World first for SA: All-access for blockbuster TB drug

World first for SA: All-access for blockbuster TB drugBedaquiline is one of a handful of new TB drugs used to treat drug-resistant strains. Pediatric TB patient. (Credit: The Global Fund to Fight AIDS, TB and Malaria)

South Africa made history on Monday when the health department announced that all drug-resistant tuberculosis (DR-TB) patients will be eligible to receive the new medicine, bedaquiline, becoming the first country to do so.

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“The Department of Health’s [DoH] commitment on bedaquiline is momentous globally and marks a new era of DR-TB management where we are really prioritising the patient,” Doctors Without Borders’ Dr Anja Reuter told Health-e News.

Up until recently treating patients with DR-TB has been “difficult, with old medicines used, which had many negative side effects and over long periods – often up to 24 months”, noted the DoH in a press statement on Monday afternoon.

Even if patients take their full course of toxic medicines they have little chance of being cured and risk long-term disability, including permanent deafness.

In 2012, before bedaquiline, fewer than one in five (19 percent) South African patients with extensively drug-resistant TB (XDR-TB) were cured, according to the DoH’s Dr Norbert Ndjeka.

Bedaquiline boosts cure rate

He said new government data showed that, by 2015, after all XDR-TB patients became eligible for the drug, the portion of patients who completed treatment successfully shot up to 51 percent.

According to this data, cure rates for XDR-TB patients taking bedaquiline are as high as 80 percent in some areas.

Two thirds of all DR-TB patients in the world who are being treated with bedaquiline are in South Africa.

The World Health Organisation (WHO) recommends the drug, manufactured by Johnson & Johnson, for all XDR-TB patients, but it does not yet do the same for people with multi-drug resistant TB (MDR-TB).

MDR-TB is resistant to two of the most common anti-TB drugs and XDR-TB is resistant to four – leaving very few effective drugs available.

Reducing death and disability

For the first time, no patient will have to receive the injectable drugs that cause hearing loss in up to 60 percent of users, as they will be completely replaced by bedaquiline.

“It will have a huge impact in terms of decreasing disability,” said Reuter. “Deafness for a child, for example, can prevent the development of speech and lead to social isolation and bullying.”

In an open letter to health minister Dr Aaron Motsoaledi local organisation TB Proof wrote: “We are ecstatic that no South African with this terrible disease will have to ‘choose’ between their hearing or their life again.”

And, according to Reuter, the country’s “bold” move may influence the WHO to shift its current “conservative” stance and revise its guidelines in line with our own.

In addition to announcing an all-access policy towards bedaquiline the DoH said that it would be cutting the DR-TB treatment duration to just nine months – in line with new and ongoing research.

“This is an evidence-based decision. This is a person-centred decision. It is visionary and courageous and marks a fundamental shift in how leaders and policy makers engage with people who have TB,” wrote TB Proof.

An edited version of this story was published by Health24.com