Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial
Authors: Abdel-Salam Elgohary Mohamed ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Medhat Hasan Eman ,   Tropical Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt, Ahmad Ibrahim Amany ,   Tropical Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt, Farouk Ahmed Abdelsalam Mohamed ,   Clinical Pharmacy Department, Al Galaa Military Medical Complex (GMMC), Cairo, Egypt, Zaher Abdel-Rahman Raafat ,   Virology Department, Central Military Laboratories, Cairo, Egypt, Ibrahim Zaki Ashraf ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Bakr Elaatar Mohamed ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Thabet Elnagar Mohamed ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Emam Emam Mohamed ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Moustafa Hamada Mahmoud ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Mohamed Abdel-Hamid Taimour ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Samir Abdel-Hafez Ahmad ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Gomaa Seadawy Mohamed ,   Biological Prevention Department, Egyptian Army, Cairo, Egypt,   Mohamed Gomaa Seadawy, Biological Prevention Department, Egyptian Army, Cairo, Egypt. E-mail: biologist202054@yahoo.com, Rashad Fatoh Ahmad ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Ali Elsaied Mohamed ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Abdel-Rahman Sakr Marwa ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Omar Elkady Ahmed ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Muawad Shehata Mohamed ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Mohamed Nawar Osama ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Abu-elnaga Selem Mohamed ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Saeed Abd-aal Mohamed ,   COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt, Hafez Lotfy Hany ,   Radiology Department, Military Medical Academy, Cairo, Egypt, Refaat Elnagdy Tarek ,   Egyptian Military Medical Services Department, Egyptian Army, Cairo, Egypt, Helmy Sherine ,   Research & Development, PHARCO Pharmaceuticals, Alexandria, Egypt, Amin Mubark Magdy ,   Egyptian Military Medical Services Department, Egyptian Army, Cairo, Egypt
Published: November 2022

COVID-19 is a pandemic disease caused by SARS-CoV-2, which is an RNA virus similar to the hepatitis C virus (HCV) in the replication process. Sofosbuvir/ledipasvir is an approved drug to treat HCV infection. This study investigates the efficacy of Sofosbuvir/ledipasvir as a treatment for patients with moderate COVID-19 infection. This is a single-blinded parallel-randomized controlled trial. The participants were randomized equally into the intervention group that received Sofosbuvir/ledipasvir (S.L. group), and the control group received Oseltamivir, Hydroxychloroquine, and Azithromycin (OCH group). The primary outcomes were the cure rate over time and the incidence of serious adverse events. The secondary outcomes included the laboratory findings. 250 patients were divided equally into each group. Both groups were similar regarding gender, but age was higher in the S.L. group (p=0.001). In the S.L. group, 89 (71.2%) patients were cured, while only 51 (40.8%) patients were cured in the OCH group. The cure rate was significantly higher in the S.L. group (RR=1.75, p<0.001). Kaplan-Meir plot showed a considerably higher cure over time in the S.L. group (Log-rank test, p=0.032). There were no deaths in the S.L. group, but there were six deaths (4.8%) in the OCH group (RR=0.08, p=0.013). Seven patients (5.6%) in the S.L. group and six patients (4.8%) in the OCH group were admitted to the intensive care unit (ICU) (RR=1.17, P=0.776). There were no significant differences between treatment groups regarding total leukocyte and neutrophils count, lymph, and urea. Sofosbuvir/ledipasvir is suggestive of being effective in treating patients with moderate COVID-19 infection. Further studies are needed to compare Sofosbuvir/ledipasvir with new treatment protocols.