India: More Cases of Antibiotic Resistance Tuberculosis

Of the 40 000 tuberculosis (TB) cases recorded in the city [Mumbai, Maharashtra state] in 2013, more than 4000 patients were relapse cases, according to civic health department data. The count of relapse cases has remained constant over the last few years -- an indicator of the poor living conditions and of the hurdles in the treatment regime followed in public hospitals. According to estimates, the actual count of relapse cases may be higher, as not all private hospitals are accounted for by the civic health department.

Over the last 3 years, the count of multi drug resistant (MDR) and extensively drug resistant (XDR) TB cases has noticeably increased. From 181 new patients diagnosed with MDR TB and 288 already receiving treatment for it in 2011, the figure rose to 2195 new patients diagnosed with MDR TB and 1935 on treatment in 2012. In 2013, a whopping 2903 patients were diagnosed with MDR TB and 2604 were on treatment.

Dr Minnie Khetarpal, BMC's TB control officer, said, "Though MDR cases are rising, patients receive 2nd-line treatment. But in XDR cases, patients respond to very few drugs. Currently, Bedaquilin is considered a wonder drug, but is under clinical trials in India." The drug, which has been used on 5 patients in Mumbai, is being imported from Belgium.

Bedaquiline was described for the first time in 2004  One of the first published trials of Bedaquiline was a Phase II trial of 47 patients, which showed that the drug was effective in reducing the time to TB-free sputum cultures

It is manufactured by Johnson & Johnson (J&J), who sought accelerated approval of the drug, a type of temporary approval for diseases lacking other viable treatment options. By gaining approval for a drug that treats a neglected disease, J&J is now able to request expedited FDA review of a future drug

It was formally approved for use by the U.S. Food and Drug Administration (FDA) for use in tuberculosis (TB) treatment, as part of a fast-track approval for use only in cases of multidrug-resistant tuberculosis, and the more resistant extensively drug resistant tuberculosis.

There is some controversy over the approval for the drug, as the FDA's ruling was based on a surrogate outcome (sputum cultures) as opposed to patient deaths. In the clinical trials used for approval, the patients taking bedaquiline were more likely to die, even though they had resolution of TB based on sputum cultures. The most common side effects of bedaquiline in studies were nausea, joint and chest pain, and headache. The drug also has a black-box warning for arrhythmias.