutol followed by four months of isoniazid and rifampin (2HRZE/4HR)?
Answer: In children and adolescents between 3 months and 16 years of age with non-severe TB (without suspicion or evidence of multidrug-resistant rifampin-resistant TB), we recommend the use of a four-month treatment regimen of 2HRZ(E)/2HR rather than the six-month drug-susceptible TB regimen of 2HRZ(E)/4HR (strong recommendation, moderate certainty of evidence).
Question: In adolescents aged 14 and older and adults with rifampin-resistant pulmonary TB, is a six-month bedaquiline, pretomanid, and linezolid (BPaL) regimen as efficacious and safe as the current 15-month or longer drug-resistant TB regimens?
Answer: In adolescents aged 14 and older and adults with rifampin-resistant pulmonary TB with resistance or patient intolerance to fluoroquinolones, who either have had no previous exposure to bedaquiline and linezolid or have been exposed for less than one month, we recommend the use of the six-month treatment BPaL regimen, rather than more than 15-month regimens (strong recommendation, very low certainty of evidence).
Question: In adolescents aged 14 and older and adults with rifampin-resistant, fluoroquinolone-susceptible pulmonary TB, is a six-month bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) regimen as effective and safe as the 15-month or longer drug-resistant TB regimens?
Answer: In adolescents aged 14 and older and adults with rifampinresistant, fluoroquinolone-susceptible pulmonary TB, we recommend the use of a six-month BPaLM treatment regimen, rather than the 15-month or longer regimens in patients with MDR/RR-TB (strong recommendation, very low certainty of evidence).
“While these new regimens have allowed significant treatment shortening, it is important to recognize that drug-resistance in TB isolates could emerge with incomplete adherence to these regimens,” says Saukkonen in a release. “Directly observed treatment, close monitoring for safety and effectiveness of regimens, and drug-susceptibility testing are essential to the effective treatment of TB and for the overall success of TB programs.”
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