In March 2014, the South African Department of Health in partnership with nongovernmental organisations like Right to Care and Medicines Sans Frontières (MSF) began a programme to treat a small number of extensively drug-resistant (XDR-TB) patients with the first new TB drug in 40 years, bedaquiline.
XDR-TB is resistant to both of the most common anti-TB drugs as well as at least half of the mostly commonly used second-line drugs. It is also deadly. Only about 20 percent of South Africa’s XDR-TB patients are ever cured.
Initially launched at four sites in Klerksdorp, Edenvale, Khayelitsha and Durban, the programme is collecting safety and efficacy data to motivate for Medicines Control Council (MCC) registration of the drug for use in South Africa.
As part of the programme, more XDR-TB patients on bedaquiline are getting better and faster, according to early results from about 4o patients enrolled in the programme presented yesterday at the South African TB Conference. Within two months, almost 60 percent of patients did not show signs of XDR-TB when they provided samples for culture. This is also termed as “culture conversion.”
This rate jumped to about 75 percent at three months of treatment.
Dr Norbert Ndjeka, heads the department’s division on HIV, TB and drug-resistant TB. He says although early and confined to a small number of patients, the results have convinced him and Department of Health management that the country is on the right track to provide the drug to more patients – pending more data and MCC approval.
“These patients would not have converted on our standard treatment regimens,” Ndjeka told Health-e News. “We are saving lives.”
The country is also likely to introduce the new multidrug-resistant (MDR-TB) treatment, delamanid following World Health Organisation guidance expected in the next six months, Ndjeka added.
Lack of dual access to bedaquiline, linezolid “a tragedy”
Ndjeka admitted however that most patients in the bedaquiline programme are also receiving the drug linezolid, which currently costs more than R700 per daily pill because the MCC has yet to register a generic for use in the country.
MSF purchases generic linezolid internationally for about R80 per pill and the humanitarian organisation launched a March 2014 MCC appeal for compassionate access to a generic.
As of early June, no panel had been established to hear the appeal.
Southern African HIV Clinicians Society President Dr Francesca Conradie works with Right to Care on the programme. She says that for justice to be done, all patients receiving bedaquiline must have access to an affordable version of linezolid.
“This isn’t a clinical trial but the combination of drugs seems to work in a pragmatic way,” Conradie told Health-e News. “There were two patients who were not also given linezolid not because there was a counter-indication, but because there was not funding in their provinces to support that.”
“To me, that is a tragedy,” she added. “In terms of justice and equity, this is the best treatment available and it is my opinion that everyone should be afforded access to these drugs.” – Health-e News Service.
An edited version of this story was first published in 12 June edition of The Mercury.