Compassionate use of bedaquiline in highly drug-resistant tuberculosis patients in Mumbai, India

[摘要] ExtractBedaquiline; a mycobacterial ATP synthase inhibitor [1]; is the first new tuberculosis (TB) drug in almost 50xe2x80x85years. So far; over 800 patients have received the drug globally through compassionate use (CU) programmes. Drug-resistant TB has emerged as global public health priority [2] and TB strains are being reported with increasing levels of resistance; such as those that are multidrug resistant (MDR); extensively drug resistant (XDR) and beyond [2xe2x80x934]. India bears the burden of the largest number of MDR cases in the world [2] and alarming patterns of resistance are frequently encountered in urban hot-spots like Mumbai; including the first Indian cases resistant to all first-line drugs and second-line drugs (SLDs) [5]. Several studies around the world have shown increased treatment efficacy after addition of bedaquiline to optimised background regimens (OBRs) [6xe2x80x938]. In such settings; newer drugs like bedaquiline are urgently needed; however; accessing them has proven to be challenging in India. Of the 76 applications received from India; no more than 52 Indian patients throughout the country have received bedaquiline under the CU programme (personal communication: Janssen Pharmaceuticals; India; August 2; 2016). At the P.D. Hinduja hospital; a large private hospital in Mumbai; we have been treating patients with MDR-TB for the last two decades [9]. Between January 2013 and September 2015; 27 patients with drug-resistant TB strains were considered for bedaquiline. Applications for all 27 patients were made to the Janssen pharmaceuticals CU programme and; of these; 20 were approved and bedaquiline was administered. The resulting cohort is the largest in India to have received bedaquiline (20 patients from a countrywide total of 52). Bedaquiline was considered for patients based on the clinical judgement of the treating physician and there was no consultation with any panel of experts or TB consilium at this stage.

[学科分类] 呼吸医学