“…All of the symptomatic patients in this study were managed without discontinuation or modification in sofosbuvir plus daclatasvir regimen, and none of them had a serious adverse effect that lead to premature discontinuation of treatment and no deaths occurred. This result agrees with the studies done by Babatin et al 8 , Ahmed et al 9 , El-Gammal et al 10 , Abdel-Moneim et al 11 and Aboud et al 12 Abouelkheir et al 13 , Osman et al 14 . However, few studies reported adverse effects that led to discontinuation of the sofosbuvir plus daclatasvir regimen in a few patients, and they were diagnosed as severe asthma exacerbation 19 , and an acute respiratory failure secondary to chronic obstructive pulmonary disease exacerbation 20 .…”
Section: Resultssupporting
confidence: 91%
“…On the other hand, the spirometric results (FVC, FEV1, FEV1/FVC%) of the included patients in the current study were normal in both stations with no statistically significant changes. This result agrees with the result of the study done by Aboud et al 12 , but it disagreed with that of Abouelkheir et al 13 who found a reduction in FEV1 and FEV1/FVC%, and the obstructive ventilatory defect was the prominent pattern in their study on patients treated with sofosbuvir plus daclatasvir with ribavirin regimen. The results of Abouelkheir et al study were different from the results of our study, because they used ribavirin in their regimen, and they didn't exclude smokers or patients with cirrhotic liver from their study.…”
Background: Egypt has one of the highest hepatitis C virus (HCV) prevalence rates in the world, which led the government to strive to control it. The national guidelines for chronic HCV treatment had been modified to be interferon-free regimens by giving, the pan-genotypic direct acting antiviral agents (DAAs), sofosbuvir plus daclatasvir with or without ribavirin regimen. The aim of the study was the evaluation of the development of any considerable pulmonary complications among Egyptian patients receiving the combination of sofosbuvir plus daclatasvir for the treatment of chronic HCV infection. Patients and Methods: The study included fifty patients with chronic HCV who were planned to be treated with sofosbuvir plus daclatasvir regimen. They were followed up during the course of the treatment to report and diagnose any developed respiratory symptoms, with two main stations of assessment (pre-and post-treatment), to compare between both outcomes. Results: Nine patients (18%) developed respiratory symptoms during this regimen, in the form of cough (16%), sputum production (6%), dyspnea (6%), fever (6%), and rhinorrhea (4%). Their diagnoses were; acute bronchitis (2 patients), flu-like symptoms (2 patients), cough due to gastro-esophageal-reflux-disease (1 patient), mild airway hyperresponsiveness (1 patient), community-acquired pneumonia (1 patient), community-acquired pneumonia with para-pneumonic effusion (1 patient) and idiopathic pleural effusion (1 patient). They were managed without discontinuation of the regimen. Conclusion: Sofosbuvir plus daclatasvir regimen was generally safe on the respiratory system, and some patients developed manageable nonserious respiratory events during the course of treatment.
“…All of the symptomatic patients in this study were managed without discontinuation or modification in sofosbuvir plus daclatasvir regimen, and none of them had a serious adverse effect that lead to premature discontinuation of treatment and no deaths occurred. This result agrees with the studies done by Babatin et al 8 , Ahmed et al 9 , El-Gammal et al 10 , Abdel-Moneim et al 11 and Aboud et al 12 Abouelkheir et al 13 , Osman et al 14 . However, few studies reported adverse effects that led to discontinuation of the sofosbuvir plus daclatasvir regimen in a few patients, and they were diagnosed as severe asthma exacerbation 19 , and an acute respiratory failure secondary to chronic obstructive pulmonary disease exacerbation 20 .…”
Section: Resultssupporting
confidence: 91%
“…On the other hand, the spirometric results (FVC, FEV1, FEV1/FVC%) of the included patients in the current study were normal in both stations with no statistically significant changes. This result agrees with the result of the study done by Aboud et al 12 , but it disagreed with that of Abouelkheir et al 13 who found a reduction in FEV1 and FEV1/FVC%, and the obstructive ventilatory defect was the prominent pattern in their study on patients treated with sofosbuvir plus daclatasvir with ribavirin regimen. The results of Abouelkheir et al study were different from the results of our study, because they used ribavirin in their regimen, and they didn't exclude smokers or patients with cirrhotic liver from their study.…”
Background: Egypt has one of the highest hepatitis C virus (HCV) prevalence rates in the world, which led the government to strive to control it. The national guidelines for chronic HCV treatment had been modified to be interferon-free regimens by giving, the pan-genotypic direct acting antiviral agents (DAAs), sofosbuvir plus daclatasvir with or without ribavirin regimen. The aim of the study was the evaluation of the development of any considerable pulmonary complications among Egyptian patients receiving the combination of sofosbuvir plus daclatasvir for the treatment of chronic HCV infection. Patients and Methods: The study included fifty patients with chronic HCV who were planned to be treated with sofosbuvir plus daclatasvir regimen. They were followed up during the course of the treatment to report and diagnose any developed respiratory symptoms, with two main stations of assessment (pre-and post-treatment), to compare between both outcomes. Results: Nine patients (18%) developed respiratory symptoms during this regimen, in the form of cough (16%), sputum production (6%), dyspnea (6%), fever (6%), and rhinorrhea (4%). Their diagnoses were; acute bronchitis (2 patients), flu-like symptoms (2 patients), cough due to gastro-esophageal-reflux-disease (1 patient), mild airway hyperresponsiveness (1 patient), community-acquired pneumonia (1 patient), community-acquired pneumonia with para-pneumonic effusion (1 patient) and idiopathic pleural effusion (1 patient). They were managed without discontinuation of the regimen. Conclusion: Sofosbuvir plus daclatasvir regimen was generally safe on the respiratory system, and some patients developed manageable nonserious respiratory events during the course of treatment.
“…Although DAAs initially showed significant promise when introduced to the market, subsequent studies noted a few limitations and deleterious side effects of these treatments. Therefore, a detailed investigations to explore interventions of DAAs with molecular pathways, cellular physiology and subcellular organelles are required (Maciocia et al ., 2016; Abouelkheir Abdalla et al ., 2017; Kim et al ., 2017; Andrade et al ., 2018; Hirose et al ., 2019; Kogiso et al ., 2019). Researchers were particularly concerned over the possible increase in incidence and relapse of HCC recorded in HCV patients after DAA therapy (Giovannini et al ., 2020; Lithy et al ., 2020; Muzica et al ., 2020; Pop et al ., 2020).…”
Summary
Sofosbuvir and Daclatasvir are among the direct‐acting antiviral (DAA) medications prescribed for the treatment of chronic hepatitis C (CHC) virus infection as combination therapy with other antiviral medications. DAA‐based therapy achieves high cure rates, reaching up to 97% depending on the genotype of the causative hepatitis C virus (HCV). While DAAs have been approved as an efficient and well‐tolerated therapy for CHC, emerging concerns about adverse cardiac side effects, higher risk of recurrence and occurrence of hepatocellular carcinoma (HCC) and doubts of genotoxicity have been reported. In our study, we investigated in detail physiological off‐targets of DAAs and dissected the effects of these drugs on cellular organelles using budding yeast, a unicellular eukaryotic organism. DAAs were found to disturb the architecture of the endoplasmic reticulum (ER) and the mitochondria, while showing no apparent genotoxicity or DNA damaging effect. Our study provides evidence that DAAs are not associated with genotoxicity and highlights the necessity for adjunctive antioxidant therapy to mitigate the adverse effects of DAAs on ER and mitochondria.
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