A retrospective cohort study of prescribing outcomes in outpatients treated with nirmatrelvir-Ritonavir for COVID-19 in an interdisciplinary community clinic

PLoS One. 2023 Oct 19;18(10):e0293302. doi: 10.1371/journal.pone.0293302. eCollection 2023.

Abstract

Background: Large observational studies have demonstrated the real-world effectiveness of nirmatrelvir-ritonavir in preventing severe COVID-19 in higher risk individuals, but have provided limited information on other aspects of nirmatrelvir-ritonavir use. Our objective was to evaluate prescribing outcomes such as the prevalence of drug-drug interactions (DDI), adverse drug events (ADE) and treatment adherence in an outpatient community clinic setting.

Methods: We conducted a single-centre retrospective cohort study of adult outpatients prescribed nirmatrelvir-ritonavir in our community COVID-19 assessment clinic in Toronto, Ontario between March 3 and September 20, 2022. We performed a descriptive analysis of the patient population, DDIs, DDI interventions, treatment adherence, ADEs and clinical outcomes of patients prescribed nirmatrelvir-ritonavir.

Results: There were 637 individuals prescribed nirmatrelvir-ritonavir during the study period. The median age was 70, the median number of risk factors for severe disease were 2, 45% were immunocompromised and 82% had received 3 or more COVID-19 vaccine doses. 95% (542/572) completed the 5-day course of therapy with 68% (388/572) having complete symptom resolution by 28-day. Eleven percent (60/572) experienced recurrent symptoms following the completion of nirmatrelvir-ritonavir. Over 70% had one or more clinically significant DDIs requiring mitigation and 62% of patients experienced at least one ADE, which was most commonly dysgeusia or gastrointestinal-related. Ninety-five percent (542/572) of patients completed therapy as prescribed. Overall, hospitalization within 28 days was 3.3% with 1.2% attributed to COVID-19 and there were no deaths.

Interpretation: Nirmatrelvir-ritonavir was associated with a high prevalence of clinically significant DDIs, which required mitigation strategies and a high frequency of mild ADEs. Collaborative assessment to address medication alterations resulted in high treatment adherence.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antiviral Agents / therapeutic use
  • COVID-19 Drug Treatment
  • COVID-19 Vaccines
  • COVID-19* / epidemiology
  • Didanosine
  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • Outpatients
  • Retrospective Studies
  • Ritonavir / therapeutic use

Substances

  • nirmatrelvir
  • COVID-19 Vaccines
  • Ritonavir
  • Didanosine
  • Antiviral Agents

Grants and funding

This project was funded by the TD Community Health Solutions Research Grant and by in-kind contributions from MGH. TD had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.