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Battle for Bedaquiline
Jan 11, 2017

Why in news:

An 18-year-old girl has taken the Indian government to court after being refused access to blockbuster tuberculosis drug bedaquiline. The girl has extensively drug-resistant tuberculosis or XDR TB

What is the issue:

She has been denied treatment with Bedaquiline, the last form of medication that could save her life, simply because she is not a domicile of Delhi. She is resistant to all the available drugs available for TB so far.

What is Bedaquiline and USES:

  • Bedaquiline is a bactericidal drug which belongs to a new class of antibiotics (diarylquinolines). 
  • Although the drug is active against many different bacteria, it has been registered specifically for the treatment of MDR-TB
  • The drug is unique among the anti-tuberculosis drugs currently used in that it interferes with the function of an enzyme required by the tuberculosis bacterium to produce energy and to replicate. 
  • The drug has been tested for the treatment of MDR-TB in addition to conventional treatment regimens including several drugs.

Bedaquiline should not be used for the treatment of:

  • Latent infections due to Mycobacterium tuberculosis
  • Drug sensitive tuberculosis
  • Extrapulmonary tuberculosis
  • Infections caused by non tuberculosis mycobacteria.

The safety and efficacy of bedaquiline in the treatment of HIV positive patients with MDR-TB has not yet been established.

How it works:

Should be used cautiously

The drug was prepared in response to the World Health Organization’s call in 2012 to work on anti TB medication. While trials in Africa have shown promising results, experts admit that not much research has been undertaken now on anti-microbials of any type

Significance of this drug:

The last time a drug was introduced specifically for the treatment of TB was in the late 1960s. That drug was rifampicin. Since then, resistance to rifampicin has been increasingly reported in the world. This is a major concern given that it remains among the most effective anti-TB drugs available today. 

Bedaquiline and India:

  • The drug Bedaquiline was incorporated into the Revised National Tuberculosis Control Programme in February 2016 
  • It is given at six hospitals in five cities – Delhi, Mumbai, Chennai, Ahmedabad, and Guwahati
  • How this drug can be accessed:Citing compassionate use, a doctor can get the medicine free-of-cost from a drug manufacturer, provided the doctor has convincing evidence that the patients will die without the medicine. This is a commonly-used method of accessing Bedaquline.

Criticism of Government’s strategy to roll out Bedaquiline

The severe restrictions the Indian government has placed on BDQ — with officials saying it should only be used for the worst, most resistant cases — actually increase the chance of generating BDQ resistance. Data from South Africa show that the sooner a person is offered access to BDQ, the better the outcome for the individual patient and for the community. When the drug is saved as a last resort only for the most resistant patients, those patients are usually very ill with severe lung damage and exposure to multiple drugs, and BDQ is less likely to be helpful and resistance is more likely to develop in those cases. So early access to BDQ for persons who need it is the ideal way to decrease the development of resistance, and patients should be given all the help and support they need to successfully complete treatment.

There have been cases of persons travelling to India and becoming infected and sick with MDR-TB, so India’s refusal to scale up BDQ is really the world’s problem.

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