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Completion Rate and Safety of Tuberculosis Infection Treatment with Shorter Regimens

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Completion Rate and Safety of Tuberculosis Infection Treatment with Shorter Regimens Completion Rate and Safety of TuberculosisAndrea T. Cruz, MD, MPH, Jeffrey R. Starke, Infection MD Treatment BACKGROUND: With Shorter Regimens abstract The traditional treatment of tuberculosis (TB) infection (9 months of daily isoniazid [9H]) is safe but completion rates of <50% are reported. Shorter regimens (3 months of once-weekly isoniazid and rifapentine [3HP] or 4 months of daily rifampin [4R]) METHODS: are associated with improved adherence in adults. – – ’ This was a retrospective cohort study (2014 2017) of children (0 18 years old) seen at a children s TB clinic in a low-incidence nation. We compared the frequency of completion and adverse events (AEs) in children receiving 3HP, 4R, and 9H; the latter 2 regimens could be administered by families (termed self-administered therapy [SAT]) or as RESULTS: directly observed preventive therapy (DOPT); 3HP was always administered under DOPT. TB infection treatment was started in 667 children: 283 (42.4%) 3HP, 252 (37.8%) 9H, and 132 (19.8%) 4R. Only 52% of children receiving 9H via SAT completed therapy. – Children receiving 3HP were more likely to complete therapy than the 9H (SAT) group – (odds ratio [OR] 27.4, 95% confidence interval [CI]: 11.8 63.7). Multivariate analyses found – – receipt of medication under DOPT (OR: 5.72, 95% CI: 3.47 9.43), increasing age (OR: 1.09, – 95% CI: 1.02 1.17), and the absence of any AE (OR: 1.70, 95% CI: 0.26 0.60) to be associated with completing therapy. AEs were more common in the 9H group (OR: 2.51, 95% CI: 1.48 4.32). Two (0.9%) children receiving 9H developed hepatotoxicity; no child receiving 3HP or CONCLUSIONS: 4R developed hepatotoxicity. Shorter regimens are associated with increased completion rates and fewer AEs than 9H. WH’ AT S KNOWN on THIS SUBJECT: Treatment of tuberculosis infection is safe and well tolerated. Department of Pediatrics, Baylor College of Medicine, Houston, Texas Completion rates of 9 months of daily isoniazid (9H) Dr Cruz conceptualized and designed the study, performed data collection and analyses, drafted are <50%. Using shorter regimens (3 months of the initial manuscript, and reviewed and revised the manuscript; Dr Starke helped conceptualize once-weekly isoniazid and rifapentine [3HP] and 4 the study and reviewed and revised the manuscript; and all authors approved the final months of daily rifampin) can enhance completion. manuscript as submitted and agree to be accountable for all aspects of the work. WHAT THIS STUDY ADDS: Children receiving 3HP DOI: https:// doi. org/ 10. 1542/ peds. 2017- 2838 were more likely to complete therapy than those Accepted for publication Nov 8, 2017 receiving daily 9H (odds ratio: 27.4, 95% confidence Address correspondence to Andrea T. Cruz, MD, MPH, Department of Pediatrics, Baylor College of interval: 11.8–63.7); only 52% of those receiving Medicine, 6621 Fannin St, Suite A2210, Houston, TX 77030. E-mail: [email protected] daily 9H completed therapy. Hepatotoxicity was uncommon (0% in 3HP vs 0.9% in 9H). PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Copyright © 2018 by the American Academy of Pediatrics FINANCIAL DISCLOSURE: Dr Starke is on the data safety monitoring board for Otsuka Pharmaceuticals for pediatric pharmacokinetic studies of delamanid; and Dr Cruz has indicated she has no financial relationships relevant to this article to disclose. FUNDING: No external funding. To cite: Cruz AT and Starke JR. Completion Rate and Safety of Tuberculosis Infection Treatment With Shorter Regimens. Pediatrics. 2018;141(2):e20172838 Downloaded from www.aappublications.org/news by guest on September 27, 2021 PEDIATRICS Volume 141, number 2, February 2018:e20172838 ARTICLE Therapy for tuberculosis (TB) ability to more accurately identify and (6) children with a positive TST infection is safe, efficacious, and children who would benefit from after having previously negative TST recommended for children who therapy to prevent progression to results. For other children, positive receive test results that are positive disease, coupled with regimens TST results were followed by an γ for an infection (either the tuberculin more palatable to children and IGRA obtained in our clinic and skin test [TST] or an interferon their families, suggests strategies treatment was offered only if the release assay [IGRA]) unless1 specific to improve effectiveness of TB IGRA result was positive for TB. The contraindications exist. In contrast, infection therapy. The goal of this rationale behind why our community effectiveness (how an intervention study was to describe the trends of colleagues used TST versus IGRA was performs in real-world conditions) use, completion rates, and safety not available. has been poor. The long duration of profiles of the 3 most commonly All children were treated by the therapy with the US-recommended used regimens for TB infection in a ≥ authors using 1 of 3 regimens (Table 9 months of daily isoniazid (9H), heterogeneous cohort of children in a 1). 3HP was used in children 2 concerns that families have regarding busy US urban TB clinic. years old and always administered false-positive TSTs in children who METHODS as directly observed preventive have received the BCG vaccine, 10, 11 therapy (DOPT). Children <2 and a culture of TB prevention that years old were not prescribed has made few inroads into high- This retrospective cohort study this regimen given the absence prevalence settings have adversely included 0- to 18-year-old children of data on rifapentine dosing impacted the effectiveness of TB 14 who were offered treatment for in this group. The remaining infection therapy. These factors ’ TB infection from January 2014 regimens, 4R and 9H, were used may be particularly important for to March 2017 at a children s TB in children of all ages and could be immigrant children, a group in which ’ clinic associated with a quaternary administered as DOPT, enhanced the rate of TB infection is far higher 2 care children s hospital. This clinic self-administered therapy ([ESAT] in than for US-born children. Authors is the main referral venue for which medications were delivered of a recent study found that only immigration and refugee programs, monthly to families by health 12% of over 8200 children diagnosed public health departments, and a departments, who called periodically with TB infection before immigrating network of community pediatricians for reminders; daily medication was to the United States successfully in a metropolitan area of almost 7 administered by family members), completed therapy after arrival in the 3 million persons. Using American or self-administered therapy (SAT). United States. ≥ Thoracic Society and Centers for In general, all 3 options were Completion rates of <50% have Disease Control and Prevention presented to patients 2 years old, been reported for both children and guidelines, TB infection was defined but a preference was expressed by adults when TB medications4,5 are as having positive results12, 13 from providers for 3HP. Isoniazid (INH) administered by families. either a TST or IGRA. Children was only administered twice-weekly There are few patient-specific receiving regimens for suspected under DOPT. In DOPT, medications factors associated with completion multidrug-resistant TB infection, were delivered by a health of therapy. Our previous studies families who refused to start children department representative who found that region of origin, language, on therapy, or those still on therapy asked the family about symptoms and the method to test for TB were excluded from this study.8 Eighty before administering the subsequent infection (TST versus IGRA) were children previously published as dose. Completion was calculated for not associated6 with completion of receiving 3HP were included. the first regimen a child received. An therapy. However, provision of exception was if therapy had to be 7 All TSTs were performed before therapy by local health departments changed because of documented drug children were being seen in the TB and using shorter-course therapy resistance from an isolate from a 7 clinic. A positive TST result alone with 4 months of daily rifampin (4R) person close to the child; then, it was (without a confirmatory sequential or 3 months of once-weekly isoniazid that definitive regimen that was used 8 IGRA) defined TB infection in: (1) and rifapentine (3HP) were to evaluate completion. children identified through contact associated with completion rates of tracing of a person with TB disease, The primary outcome was 93% to 99%. (2) immunocompromised children, completion of therapy. Children The last decade has seen publication (3) children about to receive were considered to have completed of more robust data on IGRA use immunosuppressive therapy, (4) therapy (Table 1) if medication was 9 ≥ in children and on shorter10, 11 course children <2 years of age, (5) children given under DOPT, even if they did regimens such as 3HP. The with TST induration of 20 mm, not return for clinic visits as long as Downloaded from www.aappublications.org/news by guest on September 27, 2021 2 CRUZ and STARKE TABLE 1 Regimens Used to Treat Children With TB Infection Regimen No. Dose(s), in mg/kg [Maximum Dose] Schedule Optimal Completion Defined As Mode of Duration Administration INH and 283 INH: 25 mg/kg (children 2–11 y) [900 mg]; 15 Weekly 12 wk Receipt of at least 11 doses over DOPT rifapentine mg/kg (children ≥12 y) [900 mg] a 16-wk period (3HP) Rifapentine: 300 mg (10–14 kg); 450 mg (14.1–25 kg); 600 mg (25.1–32 kg); 750 mg (32.1–49.9 kg); 900 mg (≥50 kg) [900 mg] RIF (4R) 132 10–20 mg/kg [600 mg] Daily 4 mo Receipt of at least 4 mo over a DOPT, ESAT, SAT 6-mo period or 52 observed doses if DOPT INH (9H) 178 20–30 mg/kg [900 mg] Twice 9 mo Receipt of 78 doses DOPT weekly INH (9H) 74 10–15 mg/kg [300 mg] Daily 9 mo Receipt of at least 6 mo ESAT, SAT consecutively or 9 mo over a 12-mo period DOPT provided to the child and administration witnessed by a health department representative.
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