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Efficacy and Safety of Sofosbuvir/ Ledipasvir in Treatment of Patients With Covid-19; a Randomized Clinical Trial Publisher Pubmed



Nourian A1 ; Khalili H1 ; Ahmadinejad Z2 ; Kouchak HE2 ; Jafari S2 ; Manshadi SAD2 ; Rasolinejad M2 ; Kebriaeezadeh A3
Authors
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Authors Affiliations
  1. 1. Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Pharmacoeconomics and Pharmaceutical Administration, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

Source: Acta Biomedica Published:2020


Abstract

Summary. Background: There is no study regarding the use of SOF/LDP in treatment of COVID-19. Objectives: In this study, the efficacy and safety of SOF/LDP were assessed in treatment of patients with mild to moderate COVID-19. Methods: Among an open-label randomized clinical trial, 82 patients with mild to moderated COVID-19 were assigned to receive either SOF/LDP 400/100 mg daily plus the standard of care (SOF/LDP group, n=42) or the standard of care alone (control group, n=40) for 10 days. Time to clinical response, rate of clinical response, duration of hospital and ICU stay and 14-day mortality were assessed. Results: Clinical response occurred in 91.46% of patients. Although rates of clinical response were comparable between the groups but it occurred faster in the SOF/LDP group than the control group (2 vs. 4 days respectively, P= 0.02). Supportive cares were provided in the medical wards for most patients but 17.07% of patients were transferred to ICU during the hospitalization course. However, durations of hospital and ICU stay were comparable between the groups. 14-day mortality rate was 7.14% and 7.5% in the SOF/ LDP and control groups respectively. No adverse effects leading to drug discontinuation occurred. Gastrointestinal events (nausea, vomiting and diarrhea) were the most common side effects (15.85%). Conclusion: Added to the standard of care, SOF/LDP accelerated time to the clinical response. However, rate of clinical response, duration of hospital and ICU stay and 14-day mortality were not different. No significant adverse event was detected. More randomized clinical trials with larger sample sizes are needed to confirm the efficacy and safety of SOF/ LDP in the treatment of COVID-19. (www.actabiomedica.it). © Mattioli 1885.
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