After feeling ill for months, 16-year-old Sinethemba Kuse received the news that she had multidrug-resistant tuberculosis from her local clinic in Khayelitsha outside of Cape Town in December last year.
“Imagine being told that you have MDR-TB just before Christmas,” she said.
Unlike drug-sensitive, or “normal” TB, which requires six months of treatment, MDR-TB treatment can take up to two years to complete and the drugs used are toxic because this form of the disease is resistant to two of the most commonly used anti-TB medicines.
“That day, I lost hope. I thought she was going to die,” said Kuse’s grandmother, Vuyisiwa Madubela, who shares a small two-bedroom house with her granddaughter and four other family members in the Western Cape township.
But in February this year, the teenager’s problems escalated: doctors informed her she had pre-extensively drug resistant TB – a strain of the disease which even fewer drugs work to kill.
Up to 75% of people with this TB who don’t have access to newer treatments die – because the existing drugs are old, toxic and very difficult to take.
One of the drugs that have been found effective in pre-extensively drug resistant TB patients, delamanid, is new, expensive and not available to most South Africans.
Kuse was one of the lucky few who, through a special access programme run by Doctors Without Borders (MSF), has begun taking the new drug as part of her multidrug regimen.
According to MSF, although 7000 South Africans need access to the drug, only a fraction are offered it, because it has not been registered with the South African Medicines Control Council.
Because of this delay, over the past 10 months the small number of South African patients who have begun to use delamanid have been allowed to do so through a special compassionate access programme, where clinicians have to apply directly to Japanese pharmaceutical giant Otsuka on a case-by-case basis.
Of these patients, 52 are based in Khayelitsha, for whom MSF buys the six-month course at R23 600 a patient.
This group of patients in Khayelitsha is the largest in South Africa receiving delamanid, outside of clinical trials, and one of the largest in the world.
The health department is establishing a national clinical access programme with Otsuka. This would bring the drug to many more patients, but progress has been slow.
“The eventual start of a clinical access programme nationwide will be a welcome development, 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,” said MSF’s TB doctor, Jenny Hughes.
She said registration with the Medicines Control Council was needed to incorporate the drug in the country’s TB treatment guidelines, but this process could take years even when applications are urgent and expedited.
Kuse was one of the first patients to receive the drug in South Africa. It is very effective, with fewer side-effects than current drugs.
Her grandmother Madubela said that after a month of treatment Kuse went from being sick and nauseous to almost back to her normal self.
“She’s going to church, she’s singing in the church choir. Everyone wanted to know what happened.”
When clinicians and TB experts around the world met in Liverpool, United Kingdom, last week for the 47th Union World Conference on Lung Health, Madubela asked MSF to make her plea heard by Otsuka: “I would ask the manufacturer of delamanid to get more drugs for other patients. 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 drug-resistant TB. TB is a giant but not a killer. TB can be cured.”