LTBI - Recommended Regimens

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Recommended Regimens

Determine which regimen is most appropriate for your patient and support adherence to ensure successful completion.  Evidence shows that patients are more likely to complete shorter regimens.

INH

Interval and Duration

Adult Dosage (Max)

Pediatric Dosage (Max)

Completion Criteria

Daily
for 9 mos.

5 mg/kg
(300 mg)

10–20 mg/ kg (300 mg) preferred regimen for children <12 years of age

270 doses within
12 mos.

Twice-weekly for 9 mos.

15mg/kg
(900 mg)

20–40** mg/kg
(900 mg)

76 doses within
12 mos.

DOT must be used with twice-weekly dosing

Indications
Recommended for most persons, and preferred for children under 12 years.
Not indicated for persons exposed to
INH-resistant TB.
Completion of 9 mos. regimen is
>90% effective.*
In HIV-infected persons, INH may be given concurrently with NRTIs, protease inhibitors, or NNRTIs.

Adverse Reactions
Hepatic enzyme elevation, hepatitis (nausea, vomiting, abdominal pain, anorexia, yellow eyes/skin, light stools, dark urine), rash, peripheral neuropathy, mild CNS effects, drug interactions

Considerations with this Regimen
Hepatitis risk increases with age, alcohol use, and concurrent use of other hepatotoxic drugs. Supplementation with pyridoxine (B6) should be considered in certain populations.  
See Managing Patients on Treatment.

INHand RPT

Interval and Duration
Once-weekly for 12 weeks

Adult Dosage (Max) + Pediatric Dosage (Max)
INH:15 mg/kg rounded up to the nearest 50 or 100 mg (900 mg max)

RPT: 10.0–14.0 kg (300 mg)
14.1–25.0 kg (450 mg)
25.1–32.0 kg (600 mg)
32.1–49.9 kg (750 mg)
>50.0 kg (900 mg max)

Rifapentine is a long acting rifamycin.

DOT must be used with
12-dose regimen

Completion Criteria
12 doses

Indications
Recommended for otherwise healthy persons 12 years of age and older who were recently in contact with infectious TB or who recently converted  their TB test from negative to positive or who have radiographic evidence of healed pulmonary TB.

May be used in otherwise healthy HIV+ persons >12 years of age who are not on antiretroviral medications. May be considered for children aged 2-11 years if completion of 9 mos. INH is unlikely and hazard of TB is great.

Not recommended for:
• Children younger than 2 years old
• People with HIV/AIDS who are taking antiretroviral treatment
• People presumed to be infected with INH- or RIF-resistant M.tb.
• Pregnant women or women expecting to be pregnant while taking this regimen

Adverse Reactions
INH:  as above

RPT: Hematologic toxicity, hypersensitivity reaction (e.g. hypotension or thrombocytopenia), GI symptoms, polyarthralgia, hepatotoxicity, pseudo jaundice, flu-like symptoms, orange discoloration of bodily fluids

Considerations with this Regimen
Hepatitis risk increases with age, alcohol use, and concurrent use of other hepatotoxic drugs.

Supplementation with pyridoxine (B6) should be considered in certain populations.  See Managing Patients onTreatment.

Vigilance for drug hypersensitivity reactions, ranging from mild reactions such as dizziness  to more severe reactions including hypotension and thrombocytopenia.

Consider possible rifamycin-associated drug interactions. See Managing Patients on Treatment. Women who use any form of hormonal birth control should be advised to also use a barrier method.

Educate patients that orange discoloration of bodily fluids is expected and harmless.

Train DOT provider to ask patients about adverse reactions at each DOT visit.

RIF

Interval and Duration

Adult Dosage (Max)

Pediatric Dosage (Max)

Completion Criteria

Daily for 4 mos.

RIF 10 mg/kg (600 mg)

 

120 doses within 6 mos.

Daily for 6 mos.

 

10–20 mg/kg (600 mg)

180 doses within 9 mos.

Indications
For contacts of patients with INH- resistant,  RIF-susceptible TB, persons with allergy/intolerance to or serious adverse effects from INH, or when shorter course treatment is preferred.
In HIV-infected persons certain antiretroviral medications should not be given concurrently with RIF. An alternative with protease inhibitors is rifabutin 300 mg t/w or 150mg daily. See www.aidsinfo.gov.

Adverse Reactions
GI intolerance, drug interactions, hepatitis, bleeding problems (from gums or other sites, easy bruising), flu-like symptoms, orange discoloration of bodily fluids

Considerations with this Regimen
Consider possible rifamycin-associated drug interactions. See Managing Patients on Treatment. Women who use any form of hormonal birth control should be advised to also use a barrier method.
Educate patients that orange discoloration of bodily fluids is expected and harmless.

Monitoring For All Patients
Evaluate at least monthly: Include careful  questioning  about adherence and side effects, and a brief physical examination. Check for evidence of hepatotoxicity, RPT hypersensitivity, or other adverse reactions: fever, anorexia, dark urine, icterus, rash, persistent parasthesia of hands and feet, fatigue or weakness lasting 3 or more days, abdominal tenderness (especially in the right upper quadrant), easy bruising or bleeding, arthralgia, nausea, or vomiting.
• Routine monthly monitoring  of LFTs is not generally indicated.

Baseline LFTs are indicated for:

– HIV infection
– Risks for hepatic disease, including other potentially hepatotoxic  drugs (e.g.anti-convulsants) or over-the-counter drugs (e.g. acetaminophen)
– Regular alcohol  use      
– Pregnancy or <3 months postpartum
– History of liver disease or liver disorders

• Periodic LFTs are indicated for persons at risk for, or with a history of, hepatic disease, persons who have abnormal baseline LFTs, or those who develop symptoms consistent with hepatotoxicity.
• If side effects occur, a prompt physician’s evaluation is necessary with treatment changes as indicated

Medication should be withheld and patients evaluated if:
• Transaminase levels >3 times upper limit of normal in presence of symptoms
• Transaminase levels >5 times upper limit of normal in asymptomatic patient
• If children taking LTBI treatment develop hepatitis, discontinue LTBI treatment and seek other causes, noting transaminase levels stated above.

when LFTs have returned to normal, consider an alternate  regimen,  with close clinical and laboratory monitoring.  Consult with  TB expert.

Report adverse events to CDC Division of Tuberculosis Elimination  by sending an email to LTBIdrugevents@cdc.gov