果冻影院

The study, published by The New England Journal of Medicine, tested three novel combinations of TB treatments taken orally over six months against the accepted standard of care. All were shown to be more effective - with fewer side effects - than the current nine-month regimen that is used to treat drug-resistant TB.

The findings are the results from the TB-PRACTECAL trial - the first-ever multi-country, randomised, controlled clinical trial to report on the efficacy and safety of a six-month, all-oral treatment regimen. Coordinated by Medicine Sans Frontiers (MSF), the TB-PRACTECAL trial involved 552 patients in seven sites across Belarus, South Africa, and Uzbekistan.

Study collaborator Tim McHugh, Professor of Medical Microbiology at 果冻影院 and lead of the microbiology and lab-testing components of the trial said: 鈥淪tandard treatment for TB normally requires four drugs in six months and the drugs aren't very pleasant to take. But in many cases that treatment is successful. However, in an increasing number of cases, we're seeing the emergence of drug-resistant TB. The established treatments for drug-resistant TB are longer (routinely nine months) and the drugs are worse in their side-effects due to increased toxicity.鈥�

The TB-PRACTECAL trial found that a six-month regimen using the TB drugs bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) proved most effective and safe. The trial also studied a bedaquiline, pretomanid, and linezolid (BPaL) regimen; and a bedaquiline, pretomanid, linezolid, and clofazimine (BPaLC) regimen. All of which performed significantly better than the standard of care.

鈥淲e began the TB-PRACTECAL clinical trial nine years ago because something had to be done,鈥� said Bern-Thomas Nyang鈥檞a, MSF medical director and chief investigator of the trial. 鈥淧atients were telling us that the previous regimens were lengthy, ineffective, and grueling and that the side effects were worse than the disease itself. They also weren鈥檛 very effective; just one in two people were cured. The new regimen, BPaLM, has an 89 percent cure rate, is safer, shorter, and more tolerable with fewer pills.鈥�

The results from the TB-PRACTICAL study, together with results from a linked study (ZeNix)* published in the New England Journal of Medicine, have prompted the World Health Organization (WHO) to update global drug-resistant TB treatment guidelines.

鈥淭he impact of these two studies is significant - the main outcome, for me, is the fact that these two trials have changed WHO guidance and clinical practice, with safer more effective treatment options now available for TB patients,鈥� said聽Professor McHugh who together with Prof Angela Crook, Medical Statistician MRC Clinican Trials Unit聽at 果冻影院, was a key collaborator on ZeNix.聽

For the 果冻影院 research team, the next phase of the TB-PRACTICAL study will be to work with trial collaborators in Uzbekistan in using whole genome sequencing analysis to extract further information from the data obtained.聽

* . ZeNix clinical trial results. New England Journal of Medicine, September 2022

Further information

• TB-PRACTICAL trial:聽. NEJM. December 2022
• 果冻影院-TB News:聽ZeNix trial success announced
• 果冻影院 News:聽Shorter treatment effective for drug-resistant tuberculosis聽STREAM clinical trial
• 果冻影院 Division of Infection and Immunity
• 果冻影院 TB network
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