Primary efficacy endpoints in phase 3 non-inferiority trials to establish new tuberculosis treatment regimens should only include microbiological outcomes

Treatment regimens for tuberculosis remain protracted and burdensome, both for patients to adhere to and for health-care providers to administer. Particularly, many current regimens for drug-resistant tuberculosis are poorly tolerated by patients and carry an unacceptable side-effect profile. The rapid emergence of bedaquiline resistance necessitates treatment regimens that are active against resistant strains, regimens with a high genetic barrier to acquired resistance, and regimens containing antimicrobials for which near-patient drug-susceptibility testing is available. A pressing need therefore exists to develop and evaluate novel tuberculosis treatment regimens.