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P58 An antiviral dilemma -- reflections on the pocapavir predicament
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  1. Clara Danielsen
  1. University Hospital UK

Abstract

September to December 2022 seven neonates were admitted across two Level 3 Paediatric Critical Care Units (PCCU) with neonatal enteroviral myocarditis (NEM). Enterovirus is a common and often self-limiting virus; however, myocarditis is a very rare complication.1

Standard of care for NEM is currently supportive, with mortality rates high and long-term outcomes poor. Two patients were initially admitted and pharmacy were asked to review and procure pocapavir in the hope this may improve predicted outcomes. In doing this several questions were raised regarding practical and ethical considerations in obtaining an unlicensed and experimental treatment; and if/when more patients presented whether such a treatment could be expected to become standard of care. The national public health body reported higher than average levels of circulating enterovirus throughout the childhood population and it was feared that numbers of NEM cases would rise.1

Potential antiviral treatments were reviewed and pocapavir had recently been obtained for a patient within the hospital for a different indication. Due to supply therefore being available within the hospital it was felt that treatment of the patients with NEM should be attempted.

Personalised weight-based doses were manufactured, but subsequently more patients were diagnosed and pocapavir treatment was again requested, problems arose obtaining pocapavir in a timely manner as patients were admitted. It is an unlicensed medication and still considered to be in phase two clinical trials; it was supplied on a compassionate use basis from the manufacturer on the agreement that pharmacokinetic studies would be undertaken.

A local pharmacy manufacturing unit facilitated import and aided with completion of the MHRA import request. They then produced individualised weight-based doses. Unlicensed medicines forms, parental consent forms were completed and parents counselled.

Pharmacy worked with the infectious disease team to produce guidance for critical care teams on the use of pocapavir, administration and storage guidance.

Pocapavir was supplied to 5/7 patients diagnosed with NEM, of those four completed the course and one stopped due to becoming nil by mouth. The 5 patients who were given pocapavir survived, however, effectiveness and long-term outcomes remain unknown.

Pocapavir is unlicensed, with no clinical trials currently ongoing. If it is to be used for conditions such as NEM a formal clinical trial is needed to monitor outcomes and safety.

On reflection and review of the patients with a wider multi-disciplinary team (MDT), concerns regarding resistance were raised. If this treatment was to be used in the future, a combination approach with a second antiviral agent may be more appropriate, to reduce the risk of resistance in the wider population.

A fast response to an acute situation subsequently led to an expectation that an experimental and unlicensed medication would become standard of care for NEM. PCCU was fortunate to work closely with the pharmacy manufacturing unit to aid import and manipulation of the product, however it became clear that it was not possible to replicate this process so easily in other PCCU’s further away.

Reference

  1. Zhang M, Wang H, Tang J, et al. Clinical characteristics of severe neonatal enterovirus infection: a systematic review. BMC Paediatrics 2021;21:127.

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