A new study finds that self-administered therapy for latent tuberculosis infection (LTBI) may be a viable option for patients where direct medical oversight is not available. These results were published online November 7 in the Annals of Internal Medicine.
As part of an open-label, phase 4 randomized clinical trial, researchers enrolled 1002 patients from outpatient TB clinics in the United States, Spain, Hong Kong, and South Africa between September 2012 and April 2014. Patients with active TB, prior treatment for TB lasting more than 1 week, contact with someone with a resistant form of TB, or prior intolerance to anti-TB agents were excluded. The majority of enrolled patients (n = 774) were in the United States; however, participants were demographically similar between groups. The median age was 36 years, and 48.1% of the patients were women.
Patients were randomly assigned to receive isoniazid or rifapentine once weekly by directly observed therapy (DOT), self-administered therapy (SAT) with weekly text message reminders, or SAT without reminders. The primary objective of the study was to compare treatment adherence, defined as completion of 11 or more doses of medication within 16 weeks. All participants were counseled on correct pill-taking and symptoms of drug toxicity. All patients had monthly follow-up visits both during therapy and for 28 days after the last dose to assess adherence and monitor for adverse events.
The researchers documented overall completion rates of 87.2% (95% confidence interval [CI], 83.1% – 90.5%) in the DOT group, 74.0% (CI, 68.9% – 78.6%) in the SAT group, and 76.4% (CI, 71.3% – 80.8%) in the SAT with reminders group.
Specifically, among the US patients, the researchers noted treatment completion rates of 85.4% (CI, 80.4% – 89.4%), 77.9% (CI, 72.7% – 82.6%), and 76.7% (CI, 70.9% – 81.7%), respectively. Using a 15% difference to define noninferiority, the researchers found SAT without reminders to be noninferior to DOT in the United States.
The researchers also found that adverse events were similar between all 3 groups.
In an accompanying editorial, Haileyesus Getahun, MD, from the World Health Organization Global TB Programme, Geneva, Switzerland, and Alberto Matteelli, MD, from the University of Brescia, Italy, write: “Ensuring adherence to therapy among patients with LTBI requires addressing not only patient-related factors but also health system and broad socioeconomic barriers.”
Dr Getahun and Dr Matteelli note that the current study provides evidence that SAT should be considered in certain settings and that “[a] platform of shared decision making between patients and providers will be essential in identifying circumstances in which self-administration is likely to be successful.”
The researchers acknowledge limitations in the study, such as the fact that not all patients assigned to receive weekly reminders had access to text messages and that findings may vary in areas with a higher TB burden.
“This self-administered regimen with monthly monitoring may be an acceptable strategy for treating LTBI in the United States and could be considered in countries with similar approaches to TB prevention when DOT is not feasible,” concluded the study authors.
Funding for this study was provided by the Centers for Disease Control and Prevention through the Tuberculosis Trials Consortium. Sanofi supplied isoniazid and rifapentine and has donated $2.9 million to the CDC Foundation for rifapentine research. The authors and editorialists have disclosed no relevant financial relationships.
Ann Intern Med. Published online November 7, 2017. Article abstract, Editorial extract
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