Top 5 Takeaways

1. New Regimen Recommendation: A 4-month regimen with rifapentine (RPT), moxifloxacin (MOX), isoniazid (INH), and pyrazinamide (PZA) is recommended for treating drug-susceptible pulmonary tuberculosis in patients aged ≥12 years.
2. Clinical Trial Evidence: The recommendation is based on a clinical trial showing the 4-month regimen is as effective as the standard 6-month regimen.
3. Patient Eligibility: The regimen is suitable for patients with body weight ≥40 kg and no contraindications, but not recommended for certain groups, including pregnant women and those with drug-resistant TB.
4. Implementation Considerations: The regimen requires specific diagnostic and monitoring infrastructure, including drug susceptibility testing and adverse event monitoring.
5. Special Cases: Clinical consultation is advised for patients with increased risk for drug resistance or other complicating factors.

Original Article Author and Citation

Corresponding Author

Wendy Carr, ibt5@cdc.gov, 404-639-8583

Suggested Citation

Carr W, Kurbatova E, Starks A, Goswami N, Allen L, Winston C. Interim Guidance: 4-Month Rifapentine-Moxifloxacin Regimen for the Treatment of Drug-Susceptible Pulmonary Tuberculosis — United States, 2022. MMWR Morb Mortal Wkly Rep 2022;71:285–289. DOI: http://dx.doi.org/10.15585/mmwr.mm7108a1

Summary

The CDC recommends a 4-month treatment regimen for drug-susceptible pulmonary tuberculosis in patients aged ≥12 years. This regimen, consisting of rifapentine, moxifloxacin, isoniazid, and pyrazinamide, has been shown to be as effective as the standard 6-month regimen. The recommendation is based on a clinical trial conducted by the CDC’s Tuberculosis Trials Consortium and the NIH-sponsored AIDS Clinical Trials Group.

Methods

The interim guidance was developed based on evidence from a clinical trial (Study 31/A5349), preclinical and animal studies, previous clinical trial findings, and pharmacokinetic and pharmacodynamic modeling. A CDC writing group reviewed the evidence and drafted the guidance, which was then reviewed by external TB experts and made available for public comment.

Discussion

The 4-month RPT-MOX regimen offers a shorter treatment duration for drug-susceptible pulmonary TB, potentially improving patient adherence and quality of life. However, it is not recommended for certain patient groups, such as those with drug-resistant TB or pregnant women. Further studies are needed to evaluate the regimen’s efficacy in these groups.

Conclusion

The 4-month RPT-MOX regimen is a viable treatment option for drug-susceptible pulmonary TB in patients aged ≥12 years. Healthcare providers should consider patient history, concurrent medications, and risk factors for adverse reactions when deciding to use this regimen. Ongoing monitoring and updates to clinical guidelines will be necessary as more data become available.

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