This study aims to answer the 2 research questions what is the comparative safety of liver, abdominal, anaphylactic reactions, and other outcomes, in patients with moderate or severe hepatic impairment exposed to Paxlovid and what is the comparative safety of abdominal, anaphylactic reactions, and other outcomes, in patients with moderate or severe renal impairment exposed to Paxlovid?
The primary objective is to assess the safety of Paxlovid relative to the comparator populations who used molnupiravir for COVID-19 and to unexposed patients with COVID-19 with respect to hospitalisations or emergency room visits for the following outcomes among individuals with moderate or severe renal impairment: severe vomiting, nausea, diarrhoea, or abdominal pain, dysgeusia, headache, or hypertension, anaphylactic reactions, and for the same outcomes in addition to hepatic transaminase elevations, clinical hepatitis, or jaundice among individuals with moderate or severe hepatic impairment. The study will focus on the target populations. Within each population, there will be a descriptive analysis and comparative analyses. Molnupiravir, an antiviral with a similar recommended usage, will be used as an active comparator in the data sources for which it is available, other drugs may be incorporated as active comparators as more information becomes available. A second comparator group is included in the study: individuals who were at increased risk for progression to severe COVID-19 but had not received Paxlovid or molnupiravir. This PASS will make secondary use of several data sources from electronic health records and/or claims data in European countries that have the ability to capture Paxlovid exposure and where the target populations, study outcomes, and key covariates can be ascertained.