Safety profile of Paxlovid® against SARS-CoV2 in patients at a hospital in Mexico

Introduction: Due to the increase in infections of the Omicron variant of Coronavirus Disease 2019, the Mexican health authority authorized the oral antiviral Paxlovid® for the outpatient treatment of patients with mild to moderate infection. Having a limited safety profile, the objective was to describe the adverse reactions and other safety problems related to the use, treated in a tertiary hospital in Mexico and compare them with those reported in other countries. Method: Semilongitudinal and prospective clinical series developed out at the Regional High Specialty Hospital of the Yucatan Peninsula between October 17, 2022, and July 10, 2023. Patients treated with Paxlovid® were interviewed by telephone calls and were asked about any adverse reactions presented. Results: A total of 65 patients were included. The average age was 46,8±15,3 years. 89,2 % (n=58) presented one or more adverse reactions and 13,8 % (n=9) discontinued treatment due to them. In general, 132 adverse reactions were identified, 2±1 per patient, the most frequent being mild (78 %) such as bitter taste, nausea and fatigue. Other adverse reactions not reported in the Paxlovid® package insert was identified. Conclusions: Paxlovid® has an acceptable safety profile comparable to that of other studies, this being consistent with previous clinical experience and supporting the safety of the use of nirmatrelvir y ritonavir combination drug as a therapeutic option against Coronavirus Disease 2019.