Self-administered isoniazid, rifapentine noninferior to directly observed treatment of latent TB infection
Self-administered, once-weekly isoniazid and rifapentine to treat latent tuberculosis infection is feasible in the United States, and this treatment can be used in similar settings when direct observation is not viable, suggests a new study.
A total of 1,002 adults (median age 36 years; 48 percent women; 77 percent enrolled at the US sites) from outpatient tuberculosis clinics in the US, Spain, Hong Kong and South Africa received once-weekly isoniazid and rifapentine by direct observation, self-administration with monthly monitoring, or self-administration with weekly text message reminders and monthly monitoring.
Treatment completion, defined as 11 or more doses within 16 weeks and measured using clinical documentation and pill counts for direct observation, and self-reports, pill counts and medication event-monitoring devices for self-administration, was the primary outcome. The secondary outcomes were adverse events.
Treatment completion was highest in the direct-observation group at 87.2 percent (95 percent CI, 83.1 to 90.5 percent), followed by 76.4 percent (71.3 to 80.8 percent) in the self-administration‒with‒reminders group and 74.0 percent (68.9 to 78.6 percent) in the self-administration group.
In the US, treatment completion was 85.4 (80.4 to 89.4), 76.7 (70.9 to 81.7 percent) and 77.9 (72.7 to 82.6 percent), respectively. Self-administered therapy without reminders was noninferior to direct observation in the US, and no other comparisons met the noninferiority criteria.
There were a few and similar drug-related adverse events across all groups.
“Expanding latent tuberculosis treatment is important to decrease active disease globally. Once-weekly isoniazid and rifapentine for 12 doses is effective but limited by requiring direct observation,” researchers said.