German health authorities are investigating symptoms of contact with patient in Rwanda's Marburg region

In long-term follow-up of patients in a phase 3 clinical trial, researchers found that a two-drug regimen containing bedaquiline for rifampicin-resistant tuberculosis (TB) compared to a 9-month injection-based regimen at 132 weeks. announced that it had discovered that it maintains its superiority. reported yesterday in Lancet Respiratory Medicine.

The STREAM Stage 2 trial randomly assigned rifampicin-resistant tuberculosis patients aged 15 years and older from seven countries to receive one of four treatments: long-term therapy (World Health Organization (20 months of therapy recommended by (contains bedaquiline and supplemented with kanamycin for 8 weeks).

Initial analysis at week 76 showed that the oral and 6-month regimens were superior to the control regimen for the primary outcome of well-being (culture negative). Mycobacterium tuberculosis). The trial for the long-term treatment group was terminated early.

Effective and safe treatment for drug-resistant tuberculosis

In a follow-up analysis, researchers looked at unfavorable conditions (death or positive culture from one of the two most recent samples) at week 132 in the remaining three groups. Among 517 patients in the modified intention-to-treat population, the proportion of unfavorable conditions was 19.6% in the oral regimen group, 29.3% in the control regimen group, and 9.8% in the 6-month regimen group.

Few serious adverse events were reported after week 76. Hearing loss that occurred during treatment was significantly less recorded in participants on the oral regimen (3%) than on the control regimen (8%), and there was no significant difference in severe hearing loss. between the oral regimen and the 6-month regimen.

Mortality rates for participants assigned to the two bedaquiline-containing treatment groups were lower (1.01 per 100 person-years) compared with participants on the control regimen (1.52/100 person-years).

“Results from the STREAM Stage 2 trial, when combined with results from previous trials, demonstrate that a short-course regimen containing bedaquiline is an effective and safe treatment for patients with multidrug-resistant tuberculosis,” the study said. they wrote. “These data support the value of the nine-month regimen recommended by current WHO guidelines and support the use of the six-month regimen.”

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