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Bedaquiline and the treatment of tuberculosis

The Indian government is lagging behind in the issue of Tuberculosis (TB) treatment according to  Harvard Medical School expert, Jennifer Furin in an email interview with The Hindu. The focal point of the matter is India’s lack of access to treatment via Bedaquiline, a drug capable of treating multi-drug resistant TB (MDR-TB). Created in response to the World Health Organization’s (WHO) call in 2012 for research into anti-TB medication, bedaquiline is the first US Food and Drug Administration (FDA) approved TB medication in 40 years.

Issued in India in March of 2016, bedaquiline was introduced in a number of controlled doses in some hospitals. These pilot projects took place in Delhi, Chennai, Ahmedabad and Guwahati. India accounts for roughly 23% of the world’s TB patients and so any new medication capable of treating the disease, notorious for its rapid development of resistance to drugs, is positive news.

Months later in August it was announced that Mumbai would host the first wave of government funded bedaquiline treatment. First priority was those diagnosed with extremely drug resistant TB (XDR-TB), as bedaquiline has received a reputation as a “miracle drug”, able to effectively treat patients resistant even to drugs such as Isoniazid, which is typically utilised where other TB drugs have failed.

Despite claims in The Hindu’s article that there is a lack of effort by world organisations to provide the drug, USAID partnered with Johnson and Johnson are running a Bedaquiline donation programme to a number of TB affected countries. This access programme for the drug includes India, as well as bordering countries Myanmar, Bangladesh and Pakistan.

What makes bedaquiline unique is its mechanism of action, the drug selectively binds to the oligomeric and proteolipic subunit-c of mycobacterial ATP synthase. This allows the drug to specifically interrupt the function of mycobacterial species within the patient, in this case TB. The effect of the drug is to inhibit the function of the enzyme ATP synthase, this is a vital component for the production of ATP within the cell, without which the cell is unable to produce energy and as a result dies off.

This differing mechanism to previously utilised TB medication is what has allowed it such a degree of success in treatment, with no reported signs of resistance as of yet. The trial of the first five DR-TB patients treated in India showed overwhelmingly positive results, with all five patients showing a significant improvement of symptoms with no adverse effects.

It brings into question why, if this drug shows such positive results, is it not more readily available? This is the situation both in India as well as globally. The drug has not been extensively tested yet, and during initial clinical trials it was revealed the risk of death is increased upon taking the drug from 2.5 percent (placebo) to 11.4 percent. In a scientific study this would be considered a significant rise, and this is what has led to bedaquiline only being administered to patients with XDR-TB.

The rise in fatalities associated with the medication has been linked to issues with the heart’s electrical activity, causing prolongation of the QT interval. This leads to abnormal heart rhythms that can potentially cause to complications resulting in fatality.

The article in The Hindu downplays this concern of the risk of the fatalities associated with the clinical trials of bedaquiline, which are even noted under guidance from the WHO. What is noted is that the government opposes more extensive usage due to the potential development of antibiotic resistance to the drug, which is a valid concern, as it has rendered many previously used medications useless in thousands of cases. While their case that not utilising a drug to prevent it being less effective in the future is valid, the reasoning for bedaquiline only being issued in XDR-TB still lingers. Fatality is a side effect many would not like to risk.

This argument for the more extensive use of bedaquiline presents valid issues on both sides. By not using the drug, many more will lose their lives to tuberculosis, in using it extensively, the related death due to abnormal heart rhythm may become a more frequent occurrence. The restriction on the medication by the Indian government is being taken to the New Delhi courts. The government has indicated it wishes to expend the drugs usage, though this court case may force them to play their hand at a faster rate.

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