SA studies have led to global use of new TB wonder drug
We were way ahead of the curve by testing bedaquiline - now, patients are four times more likely to be cured
SA doctors played an essential role in the global approval of the first new tuberculosis drug in 50 years that cures almost all multidrug-resistant TB patients.
SA trialled bedaquiline (trade name Sirturo) here from 2013, on multidrug-resistant patients who would probably have died otherwise. Data on how the patients fared and the effectiveness of the drug were shared globally.
Fears from earlier trials that bedaquiline could damage patients’ hearts have now been allayed.
The drug used before bedaquiline had a cure rate of only about 40%, took up to two years to work, and had side-effects including the risk of becoming deaf.
With bedaquiline, drug-resistant TB patients are four times likely to be cured and won’t go deaf, according to a study in the journal Lancet Respiratory Diseases. The journal said 190,000 people died from drug-resistant TB last year.
In July, the World Health Organisation (WHO) recommended the use of bedaquiline in all multidrug-resistant patients around the world and some of the data on the drug’s safety and success came straight from SA.
Nazir Ismail, of the National Institute for Communicable Diseases, said SA studies led to the use of the lifesaving drug globally.
“South Africa certainly has generated data that has been used for WHO policy making and has also been published in well-respected journals showing reductions in mortality and improvement in success rates for multidrug- and extremely drug-resistant TB.”
Last week, the drug made headlines, with international news agency AFP reporting it had cured 93% of multidrug-resistant-TB patients in Belarus and it would now be used in drug-resistant TB patients across Eastern Europe.
The results were “startling”, said the report. “Of the 181 patients given the new drug, 168 were totally cured.”
However, the drug is not as new as the story suggests.
Ismail said more than 15,000 multi- and extremely drug-resistant patients had been given this drug in SA since 2013, under strict conditions. In 2014, the Medicines Control Council approved its use in patients with extremely drug-resistant TB.
South Africa is the biggest consumer of bedaquiline, said Médecins Sans Frontières (MSF) TB doctor Anja Reuter.
From March 2013, bedaquiline was provided for compassionate use in SA. This refers to drugs that may be the last hope for the dying but have not completed all trials. It is one of the drugs that has been regulated and licensed the quickest in SA, said Reuter.
She said doctors lobbied the regulator, the Medicines Control Council, to allow use of the drug in extremely drug-resistant TB patients.
“South Africa has long been a world leader in setting policies to secure access to bedaquiline, supporting a successful clinical access programme in the same year that bedaquiline received US Food and Drug Administration approval and approving local registration in 2014,” MSF said recently.
In June, SA was the first country to announce it would use the bedaquiline for all multi drug resistant TB patients in place of on an old antibiotic called Kanamycin. This antibiotic was administered via injections and caused deafness in about 60% of patients, said Reuters.
According to Ismail’s research there are about 8,000 South African patients a year who get multi drug-resistant TB .
A month after South Africa announced the use of the drug for every drug-resistant TB case, the World Health Organisation said it should be used worldwide in all multi-drug resistant patients.
In July, Johnson & Johnson announced that it would sell the drug to South Africa for just over R4,000 for a treatment.
“South Africa has shown tremendous leadership in the fight against TB. Bedaquiline will replace injectable drugs, which are known to have severe adverse effects, including irreversible hearing loss in 40-60% of patients. This commitment spurred Johnson & Johnson to work with the government to initiate a price reduction that will enable more rapid scale-up of bedaquiline.”