FDA approves Priftin for children with latent TB infection

The FDA today approved rifapentine for use in combination with isoniazid for the treatment of latent tuberculosis infection in patients aged 2 years and older at high risk for progression to tuberculosis disease, according to the drug’s manufacturer.

The expanded indication of rifapentine (Priftin, Sanofi) is intended for the treatment of latent tuberculosis infection (LTBI) caused by Mycobacterium tuberculosis in patients at increased risk for TB disease. High-risk individuals include those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients or those exhibiting pulmonary fibrosis on radiograph.

“For people at high risk for progressing to active TB, treating LTBI is an important public health strategy for tuberculosis control,” Robert Belknap, MD, director of the Denver Metro Tuberculosis Control Program at Denver Public Health, said in a press release. “A study published in the New England Journal of Medicine showed that more patients completed the 12-dose, once-weekly regimen of directly observed rifapentine and isoniazid [INH] than 9 months of daily self-administered INH.”

Robert Belknap

The FDA based its approval of rifapentine in part on results of the PREVENT TB study, which compared a 12-week, once-weekly regimen of rifapentine plus INH with 9 months of self-administered daily INH. According to study results, TB disease developed in five of 3,074 randomly assigned patients in the combination group (cumulative rate, 0.16%) vs. 10 of 3,074 patients in the INH group (cumulative rate, 0.32%), for a difference in cumulative rates of 0.17% (95% CI, –0.43 to 0.09).

Eighty-one percent of patients in the combination group completed treatment compared with 68.3% in the INH group, for a difference of 12.8% (95% CI, 10.7-15).

CDC has subsequently updated its treatment guidelines for LTBI to recommend the 12-dose rifapentine-INH combination as an alternative to 9 months of daily INH. Additionally, guidelines released in October from WHO currently recommend a 12-week regimen of weekly rifapentine plus INH as a viable treatment option for LTBI.

“Today’s approval highlights the importance of public-private partnerships to address unmet public health challenges, with Sanofi working with CDC to study new opportunities to treat latent TB infection,” Paul Chew, MD, chief medical officer for Sanofi Global, said in the release. “The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century.”