A pilot programme to test the toxicity, particularly cardio-toxicity, of bedaquiline drug (for combating multidrug- resistant TB) in the Indian population, to assess its ability to achieve culture conversion and to check the feasibility of using the drug to treat MDR-TB patients will start in India by the end of this month or on World TB Day.
Six hundred MDR-TB patients will be enrolled in six institutions — two in Delhi and one each in Mumbai, Ahmedabad, Guwahati, and Chennai — to study the suitability of the drug for the Indian population. Only those resistant to both rifampicin and isoniazid, the first-line TB drugs, will be enrolled.
In its interim guidance, the World Health Organisation (WHO) had laid special emphasis on closely monitoring the response to treatment and informing the patients of the benefits and possible harms of the drug.
The pilot programme would last for six months. As per the WHO’s recommendation, bedaquiline will be given to patients, besides the regular multidrug treatment regimen. Unlike clinical trials, the six institutions will not enrol a certain number of patients each. Instead, patients willing to participate in the programme will be enrolled on a first come, first served basis. The pilot programme was to have been launched on January 29 and then pushed to February 4.
