Clinical Advisory  Four-month regimen for the treatment of pulmonary tuberculosis

Date:	08/18/2022
Organization:	Bureau of Infectious Disease and Laboratory Sciences
Referenced Sources:	Interim Guidance: 4-Month Rifapentine-Moxifloxacin Regimen for the Treatment of Drug-Susceptible Pulmonary Tuberculosis — United States, 2022

Update: Four-month regimen for the treatment of pulmonary tuberculosis

A four-month regimen containing isoniazid (H), rifapentine (P), moxifloxacin (M), and pyrazinamide (Z), abbreviated HPMZ, has been recommended by the US Centers for Disease Control and Prevention (CDC) as a treatment option for certain patients age 12 years and older with drug-susceptible pulmonary tuberculosis (TB).

In accordance with this guidance from the CDC, the Massachusetts Department of Public Health (DPH) similarly recommends the consideration of the four-month HPMZ regimen for the treatment of drug-susceptible pulmonary TB as an alternative to the standard six-month regimen containing isoniazid, rifampin (R), pyrazinamide, and ethambutol (E), abbreviated HRZE. Providers considering the HPMZ regimen are advised to review eligibility, implementation, and management requirements.

Treatment eligibility

• Patients must be aged ≥ 12 years with body weight ≥ 40 kg, not pregnant (or intending to become pregnant), and with no evidence of extrapulmonary TB.
• Treatment with the HPMZ regimen is only recommended for pulmonary TB caused by organisms that are not known or suspected to be drug resistant.
• Patients must be able to participate in directly observed therapy for the entire four-month course. The Local Board of Health for the patient's residence should be engaged in providing direct community case management including directly observed therapy.
• The HPMZ regimen can be used in persons with an HIV infection who have CD4 counts ≥100 cells/μL and are receiving or planning to initiate efavirenz as part of their antiretroviral therapy regimen.

Preparing for treatment

• Before initiating treatment with the HPMZ regimen, providers should conduct microbiologic, laboratory, and clinical assessments to evaluate whether patients are suitable and the regimen is acceptable to the patient compared with the standard 6-month regimen.
• Baseline molecular drug-susceptibility testing for rapid identification of mutations associated with resistance to at least INH, PZA, RIF, and fluoroquinolones is advisable.
• Patients should undergo an electrocardiogram prior to starting treatment and after two to four weeks on treatment to assess for prolongation of the QT interval due to moxifloxacin. Patients at risk for or with prolonged QTc should not receive this regimen.
• Prescribers should verify the availability of the component medications for the duration of the HPMZ regimen with the intended supplying pharmacy prior to initiation of treatment.

Additional details about treatment are available at CDC: https://www.cdc.gov/mmwr/volumes/71/wr/mm7108a1.htm

Provider guidance is available through the National Tuberculosis Controllers Association:

https://survey.alchemer.com/s3/6879708/HPMZ-Regimen-Provider-Guidance-Publication-Registration-V1

Questions may be directed to the DPH Tuberculosis Program by calling [phone].

www.mass.gov/tuberculosis