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WHO has released guidelines for use of a new medicine to treat multi-drug resistant tuberculosis (MDR-TB) (see box). Issued on June 13, the interim policy guidance provides advice on including bedaquiline in combination therapy for
Bedaquiline is the first MDR-TB drug for adults to be approved in 50 years. All drugs get registered only after Phase-III trials carried out on humans. But bedaquiline was granted accelerated approval by the US Food and Drug Administration (FDA) in December 2012 only after two Phase-II trials owing to an urgent need for a treatment for drugresistant tuberculosis. Waiting for Phase-III trial could have kept the drug from being released in the market until 2022, says a document by the Global TB Community Advisory Board of New York-based Treatment Action Group.
The FDA approval allows for Janssen pharmaceuticals (a subsidiary of Johnson and Johnson) to market the drug in the US while carrying out Phase- III trials to confirm its efficacy and safety. WHO strongly recommends acceleration of the trials to generate a more comprehensive evidence to inform future policy on bedaquiline.
The newly issued guidelines highlight an urgent need for the medicine in a country like India. Every year, 1,800,000 Indians develop the disease and until recently 1,000 people died of TB every day, according to TBC India, the official website of Directorate General of Health Services. Over 3 per cent of new cases and 20 per cent patients previously treated for TB develop multi-drug resistant tuberculosis. MDR-TB refers to tuberculosis resistant to isoniazid and rifampicin, the most powerful first-line drugs for the disease. India, China, Russia and South Africa have almost 60 per cent of the world’s total MDR-TB cases.
Despite the dismal statistics, bedaquiline is yet to be registered in India. Johnson and Johnson spokesperson informs the firm has already made a regulatory submission for bedaquiline to Drug Controller General of India in May. But no initiative in this regard has been taken as yet by the policy makers.
Resistance risk
At present, the government follows Direct Observed Therapy (DOT) to treat TB. However, the medicines are available over the counter too. The treatment relies on antibiotics developed long time back. Several of these drugs have severe side effects like nausea, deafness and psychosis. Patients receive painful injections for six months and have to take up to 17 pills a day for two years. Health experts demand bedaquiline be brought to the country urgently and a proper mechanism be developed for its distribution to avoid indiscriminate antibiotic use, which fuels drug resistance.
While applying for WHO guidelines, Johnson and Johnson has also requested the medicine be distributed only through DOT to ensure close monitoring.
Blessina Kumar, vice-chairperson of Stop TB partnership, a group of 1,000 organisations across the world engaged in advocacy to eliminate TB, says she had written to health officials last month demanding a strong mechanism for bedaquiline distribution. “My fear is that lack of planning and strategy will land us in a situation that we all dread—of resistance to bedaquiline. We have been requesting for a programme to develop guidelines for new drugs, specifically bedaquiline,” reads the letter. She wrote it after reading media reports about how a few doctors have already started prescribing bedaquiline to patients.
Soumya Swaminathan, director of the Chennai-based National Institute for Research in Tuberculosis, says India also needs to develop its own protocol to identify patients who really need the new medicine. “We need to identify the centres from where the medicine will be distributed and tightly monitor this system,” she says.
Leena Menghaney, India campaign manager of Médecins Sans Frontières’ (MSF) Access Campaign, agrees. “The government must ensure MDR-TB patients can access new TB drugs, like Bedaquiline, free of charge. Simultaneously, other formalities should be completed like registration and Phase-III trial in India,” says Menghaney.
MSF, in a statement, says it is equally worried about indiscriminate use of TB drugs in the private sector and poor management of TB treatment. This in the past has fuelled drug resistance in the country and is making MDR-TB a serious public health challenge.