Methods: A prospective observational cohort of patients diagnosed with LTBI at 16 U.S. sites was offered treatment with the once weekly 12 dose, directly observed regimen of isoniazid and rifapentine (INH-RPT) between July 1, 2011, and December 31, 2013. Demographic information was collected from all patients. At 10 of 16 sites, additional data on medical and social risk factors for TB, as well as concomitant medication use were collected. All patients receiving treatment were monitored for adverse events (AE) using a standardized questionnaire. We conducted descriptive analyses and identified factors associated with non-completion of INH-RPT. Bivariate and multivariate adjusted relative risks are reported with 95% confidence intervals (CI).
Results: Data were collected on 3,307 eligible patients. The overall treatment discontinuation rate was 13% [423/3307]; the median age was 41 years of age and 50% were male [211/423]. Among patients stopping treatment, 58% [247/423] stopped due to an AE while the remaining 42% [176/423] stopped because of moves, loss to follow-up, or refusal to continue the regimen. No patient stopped treatment as a result of death. Treatment was most commonly stopped after the fourth dose (median: 4, IQR: 2, 6). The risk of non-completion was greater for persons experiencing homelessness [ARR=2.18, 95% CI= 1.39, 3.40], aged ≥ 65 [ARR=1.98, 95% CI= 1.35, 2.90], who were non-Hispanic white [ARR=1.57, 95% CI= 1.22, 2.03], or had a history of smoking [ARR=1.34, 95% CI= 1.02, 1.75]. The risk of non-completion was less for persons having recent contact to an infectious TB patient [ARR=0.53, 95% CI= 0.39, 0.73] and for students [ARR=0.32, 95% CI= 0.14, 0.73].
Conclusion: Homeless persons, older adults, non-Hispanic whites, and smokers were at greater risk for non-completion of LTBI treatment. TB programs should prioritize efforts and target resources to these subpopulations to optimize completion of treatment.
A. Sandul, None
S. Morris, None
S. Marks, None