21st June, Johannesburg – The Treatment Action Campaign (TAC) salutes the announcement by the Department of Health this week that a new medicine will become part of the standard treatment for people with multi-drug resistant tuberculosis (MDR-TB) in South Africa. The medicine, bedaquiline, will replace an injectable medicine that is extremely painful, toxic and associated with very serious side effects such as deafness.
“We salute the Department of Health’s revolutionary decision to be the first country in the world to change its guidelines on MDR-TB treatment,” said Sibongile Tshabalala, TAC National Chairperson. “The World Health Organization has been dragging its feet in amending their own guidelines. Something TAC and other activists globally have been calling out. While our own government could have dug its heels in and waited for the WHO mandate, instead they considered the available evidence and the seriousness of the side effects of existing medicines and came to this conclusion. Their bold decision will both save lives and prevent many people from suffering irreversible hearing loss. TAC will be monitoring the rollout of bedaquiline in the public health system. We also stand in solidarity with our comrades around the world and urge the WHO and more governments to urgently change their own guidelines.”
Bedaquiline is one of only two new medicines approved to treat MDR-TB in the last 50 years. While phase III trials (STREAM stage I) are still in progress, bedaquiline appears to be much safer than any of the injectable medicines currently used. Findings reported this week from the Department of Health also show that people taking bedaquiline are much more likely to be cured of MDR-TB than those taking older medicines. A cohort analysis showed that the use of bedaquiline lead to a 41% increase in treatment success and three times less people died than with any other regimens that did not contain bedaquiline. While bedaquiline has already been provided in South Africa, to date this was only in cases where the standard treatment regimen failed or where other clinical challenges were experienced.
While the Department’s announcement is an important step forward, barriers to accessing bedaquiline remain. In South Africa the cost of bedaquiline in the public sector remains considerable at ZAR 9 950 per treatment course. This while researchers from the University of Liverpool have calculated that if bedaquiline was widely used and produced at economies of scale, it could be produced and sold at a profit at a price of around ZAR 1 338 (US$ 98) per treatment course. With over 19,000 people reportedly getting MDR-TB a year in South Africa alone, price reductions will be critical to ensure widespread scale up.
“In order to ensure that the South African government, and others across the world, are able to afford bedaquiline for everyone who needs it, we demand that pharmaceutical company Janssen urgently drop the price. We cannot allow the suffering, misery, and death associated with these toxic injections to continue when superior alternatives are available.”
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The Global TB Community Advisory Board (TB CAB) and various other organisations and individuals have previously argued in favour of replacing the injectables with bedaquiline. In February 2018, the Global TB CAB and over 30 other organisations wrote a letter to the World Health Organization (WHO) urging it “to recommend bedaquiline as part of the preferred regimen for MDR-TB and to relegate the injectables for use only in more complicated cases, and with absolute requirement and assurance of monitoring for hearing loss.” That letter and an accompanying position paper can be read here: http://www.tbonline.info/media/uploads/documents/letter_to_who_re_mdr_guideline s_final_2.1.18.pdf