Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Self-Administered Treatment for Latent Tuberculosis

Ann Intern Med; ePub 2017 Nov 7; Belknap, et al

Self-administered, once-weekly isoniazid and rifapentine to treat latent tuberculosis infection in the US is viable, and such treatment should be considered. The open-label, phase 4 randomized clinical trial included 1,002 adult patients (median age 36 years) recommended for treatment of latent tuberculosis infection from outpatients TB clinics in the US, Spain, Hong Kong, and South Africa. Participants received once-weekly isoniazid and rifapentine by 1) direct observation, 2) self-administration with monthly monitoring, or 3) self-administration with weekly text message reminders and monthly monitoring. The primary outcome was treatment completion and secondary outcome was adverse events. Researchers found:

  • Treatment completion was 87.2% in the direct-observation group, 74.0% in the self-administered group, and 76.4% in the self-administration with reminders group.
  • In the US, treatment completion was 85.4%, 78.0%, and 76.7%, respectively.
  • Self-administered therapy without reminder was noninferior to direct observation in the US.
  • Drug-related adverse events were few and similar across groups.

Citation:

Belknap R, Holland D, Feng P, et al. Self-administered versus directly observed once-weekly isoniazid and rifapentine treatment of latent tuberculosis infection: A randomized trial. [Published online ahead of print November 7, 2017]. Ann Intern Med. doi:10.7326/M17-1150.

Commentary:

The vast majority (86%) of active TB cases in the US occur after reactivation from latent TB infection (LBTI).1 The standard treatment for LTBI is daily INH for 6-9 months. A previous study, the PREVENT TB study, showed that 3 months of once-weekly INH and rifapentine given by directly observed therapy (DOT) was as effective as 9 months of daily INH by self-administered therapy (SAT).2 This is likely because many patients miss numerous doses of daily INH. Approximately 30% of self-administered doses of INH are not taken. The current study shows that self-administration of once weekly therapy with isoniazid and rifapentine works as well as the standard treatment of daily INH for 9 months. Surprisingly, text reminders, which seem to make so much sense, do not seem to improve adherence to the medications according to this study. —Neil Skolnik, MD

  1. Yuen CM, Kammerer JS, Marks K, Navin TR, France AM. Recent transmission of tuberculosis—United States, 2011–2014. PLoS One. 2016;11:e0153728. doi:10.1371/journal.pone.0153728.
  2. Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven- Sizemore E, et al; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011;365:2155-66. doi:10.1056/NEJMoa1104875.