TB-PRACTECAL, a clinical trial led by Médecins Sans Frontières (MSF) with partners including Swiss TPH, has found that a new all-oral six-month treatment regimen is safer and more effective at treating rifampicin-resistant tuberculosis (RR-TB) than the current accepted standard of care.
The phase II/III clinical trial found that the new shorter treatment regimen was very effective against RR-TB. 89% of patients in the BPaLM group were cured, compared to 52% in the standard of care group. Additionally, trial results showed that the new drugs lead to a significantly lower rate of major side effects.
“After months of intense, expedited data cleaning for this complex clinical trial, we are thrilled to see the positive results and hope that this data will help bring this shorter treatment regimen to the patients who suffer from DR-TB very soon,” said Suzanne Gajewski, Project Responsible at Swiss TPH. “The data will be also shared with the World Health Organisation (WHO) ahead of the WHO DR-TB treatment guideline review with the hope of influencing national DR-TB guidelines and ultimately clinical practice.”
A brighter future for DR-TB treatment
This regimen will replace the often lengthy treatment regimens that last up to 20 months and include painful injections and up to 20 pills a day that can cause severe side-effects. These regimens only cure half of the patients and often have a catastrophic effect on people’s physical and mental health, as well as their financial and social lives.
The result will serve as a major contribution to the growing body of evidence for global treatment recommendations, which should now also include a short, effective, and safe treatment regimen.
TB-PRACTECAL is the first-ever multi-country, randomised, controlled clinical trial to report on the efficacy and safety of a six-month, all-oral regimen for RR-TB. It tested a six-month regimen of bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM), against the locally accepted standard of care. The trial enrolled 552 patients overall, of which 301 were included in the analysis at this stage. The trial took place in seven sites across Belarus, South Africa and Uzbekistan.
Swiss TPH is responsible for the clinical monitoring of TB-PRACTECAL at the study sites. Since 2015, the Clinical Operations Unit at Swiss TPH has been instrumental in the study set-up at the clinical sites, and continues to work closely with the local teams and MSF to ensure that the trial is conducted according to the highest quality standards, the International Council for Harmonization Good Clinical Practice (ICH-GCP) and the local regulatory requirements.