Global TB research organisation TB Alliance announced the 200-person trial today. The “Nix TB” trial will combine two drugs currently used to treat XDR-TB, bedaquiline and linezolid, with a completely new drug PA-824. Already enrolling patients, the study will evaluate the drug trio’s ability to cure patients in as little as six months of treatment.
This could shave 18 months off of traditional treatment regimens, which require handfuls of pills and daily injections as well as substantial guesswork by doctors to handcraft drug combinations that work for patients.
The trial will also importantly include both HIV-positive patients and adolescents as young as 14 years old – two groups sometimes often neglected in clinical research.
Currently, there is no regulatory-approved, standardised treatment regimen for curing XDR-TB, according to the TB Alliance.
Dr Francesca Conradie is non-profit Right to Care’s Clinical Advisor to Sizwe Hospital and is working on the trial. She said that while bedaquiline and linezolid have been offered to a limited number of South African patients before through a small, government-run clinical access programme, the trial is significant in its introduction of a novel new drug.[quote float= right]South Africa accounts for about half of those started on bedaquiline globally
“The beauty of this trial is that we’re adding a fresh drug, PA-824, to which there should be no resistance,” said Conradie, adding that this new combination of drugs will let patients avoid the painful intramuscular injections that accompany standard treatment.
Conradie credits government’s political will for the trial.
“One of the reasons for this trial is that the National Department of Health and in particular Dr Norbert Ndjeka, head of the drug-resistant TB department, has shown great leadership in getting research into these really complicated (drugs),” she told Health-e News. “The national government is really putting its money where its mouth is in in terms of pushing the research agenda.”
XDR-TB is resistant to both the most commonly used anti-TB drugs as well at least half of the mostly commonly used second-line drugs. More than 1,500 XDR-TB cases are diagnosed each year in South Africa and almost half of these patients will die, according to 2012 research by the University of Cape Town’s Lung Infection and Immunity Unit.
South Africa leading bedaquiline roll out globally
The Department of Health initiated 211 patients on bedaquiline between March 2013 and December 2014 through the bedaquiline clinical access programme, which aimed to gather additional safety data on the drug, according to Ndjeka.[quote float= left]Applications for the registration and use MDR-TB drug delamanid in South Africa are being prepared
The drug now forms part of national TB guidelines following its October Medicine Control Council registration and the Department of Health began scaling up access to the drug in late March, Ndjeka added.
A patient in Upington, Northern Cape recently became the first of about 100 XDR-TB patients to receive bedaquiline as part of the roll out – making South Africa the first country in the world to scale up access to the drug, Ndjeka told Health-e News.
He added that South Africa accounts for about half of those started on the drug globally.
Bedaquiline maker Janssen Pharmaceuticals has arranged to offer the drug to the South African government at an affordable rate to assist with the national roll out of the drug following the programme’s closure, according to Abeda Williams, technical and medical affairs director at Janssen Pharmaceuticals in South Africa.
However Williams said that she could not disclose the medicine’s price until the national tender has been finalised.
While making up less than 3 percent of all TB cases, XDR-TB and other forms of drug-resistant TB consume as much as 32 percent of the national TB budget, according to the TB Alliance.
Ndjeka added the Department of Health is also preparing Medicine Control Council and ethics applications for the drug delamanid used to treat multidrug-resistant TB, which is resistant to both commonly used anti-TB drugs.
A framework on delamanid’s use in South Africa will be launched at the upcoming SA AIDS Conference in June. – Health-e News.