January 23, 2013
New TB Drug Welcomed in Hard-Hit South Africa
A medication for multi-drug-resistant tuberculosis, bedaquiline, will soon become available in South Africa after being preliminarily cleared by the U.S. drug authority.
The prospect is welcomed by health groups who say there is a growing need for treatment in the nation with one of the world’s highest HIV rates, and where TB is often the major cause of death. The drug has not cleared a full set of medical trials, but experts say the sick and dying can not wait.
Dr. Dalene von Delft did not think much of it when she developed a dry cough after working in the neonatal ward at a Cape Town hospital. But then the cough would not go away. A colleague urged her to get it checked out.
That is when von Delft, now 30, found out that she had contracted multiple drug-resistant tuberculosis. This was in 2010.
But von Delft had medical knowledge that many of South Africa’s TB patients do not. Her multi-drug regimen started to cause hearing loss. She did some research and asked her doctor to switch one of her medications for a drug that was still in clinical trials: bedaquiline.
"I basically pushed for that choice," said von Delft. "I told my physician, 'but what if I can get this drug and we can stop this drug and I can still have my hearing?’ He said, 'well, that's an idea that might work.' But yeah, it was a huge risk that I had to take. And obviously, at that stage we also didn't have a lot of information about this new drug yet…. and I'm very glad that I did because I have my hearing and I've been cured from the TB. I can't really say that that drug cured me of the TB, because I was still taking six other drugs, but it definitely made a huge difference in that respect."
She is ecstatic that the medication that saved her hearing will this year be available in South Africa for other TB patients.
This stubborn strain of the dangerous lung infection is extremely prevalent in South Africa. South Africa has the world’s highest population with HIV/ AIDS, with an estimated 5.7 million cases. Tuberculosis often afflicts and kills HIV patients with seriously suppressed immune systems.
The World Health Organization says some 10,000 South Africans are diagnosed with multi-drug resistant, or MDR, tuberculosis each year. And the WHO says TB is second only to AIDS as the biggest killer worldwide.
Africa is especially hard-hit. In 2011, seventy-nine percent of the world’s estimated 1.1 million new cases of TB among HIV-positive patients were in sub-Saharan Africa.
The U.S. Food and Drug Administration approved bedaquiline for use in late 2012 for patients who have few other options. It is not yet widely approved, and will be further tested.
Epidemiologist Dr. Helen Cox of the medical aid group Doctors Without Borders says clinicians are welcoming the new option. She says it is the first new TB drug released in decades.
"There's such an urgent need for new drugs, and new treatments for multi-drug resistant TB," said Cox. "The current treatment is very long, it's 18 to 24 months, and it's associated with lots and lots of side effects that are really difficult for patients to cope with. And it's not very successful in all patients. There are a lot of patients who take all their drugs, as they're supposed to, and are still not cured."
Cox says for now, bedaquiline could be a lifesaver when used under the “compassionate use” principle. That allows for experimental or potentially lifesaving drugs to be used before the end of their clinical trials. Cox says France is also using the drug under this principle.
Cox says the drug is not without risks. One possible side effect, she notes, is heart rhythm abnormalities. And like all serious drugs, it comes with a list of warnings and possible side effects, and it may not be suitable for everyone.
She says she does not know how much the drug will eventually cost. But she says the drug company has made assurances it will be affordable. TB drugs are generally very expensive.
Still, Cox says, for some patients and their doctors the risk is worth it.
"For those patients that have very limited other options, in a sense, they're very highly likely to die if they don't try this drug, and if the patient agrees, then we can give this drug to them, to give them, sort of, one last chance for a cure," said Cox. "... But I think we should also remember that the current drugs that we use for MDR TB, the injectable drugs that we use, have a very high chance of people going deaf. At least 10 percent of patients in some settings will go deaf on this drug, and it's permanent. So we also have to balance it against the risk from the drugs we're using now, which are not nice drugs. And so although we can always test these drugs for much longer, at the moment the evidence suggests that it is relatively safe, and certainly safer than the existing drugs that we're using."
Von Delft now works in a private emergency room. She says she had to leave the public health sector because the risk is too high that she might contract TB again. She also noted that in South Africa, there is no protocol for regularly testing health workers for TB.
But von Delft says she is glad that others may get what bedaquiline gave her: another chance.