An extended follow-up of patients in a phase 3 clinical trial found that two bedaquiline-containing drug regimens for rifampicin-resistant tuberculosis (TB) were superior compared to 9 months of injectable therapy at 132 weeks, researchers said reported yesterday in the Lancet Respiratory Medicine.

In the STREAM stage 2 trial, patients aged 15 years and older with rifampicin-resistant tuberculosis in seven countries were randomized to one of four treatments: long-term treatment (the 20-month treatment recommended by the World Health Organization from 2011 to 2018) and one Control treatment treatment (a 9-month treatment with the second-line injectable kanamycin), an oral treatment (9 months with bedaquiline as a replacement for kanamycin), or a 6-month treatment (containing bedaquiline and supplemented with 8 weeks of kanamycin).

An initial analysis at 76 weeks showed that the oral regimen and the 6-month regimen were superior to the control regimen for the primary outcome of favorable status (negative cultures for). Mycobacterium tuberculosis). The long-term therapy part of the study was ended early.

Effective and safe treatments for drug-resistant tuberculosis

In follow-up analysis, researchers examined adverse status (death or a positive culture from one of the final two samples) at week 132 in the three remaining groups. Among 517 patients in the modified intention-to-treat population, the proportion with unfavorable status was 19.6% in the oral therapy arm, 29.3% in the control therapy arm, and 9.8% in the 6-dose arm. Monthly therapy.

Few serious or serious adverse events were reported after week 76. Treatment-related hearing loss was noted in significantly fewer participants in the oral therapy (3%) than in the control therapy (8%), and there was no significant difference in severe hearing loss between the oral treatment and the 6-month treatment.

Death rates were low for participants assigned to the two bedaquiline-containing arms (1.01 per 100 person-years) compared to participants in the control group (1.52/100 person-years).

“The results of the STREAM stage 2 study, combined with the results of previous studies, show that shorter bedaquiline-containing regimens represent an effective and safe treatment for patients with multidrug-resistant tuberculosis,” the researchers wrote. “These data confirm the value of the 9-month regimen recommended in current WHO guidelines and support the use of 6-month regimen.”