A study led by University College London and the Liverpool School of Tropical Medicine has found that shorter treatment duration is safe and effective in the management of drug-resistant tuberculosis (TB).
The phase 3 noninferiority STREAM trial involved patients with rifampin-resistant TB that was susceptible to fluoroquinolones and aminoglycosides. Participants were randomly assigned to receive a short regimen (9-11 months) of high-dose moxifloxacin or a long regimen (20 months) that followed the 2011 WHO guidelines.
The primary efficacy outcome was a favourable status, defined as negative Mycobacterium tuberculosis cultures at 132 weeks and at a previous occasion, with no intervening positive culture or previous unfavourable outcome.
The study findings, reported in the The New England Journal of Medicine,show that favourable status was achieved in 79.8 per cent of participants in the long-regimen group and in 78.8 per cent of those in the short-regimen group.
Adverse events of grade ≥3 occurred in 45.4 per cent in the long-regimen group and 48.2 per cent in the short-regimen group. Prolongation of either the QT interval or corrected QT interval to 500 msec occurred in 11.0 per cent of participants in the short-regimen group compared with 6.4 per cent in the long-regimen group (P=.14). However, because of the greater incidence in the short-regimen group, participants were closely monitored; and some received medication adjustments.
Death occurred in 8.5 per cent of the short-regimen group and 6.4 per cent of the long-regimen group. Acquired resistance to fluoroquinolones or aminoglycosides occurred in 3.3 per cent and 2.3 per cent, respectively.
The authors concluded that in persons with rifampin-resistant TB that is susceptible to fluoroquinolones and aminoglycosides, a short regimen is noninferior to a long regimen in terms of primary outcomes and safety.
