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The Centers for Disease Control and Prevention (CDC) collaborated with the Food and Drug Administration (FDA) to explore whether the Sentinel Distributed Database (SDD) could enhance CDC’s and FDA’s understanding of the epidemiology of latent tuberculosis infection (LTBI). This CDC-FDA collaborative study assessed LTBI testing, clinical management, and treatment duration in individuals treated for LTBI.
Among 113,338 patients who filled prescriptions for drugs indicated for LTBI, INH-only was the most commonly prescribed LTBI treatment with 80% (90,377) receiving isoniazid (INH) only, 19% (21,235) rifampin (RIF) only, and 2% (1,726) INH + rifapentine (RPT). Overall, 88% of patients had at least one element of diagnostic evaluation documented before starting treatment. Most persons who filled a prescription for LTBI treatment did not have evidence of completing the recommended treatment durations. The data further support preferential use of shorter-course regimens such as INH + RPT.
Using Sentinel data, this study was able to describe the common LTBI treatment regimens and provide insight into prescribing behavior. The study also showed the treatment duration for each regimen, highlighting the need for additional interventions to support patients’ completion of/adherence to LTBI therapy. Additionally, the study identified varying rates of diagnostic testing among LTBI patients by treatment regimen, suggesting a potential lack of provider familiarity with recommendations.
Due to limitations in this study common to claims-based data sources, such as lack of information on tuberculosis related test results, incomplete race and ethnicity data, and restriction to individuals with health insurance, FDA’s Sentinel System may not be suitable for general population-level LTBI surveillance in the United States. Nevertheless, the FDA Sentinel System can serve as a complementary source of data to augment surveillance of adverse events related to LTBI treatment regimens, describe specific groups of individuals with LTBI, and provide insight into prescribing patterns for LTBI.