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Short Standardized Regimens for Rifampicin-Resistant Tuberculosis

Compared with a 9-month regimen that included injectable agents, a 9-month oral regimen and a 6-month regimen with 8 weeks of injectable agents had superior outcomes with fewer cases of hearing loss, according to the STREAM stage 2 study. “The findings of the STREAM stage 2 trial, combined with results of previous trials, show that shorter bedaquiline-containing regimens are an effective treatment for patients with multidrug-resistant-tuberculosis,” the authors write.

The phase 3, noninferiority trial included 588 patients aged 15 years or older at 13 hospital clinics in 7 countries. Treatments were a  9-month control regimen, a 9-month oral regimen with bedaquiline (primary comparison), or a 6-month regimen with bedaquiline and 8 weeks of second-line injectable agent. The primary outcome was a negative Mycobacterium tuberculosis culture at 76 weeks without a preceding unfavorable outcome (any death, bacteriological failure or recurrence, or major treatment change). The results showed: “Of 517 participants in the [modified intention-to-treat (mITT)] population, 133 (71%) of 187 on the control regimen and 162 (83%) of 196 on the oral regimen had a favourable outcome: a difference of 11.0% (95% CI 2.9–19.0), adjusted for HIV status and randomisation protocol (P <0.0001 for non-inferiority). By 76 weeks, 108 (53%) of 202 participants on the control regimen and 106 (50%) of 211 allocated to the oral regimen had an adverse event of grade 3 or 4; five (2%) participants on the control regimen and seven (3%) on the oral regimen had died. Hearing loss (Brock grade 3 or 4) was more frequent in participants on the control regimen than in those on the oral regimen (18 [9%] vs four [2%], P = 0.0015). Of 134 participants in the mITT population who were allocated to the 6-month regimen, 122 (91%) had a favourable outcome compared with 87 (69%) of 127 participants randomly assigned concurrently to the control regimen (adjusted difference 22.2%, 95% CI 13.1–31.2); six (4%) of 143 participants on the 6-month regimen had grade 3 or 4 hearing loss.”

Source: Lancet