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New Bedaquiline trial shows promising results

A new weapon in the fight against tuberculosis may have been found during a trial in Belarus. The drug, named Bedaquiline, was shown to have more than a ninety percent cure rate when given in combination with other TB medicines. By comparison, current TB drugs were shown to be effective in just over half of cases.

Image ID : 83587190 Copyright : Puwadol JaturawutthichaiLike India, Belarus has a growing rate of multi drug-resistant cases of TB (MDR-TB). The global rate of MDR-TB is expected to rise considerably in the coming years, making it of the utmost importance that new treatment options are created as first line therapies become constantly less viable. Such a reduction in efficacy of first line therapies presents a dangerous situation in which disease cases surge as treatment becomes ever more difficult.

The trial involved 181 individuals. Of these, 168, or 93 percent, were cured, compared to just over half of people treated with existing drugs, according to the study results. These trials have been replicated elsewhere, but the promising early results suggest that Bedaquiline may be a key component of future treatments for TB.

What makes Bedaquiline unique is its mechanism of action, the drug selectively binds to mycobacterial ATP synthase. This allows the drug to specifically interrupt the function of TB — a mycobacterial species — within the patient. 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 used 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.

Controversy has, however, shadowed Bedaquiline since its inception. During numerous trials for the drug, it was found that more people died in the treatment group than in the placebo control group, raising questions about its safety. This increase was considerable, with 2.5 percent of the placebo group dying during the trial compared to 11.4 percent in the Bedaquiline treatment group. Assessment of the deaths pointed towards the creation of imbalances in the heart’s QT rhythm, which, when interrupted, can cause heart attacks.

The World Health Organization appear to have acknowledged this fact, recommending all those receiving the drug be monitored for the duration.

Bedaquiline was first issued in India in March of 2016 in a number of controlled doses in some hospitals. India may soon increase the scale of Bedaquiline access as USAID partnered with Johnson and Johnson are running a Bedaquiline donation programme to a number of TB affected countries. The access programme for the drug includes India, as well as bordering countries Myanmar, Bangladesh and Pakistan.


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