shobha shukla, citizen news service - cns hope for shorter and more effective new tb drugs license dmca multidrug-resistant tb (mdr-tb) remains a public health crisis. as per who's global tb report 2016, 480,000 people fell ill with mdr-tb in 2015, with 3 countries - india, china, and russia - carrying the major burden and together accounting for nearly half of all mdr-tb cases globally. detection and treatment gaps continue to plague the mdr-tb response. in 2015, only 1 out of every 5 people needing treatment for mdr-tb were able to access it and only 52% of those who started mdr-tb treatment were cured. "these sobering statistics remind us of our urgency to continue the fight to develop better, faster and affordable treatments that will finally bring this pandemic under control," said dr mel spigelman, ceo of tb alliance, which is working to advance several promising regimens to tackle all forms of tb. the current mdr-tb regimen lasts for 2 years or more. it includes medicines and injectables that are not only toxic but also come at a cost that is higher than what many patients and healthcare systems can afford. even the new 9 month mdr-tb regimen that has recently been endorsed by who, though shorter, does include 4 months of injectables. however new results from 2 clinical studies conducted by tb alliance point to an emerging paradigm, where countries may soon have the short, all-oral, and affordable drug regimens needed to treat all people with tb. late stage clinical results from these two studies were unveiled yesterday at the 47th union world conference on lung health in liverpool. the nc-005 study - advertisement - the nc-005 study investigates an oral, injection free regimen that purports to treat both drug-sensitive and mdr-tb with a short, simple, safe, and affordable treatment. a phase 2b, 2 month study tested various combinations of bpamz--bedaquiline (b), pretomanid (pa), moxifloxacin (m) and pyrazinamide (z). it was conducted at 10 sites in 3 countries (uganda, south africa, and tanzania). a total of 240 patients were enrolled in the study-- 180 patients with drug-sensitive tb received bpaz and 60 patients with mdr-tb received bpamz. the study also investigated a simpler dosing scheme for bedaquiline, which could lead to fewer pills and an overall less complicated treatment for patients. nc-005 showed that the best regimen was a combination of all four drugs, bpamz, which was examined in an arm of the trial. data showed that at the end of 2 months, clinical study participants receiving bpamz cleared tb bacteria from their sputum 3 times as quickly as those on the standard treatment regimen. almost all participants had culture conversion after the 2 months of treatment. this is the fastest rate of culture conversion that has ever been seen and indicates the potential of bpamz to treat all forms of tb-drug-sensitive as well as mdr-tb with the same regimen. the regimens appeared safe. the study showed that it was possible to simplify the dosing of bedaquiline and found that a daily dose of bedaquiline (200 mg) is at least as active and safe as the labelled dose. this will allow for simpler daily dosing with the regimen and to be combined in a fixed dose combination. the bpamz regimen is being tested to see if it can cure the vast majority of tb patients in as less as 3 months. if successful, the regimen could reshape the treatment landscape of tb, especially for people with mdr-tb, who currently face an arduous 9-24 month treatment journey that is too often unsuccessful. the results of nc-005 could pave the way to a global phase 3 trial. the nix-tb study ('nix' means to put an end to) - advertisement - it is estimated that 9% of all the mdr-tb patients suffer from extensively drug-resistant tb (xdr-tb) that is resistant to at least four commonly used anti-tb drugs. xdr-tb is often considered a death sentence. most xdr-tb is not treated at all because of the cost and complexity of the treatment. of those who do receive treatment, less than one third get cured. in may 2015, tb alliance and partners launched the world's first clinical study-- the nix-tb study-to test a new xdr-tb drug regimen called bpal, consisting of bedaquiline (b), pretomanid (pa), and linezolid (l) in patients who have no other treatment options. it is the first study to test an all-oral drug regimen, comprised of drugs with minimal pre-existing resistance, that has the potential to shorten, simplify, and improve treatment for xdr-tb. nix-tb is an open-label study that is being conducted at 2 sites in south africa--at sizwe hospital in johannesburg and at brooklyn chest hospital in cape town. additional sites to expand the study are planned. patients who have xdr-tb, or have failed their current mdr-tb treatment or who have side effects of their current mdr-tb treatment, are enrolled.till to date, 50 patients have been enrolled in the study, including patients as young as 14 and those who are co-infected with hiv with a cd4 cell count of 50 or higher.
transforming hope into reality for patients of drug-resistant tb
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