Cape Town - Deaf or dead. Those were the two options offered to Somerset West doctor Delene von Delft, when she was diagnosed with multidrug-resistant (MDR) tuberculosis in 2010.
Her existing regimen of seven drugs was causing hearing loss. Then there was the option of a new drug – the first new TB drug developed in 42 years to get Food and Drug Administration approval in the US – but the clinical trial was already full.
Besides, the new drug came with serious side-effects too, including sudden cardiac arrest, and possible death.
That was the difficult choice for Von Delft, a young doctor working at a public hospital in the Western Cape, who contracted TB from a patient. She’d had a scratchy cough that she put down to sinusitis, but a colleague insisted she get it checked. And on Christmas Eve, 2010, she discovered that she had MDR-TB.
Von Delft is telling her story as the local medical industry buzzes with the recent FDA approval of the new, little-tested bedaquiline. Manufactured by
Johnson & Johnson subsidiary Janssen Pharmaceuticals, bedaquiline is controversial because there is limited data on its safety, and there is some evidence that it raises the risk of potentially fatal heart problems.
The fast-track approval for the drug in the US means it can be sold while further clinical trials continue. Phase three trials are still required.
Bedaquiline is not available in South Africa, but the Medicines Control Council (MCC) has called for a fast-track review of the drug, and allowed for a clinical access programme which will collect further clinical data. It will be given to patients at four sites as part of a clinical trial.
In April last year Von Delft applied for compassionate access to the drug. This type of access allows patients to access unregistered drugs in the testing phase in order to save their lives.
At the time however, the only people accessing it were those in a clinical trial, which was already closed. They had all been diagnosed as having extremely drug-resistant (XDR) TB, or were deemed pre-XDR.
Von Delft wasn’t either, but when she started experiencing hearing loss, she was finally granted access to the drug.
Compassionate access has since been revoked by the MCC. And
Von Delft, who was able to take it for six months, was among only four South Africans to get access via this route.
And she credits the drug with saving her life.
Faced with the serious side-effect called QT prolongation, which alters the heart’s electrical current and could result in sudden cardiac arrest and death, Von Delft recalls: “I had a choice between going deaf, and possibly dying and infecting my family members, or sudden death from cardiac arrest.
“I was willing to take that risk, but it was an informed decision. I think that people making the decision need to have all the information.”
Her husband Arne von Delft, also a medical doctor, said the couple consulted other doctors and experts.
But nobody could tell us anything because it’s a completely novel compound,” he said.
During the six months she was on the drug, Von Delft experienced QT prolongation, but this never resulted in major cardiac problems. By regularly monitoring her heart rate, avoiding stimulants like coffee and taking magnesium, she was able to keep the side effects in check.
“There are completely valid concerns about this drug, but the problem is that doctors are scraping the barrel when it comes to drugs to treat drug-resistant and extreme drug-resistant TB. There are very few drugs being developed and the FDA, by fast-tracking the drug, hoped that the benefits would outweigh the risk,” her husband said.
Now, two years later, Von Delft says her health is back on track. A chest X-ray last week showed up normal, although she admits the disease took its toll on her life.
She was unable to work while on treatment, and only went back to work at a new job at the end of last year.
As a doctor who has had TB, future job prospects may be negatively affected, along with her ability to emigrate or work in certain countries.
When Von Delft was first diagnosed she was isolated in hospital for two weeks, then was in isolation at home for two and a half months. She had her own room, and she and her husband had to wear masks when they were in the same room.
“I stayed alone for a while when I first came out of the hospital, and when Arne came home we wore masks. We had the windows open. But I remember it was summer and it was quite hot. We were driving somewhere and we had the windows open but we had to wear masks. We got stuck in traffic and I remember the heat and the smell of the car fumes, and everyone looking at us.”
The couple now advocate for TB patients.
“We’re doctors who had access to professional opinions, optimal diagnostics and family support. In patients in less-resourced settings, this isn’t the case. You get people sharing a shack with 10 other people. The treatment makes you so sick that you can’t work, and patients discontinue treatment to try and help their families. But then they’re at greater risk of infecting them,” her husband says.
They want to see TB get the same international attention as HIV, so encouraging drug companies to develop more new drugs.
They’re also on a mission to teach medical students and young doctors to take precautions, ranging from wearing masks, to getting regular checks.
“There is this idea that you can’t get TB if you’re healthy, and that’s wrong. We know of a lot of medical students and medical professionals who have contracted TB. Medical professionals are three times more likely to contract it than anyone else,” the doctors say. - Weekend Argus