Study Implementation Manager Pfizer Inc Tampa, United States
Background: PAXLOVID TM (nirmatrelvir tablets, ritonavir tablets) is under emergency use authorization in the United States (US) for the treatment of mild-to-moderate COVID-19 in individuals 12 years of age and older who are at high risk for progression to severe COVID-19. Truveta Studio aggregates, deduplicates using highly accurate probabilistic matching, and deidentifies clinical data from member health systems that are demographically representative of the US, allowing for near real-time analysis of real-world data.
Objectives: To assess the feasibility and capacity of Truveta member health system data to describe the SARS-CoV-2 testing patterns post-PAXLOVID prescription orders (PPOs) and to characterize the population of patients prescribed PAXLOVID more than once in near real-time.
Methods: Using Truveta Studio, a descriptive analysis of SARS-CoV-2 testing patterns among patients with a PPO was performed. The testing definition included polymerase chain reaction, antigen, and antibody tests. The analysis was stratified by hospitalization for any cause within the 30 days after the PPO. In addition, a descriptive analysis of patients with multiple PPOs, defined as having a second PPO at least 5 days after the first, was performed.
Results: As of 17 January 2023, the analyses included data from 14 Truveta member health systems representing 78,251,102 patients. 225,116 patients had at least one PPO; almost all (98%) patients were not hospitalized for any cause in the 30 days after the PPO. Among the 221,419 patients not hospitalized, 3,074 (1.4%) had a record of a SARS-CoV-2 test in the 6 to 27 days following the PPO; among the 3,697 patients hospitalized, 867 (23.5%) did. Among those not hospitalized, 25 patients had a record of a negative test result followed by a positive test result; among those hospitalized, 22 did. There were 2,937 patients with multiple PPOs observed; 1,731 (58.9%) were female , 1,227 (41.8%) were ≥65 years of age, 2,308 (78.6%) were white race, and 2,166 (74.1%) had at least one comorbidity, including hypertension and obesity.
Conclusions: Truveta member health system data were able to yield meaningful information on SARS-CoV-2 testing patterns, PPOs, and the clinical characteristics of a large cohort of Paxlovid-prescribed patients in near-real time. Further validation of the data is needed, but initial results suggest this model as a powerful tool in pharmacovigilance. Truveta’s innovative approach to aggregating large, diverse sets of real-world data in an easy-to-use platform has the potential to provide earlier insight into signal detection compared to traditional methods and can be a very powerful tool for signal refinement.
