Developing Mitigation Measures for Full or Partially Missed
Nirmatrelvir-Ritonavir Doses using Physiologically-Based Pharmacokinetic
Modelling
Abstract
Aims. Nirmatrelvir/ritonavir is the preferred treatment of vulnerable
COVID-19 patients. Current manufacturer’s recommendations are inadequate
in addressing diverse medication errors due to full or partially missed
nirmatrelvir/ritonavir doses. We aimed to develop a decision tree to
mitigate these medication errors using a published physiologically-based
pharmacokinetic (PBPK) model. Methods. Medication errors of missed
nirmatrelvir/ritonavir doses were documented from 1st January 2023 to
31st March 2024 in a local hospital. We performed PBPK simulations in
adults, including those with moderate renal impairment and Chinese
elderly under different scenarios of missed doses and mitigation
measures. The decision tree was verified in clinically reported
medication error scenarios. Results. Ten errors were reported. In adults
and Chinese elderly who missed the full standard nirmatrelvir/ritonavir
(300 mg/100 mg) dose or full nirmatrelvir component (300 mg),
administering the missed dose after 8 hours simulated sub-therapeutic
nirmatrelvir troughs for at least one dosing interval. This problem was
circumvented by skipping and administering the missed
nirmatrelvir/ritonavir dose 12 hours after completing the last scheduled
dose in line with manufacturer’s recommendation. When a tablet of
nirmatrelvir (150 mg) was missed in a standard or renal dose, no
therapeutic consequence was found. No sub-therapeutic nirmatrelvir
trough was simulated with a missed ritonavir dose. For the clinically
reported medication error scenarios, our decision tree ensured minimally
120 hours of therapeutic nirmatrelvir troughs during the treatment
duration. Conclusion. PBPK model-informed mitigation measures to address
missed nirmatrelvir/ritonavir doses were successfully verified. Further
studies should investigate the implementation and efficacy of these
mitigation measures.