More effective and short-duration treatment for highly drug-resistant forms of Tuberculosis (TB) may be just around the corner. The results of a Phase III clinical trial that took place in 11 sites across Georgia, Moldova, Russia, and South Africa, shows a combination of antibiotics bedaquiline (B), pretomanid (Pa) and linezolid (L) or BPaL treatment remains effective against highly drug-resistant strains of TB. It either reduced the dosage or duration of the linezolid component of the regimen.
The BPaL treatment, which received its first regulatory approval in August 2019 for use against highly drug-resistant strains of TB, carried the risk of side-effects of linezolid and the inconvenience of 18 months or longer treatment regime.
The new ZeNix trial has shown the dosage of linezolid can be reduced while bringing down the treatment time for highly drug-resistant forms of TB from 18 months or longer to a six-month duration.
India has the leading number of TB cases globally, accounting for more than 1 in 4 of all active TB cases, including around 120,000 cases of drug-resistant forms of TB.
Prime Minister Narendra Modi has set an ambitious goal of TB eradication in India by 2025, ahead of the 2030 target of the Sustainable Development Goals.
The results from the trial, led by TB Alliance, a non-profit TB drug developer, were announced ahead of an oral abstract presentation next week at the 11th IAS Conference on HIV Science.
"We now have evidence that the BPaL regimen can be optimised to make it even easier to use," said Mel Spigelman, President and CEO of TB Alliance, which developed pretomanid for use in the regimen. "Until recently, patients with highly drug-resistant TB -- among the most difficult infections to identify and treat -- had to suffer through a combination of as many as eight antibiotics, some involving daily injections, for 18 months or longer," Spigelman said.
The ZeNix trial was a four-arm, randomised, double-blinded study as to dosage and duration of linezolid that enrolled 181 patients with highly drug-resistant forms of TB in South Africa, Russia, Georgia and Moldova.
Of these participants, 36 (20 per cent) were HIV positive. Patients were treated for six months with bedaquiline, pretomanid and varying doses and durations of linezolid, with follow-up, reported thus far to the primary endpoint six months after completion of treatment.
The trial aimed to evaluate whether the efficacy of the BPaL regimen could be maintained while reducing a patient's exposure to linezolid and its associated side effects.
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