Drugs Xagena
Delamanid ( Deltyba ), a nitroimidazo-oxazole derivative, is a new anti-tuberculosis ( TB ) drug which exhibits potent in vitro and in vivo antitubercular activity against drug-susceptible and -resistant strains of Mycobacterium tuberculosis. It is approved in several countries for use as part of an appropriate combination regimen in adults with multidrug-resistant tuberculosis ( MDR-TB ) when an effective treatment regimen cannot otherwise be composed due to resistance or tolerability.
In a robust phase II trial in adult patients with MDR-TB, oral Delamanid 100 mg twice daily for 2 months plus an optimized background regimen improved sputum culture conversion rates to a significantly greater extent than placebo.
In a 6-month extension study, long-term ( less or equal to 8 months ) treatment with Delamanid was associated with a higher incidence of favourable outcomes ( i.e. cured or completed all treatment ) than short-term ( less than or equal to 2 months ) treatment, with an accompanying reduction in unfavourable outcomes as defined by the WHO ( i.e. pre-specified proportion of TB-positive sputum cultures, death or treatment discontinuation for greater than or equal to 2 months without medical approval ).
Delamanid was not associated with clinically relevant drug-drug interactions, including with antiretroviral drugs and those commonly used in treating tuberculosis.
Delamanid was generally well tolerated in patients with MDR-TB, with gastrointestinal adverse events and insomnia reported most commonly.
Although the incidence of QT interval prolongation was higher with Delamanid-based therapy, it was not associated with clinical symptoms such as syncope and arrhythmia.
In conclusion, Delamanid is a useful addition to the treatment options currently available for patients with MDR-TB. ( Xagena )
Blair HA, Scott LJ, Drugs 2015;75:91-100
XagenaMedicine_2015
