Bedaquiline to be used in TB treatment, but with caution

Final phase trials of drug pending; World Health Organization issues guidelines on interim use

Published on:

13 Jun 2013, 3:36 pm

Despite the lack of a Phase III clinical trial report of bedaquiline, the newly discovered drug for treatment of multidrug-resistant tuberculosis (MDR-TB), the World Health Organization (WHO) on Thursday issued an interim policy guidance notification on the use of the drug. Bedaquiline was discovered after a fifty year lull in development of drugs against TB – a period during which drug resistance of the disease made treatment difficult.

Conditions for use of bedaquiline

Treatment to be closely monitored for effectiveness and safety, using protocols approved by relevant national authorities
Proper patient inclusion; caution when used in elderly, HIV infected. Not to be administered to pregnant women and children
Patients to be made aware of potential benefits and harsm; to give documented informed consent
Adherence to WHO recommendations, particularly inclusion of four effective second-line drugs
Active pharmacovigilance to detect and manage adverse drug reactions

Lack of complete data

One of few drugs effective

Global tuberculosis report 2012

Guidelines for the programmatic management of drug-resistant tuberculosis

Lives saved by tuberculosis control and prospects for achieving the 2015 global target for reducing tuberculosis mortality

bedaquiline