Dataset Information

High Completion Rate for 12 Weekly Doses of Isoniazid and Rifapentine as Treatment for Latent Mycobacterium tuberculosis Infection in the Federal Bureau of Prisons.

ABSTRACT: CONTEXT:Correctional facilities provide unique opportunities to diagnose and treat persons with latent tuberculosis infection (LTBI). Studies have shown that 12 weekly doses of isoniazid and rifapentine (INH-RPT) to treat LTBI resulted in high completion rates with good tolerability. OBJECTIVE:To evaluate completion rates and clinical signs or reported symptoms associated with discontinuation of 12 weekly doses of INH-RPT for LTBI treatment. SETTING/PARTICIPANTS:During July 2012 to February 2015, 7 Federal Bureau of Prisons facilities participated in an assessment of 12 weekly doses of INH-RPT for LTBI treatment among 463 inmates. MAIN OUTCOME MEASURES:Fisher exact test was used to assess the associations between patient sociodemographic characteristics and clinical signs or symptoms with discontinuation of treatment. RESULTS:Of 463 inmates treated with INH-RPT, 424 (92%) completed treatment. Reasons for discontinuation of treatment for 39 (8%) inmates included the following: 17 (44%) signs/symptoms, 9 (23%) transfer or release, 8 (21%) treatment refusal, and 5 (13%) provider error. A total of 229 (49.5%) inmates reported experiencing at least 1 sign or symptom during treatment; most frequently reported were fatigue (16%), nausea (13%), and abdominal pain (7%). Among these 229 inmates, signs/symptoms significantly associated with discontinuation of treatment included abdominal pain (P < .001), appetite loss (P = .02), fever/chills (P = .01), nausea (P = .03), sore muscles (P = .002), and elevation of liver transaminases 5× upper limits of normal or greater (P = .03). CONCLUSIONS:The LTBI completion rates were high for the INH-RPT regimen, with few inmates discontinuing because of signs or symptoms related to treatment. This regimen also has practical advantages to aid in treatment completion in the correctional setting and can be considered a viable alternative to standard LTBI regimens.

SUBMITTER: Schmit KM

PROVIDER: S-EPMC6336524 | biostudies-literature | 2019 Mar/Apr

REPOSITORIES: biostudies-literature

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High Completion Rate for 12 Weekly Doses of Isoniazid and Rifapentine as Treatment for Latent Mycobacterium tuberculosis Infection in the Federal Bureau of Prisons.

Schmit Kristine M KM Lobato Mark N MN Lang Simona G SG Wheeler Sherri S Kendig Newton E NE Bur Sarah S

Journal of public health management and practice : JPHMP 20190301 2

<h4>Context</h4>Correctional facilities provide unique opportunities to diagnose and treat persons with latent tuberculosis infection (LTBI). Studies have shown that 12 weekly doses of isoniazid and rifapentine (INH-RPT) to treat LTBI resulted in high completion rates with good tolerability.<h4>Objective</h4>To evaluate completion rates and clinical signs or reported symptoms associated with discontinuation of 12 weekly doses of INH-RPT for LTBI treatment.<h4>Setting/participants</h4>During July ...[more]

PMID: 30024493

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Project description:ObjectivesTo describe COVID-19 vaccine distribution operations in United States Federal Bureau of Prisons (BOP) institutions and offices from December 16, 2020-April 14, 2021, report vaccination coverage among staff and incarcerated people, and identify factors associated with vaccination acceptance among incarcerated people.MethodsThe BOP COVID-19 vaccination plan and implementation timeline are described. Descriptive statistics and vaccination coverage were calculated for the BOP incarcerated population using data from the BOP electronic medical record. Coverage among staff was calculated using data from the Centers for Disease Control and Prevention Vaccination Administration Management System. Vaccination coverage in the BOP versus the overall United States adult population was compared by state/territory. Univariate and multivariable logistic regression models were developed to identify demographic, health-related, and institution-level factors associated with vaccination acceptance among incarcerated people, using hierarchical linear modeling to account for institution-level clustering.ResultsBy April 14, 2021, BOP had offered COVID-19 vaccination to 37,870 (100%) staff and 88,173/126,413 (69.8%) incarcerated people, with acceptance rates of 50.2% and 64.2%, respectively. At the time of analysis, vaccination coverage in BOP was comparable to coverage in the overall adult population in the states and territories where BOP institutions and offices are located. Among incarcerated people, factors associated with lower vaccination acceptance included younger age, female sex, non-Hispanic Black and Asian race/ethnicity, and having few underlying medical conditions; factors associated with higher acceptance included having a prior SARS-CoV-2 infection, being born outside the United States, and being assigned to a Federal Detention Center.ConclusionsEarly COVID-19 vaccination efforts in BOP have achieved levels of coverage similar to the general population. To build on this initial success, BOP can consider strategies including re-offering vaccination to people who initially refused and tailoring communication strategies to groups with lower acceptance rates.

Project description:BackgroundExpanding 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.ObjectiveTo compare treatment completion and safety of once-weekly isoniazid and rifapentine by self-administration versus direct observation.DesignAn 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).SettingOutpatient tuberculosis clinics in the United States, Spain, Hong Kong, and South Africa.Participants1002 adults (aged ≥18 years) recommended for treatment of latent tuberculosis infection.InterventionParticipants 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.MeasurementsThe 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.ResultsMedian 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.LimitationPersons with latent tuberculosis infection enrolled in South Africa would not routinely be treated programmatically.ConclusionThese 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 sourceCenters for Disease Control and Prevention.

Project description:Isoniazid pharmacokinetics are not yet well-described during once weekly, high-dose administrations with rifapentine (3HP) for latent tuberculosis infection (LTBI). Fewer data describe 3HP with dolutegravir-based antiretroviral therapy for the treatment of human immunodeficiency virus (HIV). The only prior report of 3HP with dolutegravir reported elevated isoniazid exposures. We measured the plasma isoniazid levels in 30 adults receiving 3HP and dolutegravir for the treatment of LTBI and HIV. The patients were genotyped to determine NAT2 acetylator status, and a population PK model was estimated by nonlinear mixed-effects modeling. The results were compared to previously reported data describing 3HP with dolutegravir, 3HP alone, and isoniazid with neither dolutegravir nor rifapentine. The isoniazid concentrations were adequately described by a one compartment model with a transit compartment absorption process. The isoniazid clearance for slow (8.33 L/h) and intermediate (12 L/h) acetylators were similar to previously reported values. Rapid acetylators (N = 4) had clearance similar to those of intermediate acetylators and much slower than typically reported, but the small sample size was limiting. The absorption rate was lower than usual, likely due to the coadministration with food, and it was faster among individuals with a low body weight. Low-body weight participants were also observed to have greater oral bioavailability. The isoniazid exposures were consistent with, or greater than, the previously reported "elevated" concentrations among individuals receiving 3HP and dolutegravir. The concentrations were substantially greater than those presented in previous reports among individuals receiving 3HP or isoniazid without rifapentine or dolutegravir. We discuss the implications of these findings and the possibility of a drug-drug interaction that is mediated by cellular transport. (This study has been registered at ClinicalTrials.gov under identifier NCT03435146 and has South African National Clinical Trial Registration no. DOH-27-1217-5770.).

Project description:ContextLatent tuberculosis infection diagnosis and treatment is a strategic priority for eliminating tuberculosis in the U.S. The Centers for Disease Control and Prevention has recommended the short-course regimen of 3-month isoniazid-rifapentine administered by directly observed therapy. However, longer-duration regimens remain the most widely prescribed latent tuberculosis infection treatments. Limitation on adoption of 3-month isoniazid-rifapentine in the U.S. might be because of patients' preference for self-administered therapy, providers' lack of familiarity with 3-month isoniazid-rifapentine, or lack of resources to support directly observed therapy. This review examines the most recent evidence regarding 3-month isoniazid-rifapentine's effectiveness, safety, and treatment completion when directly compared with other latent tuberculosis infection regimens primarily comprising 9-month isoniazid treatment.Evidence acquisitionUsing Community Guide methodology, reviewers identified, evaluated, and summarized available evidence published during January 2006-June 2017. Analysis of the data was completed in 2017.Evidence synthesisThe analysis included 15 unique studies. Three-month isoniazid-rifapentine was determined to be equal to other latent tuberculosis infection regimens in effectiveness (OR=0.89, 95% CI=0.46, 1.70), and has higher treatment completion (87.5%, 95% CI=83.2%, 91.3%) compared with other latent tuberculosis infection regimens (65.9%, 95% CI=53.5%, 77.3%). Three-month isoniazid-rifapentine was associated with similar risk to other latent tuberculosis infection regimens for adverse events (relative risk=0.59, 95% CI=0.23, 1.52); discontinuing treatment because of adverse events (relative risk=0.48, 95% CI=0.17, 1.34); and death (relative risk=0.79, 95% CI=0.56, 1.11).ConclusionsThe 3-month isoniazid-rifapentine regimen is as safe and effective as other recommended latent tuberculosis infection regimens and achieves significantly higher treatment completion rates.

Dataset Information

High Completion Rate for 12 Weekly Doses of Isoniazid and Rifapentine as Treatment for Latent Mycobacterium tuberculosis Infection in the Federal Bureau of Prisons.

Publications

High Completion Rate for 12 Weekly Doses of Isoniazid and Rifapentine as Treatment for Latent Mycobacterium tuberculosis Infection in the Federal Bureau of Prisons.

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