Cargando…

Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial

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 wi...

Descripción completa

Detalles Bibliográficos
Autores principales: Elgohary, Mohamed Abdel-Salam, Hasan, Eman Medhat, Ibrahim, Amany Ahmad, Abdelsalam, Mohamed Farouk Ahmed, Abdel-Rahman, Raafat Zaher, Zaki, Ashraf Ibrahim, Elaatar, Mohamed Bakr, Elnagar, Mohamed Thabet, Emam, Mohamed Emam, Hamada, Mahmoud Moustafa, Abdel-Hamid, Taimour Mohamed, Abdel-Hafez, Ahmad Samir, Seadawy, Mohamed Gomaa, Fatoh, Ahmad Rashad, Elsaied, Mohamed Ali, Sakr, Marwa Abdel-Rahman, Elkady, Ahmed Omar, Shehata, Mohamed Muawad, Nawar, Osama Mohamed, Selem, Mohamed Abu-elnaga, Abd-aal, Mohamed Saeed, Lotfy, Hany Hafez, Elnagdy, Tarek Refaat, Helmy, Sherine, Mubark, Magdy Amin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Carol Davila University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9015168/
https://www.ncbi.nlm.nih.gov/pubmed/35449996
http://dx.doi.org/10.25122/jml-2021-0175
_version_ 1784688331565563904
author Elgohary, Mohamed Abdel-Salam
Hasan, Eman Medhat
Ibrahim, Amany Ahmad
Abdelsalam, Mohamed Farouk Ahmed
Abdel-Rahman, Raafat Zaher
Zaki, Ashraf Ibrahim
Elaatar, Mohamed Bakr
Elnagar, Mohamed Thabet
Emam, Mohamed Emam
Hamada, Mahmoud Moustafa
Abdel-Hamid, Taimour Mohamed
Abdel-Hafez, Ahmad Samir
Seadawy, Mohamed Gomaa
Fatoh, Ahmad Rashad
Elsaied, Mohamed Ali
Sakr, Marwa Abdel-Rahman
Elkady, Ahmed Omar
Shehata, Mohamed Muawad
Nawar, Osama Mohamed
Selem, Mohamed Abu-elnaga
Abd-aal, Mohamed Saeed
Lotfy, Hany Hafez
Elnagdy, Tarek Refaat
Helmy, Sherine
Mubark, Magdy Amin
author_facet Elgohary, Mohamed Abdel-Salam
Hasan, Eman Medhat
Ibrahim, Amany Ahmad
Abdelsalam, Mohamed Farouk Ahmed
Abdel-Rahman, Raafat Zaher
Zaki, Ashraf Ibrahim
Elaatar, Mohamed Bakr
Elnagar, Mohamed Thabet
Emam, Mohamed Emam
Hamada, Mahmoud Moustafa
Abdel-Hamid, Taimour Mohamed
Abdel-Hafez, Ahmad Samir
Seadawy, Mohamed Gomaa
Fatoh, Ahmad Rashad
Elsaied, Mohamed Ali
Sakr, Marwa Abdel-Rahman
Elkady, Ahmed Omar
Shehata, Mohamed Muawad
Nawar, Osama Mohamed
Selem, Mohamed Abu-elnaga
Abd-aal, Mohamed Saeed
Lotfy, Hany Hafez
Elnagdy, Tarek Refaat
Helmy, Sherine
Mubark, Magdy Amin
author_sort Elgohary, Mohamed Abdel-Salam
collection PubMed
description 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.
format Online
Article
Text
id pubmed-9015168
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Carol Davila University Press
record_format MEDLINE/PubMed
spelling pubmed-90151682022-05-01 Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial Elgohary, Mohamed Abdel-Salam Hasan, Eman Medhat Ibrahim, Amany Ahmad Abdelsalam, Mohamed Farouk Ahmed Abdel-Rahman, Raafat Zaher Zaki, Ashraf Ibrahim Elaatar, Mohamed Bakr Elnagar, Mohamed Thabet Emam, Mohamed Emam Hamada, Mahmoud Moustafa Abdel-Hamid, Taimour Mohamed Abdel-Hafez, Ahmad Samir Seadawy, Mohamed Gomaa Fatoh, Ahmad Rashad Elsaied, Mohamed Ali Sakr, Marwa Abdel-Rahman Elkady, Ahmed Omar Shehata, Mohamed Muawad Nawar, Osama Mohamed Selem, Mohamed Abu-elnaga Abd-aal, Mohamed Saeed Lotfy, Hany Hafez Elnagdy, Tarek Refaat Helmy, Sherine Mubark, Magdy Amin J Med Life Original Article 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. Carol Davila University Press 2022-03 /pmc/articles/PMC9015168/ /pubmed/35449996 http://dx.doi.org/10.25122/jml-2021-0175 Text en ©Carol Davila University Press https://creativecommons.org/licenses/by/3.0/This article is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/ (https://creativecommons.org/licenses/by/3.0/) ), which permits unrestricted use and redistribution provided that the original author and source are credited.
spellingShingle Original Article
Elgohary, Mohamed Abdel-Salam
Hasan, Eman Medhat
Ibrahim, Amany Ahmad
Abdelsalam, Mohamed Farouk Ahmed
Abdel-Rahman, Raafat Zaher
Zaki, Ashraf Ibrahim
Elaatar, Mohamed Bakr
Elnagar, Mohamed Thabet
Emam, Mohamed Emam
Hamada, Mahmoud Moustafa
Abdel-Hamid, Taimour Mohamed
Abdel-Hafez, Ahmad Samir
Seadawy, Mohamed Gomaa
Fatoh, Ahmad Rashad
Elsaied, Mohamed Ali
Sakr, Marwa Abdel-Rahman
Elkady, Ahmed Omar
Shehata, Mohamed Muawad
Nawar, Osama Mohamed
Selem, Mohamed Abu-elnaga
Abd-aal, Mohamed Saeed
Lotfy, Hany Hafez
Elnagdy, Tarek Refaat
Helmy, Sherine
Mubark, Magdy Amin
Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial
title Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial
title_full Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial
title_fullStr Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial
title_full_unstemmed Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial
title_short Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial
title_sort efficacy of sofosbuvir plus ledipasvir in egyptian patients with covid-19 compared to standard treatment: a randomized controlled trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9015168/
https://www.ncbi.nlm.nih.gov/pubmed/35449996
http://dx.doi.org/10.25122/jml-2021-0175
work_keys_str_mv AT elgoharymohamedabdelsalam efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT hasanemanmedhat efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT ibrahimamanyahmad efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT abdelsalammohamedfaroukahmed efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT abdelrahmanraafatzaher efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT zakiashrafibrahim efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT elaatarmohamedbakr efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT elnagarmohamedthabet efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT emammohamedemam efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT hamadamahmoudmoustafa efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT abdelhamidtaimourmohamed efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT abdelhafezahmadsamir efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT seadawymohamedgomaa efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT fatohahmadrashad efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT elsaiedmohamedali efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT sakrmarwaabdelrahman efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT elkadyahmedomar efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT shehatamohamedmuawad efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT nawarosamamohamed efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT selemmohamedabuelnaga efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT abdaalmohamedsaeed efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT lotfyhanyhafez efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT elnagdytarekrefaat efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT helmysherine efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial
AT mubarkmagdyamin efficacyofsofosbuvirplusledipasvirinegyptianpatientswithcovid19comparedtostandardtreatmentarandomizedcontrolledtrial