A pilot programme to test the toxicity, particularly cardio-toxicity, of bedaquiline drug (used for combating multidrug-drug resistant TB) in the Indian population, assess its ability to achieve culture conversion and check the operational feasibility of using the drug to treat MDR-TB patients would start in India by the end of this month or on World TB day.
Six hundred MDR-TB patients would 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 patients who are resistant to both rifampicin and isoniazid, the first-line TB drugs, will be enrolled in the programme.
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 the patients in addition to 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 in any of the institutions on a first come first served basis.
The pilot implementation was supposed to have been launched on January 29 and then later pushed to February 4. Enrolment of 600 MDR-TB patients is expected to take time as second-line drug susceptibility testing has to be first carried out in those willing to participate and their informed consent has to be taken. The toxicity of the drug may delay the enrolment, a senior official told The Hindu.
Phase III trials using this drug have not been completed yet and based on Phase IIb trials done outside India, the drug was found to disturb the functioning of the heart (cause abnormal and potentially fatal heart rhythm) and cause adverse drug reactions in the liver. Most importantly, unexplained increase in mortality was reported during the trials.