The Expert Committee noted that tuberculosis is a major cause of ill health and one of the top 10 causes of death worldwide. About a quarter of the world’s population is infected with Mycobacterium tuberculosis, with the life-time risk of developing tuberculosis disease of about 5–10% among those infected.
The Committee noted the results from Study 31 that a shorter 4-month regimen containing isoniazid, moxifloxacin, rifapentine and pyrazinamide was shown to be non-inferior to the standard 6-month regimen containing ethambutol, isoniazid, pyrazinamide and rifampin for patients with drug-susceptible tuberculosis. The Committee also noted that the 4-month regimen containing moxifloxacin and rifapentine will be included in the updated WHO guidelines for treatment of drug-susceptible tuberculosis. The Committee considered that a reduction in the length of the course of treatment from 6 months to 4 months may improve patient adherence and result in cost savings.
The Expert Committee therefore recommended the inclusion of moxifloxacin 400 mg tablets and rifapentine 150 mg and 300 mg tablets on the core list of the EML for the new indication of treatment of drug-susceptible tuberculosis in adults and children older than 12 years of age.