The World Health Organisation (WHO) has revealed a new drug to stem the global spread of multi-drug resistant (MDR) tuberculosis, but has cautioned that its use must follow a set of guidelines issued by it.
Pointing out that since information about this new drug, Delamanid, remains limited, as it has only been through Phase IIb trial [the phase specifically designed to study efficacy — how well the drug works at the prescribed dosage] and studies for safety and efficacy, the WHO has issued interim policy guidance that lists five conditions that must be in place if the new drug is used to for treatment of MDR-TB.
According to the WHO 4,80,000 people developed MDR-TB in the world in 2013 and more than half of these cases occurred in India, China and the Russian federation. Almost 84,000 patients with MDR-TB were notified to the WHO globally in 2012, up from 62,000 in 2011. The biggest increases were in India, South Africa and Ukraine.
The new drug is being described as “a novel mechanism of action” for treatment of adults with multidrug-resistant tuberculosis (MDR-TB). (MDR-TB is TB that does not respond to at least isoniazid and rifampicin, the two most powerful anti-TB drugs.)
Delamanid has been granted conditional approval by the European Medicine Agency in April 2014 and can be used for the treatment of tuberculosis resistant to at least isoniazid and rifampicin, the main first-line drugs.
The WHO has advocated “special caution” for the use of Delamanid in people aged 65 and over, in adults living with HIV, patients with diabetes, hepatic or severe renal impairment, or those who use alcohol or substances.
“When Delamanid is included in treatment, all principles on which the WHO-recommended MDR-TB treatment regimens are based must be followed, particularly the inclusion of four effective second-line drugs as well as pyrazinamide. Delamanid should not be introduced alone into a regimen in which the companion drugs are failing to show effectiveness,” the WHO has cautioned.
It has also called for effective treatment and monitoring and pharmaco-vigilance measures to be in place to ensure early detection and proper management of adverse drug reactions and potential interactions with other drugs.
