South African scientists are spearheading the world's first trial into shorter and better treatment for extensively drug resistant tuberculosis (XDR-TB), which kills about half of all those diagnosed with the condition in South Africa, reports Health-e.
Global TB research organisation TB Alliance announced the 200-person trial saying 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.
Dr Francesca Conradie, non-profit Right to Care's clinical advisor to Sizwe Hospital is working on the trial and 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. "The beauty of this trial is that we’re adding a fresh drug, PA-824, to which there should be no resistance," said Conradie in the report, adding that this new combination of drugs will let patients avoid the painful intramuscular injections that accompany standard treatment.
Conradie said: "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). The national government is really putting its money where its mouth is in in terms of pushing the research agenda."
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. 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 said. 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.
[link url="http://www.health-e.org.za/2015/05/14/sa-hosts-worlds-first-study-into-better-xdr-tb-treatment/"]Full Health-e report[/link]