Guidelines Released on New, Shorter Regimen for LTBI >> CDC - News from DTBE - TB Notes 4, 2011 - TB

Guidelines Released on New, Shorter Regimen for LTBI
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These are exciting times in TB control! Global resource-sharing partnerships are speeding up progress; new technologies are providing faster and more accurate diagnoses; and better drugs are making their way into the research pipeline. And while finding and curing TB is the first goal of TB control, preventing TB by treating latent TB infection (LTBI) is also a cornerstone of the U.S. TB elimination strategy. The Division of Tuberculosis Elimination is pleased to announce the December 2011 release of guidelines for using a new two-drug, 12-dose regimen for preventing TB disease. The guidelines are based on three randomized controlled trials, especially a 10-year, 8,000-patient study that was carried out by CDC’s TB Trials Consortium (TBTC), “TBTC Study 26, PREVENT TB.” The recommendations are available in CDC’s Morbidity and Mortality Weekly Report (MMWR) dated Dec. 9, 2011.1

The New LTBI RecommendationThe treatment trials showed that a regimen of isoniazid (INH) and rifapentine (RPT) taken once weekly for 12 weeks as directly observed therapy (DOT) is well tolerated, is as effective in preventing TB as other regimens, and has greater completion rates than 9 months of INH given without DOT. CDC recommends this regimen as an equal option for most persons diagnosed with LTBI who are at least 12 years old, with caveats listed below. The weekly dose is 900 mg INH and 900 mg RPT for persons weighing at least 50 mg (110 pounds). Please refer to the MMWR guidelines for specifics before prescribing the new regimen or making any programmatic changes.

Examples of settings in which the regimen offers advantages:
•Correctional settings
•Clinics for recent immigrants
•Homeless shelters

Persons for whom the regimen is not recommended:
•Children younger than 2 yrs
•HIV-infected persons taking antiretroviral therapy
•Women who are pregnant or expect to become pregnant during treatment
•Persons with LTBI with presumed INH- or RIF-resistant organisms.
Important things to keep in mind
•RPT induces or speeds up the metabolism of many drugs.
•Missed doses and other regimen alterations could lessen effectiveness or cause adverse effects: use DOT.
•Patients should receive clinical evaluations at least monthly.
•Patients should be educated about adverse events and asked about symptoms at each DOT encounter and at clinical evaluation visits.
•Patients with the following conditions should undergo baseline blood tests, and then follow-up tests as clinically indicated:
•HIV infection
•Liver disorders
•Regular alcohol usage
What About Previous LTBI Recommendations?CDC’s previous recommendations for LTBI treatment regimens are unchanged. The recommendations for the new regimen do not replace the guidance for using 9 months of isoniazid; rather, they give clinicians another option for treating LTBI. The standard 9-month regimen has been shown to prevent TB in most groups, including children and HIV-infected persons, and is highly efficacious. The 9-mo INH regimen can still be used; however, the long treatment duration and rare but serious cases of liver injury have been long-time barriers to its use. When INH cannot be used, a daily, 4-month regimen of rifampin (6 months for children) is still recommended.2 The RIF/PZA regimen2 is not recommended.

The new regimen was well tolerated in trials, and the most notable adverse effects were episodes of reversible hypotension, possibly indicating hypersensitivity. Adverse effects leading to hospital admission or death should be reported to local or state health departments for inclusion in this system (e-mail: LTBIdrugevents@cdc.gov). Adverse events or medication errors also should be reported to FDA MedWatch by submitting a MedWatch Form 3500  or by calling 1-800-FDA-1088.
—Reported by John Jereb, Krista Powell, Stefan Goldberg, M. Elsa Villarino, and Philip LoBue
Div of TB Elimination

References
1.CDC. Guidelines for a combination regimen of isoniazid and rifapentine in 12 once-weekly doses under direct observation for treating latent Mycobacterium tuberculosis infection. MMWR 2011 Dec. 9; 60 (RR–#).
2.CDC. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR 2000; 49 (RR–6).
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CDC - News from DTBE - TB Notes 4, 2011 - TB