The 4-month regimen of rifampin was found to have a higher rate of treatment completion and better safety profile compared to the 9-month regimen of isoniazid for the prevention of active tuberculosis, reports a recent study published in NEJM.
Tuberculosis(TB) is a major global health problem. It has been estimated that one-quarter of the global population has latent tuberculosis infection.
World Health Organization (WHO), recommends the treatment of latent tuberculosis infection with isoniazid for 6 or 9 months with the longer duration showing evidence of greater protective efficacy but the benefit of treatment with isoniazid is substantially reduced because of poor rates of regimen completion and hepatotoxic effects.
Dick Menzies et al. conducted phase 3 trial to compare the effectiveness and efficacy of a 4-month regimen of rifampin with a 9-month regimen of isoniazid for the prevention of active TB.
The researchers in an open-label trial randomly assigned adults with latent tuberculosis infection to receive treatment with a 4-month regimen of rifampin or a 9-month regimen of isoniazid for the prevention of confirmed active tuberculosis within 28 months after randomization.
The primary outcome was the assessment of noninferiority and potential superiority. Secondary outcomes included clinically diagnosed active tuberculosis, adverse events of grades 3 to 5, and completion of the treatment regimen.
Key study findings:
- The rate of treatment completion was higher in the rifampin group than in the isoniazid group.
- The rifampin regimen was not superior to the isoniazid regimen
- In the rifampin group, there was a significantly lower incidence of adverse events of grades 3 to 5, particularly hepatotoxic adverse events than in the isoniazid group in analyses that included all such adverse events, that included only events that were adjudicated as being drug-related, and that included only events that occurred in the first 146 days after randomization.
The study concluded that a 4-month regimen of rifampin was not inferior to a 9-month regimen of isoniazid for the prevention of active tuberculosis. Moreover, the rifampin group had a significantly higher rate of treatment completion and fewer drug-related adverse events of grades 3 to 5.
For reference log on to https://www.nejm.org/doi/full/10.1056/NEJMoa1714283