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 M. tuberculosis, with the lifetime risk of developing active disease of about 5–10% among those infected.
The Committee considered that tuberculosis preventive treatment reduces the risk of progression from tuberculosis infection to tuberculosis disease by about 60% but can be as high as 90% among certain high-risk groups. Systematic tuberculosis preventive treatment is currently recommended by WHO for target populations at high risk. Furthermore, with the commitments from governments and donors, the availability of shorter regimens is expected to facilitate uptake of tuberculosis preventive treatment.
The Committee noted that WHO recommends tuberculosis preventive treatment regimens including rifapentine in combination with isoniazid as a weekly dose for 3 months (3HP) or a daily regimen for 1 month (1HP). The Committee noted that both rifapentine and isoniazid as single agents have been included as antituberculosis medicines on the core list of the EML for several years and that the effectiveness and potential harms of the two medicines are expected to be similar for the single-pill formulations and the fixed-dose combination.
Therefore, the availability of rifapentine and isoniazid in a fixed-dose combination tablet would reduce the pill burden substantially and improve adherence to treatment. This fixed-dose combination should be primarily used in the 3HP regimen for individuals older than 14 years, but it may also be used for younger children able to swallow the dosage form. Individuals on shorter regimens were shown to be 1.5–3 times more likely to complete treatment, which is beneficial as it is important to maximize its effectiveness in preventing active tuberculosis.
The Committee noted that countries have access to different formulations (in terms of registration, affordability and supply) and adding options may increase availability and the pool of suppliers.
The Expert Committee therefore recommended adding the fixed-dose combination of isoniazid and rifapentine to the core list of the EML and EMLc for tuberculosis preventive treatment for use in line with dosing recommendations in WHO guidelines.