P35 Remdesivir in a pre-term neonate – was it worth it?

Background Situation On day 24 of life, a pre-term neonate (GA at birth 31+2 weeks) with achondroplasia tested SARS-CoV-2 positive on PCR. The patient was ventilated for increasing oxygen requirements, eventually necessitating transfer to the regional PICU. Meeting clinical case definition severe acute respiratory COVID-19, initiated hydrocortisone 0.5 mg/kg BD as per Scottish Paediatric Consensus Guidelines COVID-19. 1 Respiratory decline, bilateral consolidation chest X-Ray led oscillation 27 life. An MDT set up consider next steps. There is paucity evidence managing COVID-19 in this age group. considered unlicensed use tocilizumab (TOC) and remdesivir (RDV) potential therapies. Evidence utility RDV conflicting. 2 3 TOC <18 years extrapolated from adult data, sparse dosing information <1 years. CRP remained below threshold (44). Concern regarding immunosuppressive effect raised secondary bacterial infection had not been excluded. balance, concluded be offered ‘next step’ treatment option. Renal liver function were normal pre-RDV (ALT 19, AST 57), however within 48hour (2 doses) RDV, transaminases increased >5x ULN 354, 873). Clinical status otherwise stable, no other changes medication identified, thus decision made withdraw likely cause. 48 hours post withdrawal has normalised. clinically improved over 5 days extubated ~7 later. Contribution Pharmacy played significant role MDT, heavily involved all risk:benefit making. Initial literature searches conducted establish current data both A Phase 2/3 trial protocol evaluating safety, tolerability pK patients birth-18 obtained further guide Assessment eligibility based UK CAS alert study undertaken, along assessment baseline parameters. treat, supported ULM application process (internal Gilead compassionate access scheme) advised dosing, administration monitoring. pivotal monitoring recognition adverse events. identifying rapidly developing transaminitis, full review undertaken determine causative agent support treatment. Yellow Card completed. Conclusion Despite after only days, discharged short time after, raising question whether any benefit case. Managing neonates presents challenge teams. remains 4 Treatment decisions are case-by-case basis, outcomes rarely published. More required before conclusions can drawn about or safety profile neonates. References Pollock L, McLellan K. ‘Scottish related conditions’, produced by Hyperinflammatory MDT; NHS GG&C Guidelines; 2020, V3. Beigel J, Tomashek K, Dodd et al . Remdesivir COVID-19- final report. New England Journal Medicine 2020; 383 :1813–1826. Hongchao P, Peto R, Henao-Restrepo AM, Repurposed antiviral drugs – interim WHO solidarity trail results (WHO Solidarity Trail Consortium). 2021; 384 :497–511. Swann O, Holden Turtle characteristics children young people admitted hospital United Kingdom: prospective multicentre observational cohort study. BMJ 370 :m3249.