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FDA Expands Labeling for Rifapentine (Priftin) to Include Latent TB

Drug previously approved only for active disease

Following a priority review, the FDA has approved rifapentine (Priftin, Sanofi) in combination with isoniazid for a new indication for the treatment of latent tuberculosis infection (LTBI) in patients 2 years of age and older at high risk of progression to TB disease.

Rifapentine is an antimycobacterial agent that has been approved since 1998 for use in combination with one or more anti-TB drugs for the treatment of active pulmonary TB caused by Mycobacterium tuberculosis.

A person with LTBI is infected with the bacteria that cause TB but does not feel sick or have symptoms and cannot spread the bacteria to others. More than 11 million people in the U.S. have LTBI, and approximately 5% to 10% of those individuals –– more than 1 million people –– will develop TB disease if not treated. The treatment of LTBI in patients at risk of progression greatly reduces the risk that TB infection will progress to TB disease.

The new approval for rifapentine was partly based on results from the PREVENT TB study conducted by the Centers for Disease Control and Prevention’s (CDC’s) Tuberculosis Trials Consortium and published in the New England Journal of Medicine in 2011.

The PREVENT TB trial compared a 12-week, once-weekly regimen of rifapentine plus isoniazid with 9 months of self-administered daily isoniazid alone. TB disease developed in five of 3,074 patients randomly assigned to the rifapentine/isoniazid group (cumulative rate, 0.16%) compared with 10 of 3,074 patients in the isoniazid group (cumulative rate, 0.32%), for a difference of 0.17%. The proportions of patients completing treatment were 81.2% in the rifapentine/isoniazid group and 68.3% in the isoniazid group, for a difference of 12.8%.

After this trial, the CDC updated its treatment guidelines for LTBI to recommend the 12-dose rifapentine/isoniazid combination as an equal alternative to 9 months of daily isoniazid. In addition, World Health Organization guidelines on the management of LTBI released in October 2014 recommend a 12-week regimen of weekly rifapentine plus isoniazid as a treatment option.

Rifapentine (Priftin) is now indicated for use in the following populations:

  • Adults and children 12 years of age and older for the treatment of active pulmonary TB caused by M. tuberculosis
  • Adults and children 2 years of age and older for the treatment of LTBI caused by M. tuberculosis in patients at high risk of progression to TB disease (including those in close contact with active TB patients; persons with a recent conversion to a positive tuberculin skin test; human immunodeficiency virus (HIV)-infected patients; or those with pulmonary fibrosis on radiographs)

Rifapentine must always be used in combination with isoniazid as a 12-week, once-weekly regimen for the treatment of LTBI.

Source: Sanofi; December 2, 2014.

 

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