Doctors Without Borders (MSF) applauds the South African National Department of Health (NDoH) for announcing on 18 June that a promising new oral medicine called bedaquiline will replace an injectable drug in the standard multidrug-resistant tuberculosis (MDR-TB) treatment regimens for adolescents and adults, from the start of treatment.
South Africa is the first country in the world to take this bold step aimed at scaling up access to an effective new drug, making MDR-TB treatment more tolerable, and reducing the devastating impact of side effects caused by the injectable agents.
“The standard treatment for MDR-TB is currently effective only 50% of the time, and includes a painful injectable antibiotic known to cause terrible toxic side effects, including kidney failure and hearing loss. Experience with bedaquiline in treating drug-resistant TB – mainly from South Africa – demonstrates improved clinical outcomes in people living with MDR-TB, and initial evidence shows that it can be safely and effectively used in place of the toxic injectable,” says MSF’s Dr. Anja Reuter, a DR-TB doctor in Khayelitsha in the Western Cape, where MSF has run a DR-TB program since 2007.
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 (2012); approving local registration in 2014; and in 2015 introducing bedaquiline into the South African National TB Program in line with World Health Organization (WHO) guidelines. (Existing WHO guidance recommends that bedaquiline be reserved for people with extensively drug-resistant TB (XDR-TB), and those who have experienced hearing loss or other toxicity of the injectable on standard MDR-TB treatment.)
“There is no question we should be offering people the best options we have for more effective and less toxic treatment, but progress on this agenda has to date been slow in most countries. South Africa has taken a positive step towards ensuring that no one with DR-TB should be denied access to this drug,” says Reuter.
While hurdles to implementation remain—health facilities must be supported in developing the capacity to use bedaquiline and other new drugs, and manufacturers must reduce the prices they charge in South Africa and globally—South Africa’s bold announcement on bedaquiline comes at a critical time. Worldwide, more than half a million people are infected with MDR-TB every year, but extremely few who could have benefited had access to newer TB drugs such as bedaquiline.