Deaf or dead. Those were the two options offered to doctor Delene von Delft when she was diagnosed with multi- drug-resistant tuberculosis three years ago.
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 (FDA) approval in the US – but the clinical trial was already full.
But the new drug came with serious side-effects, including sudden cardiac arrest, and death.
That was the difficult choice for Von Delft, a doctor working at a public hospital in the Western Cape and living in Somerset West, who contracted TB from a patient.
She’d had a scratchy cough that she put down to sinusitis, but a colleague insisted that she get it checked out. And on Christmas Eve in 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 has called for a fast-track review of the drug, and has 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 allows patients to access unregistered drugs in the testing phase, 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 began to suffer from hearing loss, she finally received 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Compassionate access has since been revoked by the MCC.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 got 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 a vast array of 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 did have QT prolongation, although 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 extremely 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 also 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.
“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.
They want TB to receive the same international attention as HIV/Aids, and in so doing encourage drug companies to develop more new drugs.
They also aim to teach medical students and young doctors to take precautions, ranging from masks to 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.
Source: IOL