12 October 2017

Today at the 48th Union World Conference on Lung Health in Mexico, early data from programmes run by Doctors Without Borders (MSF) in South Africa, India and Armenia demonstrate the potential to significantly improve treatment outcomes for people living with drug-resistant tuberculosis (DR-TB) if access to a new drug, delamanid, can be expanded in South Africa and globally.

Khayelitsha, Western Cape is one of very few sites in South Africa to offer delamanid to people with DR-TB, and one of several global locations where MSF is offering patients with limited treatment options the choice of delamanid, often in combination with bedaquiline — the only other new DR-TB drug to have been developed in the last 50 years and approved for use in DR-TB patients by the World Health Organization.

DR-TB patients
XDR-TB patient Hanif, taking his daily TB medication at home in the Govandi area of Mumbai. Photo by: Atul Loke

Little research exists regarding the use of the two drugs together but early results from Khayelitsha and the two international sites are promising: after six months on treatment, 74% of 23 patients with either multidrug-resistant TB (MDR-TB) or extensively drug-resistant TB (XDR-TB) who had both drugs included in their treatment regimen achieved culture conversion – an early sign that treatment my ultimately be successful.

Cure rates for MDR-TB and XDR-TB are typically poor - 48% and 24% respectively in South Africa. The data also gives an early indication that combination use is safe.

“Delamanid gave me a second chance at life,” said 18-year-old Sinethemba Kuse, who was declared cured of XDR-TB on 22 September 2017. In February 2016 Kuse became the first adolescent in Khayelitsha to receive delamanid. Looking back on her treatment journey, she called for wider access to delamanid, noting that “a lot of people [with DR-TB] suffer without hope.”

The standard treatment for DR-TB needs to be given for up to two years and comprises at least 5 different drugs, including painful injections that can cause deafness in as many as 50% of patients receiving them.

“The WHO endorses delamanid to replace the injectable agent for children and adolescents with DR-TB, giving this group a treatment option that is more effective and less toxic than standard treatment,” says MSF DR-TB Doctor Anja Reuter, based in Khayelitsha.  

“Delamanid can also strengthen the treatment regimen for more complex cases, such as people with XDR-TB, or DR-TB patients who are living with other chronic diseases like diabetes, or HIV. It is a good option for HIV co-infected patients because it doesn’t require patients to change their antiretroviral treatment,” Reuter adds.

MSF estimates that each year at least 7,000 DR-TB patients in South Africa could benefit from delamanid, but access currently remains limited.

DR-TB patients
Simphiwe visits his local clinic in Kuyasa, Khayelitsha, every weekday to receive his daily clofazimine injection and collect his treatment. Photo by: Sydelle WIllow Smith

The National Department of Health launch of the Delamanid Clinical Access Programme (DCAP) in March 2017 was a progressive step forward, although uptake has been much slower than expected, with only 10 of the 400 treatment courses pledged by pharmaceutical manufacturer Otsuka allocated to date.

This is in part due to the fact that the eligibility criteria currently exclude people with XDR-TB, and patients on bedaquiline. South Africa’s Medicines Control Council (MCC) is currently reviewing a revised protocol that would expand DCAP eligibility to these groups, as well as a dossier to fully register delamanid in South Africa.

“It is imperative that the MCC take urgent action to help expand access to delamanid,” says Reuter. “When products are registered, access improves.

DR-TB patients
Sibongile's medication at the Town 2 Clinic, Kuyasa, Khayelitsha, Western Cape, South Africa. Photo by: Sydelle WIllow Smith

The Bedaquiline Clinical Access Program started just over 200 patients in two years, but in the two years since registration and introduction into national guidelines, South Africa has initiated over 6,700 patients on bedaquiline.

We are pleased to know that the MCC is prioritizing a rapid review of delamanid for registration, and while registration is pending, we look forward to the MCC approving the expanded DCAP criteria so that currently excluded groups can benefit.”