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 (R) 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 othersafety 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 (R) 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 (R) package insert was identified. Conclusions: Paxlovid (R) 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.