ABSTRACT
AimHepatitis C Virus (HCV) infection is a major global health problem. Direct Acting Anti-viral therapy (DAA) has cure rates of 99% in adults and adolescents.1 DAAs were licensed for children 3 – 12 years during the recent coronavirus pandemic. In order to ensure equitable access and a safe, effective and convenient supply of these medications during lockdown, we established a virtual national treatment pathway for children with HCV in England and evaluated its feasibility, efficacy and treatment outcomes.MethodA paediatric Multidisciplinary Team Operational Delivery Network (pMDT ODN), supported by NHS England (NHSE), was established with relevant paediatric specialists, including pharmacists, to provide a single point of contact for referrals and information. Referral, treatment protocols and family friendly patient information were developed for all HCV therapy. On referral the pMDT ODN discussed and agreed the most appropriate DAA therapy based on clinical presentation and patient preferences, including ability to swallow tablets. Treatment was then prescribed and supplied in association with the local paediatrician and pharmacist, without the need for families to travel to national centres. All children were eligible for NHS funded therapy, each referring centre was approved by the pMDT ODN, prior to approval to dispense medication and funds were reclaimed via Blueteq authorisation. Demographic, clinical and social data was collected, and treatment outcomes were recorded. Feedback on feasibility and satisfaction on the pathway and supply of medication was sought from referrers.Results34 children were referred during the first six months;median (range) age 10 (3.9 – 14.5) years;15M;19F: Majority of referrals are HCV genotype type 1 (n=17) and 2 (n=12). DAA treatments prescribed: Sofosbuvir/Ledipasvir (n=21);Sofosbuvir/Velpatisvir (n=11) Glecaprevir/Pibrentasvir (n=2).27/34 confirmed as able to swallow tablets;3/7 have received training and are now able to successfully swallow tablets;4/7 are awaiting release of granules. All children who have completed treatment to date (11/27) have cleared virus at the end of treatment. Once the network was established, referrers found the virtual process easy to access. They valued being able to discuss their patients with the MDT providing a single point of contact with national specialists to discuss therapy. Specialist pharmacists within the pMDT were able to provide pharmaceutical information and support local Trusts to ensure safe, timely and funded supply of medication to children. There were three reported dispensing errors, where adult strength tablets were dispensed in error locally, however no doses were taken as parents noticed the error prior to giving a dose. A delay in availability of the granule or pellet formulations due to manufacturing delays during COVID, has meant a delay in referring and treating those children unable to swallow tablets.ConclusionPharmacists were a valuable resource within the National HCV Paediatric MDT Operational Delivery Network. They contributed expert knowledge on formulations and doses, supporting delivery of high-quality treatment and equity of access for children and young people with HCV in England. Education and awareness of new Paediatric formulations for local Pharmacy teams may prevent future dispensing errors.ReferenceNHS News 2021. Life saving hepatitis C treatment for children on the NHS. 24th August 2021. Available at: NHS England » Lifesaving hepatitis C treatment for children on the NHS [accessed 12th June 2022].
ABSTRACT
Background and AimsHepatitis C virus (HCV) infection is a major global health problem in adults & children. The recent efficacy of Direct Acting Anti-viral therapy (DAA) has cure rates of 99% in adults and adolescents. These drugs were licensed for children 3–12 yrs during the recent coronavirus pandemic. To ensure equitable access, safe & convenient supply during lockdown, we established a virtual national treatment pathway for children with HCV in England & evaluated its feasibility, efficacy & treatment outcomes.MethodA paediatric Multidisciplinary Team Operational Delivery Network (pMDT ODN), supported by NHS England (NHSE), was established with relevant paediatric specialists to provide a single point of contact for referrals & information. Referral & treatment protocols were agreed for HCV therapy approved by MHRA & EMA. On referral the pMDT ODN agreed the most appropriate DAA therapy based on clinical presentation & patient preferences, including ability to swallow tablets. Treatment was prescribed in association with the local paediatrician & pharmacist, without the need for children & families to travel to national centres. All children were eligible for NHS funded therapy;referral centres were approved by the pMDT ODN to dispense medication;funding was reimbursed via a national NHSE agreement. Demographic & clinical data, treatment outcomes & SVR 12 were collected. Feedback on feasibility & satisfaction on the pathway was sought from referrers.ResultsIn the first 6 months, 34 children were referred;30- England;4 - Wales;median (range) age 10 (3.9 – 14.5) yrs;15M;19F: Most were genotype type 1 (17) & 3 (12);2 (1);4(4). Co-morbidities included: obesity (2);cardiac anomaly (1);Cystic Fibrosis (1);Juvenile Arthritis (1). No child had cirrhosis. DAA therapy prescribed: Harvoni (21);Epclusa (11);Maviret (2) .27/34 could swallow tablets;3/7 received training to swallow tablets;4/7 are awaiting release of granules.11/27 have completed treatment and cleared virus;of these 7/11 to date achieved SVR 12. 30 children requiring DAA granule formulation are awaiting referral and treatment.Referrers found the virtual process easy to access, valuing opportunity to discuss their patient’s therapy with the MDT & many found it educational. There were difficulties in providing the medication through the local pharmacy. However there are manufacturing delays in providing granule formulations because suppliers focused on treatments for COVID, leading to delays in referring and treating children unable to swallow tablets.ConclusionThe National HCV pMDT ODN delivers high quality treatment & equity of access for children & young people, 3– 18 yrs with HCV in England, ensuring they receive care close to home with 100% cure rates.