P5‐93: Therapeutic effectiveness and tolerability of favipiravir in mild COVID‐19: Real world experience from India

Background & Aims: Favipiravir is approved in India for mildmoderate COVID-19. We aimed to observe effectiveness & safety of favipiravir in mild COVID-19 in real world setting. Methods: Retrospective cohort study was conducted in favipiravir treated mild COVID-19 patients(SpO2≥94) at 4 Indian centres after ethics committee approval. Medical records from Oct 2020 Feb 2021 were analyzed to capture required details. Results: 283 mild COVID-19 patients received favipiravir. Mean age was 50.5 16.7 years, M:F=1.4:1. 51.6% had co-morbidities, with hypertension (40%) and diabetes (35.7%) as frequent ones. 26.1% had multiple (≥2) co-morbidities. Mean SpO2 & RR at baseline was 96.9 1.5% & 21.5 12/min respectively. Overall CRP (30.3 46.3), d-Dimer (433.5 746.4), serum ferritin (321.8 329.5 and LDH (234.4 99.7) were raised at baseline. Fever (90.8%), cough (59.4%), myalgia (32.5%) and fatigue (30.4%) were common presenting symptoms. 55.1% required hospitalization. Favipiravir was prescribed for median duration of 14 days. 12.4% received systemic steroids. Fever resolution occurred in median duration of 4 days(1-10 d). Fever resolved in 86.2% and 90.8% by day 7 and 10. Median time to clinical cure was 5 days (1-13 days). Clinical cure rate at day 7, 10 and 14 was 79.2%, 90.5% and 94.7%. At Baseline 47 (16.6%) patients were on respiratory support which reduced from day 3 (n=34) (12%) to day 14 (n=2) (0.7%). (n=15) 5.3% had disease progression with mortality in 2. TEAEs were observed in (n=23)8.1%. Elevation of liver transaminases 14 (5%), loosemotion 5 (1.8%) weremost frequent TEAEs. Conclusion: Favipiravir was found effective in majority of mild COVID-19 patients despite high risk association. It was well tolerated and no new safety signals were detected.