{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T16:43:54Z","timestamp":1790613834782,"version":"4.1.0"},"reference-count":46,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2023,5,25]],"date-time":"2023-05-25T00:00:00Z","timestamp":1684972800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,5,25]],"date-time":"2023-05-25T00:00:00Z","timestamp":1684972800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002352","name":"Ain Shams University","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002352","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Hepatitis C virus (HCV) is the primary contributor to chronic hepatic diseases. A rapid change in the situation took place with the advent of oral direct-acting antivirals (DAAs). However, a comprehensive review of the adverse event (AE) profile of the DAAs is lacking. This cross-sectional study aimed to analyze the reported Adverse Drug Reactions (ADRs) with DAA treatment using data from VigiBase, the WHO Individual Case Safety Report (ICSR) database.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>All ICSRs reported to VigiBase with sofosbuvir (SOF), daclatasvir (DCV), sofosbuvir \/ledipasvir (SOF\/LDV) and ombitasvir\/paritaprevir\/ritonavir (OBV\/PTV\/r) in Egypt were extracted. Descriptive analysis was performed to summarize patients\u2019 and reactions\u2019 characteristics. Information components (ICs) and proportional reporting ratios (PRRs) for all reported ADRs were calculated to identify signals of disproportionate reporting. Logistic regression analysis was performed to identify the DAAs association with serious events of concern while adjusting for age, gender, pre-existing cirrhosis, and ribavirin use.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Out of 2925 reports, 1131 (38.6%) were serious. The most commonly reported reactions; anaemia (21.3%), HCV relapse (14.5%) and headache (14%). For the disproportionality signals; HCV relapse was reported with SOF\/DCV (IC 3.65, 95% CrI 3.47\u20133.79) and SOF\/RBV (IC 3.69, 95% CrI 3.37\u20133.92), while anaemia (IC 2.85, 95% CrI 2.26\u20133.27) and renal impairment (IC 2.12, 95% CrI 0.7\u20133.03) were reported with OBV\/PTV\/r.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>The highest severity index and seriousness were reported with SOF\/RBV regimen. A significant association was found for OBV\/PTV\/r with renal impairment and anaemia although being the superior regimen in terms of efficacy. The study findings call for further population-based studies for clinical validation.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s43441-023-00537-x","type":"journal-article","created":{"date-parts":[[2023,5,25]],"date-time":"2023-05-25T14:03:05Z","timestamp":1685023385000},"page":"997-1007","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study"],"prefix":"10.1007","volume":"57","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8241-5223","authenticated-orcid":false,"given":"Mai G.","family":"El-Marakby","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed H.","family":"Solayman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2611-4853","authenticated-orcid":false,"given":"Nagwa A.","family":"Sabri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,5,25]]},"reference":[{"key":"537_CR1","doi-asserted-by":"publisher","DOI":"10.1186\/s43166-020-00021-6","author":"SM Alian","year":"2020","unstructured":"Alian SM, Wahba MO, Gomaa AF, et al. 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Approval to conduct this study and extract data from VigiBase was obtained from the Egyptian Drug Authority (EDA). The study protocol was revised and approved by the Committee of Ethics, Faculty of Pharmacy, Ain Shams University (approval number: 236 dated 13-03-2019).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}