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Remdesivir for the treatment of COVID-19

What does the Early Access to Medicines Scheme mean for the use of remdesivir to treat COVID-19?

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This article was correct at time of publishing (June 4). To keep up with the latest information please visit our coronavirus hub

The Early Access to Medicines Scheme (EAMS) provides early access to medicines that have shown potentially promising effects and where there is currently a high clinical need that is unmet by existing treatments. The medicines may be unlicensed for use in the UK, or the use may be outside of the current UK licence. The scheme includes medicinal products that treat, diagnose or prevent, life-threatening or seriously debilitating conditions.(1)

EAMS reflects a scientific opinion based on an assessment of benefits vs risks by the Medicines and Healthcare products Regulatory Agency (MHRA) but should not be considered as a licence for the medicine or a future commitment by the MHRA to license the medicine for that indication. It does not reflect an endorsement to use the medicine and the risk and legal responsibility for prescribing remains with the physician. EAMS intends to inform physicians to help with the decision-making process. If a drug licence covering the indication is granted or the EAMS criteria are no longer met, the MHRA will withdraw the EAMS.(1)

What is remdesivir?

On May 26, 2020 the MHRA gave a positive scientific opinion to Gilead Sciences Ltd for the use of remdesivir in the treatment of patients with COVID-19 in secondary care. The EAMS gives patients who meet the criteria, early access to the medicine in the UK.(1)

Remdesivir is an adenosine nucleotide prodrug that has displayed broad-spectrum antiviral activity.(2) The prodrug is transported into cells where it is converted to nucleoside triphosphate, which is pharmacologically active. There it competes with natural adenosine triphosphate substrate for inclusion in new RNA chains during replication. The SARS-CoV-2 virus responsible for causing COVID-19 requires RNA-dependent RNA polymerase to replicate. When remdesivir is incorporated into the RNA strand by the RNA polymerase, replication is blocked and the virus is unable to multiply.(1)

What is remdesivir indicated for?

Remdesivir is an investigational drug that is not licensed for use anywhere in the world.(2) However, it has shown activity against the viral pathogens Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) in animal models – both in vitro and in vivo. MERS and SARS, both coronaviruses, are structurally similar to COVID-19.(2) It is unknown if this observed activity in animal models will result in clinical efficacy in those with symptomatic SARS-CoV-2 infection.(3)

Who can be treated with remdesivir?

Remdesivir is available in the UK through the EAMS therapeutic indication for the treatment of suspected or laboratory-confirmed SARS-CoV-2 infection and severe disease in hospitalised adults and adolescents. Patients must be at least 12 years old and weigh a minimum of 40kg. Severe disease is defined as patients with an oxygen saturation (SpO2) of less than or equal to 94% on room air or requiring supplemental oxygen, non-invasive or invasive ventilation or extracorporeal membrane oxygenation.(1)

How is remdesivir administered?

Remdesivir should only be initiated by physicians who are experienced in the diagnosis and treatment of COVID-19.(1)

It is administered by intravenous infusion over 30 to 120 minutes. Initial dose for all patients is 200mg daily, followed by a 100mg daily maintenance doses for nine days in patients requiring invasive ventilation, and four days in those not requiring invasive ventilation. Treatment may be increased up to a total of 10 days if there is no clinical improvement in those not requiring invasive ventilation. Hepatic testing and estimated glomerular filtration rate should be determined before initial dosing and then daily while receiving treatment.(1)

What should community pharmacists know?

Remdesivir is an investigational drug that is still being studied. Therefore, clinical experience is limited and it is possible that not all of the risks associated with the drug are known.(4)

Some possible side effects to treatment include reactions to the infusion, such as nausea, sweating, shivering, vomiting and decreased blood pressure. These reactions have been observed during administration of the medicine. Infusion site reactions may also occur, including infection, pain, bleeding and bruising of the skin. An increase in liver enzymes has also been recorded and may be a result of damage or inflammation to liver cells.(4) Any suspected side effects should be reported via the Yellow Card reporting scheme: refer to Yellow Card reporting during the COVID-19 pandemic for further information.

Interaction studies have not been conducted in humans with remdesivir. In vitro studies have shown that remdesivir is a substrate of certain CYP450 enzymes, P-gp transporters and organic anion transporting polypeptides and an inhibitor of certain enzymes. However, the relevance of these in vitro studies has not been established.

References
  1. Medicines and Healthcare products Regulatory Agency (2020) EAMS 11972/0002 Remdesivir 100 mg concentrate for solution for infusion. Early Access to Medicines Scheme – treatment protocol – information for healthcare professionals.
  2. Gilead Sciences (2020) About remdesivir.
  3. U.S. Food & Drug Administration (2020) Fact sheet for health care providers Emergency Use Authorization (EUA) of remdesivir (GS-5734).
  4. US Food and Drug Administration (2020) Fact sheet for patients and parent/caregivers Emergency Use Authorization (EUA) of remdesivir for coronavirus disease 2019 (COVID-19).
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