BREAKING NEWS: A new revolution in TB treatment as the injection falls

South Africa becomes the first country in the world to take a bold step of 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

Monday, June 18, 2018 — Doctors Without Borders (MSF) applauds the South African National Department of Health (NDoH) for announcing today 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 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.

Other countries and the formulators of WHO guidance on the use of DR-TB medicines can and should follow South Africa’s progressive example and commit to replacing the injectable and expanding access globally to effective new medicines, including bedaquiline.

As countries prepare to meet in New York this September at the first United Nations High-Level Meeting on TB, it is critical that South Africa send the highest level delegation possible, including the President, Deputy President, Minister of Health, and civil society members, to encourage other delegates to take decisive action on DR-TB treatment, and set clear targets and financial commitments for addressing the broader TB epidemic.

ENDS

For more information contact Sean Christie, 073 215 5342

MSF treatment of DR-TB and XDR-TB in South Africa

MSF supports access to new and re-purposed drugs for strengthening DR-TB treatment regimens in Khayelitsha, Western Cape (since 2007) and in Eshowe & Mbongolwane, KwaZulu-Natal (since 2017). The provision of new drugs such as bedaquiline and delamanid goes hand in hand with the decentralization of DR-TB care to the primary healthcare level, so that treatment initiation and access to drugs and patient support can occur closer to the communities where DR-TB patients live.

Close up of sachets of the drug Delamanid in the Town 2 Clinic, Kuyasa, Khayelitsha, Western Cape in South Africa. Photographer: Sydelle WIllow Smith
Simphiwe Zwide - MSF Treatment For TB in South Africa. Simphiwe takes his first delamanid tablets, which have now been included into his treatment regimen for XDR-TB.<br/><br/>Simphiwe Zwide, 43 years, lives in a one-bedroom house with his wife, Nomonde Tyala, and children in Kuyasa, Khayelitsha. Simphiwe was first diagnosed with MDR-TB in 2011. He completed six months of treatment, but when he learned that he had pre-XDR-TB and would need even more treatment, he lost heart and returned to work. <br/><br/>In June 2016, he presented back to his Khayelistha clinic as he had fallen ill again. This time test results showed he had XDR-TB. He took his first delamanid tablets on 12 October, as part of a strengthened regimen for XDR-TB.<br/>Simphiwe’s current regimen: Delamanid, bedaquiline, linezolid, levofloxacin, terizidone, clofazimine, ethionamide. Photographer: Sydelle WIllow Smith
Sinethemba takes her daily regimen for XDR-TB at 10am each day, with two additional delamanid tablets at night.<br/><br/>Sinethemba, 16 years, lives with her grandmother, Vuyisiwa Madubela, and four other family members in a two-bedroomed home in Zone C29, Khayelitsha, Western Cape, South Africa.<br/><br/>Her grandmother’s determination and love, combined with receiving a six-month trial of one the newest DR-TB drugs on the market likely saved her life this year. <br/><br/>Current regimen: delamanid, linezolid, pyrazinamide, ethambutol, clofazimine, high dose levofloxacin, terizidone. Photographer: Sydelle WIllow Smith
Sinethemba takes her daily regimen for XDR-TB at 10am each day. She also takes two additional delamanid tablets at night.<br/><br/>Sinethemba, 16 years, lives with her grandmother, Vuyisiwa Madubela, and four other family members in a two-bedroomed home in Zone C29, Khayelitsha, Western Cape, South Africa.<br/><br/>Her grandmother’s determination and love, combined with receiving a six-month trial of one the newest DR-TB drugs on the market likely saved her life this year. <br/><br/>Current regimen: delamanid, linezolid, pyrazinamide, ethambutol, clofazimine, high dose levofloxacin, terizidone. Photographer: Sydelle WIllow Smith
Ubuntu clinic (integrated TB/HIV) in Khayelitsha. Photographer: Henrik Glette
View of Khayelitsha in Western Cape, South Africa. South Africa has one of the highest burdens of TB and (Drug Resistant) DR-TB in the world, with around 20,000 people diagnosed with DR-TB in 2015. In Khayelitsha, Western Cape, which has some of the country’s highest rates of DR-TB, MSF runs a strengthened regimen programme that incorporates new drugs into treatment regimens for DR-TB patients including Delamanid and Bedaquiline. Photographer: Sydelle WIllow Smith
View of Khayelitsha in Western Cape, South Africa. South Africa has one of the highest burdens of TB and (Drug Resistant) DR-TB in the world, with around 20,000 people diagnosed with DR-TB in 2015. In Khayelitsha, Western Cape, which has some of the country’s highest rates of DR-TB, MSF runs a strengthened regimen programme that incorporates new drugs into treatment regimens for DR-TB patients including Delamanid and Bedaquiline. Photographer: Sydelle WIllow Smith
Angela Makamure Press Officer at Doctors Without Borders (MSF) Southern Africa