In an unprecedented and historic move, South African Department of Health decided to recommend including bedaquiline as the standard treatment for patients with drug-resistant TB (DR-TB). The country also released data showing that treatment regimens including bedaquiline reduced mortality 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 patients with DR-TB, including patients with multidrug-resistant TB (MDR-TB) who will now receive the drug as part of a more patient-friendly short regimen, marking a significant shift in how the country’s political leadership engages with people who have TB. For the first time, an injection-free* regimen will be made available to all patients with DR-TB. Following this decision, bedaquiline will be made available to patients suffering from resistance to the strongest anti-TB medicine, rifampicin and not as was the case previously only to extensively drug-resistant TB patients or those 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 regimen will be made available to all patients with DR-TB. Additionally, patients with MDR-TB will also receive this effective medicine as part of the patient-friendly nine months short regimen, 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 regimen. The injectables are associated with a number of serious side effects, including irreversible hearing loss. South Africa released data that have shown that introduction of bedaquiline to the treatment played a part in the significant increase of the DR-TB treatment successes but also contributed to decreased mortality rates among DR-TB patients. Bedaquiline in combination with existing TB drugs provides new hope for MDR-TB patients with very few treatment options.

South African Department of Health stated that a retrospective cohort analysis of records of all DR-TB patients receiving treatment regimens inclusive of bedaquiline were associated with a 41% increase in treatment success and a three-fold reduction in mortality 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.

* The injectables, also called aminoglycosides or injectable agents, cause hearing loss in as many as 50 percent of patients. 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.

South Africa: the country where political leadership serves the people