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No. 1, 2013

State and National TB Programs Collaborate to Assess Implementation of 12-dose Weekly Isoniazid and Rifapentine

Results of a clinical trial for latent tuberculosis infection (LTBI) therapy released at the end of 2011 showed the effectiveness of a 12-dose regimen of weekly isoniazid (INH) and rifapentine (RPT) to be equal to the standard 9 month regimen of daily isoniazid. While effectiveness between regimens was similar, the completion rate for those using the directly observed INH-RPT was much higher than those using self-administered INH. CDC recommendations were released shortly thereafter, offering this regimen as an equal alternative for persons age 12 years and older, not pregnant, or not HIV-infected on antiretroviral therapy.

Participating Sites

New York State HD

Georgia State HD

Kane County HD, Illinois

Bureau of Prisons

Oregon State HD

Virginia State HD

Columbus Ohio HD

Mississippi State HD

Arkansas State HD

South Carolina State HD

North Dakota State HD

New Mexico State HD

Kansas State HD

Nevada State HD

King County, Washington HD

California State HD

Wisconsin State HD

Tennessee State HD

Pima County Arizona HD

Hennepin Co., Minnesota HD

Hawaii State HD

Connecticut State HD

A short, easily tolerated regimen for treating LTBI could provide a game changer for TB control programs, allowing effective treatment of people with LTBI who might otherwise not finish a 9 month course of treatment. However, along with hope and enthusiasm for this new regimen comes caution gained from the previous experience of a short-course regimen using 2 months of rifampin and pyrazinamide. The prior recommendation was reversed when higher rates of hepatotoxicity, sometimes leading to liver transplant or death, became evident.

CDC’s DTBE is partnering with TB programs across the country in order to closely monitor the safety of this new 12-dose regimen and to determine completion rates under program conditions. The enhanced surveillance will allow CDC and programs to respond quickly and appropriately if serious adverse events do occur. Sites participating in the post-marketing surveillance project are those that plan on using the regimen and that can monitor patients for symptoms at each dose and report any adverse events to CDC quickly. In addition, the surveillance will capture completion rates, as well as rates of discontinuation due to adverse events, and whether these are associated with particular settings, demographics, or medical risk factors.

Twenty-one state or local health programs are participating in the CDC project; the Bureau of Prisons is collaborating as well. Newly arrived refugees and immigrants; contacts in homeless, outbreak, or incarcerated settings; health care workers with new TB test conversions; and foreign born college students represent some of the people who are being treated for LTBI using the new 12 dose regimen. The sites estimate that 4,000 patients will be started on this new regimen before the end of 2013. To date, 17 of the sites and the Bureau of Prisons have started using the regimen and share experiences with each other through monthly calls. As of October 2012, a total of 1,102 patients had started the treatment, 63 stopped due to symptomatic adverse events, and 8 patients were hospitalized while taking INH-RPT. No deaths were reported. These preliminary findings were shared at the 2012 World Lung Conference in Kuala Lumpur, Malaysia.

Reported by Christine S. Ho, MD, MPH
Div of TB Elimination

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