Details:

Alternative Title:
Ann Intern Med
Personal Author:
Belknap, Robert ; Holland, David ; Feng, Pei-Jean ; Millet, Joan-Pau ; Caylà, Joan A. ; ... More +
Belknap, Robert ; Holland, David ; Feng, Pei-Jean ; Millet, Joan-Pau ; Caylà, Joan A. ; Martinson, Neil A. ; Wright, Alicia ; Chen, Michael P. ; Moro, Ruth N. ; Scott, Nigel A. ; Arevalo, Bert ; Miró, José M. ; Villarino, Margarita E. ; Weiner, Marc ; Borisov, Andrey S. ; Less -
Description:
Background 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. Objective To compare treatment completion and safety of once-weekly isoniazid and rifapentine by self-administration versus direct observation. Design An open-label, phase 4 randomized clinical trial designed as a noninferiority study with a 15% margin. Seventy-five percent or more of study patients were enrolled from the United States for a prespecified subgroup analysis. (ClinicalTrials.gov: NCT01582711) Setting Outpatient tuberculosis clinics in the United States, Spain, Hong Kong, and South Africa. Participants 1002 adults (aged ≥18 years) recommended for treatment of latent tuberculosis infection. Intervention Participants 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. Measurements The primary outcome was 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. The main secondary outcome was adverse events. Results Median age was 36 years, 48% of participants were women, and 77% were enrolled at the U.S. sites. Treatment completion was 87.2% (95% CI, 83.1% to 90.5%) in the direct-observation group, 74.0% (CI, 68.9% to 78.6%) in the self-administration group, and 76.4% (CI, 71.3% to 80.8%) in the self-administration–with–reminders group. In the United States, treatment completion was 85.4% (CI, 80.4% to 89.4%), 77.9% (CI, 72.7% to 82.6%), and 76.7% (CI, 70.9% to 81.7%), respectively. Self-administered therapy without reminders was noninferior to direct observation in the United States; no other comparisons met noninferiority criteria. A few drug-related adverse events occurred and were similar across groups. Limitation Persons with latent tuberculosis infection enrolled in South Africa would not routinely be treated programmatically. Conclusion These results support using self-administered, once-weekly isoniazid and rifapentine to treat latent tuberculosis infection in the United States, and such treatment could be considered in similar settings when direct observation is not feasible. Primary Funding Source Centers for Disease Control and Prevention.
Subject:
[+]
Adult
Antibiotics, Antitubercular
Antitubercular Agents
Article
Directly Observed Therapy
Drug Administration Schedule
Drug Therapy, Combination
Female
Humans
Isoniazid
Latent Tuberculosis
Male
Medication Adherence
Middle Aged
Reminder Systems
Rifampin
Self Administration
Text Messaging

Source:
Ann Intern Med. 167(10):689-697. ;
Pubmed ID:
29114781
Pubmed Central ID:
PMC5766341
Document Type:
Journal Article ;
Funding:
CC999999/Intramural CDC HHS/United States ;
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:1eaf3d3079d1c6c2a5cf2e5f036c08a2dacf84093d97486506f106471a434d7e
File Type:

Supporting Files

• 	nihms928922.nxml	xml
  	nihms928922f1.gif	gif
  	nihms928922f1.jpg	jpeg
  	nihms928922f2.gif	gif
  	nihms928922f2.jpg	jpeg

More +