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			Drug-Susceptible TB Disease Treatment RegimensTreatment Regimen Considerations for Specific Groups of People with TB DiseaseEvaluation and Testing Considerations for Drug-susceptible Pulmonary TB Treatment Regimens
		
There are several treatment regimens recommended in the United States for TB disease. TB treatment can take 4, 6, or 9 months depending on the regimen. TB treatment regimens include
New4-month Rifapentine-moxifloxacin TB Treatment Regimen
Interim Guidance: 4-Month Rifapentine-Moxifloxacin Regimen for the Treatment of Drug-Susceptible Pulmonary Tuberculosis — United States, 2022. *MMWR Morb Mortal Wkly Rep*, 2022
Frequently Asked Questions (FAQs) on a 4-month rifapentine-moxifloxacin TB treatment regimen
Considerations for Specific People with TB Disease
Checklist for Healthcare Providers
6- or 9-month RIPE TB Treatment Regimen
Treatment of Drug-Susceptible Tuberculosis. *Clin Infect Dis*, 2016
Table 3. Doses of Antituberculosis Drugs for Adults and Children*Note: this table is an excerpt from**Treatment of Drug-Susceptible Tuberculosis* *and cites supporting information available in the complete guidelines.*
Highlights from the 2016 Treatment of Drug-Susceptible Tuberculosis GuidelinesMedical treatments
Shorter regimens help patients complete treatment faster. Healthcare providers can choose the appropriate TB treatment regimen based on drug-susceptibility results, coexisting medical conditions (e.g., HIV, diabetes), and potential for drug-drug interactions. The State TB Control Offices and TB Centers of Excellence for Training, Education, and Medical Consultation can provide additional assistance and support in treating people with TB disease.
Directly observed therapy (DOT) helps patients complete treatment. CDC recommends video DOT (vDOT) as an equivalent alternative to in-person DOT for patients on treatment for TB.
The State TB Control Offices and TB Centers of Excellence for Training, Education, and Medical Consultation can provide additional assistance and support in treating people with TB disease.Drug-Susceptible TB Disease Treatment RegimensTB treatment regimens vary in the duration of the regimen, the types of anti-TB drugs prescribed, and the dose and frequency of the drugs. The regimens described on this webpage are for the treatment of drug-susceptible pulmonary TB disease. For information about the treatment of drug-resistant TB, visit the Drug-Resistant TB webpage.4-month Rifapentine-moxifloxacin TB Treatment RegimenNewThe 4-month TB treatment regimen consists of
high-dose daily rifapentine (RPT) with
moxifloxacin (MOX),
isoniazid (INH), and
pyrazinamide (PZA).The 4-month rifapentine-moxifloxacin regimen has an intensive phase of 2 months, followed by a continuation phase of 2 months and 1 week (total 17 weeks for treatment).
Table 1. 4-month rifapentine-moxifloxacin TB treatment regimen
Intensive Phase
Continuation Phase**Drugs**
**Durationa**
**Frequencyb**
**Drugs**
**Durationc**
**Frequencyb**
**Total Doses**
**Commentsd,e**
**Regimen Effectiveness**RPT MOX INH PZA
8 weeks
7 days/week for 56 doses
RPT MOX INH
9 weeks
7 days/week for 63 doses
119
Recommended for people ages 12 and older with body weight at or above 40 kg, with pulmonary TB caused by organisms that are not known or suspected to be drug-resistant, and who have no contraindications to this regimen.
The 4-month rifapentine-moxifloxacin TB treatment regimen is as effective as (noninferior to) the standard daily 6-month regimen in curing drug-susceptible TB disease.Abbreviations: RPT= rifapentine; MOX= Moxifloxacin; INH = isoniazid; PZA = pyrazinamide
aMust be administered completely within 70 days from treatment initiation. If this target is not met, the patient should be considered to have interrupted therapy and should be managed as described in TB treatment guidelines.bAt least 5 of 7 weekly doses should be administered under direct observation. Directly observed therapy means that a healthcare worker watches the TB patient swallow each dose of the prescribed drugs. The healthcare worker should ask the patient how he or she is feeling, check the medications before they are taken, ask the patient if he or she is experiencing any side effects, and answer any questions the patient may have. Where local policies, allow, eDOT has been shown to be an acceptable alternative to traditional DOT. Contact your state or local TB control office for more information about eDOT policies and procedures.cMust be administered within 84 days from intensive phase completion. If this target is not met, the patient should be considered to have interrupted therapy and should be managed as described in TB treatment guidelines.dPyridoxine (vitamin B6), 25–50 mg/day, should be given with isoniazid to all patients.eDrugs are administered with food once a day, every day of the week.
CDC developed a checklist resource for healthcare providers and TB programs to ensure the correct timing of testing and monitoring for patients through the 4-month rifapentine-moxifloxacin regimen.6- to 9-month RIPE TB Treatment RegimensThe 6- to 9-month RIPE TB treatment regimens consist of
**R**ifampin (RIF),
**I**soniazid (INH),
**P**yrazinamide (PZA), and
**E**thambutol (EMB)RIPE regimens for treating TB disease have an intensive phase of 2 months, followed by a continuation phase of either 4 or 7 months (total of 6 to 9 months for treatment).
Table 2. 6- to 9-month RIPE TB treatment regimen
Intensive Phase
Continuation Phase**Drugsa**
**Duration**
**Frequencyb**
**Drugs**
**Duration**
**Frequencyb,c**
**Total Doses**
**Commentsc,d,e,f**
**Regimen Effectiveness**INH
RIF
PZA
EMB
8 weeks
7 days/week for 56 doses
5 days/week for 40 doses
INH
RIF
18 weeks
7 days/week for 126 doses
5 days/week for 90 doses
182 to 130
This is the preferred regimen for patients with newly diagnosed pulmonary TB.
Regimen EffectivenessINH
RIF
PZA
EMB
8 weeks
7 days/week for 56 doses
5 days/week for 40 doses
INH
RIF
18 weeks
3 times weekly for 54 doses
110 to 94
Preferred alternative regimen in situations in which more frequent DOT during continuation phase is difficult to achieve.INH
RIF
PZA
EMB
8 weeks
3 times weekly for 24 doses
INH
RIF
18 weeks
3 times weekly for 54 doses
78
Use regimen with caution in patients with HIV and/or cavitary disease. Missed doses can lead to treatment failure, relapse, and acquired drug resistance.INH
RIF
PZA
EMB
8 weeks
7 days/week for 14 doses then twice weekly for 12 dosesg
INH
RIF
18 weeks
2 times weekly for 36 doses
62
Do not use twice-weekly regimens in HIV-infected patients or patients with smear positive and/or cavitary disease. If doses are missed then therapy is equivalent to once weekly, which is inferior.
Abbreviations: INH = isoniazid; RIF = rifampin; PZA = pyrazinamide; EMB = ethambutol; HIV = human immunodeficiency virus
aOther combinations may be appropriate in certain circumstances; additional details are provided in the Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.bWhen directly observed therapy (DOT) is used, drugs may be given 5 days per week and the necessary number of doses adjusted accordingly. Although there are no studies that compare 5 with 7 daily doses, extensive experience indicates this would be an effective practice. DOT should be used when drugs are administered less than 7 days per week.cBased on expert opinion, patients with cavitation on initial chest radiograph and positive cultures at completion of 2 months of therapy should receive a 7-month (31-week) continuation phase.dPyridoxine (vitamin B6), 25–50 mg/day, is given with INH to all persons at risk of neuropathy (e.g., pregnant women; breastfeeding infants; persons with HIV; patients with diabetes, alcoholism, malnutrition, or chronic renal failure; or patients with advanced age). For patients with peripheral neuropathy, experts recommend increasing pyridoxine dose to 100 mg/day.eThe recommended time frame for regimen, in tuberculosis control programs in the United States and in several European countries, is to administer all of the specified number of doses for the intensive phase within 3 months and those for the 4-month continuation phase within 6 months, so that the 6-month regimen is completed within 9 months.fIn general, TB drugs are administered together, at one dosing so as to achieve maximal peak serum concentrations and to facilitate DOT. Bioavailability of all of the drugs (except for RPT) is greatest when taken on an empty stomach.gAlternatively, some U.S. TB control programs have administered intensive-phase regimens 5 days per week for 15 doses (3 weeks), then twice weekly for 12 doses.
**Note:** Use of once-weekly therapy with INH 900 mg and rifapentine 600 mg in the continuation phase is not generally recommended. In uncommon situations where more than once-weekly DOT is difficult to achieve, once-weekly continuation phase therapy with INH 900 mg plus rifapentine 600 mg may be considered for use only in persons without HIV and without cavitation on chest radiography.Treatment Regimen Considerations for Specific Groups of People with TB DiseaseHealthcare providers can choose the appropriate TB treatment regimen based on drug-susceptibility results, coexisting medical conditions (e.g., HIV, diabetes), and potential for drug-drug interactions. The State TB Control Offices and TB Centers of Excellence for Training, Education, and Medical Consultation can provide additional assistance and support for treating people with TB disease.4-month Rifapentine-moxifloxacin TB Treatment RegimenWhen using the 4-month rifapentine-moxifloxacin regimen as an option to treat people with drug-susceptible pulmonary TB disease, healthcare providers can consider the following information:
**CDC recommends** the 4-month rifapentine-moxifloxacin regimen as an option for treating pulmonary TB disease caused by organisms that are not known or suspected to be drug-resistant for
Considerations for the 4-month Rifapentine-moxifloxacin Regimen [PDF - 233 KB]
People who are 12 years and older
People with a body weight at or above 40 kg
People with HIV with CD4 counts at or above 100 cells/microliter (μL), who are receiving or planning to start efavirenz as part of their antiretroviral therapy (ART) regimen in the absence of any other known drug-drug interactions between antituberculosis and antiretroviral medications
People who have no contraindications to this regimen
People with a negative sputum culture who in the judgment of the clinician likely represent paucibacillary or low mycobacterial burden TB disease unless the person is included in one of the non-recommended groups listed below**Note**: A 4-month regimen for smear-negative, culture-negative, noncavitary pulmonary TB disease exists in the 2016 Treatment of Drug-Susceptible Tuberculosis Guidelines for the treatment of drug-susceptible TB disease and may also be used.**CDC recommends** **that clinical consultation be obtained** to determine if the 4-month rifapentine-moxifloxacin regimen is an acceptable treatment option for
People at increased risk of *Mycobacterium tuberculosis (M. tuberculosis)* resistance to any drug in the 4-month regimen
People who received more than 5 doses of TB treatment in the prior 6 months
People who received more than 5 doses of latent TB infection treatment in the prior 6 months
People who received more than 5 doses of treatment with any one or more of the following drugs for any reason (e.g., urinary tract infection, pneumonia) in the prior 30 days:
Isoniazid (INH), rifampin (RIF), rifabutin, rifapentine (RPT), pyrazinamide (PZA), or any fluoroquinolone
People who have serum or plasma alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal or total bilirubin more than 2.5 times the upper limit of normal, or with preexisting advanced liver diseasePeople who have renal insufficiency or end-stage renal disease, or
Serum or plasma creatinine level more than 2 times the upper limit of normal, or
Plasma potassium level less than 3.5 milliequivalents per liter (mEq/L)
People who have types of extrapulmonary TB that are likely to be paucibacillary, not pose a substantial risk of death or disability, and not require prolonged treatment (i.e., pleural or lymph node TB)
People with a sputum specimen that is unable to be submitted for any *M. tuberculosis* resistance testing prior to initiating the 4-month treatment regimenstop sign**CDC does *not* recommend** the 4-month rifapentine-moxifloxacin regimen for
People who are younger than 12 years old
People with a body weight below 40 kilograms (kg)
People who are pregnant or breastfeeding
People who have most types of suspected or documented extrapulmonary TB
People who have a history of prolonged QT syndrome or concurrent use of one or more QT-prolonging medications (in addition to moxifloxacin (MOX))
People who are receiving medications with known clinically relevant drug-drug interactions with INH, RPT, PZA, or MOX
People with a baseline *M. tuberculosis* isolate known or suspected to be resistant to RIF, INH, PZA, or any fluoroquinoloneFor additional questions and answers about the 4-month rifapentine-moxifloxacin regimen, visit the Frequently Asked Questions (FAQs) webpage.
The State TB Control Offices and TB Centers of Excellence for Training, Education, and Medical Consultation can provide additional assistance and support in treating people with TB disease.6-month RIPE TB Treatment Regimen**The 6-month regimen for****the treatment of drug-susceptible pulmonary TB can be used in most patients.**It consists of four anti-TB drugs and is sometimes called the RIPE regimen because of the medications
**R**ifampin
**I**soniazid
**P**yrazinamide
**E**thambutol9-month RIPE TB Treatment Regimen**CDC recommends the 9-month regimen for****the treatment of drug-susceptible pulmonary TB for the following groups:**
People with cavitary pulmonary TB caused by drug-susceptible organisms and whose sputum culture obtained at the time of completion of 2 months of treatment is positive
People whose intensive phase of treatment did not include pyrazinamide
People with HIV who are not receiving antiretroviral treatment (ART) during TB treatment
People being treated with once weekly isoniazid (INH) and rifapentine and whose sputum culture obtained at the time of completion of the intensive phase is positive*(Note: Use of once-weekly therapy with INH 900 mg and rifapentine 600 mg in the continuation phase is not generally recommended. In uncommon situations where more than once-weekly directly observed therapy is difficult to achieve, once-weekly continuation phase therapy with INH 900 mg plus rifapentine 600 mg may be considered for use, but only in persons without HIV and without cavitation on chest radiography.)*******Learn more about considerations for**
Treatment of LTBI and TB for Persons with HIV
Treatment for TB Disease & Pregnancy
TB Treatment for Children
Drug-Resistant TBEvaluation and Testing Considerations for Drug-susceptible Pulmonary TB Treatment RegimensThe 4-month TB treatment regimen (high-dose daily rifapentine with moxifloxacin, isoniazid, and pyrazinamide) and 6-month RIPE (rifapentine, isoniazid, pyrazinamide, and ethambutol) regimen have unique considerations. The below table compares the recommended evaluation and testing considerations for the two regimens.
Compares the recommended evaluation and testing considerations for the two regimens.
**Evaluation and Testing Considerations**
**4-month Rifapentine-moxifloxacin Regimen**
**Standard 6-month RIPE Regimen****Rapid molecular testing**
At baseline, test at least one specimen using a rapid molecular test.  It is advisable to test at least one specimen using a rapid molecular test for susceptibility to
isoniazid (INH),
rifampin (RIF), as a proxy for rifapentine
pyrazinamide (PZA), and
fluoroquinolones
At baseline, test at least one specimen using a rapid molecular test. For patients with risk factors for drug-resistant disease, it is recommended to test at least one specimen using a rapid molecular test for susceptibility to
INH and
RIF**Acid-fast bacilli smear microscopy and culture**
At baseline and at minimum monthly intervals until 2 consecutive specimens are negative on culture, test a respiratory specimen for acid-fast bacilli smear microscopy and culture
At baseline and at minimum monthly intervals until 2 consecutive specimens are negative on culture, test a respiratory specimen for acid-fast bacilli smear microscopy and culture**Phenotypic drug susceptibility testing**
At baseline, obtain phenotypic drug susceptibility at least for the following TB drugs
INH,
RIF,
PZA, and
fluoroquinolones (preferred fluoroquinolone is moxifloxacin)
At baseline, obtain phenotypic drug susceptibility for the following TB drugs
INH,
RIF,
ethambutol, and
PZA**Additional tests**
Recommended at baseline, obtain blood levels of
potassium,
calcium, and
magnesium
Not routinely recommended for all patientsRelated LinksState TB Control Programs
TB Centers of Excellence for Training, Education, and Medical Consultation**For People with TB Disease**
TB – General Information (Fact sheet)
TB Can Be Treated (Fact sheet)
You Can Prevent TB (Fact sheet)
Staying on track with TB medicine (Pamphlet) (PDF – 511k)
Questions and Answers About TB**For Healthcare Providers**
Treatment Fact Sheets
Treatment of Drug-Susceptible Tuberculosis Disease in Persons Not Infected with HIV
Treatment of Drug-Resistant Tuberculosis
Provisional CDC Guidance for the Use of Pretomanid as part of a Regimen [Bedaquiline, Pretomanid, and Linezolid (BPaL)] to Treat Drug-Resistant Tuberculosis Disease
Treatment Guidelines
Core Curriculum on Tuberculosis: What the Clinician Should Know
Frequently Asked Questions (FAQs) on 4-month rifapentine-moxifloxacin TB treatment regimen
Treatment Regimen Checklist for Healthcare Providers
Considerations for Specific Groups of PeopleTop of Page
							
					
							Last Reviewed:  March 22, 2023						Source: 	Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention
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