Safety of Favipiravir in Mild and Moderately Ill Indonesian COVID-19 Patients

Introduction: Favipiravir is one of the antivirals that has received Emergency Use Authorization (EUA) for COVID-19 therapy by regulators in many countries, including Indonesia. The Indonesian Guideline for the Management of COVID-19 Editions 1, 2, and 3 recommend favipiravir as the antiviral of choice for mild and moderate degrees of illness. However, evidence of its safety remains very limited, especially in the Indonesian population. Aim: This study was conducted to evaluate the safety of favipiravir compared to oseltamivir for treating mild and moderate COVID-19 patients in Indonesia. Methods: The retrospective cohort study was conducted in two Regional General Hospitals in DKI Jakarta Province, Indonesia. The safety of favipiravir was assessed based on the level of adverse drug reactions (ADR) and analysed using the Naranjo algorithm. A total of 420 medical records of COVID-19 patients who had received favipiravir or oseltamivir were analysed. Favipiravir ADRs recorded in the study included nausea (7.1%), elevated transaminase enzymes (6.2%), headaches (6.2%), hyperuricemia (4.3%), insomnia (2.9%), abdominal pain (2.9%), diarrhea (1.4%), decreased neutrophil count (1.4%), constipation (1.0%), vomiting (1.0%), heartburn (1.0%), nausea and vomiting (1.0%), and knee pain (0.5%). The study results showed 17 probable and 60 possible ADR cases, but no serious ADRs from favipiravir. Conclusion: Favipiravir demonstrated a favorable safety profile in mild and moderately ill Indonesian COVID-19 patients that is similar to the available fact sheet.