A Pragmatic Trial of a 6-Month Strategy for Rifampicin-Resistant Tuberculosis

Area of Science:

• Infectious Diseases
• Clinical Trials
• Public Health

Background:

• Rifampicin-resistant tuberculosis (TB) requires safer and more effective treatment options.
• Current standard-of-care TB regimens can be lengthy and burdensome.

Purpose of the Study:

• To evaluate a novel 6-month treatment strategy for pulmonary rifampicin-resistant TB.
• To compare the efficacy and safety of the 6-month strategy against the standard 9-month regimen.

Main Methods:

• A phase 3, open-label, randomized controlled trial was conducted in South Africa.
• Participants received either a 6-month regimen (bedaquiline, linezolid, delamanid, levofloxacin, or clofazimine) or the 9-month standard-of-care.
• The primary endpoint was successful treatment outcome at end-of-treatment and 76 weeks post-randomization.

Main Results:

• The 6-month strategy achieved a successful outcome in 86.1% of participants, compared to 86.0% in the standard-care group, demonstrating noninferiority.
• The adjusted risk difference was -0.2 percentage points (95% CI, -6.9 to 6.5).
• Grade 3 or higher adverse events occurred in 31.2% of the trial-strategy group and 37.0% of the control group.

Conclusions:

• The 6-month rifampicin-resistant tuberculosis treatment strategy is noninferior to the standard 9-month regimen in achieving successful outcomes.
• Both treatment strategies exhibited similar safety profiles.
• This shorter regimen offers a viable alternative for managing rifampicin-resistant TB.