Drug could save thousands of SA DR-TB patients, but Japanese pharma company holds key

Close up of sachets of the drug Delamanid in the Town 2 Clinic, Kuyasa, Khayelitsha, Western Cape in South Africa. (MSF, Sydelle Willow Smith)

Close up of sachets of the drug Delamanid in the Town 2 Clinic, Kuyasa, Khayelitsha, Western Cape in South Africa. (MSF, Sydelle Willow Smith)

South Africa has one of the highest burdens of tuberculosis and deadly drug-resistant tuberculosis (DR-TB), with more than 20 000 people diagnosed with DR-TB in 2015. But current DR-TB treatment — which consists of a combination of multiple pills and painful daily injections — is only successful in about half of all people who receive it.

New drugs like delamanid – one of the most promising new drugs in decades available in the fight against this deadly illness — promise the opportunity of more successful, tolerable treatment regimens to patients who have few other options available.

Khayelitsha resident Sinethemba Kuse, 16, is one of the lucky few to benefit from delamanid.

Kuse, who was diagnosed with MDR-TB just before Christmas last year, and in February this year with pre-extensively drug resistant TB (pre-XDR-TB), is grateful to have accessed this drug. She remains a symbol of hope to the thousands of DR-TB patients in her community.

Despite having a few side effects during the first days of taking delamanid — most notably nausea – Kuse’s health has improved drastically since taking the drug. A month later, she started speaking again, dancing and even singing in the church choir — things she could no longer do before due to her illness.

Like Kuse, thousands of DR-TB patients can potentially benefit from this drug if the Japanese pharmaceutical giant Otsuka can provide greater access in South Africa.

Sinethemba Kuse in the streets outside the home she shares with her grandmother and four other family members in Zone C29, Khayelitsha. (MSF, Sydelle Willow Smith)

In Khayelitsha, Doctors Without Borders (MSF) has supported the South African National Department of Health (NDoH) to start 52 DR-TB patients on treatment with delamanid since December 2015. This is the largest groups of patients taking the drug in South Africa and one of the largest cohorts in the world. MSF currently buys delamanid at a cost of US$1 700 (R23 600) per six-month treatment course.

“Delamanid is of particular interest in South Africa, given that it can be taken with the standard fixed-dose combination treatment for HIV, and over 70% of people diagnosed with TB here are also HIV-positive,” says Dr Jennifer Hughes, MSF’s DR-TB specialist in Khayelitsha.“An estimated 7 000 DR-TB patients per year in South Africa could benefit from the inclusion of delamanid in their treatment regimens, but we need Otsuka to act rapidly to register the drug and provide an interim access plan if we want people who need this drug to receive it.”

Currently access to delamanid is very limited and is being hampered by a slow start to a national clinical access programme for delamanid, which the NDoH has proactively taken steps to establish with Otsuka. Through the programme, clinicians would prescribe the drug at select clinical sites prior to the drug’s registration.

Local registration is necessary for the NDoH to then incorporate the drug into clinical guidelines, negotiate a purchasing price for the drug and licensing of patent rights. Unfortunately, Otsuka is yet to file for registration of delamanid in South Africa, a process which can take years, even when applications are expedited.

“The eventual start of a clinical access programme nationwide will be a welcome development,”says Hughes, “though it is unclear if there will be a sufficient number of treatment courses to meet demand for delamanid prior to local registration of the drug.”

As the world’s top TB researchers gather in Liverpool, United Kingdom for the 47th Union World Conference on Lung Health (26 – 29 October), MSF has called on Otsuka to urgently provide an access plan outlining its intentions for registering delamanid with the Medicines Control Council in South Africa (MCC).

Vuyisiwa Madubela, Kuse’s grandmother who helped nurse her back to health, has also issued a heartfelt plea to Otsuka:

“I would ask the manufacturer of delamanid to get more drugs for other patients,”she says.“I would ask them to give it to every patient who really needs it. I see lots of TB patients at the TB clinic. If people got this drug, they could really control DR-TB. TB is a giant but not a killer. TB can be cured.”

MSF’s DR-TB programmes in Khayelitsha

Drug-resistant tuberculosis (DR-TB) is a growing epidemic worldwide, and nowhere more so than in Khayelitsha, a large peri-urban township on the outskirts of Cape Town.

Each year, about 200 people in Khayelitsha are diagnosed with some form of DR-TB, including multidrug-resistant TB (MDR TB), extensively drug-resistant TB (XDR-TB) and pre-XDR TB. Around 90% of these patients are initiated on treatment.

In response, MSF has been working with local partners since 2007 to roll out a decentralised model of care in the township, one in which patients are initiated on treatment at primary health care level, thereby avoiding expensive hospital stays and greatly reducing the time to starting treatment.

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