Stop TB Partnership

South Africa: the country where political leadership serves the people

In an unprecedented and historic move, the South African Department of Health decided to recommend including bedaquiline as the standard treatment for people with drug-resistant (DR-TB). The country also released data showing that treatment regimens including bedaquiline reduced deaths three-fold compared with those without bedaquiline.

20 June 2018, Geneva Switzerland - The Department of Health of South Africa extended access to bedaquiline to all people living with DR-TB, including those with multidrug-resistant TB (MDR-TB) who will now receive the treatment as part of a more accessible short treatment, marking a significant shift in how the country’s political leadership engages with people who have TB. The injections, which are used around the world to treat people with MDR-TB, cause hearing loss in as many as 50 percent of people with MDR-TB.

For the first time, an injection-free* treatment will be made available to all people with DR-TB. The injections, which are unfortunately still used around the world to treat people with MDR-TB, cause hearing loss in as many as 50 percent of people with MDR-TB. Following this decision, bedaquiline will be made available to those suffering from resistance to the strongest anti-TB medicine, rifampicin, whereas it was previously only given to those with extensively drug-resistant TB or with limited treatment options.

"South Africa will now make bedaquiline available to all eligible DR-TB patients, and for the first time in history, an injection-free treatment will be made available to all people with DR-TB. Additionally, those with MDR-TB will also receive this effective medicine as part of the nine months short treatment, which is expected to improve adherence further and ensure even successful outcomes," said H.E. Dr. Aaron Motsoaledi, South African Minister of Health and Stop TB Partnership Board Chair.

The ground-breaking decision to replace the use of injectable treatment for TB is a clear sign that South Africa’s political leadership is putting the interests and rights of people with TB in the center of the country’s health policies. Bedaquiline will replace the injectable medicines that currently form part of the country’s standard treatment. The injectables are associated with a number of severe side effects, including irreversible hearing loss. South Africa released data that demonstrated that introduction of bedaquiline to the treatment played a part in a significant increase of DR-TB treatment successes and reduced deaths. Bedaquiline in combination with existing TB drugs provides new hope for people living with MDR-TB with very few treatment options.

The South African Department of Health stated that a retrospective cohort analysis of records of all people living with DR-TB receiving treatment inclusive of bedaquiline were associated with a 41% increase in treatment success and a three-fold reduction in deaths compared with those that did not receive the medication.

The Executive Director of the Stop TB Partnership praised South Africa for the "game-changing decision. South Africa contributes to the body of evidence that introduction of Bedaquiline is a critical component of a successful DR-TB treatment," she added. "As we head full speed towards the UN High-Level Meeting on TB in September, South Africa is showing the way all countries must take if we truly want the end of this devastating epidemic. I call on President Ramaphosa to be with us in New York and challenge other country leaders to take bold steps towards ending TB," Dr. Ditiu concluded.

According to latest available data, South Africa has 19,000 estimated people who developed DR-TB. See available data about TB in South Africa on Stop TB Partnership’s interactive online TB data dashboard.

* Drugs in this class include amikacin, capreomycin, and kanamycin. Apart from hearing loss, patients also report that the injections are often very painful. According to current WHO guidelines, people with MDR-TB must receive an injectable unless they are tested for and show resistance or signs of hearing loss. Based on anecdotal evidence, in most resource-limited, high TB burden settings, audiometry testing to monitor for hearing loss is not implemented. As a result, patients are allowed to go deaf, even though alternative treatment options exist.