Safety Profile of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Hepatitis C in Romania: an Analysis Conducted in VigiBase®/ WHO
| العنوان: | Safety Profile of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Hepatitis C in Romania: an Analysis Conducted in VigiBase®/ WHO |
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| المؤلفون: | Andreea Farcas, Anamaria Cristina, Camelia Bucsa, Irina Cazacu, Roxana Dondera, Roxana Stroe, Cristina Mogosan, Bogdan Apan |
| المصدر: | Journal of Gastrointestinal and Liver Diseases. |
| بيانات النشر: | Romanian Society of Gastroenterology and Hepatology, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | medicine.medical_specialty, Dasabuvir, business.industry, Gastroenterology, Hepatitis C, medicine.disease, Ombitasvir, chemistry.chemical_compound, Regimen, chemistry, Paritaprevir, Ombitasvir/paritaprevir/ritonavir, Internal medicine, Pharmacovigilance, medicine, Ritonavir, business, medicine.drug |
| الوصف: | Background and Aims: Due to the increasing number of hepatitis C virus (HCV)-infected patients being treated with direct antiviral agents (DAAs) in Romania, we aimed to conduct a pharmacovigilance study in order to comprehensively evaluate the safety profile for the ombitasvir/paritaprevir/ritonavir and dasabuvir (Om/Pa/Ri+Da) regimen. Methods: A retrospective analysis was conducted on the individual case safety reports (ICSRs), extracted from VigiBase® on 1 st February 2018, which included the Om/Pa/Ri+Da regimen as suspected for causing adverse drug reactions (ADRs). Potential drug-drug interactions (DDIs) were checked for all concomitant medication using the IBM Micromedex® tool. Results: Among the 1,102 ICSRs retrieved, 260 were serious (23.5%). Ribavirin was significantly associated with more ADRs reported per case (on average 5.1 vs. 3.2 ADRs/case, p |
| تدمد: | 1842-1121 1841-8724 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e6bd15393b696d86bd82c8af032a40a0Test https://doi.org/10.15403/jgld-2889Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....e6bd15393b696d86bd82c8af032a40a0 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 18421121 18418724 |
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