Outcomes in children treated for tuberculosis with the new dispersible fixed-dose combinations in Port Moresby

Apis, V.; Landi, M.; Graham, Stephen M.; Islam, Tauhid; Amini, James; Sabumi, G.; Mandalakas, Anna M.; Meae, T.; Cros, Philipp du; Shewade, Hemant Deepak; Welch, Henry

doi:10.5588/pha.18.0062

Cited by 4 publications

(4 citation statements)

References 10 publications

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“…A TPT regimen of 3 months of daily rifampicin and isoniazid (3RH)recommended by WHO in 2018has been associated with high uptake, completion and safety in young child contacts under programmatic conditions in resource-limited settings (18). The availability in PNG of dispersible, child-friendly combined formulations for active TB since 2016 (19), led to the successful implementation of 3RH for young child contacts of DS-TB in Daru from 2019. In Daru, up to 20% of incident TB is MDR/RR-TB (5).…”

Section: Tb Preventive Treatmentmentioning

confidence: 99%

Contact screening and management in a high-transmission MDR-TB setting in Papua New Guinea: Progress, challenges and future directions

Majumdar

Islam²,

Huang³

et al. 2023

Front. Trop. Dis

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Daru, South Fly District, Papua New Guinea is a high transmission setting for multidrug-resistant tuberculosis (MDR-TB). An emergency response by the Government in 2014 established a high-quality model for treatment and care. Household contact screening and management commenced in 2016 with TB preventive treatment (TPT) for well young child (<5 years) contacts of people with drug-susceptible TB and later expanded to young child contacts of MDR-TB. The model of care is community-based and led by non-specialist health workers, under supervision. An electronic medical record system supports care, reporting and operational research. Community engagement and education has been central, with a concerted focus on peer-led counselling and patient-centred services to improve TPT uptake and completion. Challenges include the application of households as the unit of intervention for detection of active TB and TPT provision. Our implementation experience in Daru has highlighted significant population mixing dynamics with most transmission likely occurring outside the household. We propose a community-wide screening approach with the provision of TPT based on testing to include older children, adolescents, and young adults. As there is the possibility of MDR-TB infection irrespective of the drug susceptibility of the household index case, a novel option is a combination TPT regimen of 6 months of daily isoniazid and levofloxacin (6HLfx). A sensitive aged-related algorithm to detect and exclude active TB is being developed. Ongoing community engagement, quality data systems with operational research to evaluate approaches are critical in high transmission MDR-TB settings.

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Section: Tb Preventive Treatmentmentioning

confidence: 99%

Contact screening and management in a high-transmission MDR-TB setting in Papua New Guinea: Progress, challenges and future directions

Majumdar

Islam²,

Huang³

et al. 2023

Front. Trop. Dis

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“…Except for the National Capital District, provinces in PNG do not have specific clinics to follow up child TB, and caregivers are not properly supported. PNG was one of the first countries to introduce child-friendly fixed-dose formulations to improve treatment in young children managed at Port Moresby General Hospital [65]. Recent progress has also been seen in both diagnosis and treatment of child TB in Port Moresby, under a TB/HIV project which supports additional child TB focused human resources, tools, training and transport.…”

Section: Papua New Guinea: Addressing Challenges In a High-burden Chi...mentioning

confidence: 99%

Priority Activities in Child and Adolescent Tuberculosis to Close the Policy-Practice Gap in Low- and Middle-Income Countries

et al. 2022

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Over the past 15 years, and despite many difficulties, significant progress has been made to advance child and adolescent tuberculosis (TB) care. Despite increasing availability of safe and effective treatment and prevention options, TB remains a global health priority as a major cause of child and adolescent morbidity and mortality—over one and a half million children and adolescents develop TB each year. A history of the global public health perspective on child and adolescent TB is followed by 12 narratives detailing challenges and progress in 19 TB endemic low and middle-income countries. Overarching challenges include: under-detection and under-reporting of child and adolescent TB; poor implementation and reporting of contact investigation and TB preventive treatment services; the need for health systems strengthening to deliver effective, decentralized services; and lack of integration between TB programs and child health services. The COVID-19 pandemic has had a significant negative impact on case detection and treatment outcomes. Child and adolescent TB working groups can address country-specific challenges to close the policy–practice gaps by developing and supporting decentral ized models of care, strengthening clinical and laboratory diagnosis, including of multidrug-resistant TB, providing recommended options for treatment of disease and infection, and forging strong collaborations across relevant health sectors.

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“…To date, commonly used pharmaceutical formulations are either liquid dosage forms (e.g., solutions, suspensions), fixed dose dispersible tablets and in most instances, adult tablets are often broken, crushed or mixed with food or water (co-administration) to make pediatric management possible [12][13][14][15]. Despite the availability of a few commercialized pediatric preparations, considerable global scarcity still exists, meaning that many children are unable to access these medicines [15][16][17][18][19]. Moreover, studies have shown that co-administration (with food, water etc.)…”

Section: Introductionmentioning

confidence: 99%

“…Recent studies show that the most popular age appropriate delivery systems are small sized, solid oral drug delivery systems e.g., minitablets and multi-particulates and orally disintegrating formulations like orodispersible tablets or films [18,25]. Particularly, orodispersible formulations are of choice because of their characteristic advantages such as water free administration, easy to use anywhere and at any time without the need for external help or specialized caregivers, improved stability, easier transportation, cost effectiveness and rapid disintegration when placed within the oral cavity releasing incorporated API for absorption.…”

Section: Introductionmentioning

confidence: 99%

Optimal Design, Characterization and Preliminary Safety Evaluation of an Edible Orodispersible Formulation for Pediatric Tuberculosis Pharmacotherapy

Matawo

Adeleke

Wesley-Smith

2020

IJMS

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The severity of tuberculosis (TB) in children is considered a global crisis compounded by the scarcity of pharmaceutical formulations suitable for pediatric use. The purpose of this study was to optimally develop and evaluate a pyrazinamide containing edible orodispersible film formulation potentially suitable for use in pediatrics actively infected with TB. The formulation was prepared employing aqueous-particulate blending and solvent casting methods facilitated by a high performance Box Behnken experimental design template. The optimized orodispersible formulation was mechanically robust, flexible, easy to handle, exhibited rapid disintegration with initial matrix collapse occurring under 60 s (0.58 ± 0.05 min ≡ 34.98 ± 3.00 s) and pyrazinamide release was controlled by anomalous diffusion coupled with matrix disintegration and erosion mechanisms. It was microporous in nature, light weight (57.5 ± 0.5 mg) with an average diameter of 10.5 mm and uniformly distributed pyrazinamide load of 101.13 ± 2.03 %w/w. The formulation was physicochemically stable with no evidence of destructive drug–excipient interactions founded on outcomes of characterization and environmental stability investigations. Preliminary inquiries revealed that the orodispersible formulation was cytobiocompatible, palatable and remained intact under specific storage conditions. Summarily, an edible pyrazinamide containing orodispersible film formulation was optimally designed to potentially improve TB pharmacotherapy in children, particularly the under 5 year olds.

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Outcomes in children treated for tuberculosis with the new dispersible fixed-dose combinations in Port Moresby

Cited by 4 publications

References 10 publications

Contact screening and management in a high-transmission MDR-TB setting in Papua New Guinea: Progress, challenges and future directions

Contact screening and management in a high-transmission MDR-TB setting in Papua New Guinea: Progress, challenges and future directions

Priority Activities in Child and Adolescent Tuberculosis to Close the Policy-Practice Gap in Low- and Middle-Income Countries

Optimal Design, Characterization and Preliminary Safety Evaluation of an Edible Orodispersible Formulation for Pediatric Tuberculosis Pharmacotherapy

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