THE HAGUE, Netherlands – New results from the ongoing Nix-TB trial continue to confirm a short-course treatment regimen of bedaquiline – one of the two newest drugs to treat TB in half a century – linezolid and pretomanid offers a significantly improved treatment option for people infected with drug resistant forms of tuberculosis, researchers said here.
Current recommended regimens to treat drug resistant TB require 18-24 months of treatment with multiple drugs, including painful, daily injectable drugs that often leave patients with debilitating side effects, including hearing loss and psychosis, researchers said.
Sixty-six of the first 75 participants enrolled in trial sites in Johannesburg and Cape Town, South Africa, achieved durable cure six months after the end of therapy. Forty-four patients were infected with XDR-TB and the remaining 22 patients with MDR-TB had failed prior treatment attempts, researchers said. Fifty-one percent of participants were infected with HIV. Six patients died during initial phases of the trial from severe disease, emaciation, pneumonia and other conditions.
Sixty-eight percent of participants experienced neuropathy in the hands or feet, researchers said, while two experienced damage in the optic nerve that was resolved after discontinuation of linezolid, researchers said. Nearly 30 percent of participants discontinued the use of linezolid during their treatment. While all participants experienced some kind of adverse event, researchers said, all events are managed at the site level and no participants were withdrawn from the study.
While the trial is ongoing, researchers have started to investigate the optimal dose and duration of linezolid, researchers said.