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100% SVR Rate in National Pediatric HCV Network for England-Wales-Ireland
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AASLD 2023, The Liver Meeting, November 10-14, 2023, Boston
Mark Mascolini
An HCV Operational Delivery Network (ODN) for children and adolescents across England, Wales, and Northern Ireland has a 100% treatment success rate so far, according to a 2-year analysis by health workers who run the network [1]. Referring clinicians, children, and parents report they are "extremely satisfied" with the HCV treatment system.
HCV therapy with direct-acting antivirals (DAAs) got the green light for 3- to 12-year-olds in England in 2020, with prescribing and reimbursement centralized in the National Health Service England (NHSE). When the COVID lockdown took hold, England and Wales created a virtual national treatment pathway for children with HCV to get care close to home-directed through a single point of contact, the national Paediatric Multi Disciplinary Operational Delivery Network, or pMDT ODN. Workers from pediatric centers and universities collaborated to evaluate the efficacy of that system, particularly in regard to treatment outcomes.
In December 2020 funding was allocated to treat children 3 to 18 years old through the pMDT ODN, which was launched on April 1, 2021. The plan aimed to assess children and adolescents for HCV infection confirmed by HCV RNA and to make DAA treatment available with one of four regimens licensed for children: Harvoni (ledipasvir/sofosbuvir), Maviret (glecaprevir/pibrentasvir), Epclusa (sofosbuvir/velpatasvir), and Sovaldi (sofosbuvir). The Birmingham Women's and Children's Hospital was commissioned to host the pMDT ODN.
Upon referral of a youngster with HCV, the pMDT ODN picks the most appropriate regimen based on clinical presentation, genotype, patient preference, and ability to swallow tablets. The pMDT ODN prescribes treatment through a local pediatrician and pharmacist so families do not have to travel to national centers. All children in England, Wales, and Northern Ireland are eligible for treatment funded by the NHS. The pMDT ODN approves referral centers to dispense DAAs and get reimbursed by the NHSE.
At virtual monthly meetings the pMDT ODN discusses each youngster being considered for treatment or on treatment. From April 2021 to September 2023, clinicians referred 113 children. Sustained virologic response is reported at 12 weeks (SVR12) and 12 months (12mSVR). Feedback questionnaires are provided to referring clinicians, treated children, and parents.
Among the 113 referred children, 52 had genotype 1 HCV, 4 genotype 2, 52 genotype 3, and 5 genotype 4. Median age of these 58 girls and 55 boys stood at 8.6 years (range 3.03 to 16.2). All but 1 child was vertically infected. Forty-four children were white British, 25 were other whites, 18 were Asian, and the rest had other or unknown race or ethnicity.
Thirty-one children lived in North West England, 18 in the South West, 18 in London, 16 in the East Midlands, 12 in the West Midlands, 8 in the North East, 8 in Wales, and 1 each in Guernsey and Northern Ireland.
Comorbidities recorded in 41 children were autism/learning difficulty/developmental delay in 15, fetal alcohol syndrome in 7, obesity in 6, growth delay in 4, cardiac involvement in 3, cystic fibrosis and Araskog syndrome in 1 each, and 23 minor comorbidities.
The pMDT ODN approved treatment for these 113 children so far, of whom 21 are awaiting therapy. Among the 92 treated children, 79 had cleared HCV at the end of treatment and 13 had not reached the end of treatment. Of the 79 with end-of-treatment clearance, 68 had SVR12 and 10 had not reached SVR12. Of the 68 with SVR12, 41 had 12mSVR and 27 had not reached 12mSVR.
Treating clinicians recorded 12 adverse events in 91 children, including 5 cases of headache or nausea, 3 children with problems taking DAAs (2 with swallowing problems and 1 not liking the taste), 3 children with missed doses, and 1 with intermittent nose bleeds. All these problems resolved. (The child who did not like the taste of medications was advised not to chew them.)
On follow-up questionnaires, referring clinicians reported extreme satisfaction with the pMDT ODN system, agreeing that the referral process is simple and clear, that the protocol improves quality of care, that ODN meetings are informative, that decisions are clear and communication excellent. Children and parents also gave and overall rating of "extremely satisfied," citing awareness of the pMDT ODN before referral, maintenance of confidentiality, adequate information, attentive and thoughtful staff, and outstanding service that put them at ease.
By enhancing access to DAA therapy for children and adolescents, the researchers concluded that the pMDT ODN "has made a fundamental contribution to achieving [the] NHSE target to eliminate HCV in children and adolescents ahead of the WHO 2030 target."
Reference
1. Llyod C, Brown M, Abassi T, et al. Eliminating hep C in children: care closer to home. AASLD 2023, The Liver Meeting, November 10-14, 2023, Boston
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