Medical experts push for use of unregistered TB drug

Pressure is mounting on the South African government to allow doctors to use a promising but not yet registered antibiotic to treat extensively drug-resistant tuberculosis.

The drug, known as Bedaquiline, forms part of a new generation of highly active antibiotics.

It has been shown, in several local and international clinical trials, to be a cure for drug-resistant TB.

However, it is not yet available in the market for general use because it still has to undergo confirmatory trials.

Confirmatory trials can take up to three years to complete. There is no indication as to when the Bedaquiline confirmatory trials will begin.

Due to the uncertainty, medical experts, including the president of the Southern African HIV Clinicians Society, Dr Francesca Conradie, and world-renowned epidemiologist Dr Quarraisha Abdool Karim wrote an open letter to Health Minister Aaron Motsoaledi and Medicines Control Council registrar Mandisa Hela urging them to expedite access to Bedaquiline through “compassionate use”.

Compassionate use is considered in cases where a patient has XDR-TB and the existing treatment options are failing to cure him.

Conradie and Abdool Karim, together with the Global Tuberculosis Community Advisory Board (TB CAB), argued that, “patients are dying because the current drug-resistant TB treatments are failing to cure XDR-TB except in a select few cases”.

XDR-TB is a potentially deadly and the most difficult TB strain to treat. It kills at least 40% of the people who are infected with it every year in the country.

In 2010, there were 741 recorded cases of the disease in South Africa.

This meant that about 297 of those patients died because the treatment was not effective.

Dr David Mametja, the health department’s chief director for TB control and management, acknowledged that limited XDR-TB treatment options meant that a high number of people died because of this infectious disease.

However, he said: “The MCC can not allow Bedaquiline to be used in an uncontrolled manner.”

“Bedaquiline has shown positive outcomes and we are all hoping that it would be the answer to drug-resistant TB but it is still under research. We are in discussion with the MCC to explore the possibility of compassionate use and even then the risks and benefits will have to be weighed,” Mametja said.

Dr Iqbal Master, a leading drug-resistant TB expert based at the King George V Hospital in Durban agreed with Mametja that all parties needed to be careful going forward.

But, he said: “While we wait for more trials to be conducted on the efficacy of Bedaquiline it would be good to offer it to some patients that meet the compassionate use criteria.”
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