Gilead and the EMA are hiding adverse effects from patients

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Gilead and the EMA are hiding adverse effects from patients

机译：Gilead和EMA正在隐藏患者的不利影响

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No known adverse effects? Does this mean, miraculously, that neither sofosbuvir nor velpatasvir has any adverse effects of which patients should be warned? The Adverse Effects section of the European summary of product characteristics (SPC) for Epclusa0 mentions few adverse effects: headache, fatigue and nausea, as well as anaemia when combined with ribavirin, based solely on cases observed during clinical trials of Epclusa0 (1 ).The SPC also mentions a risk of cardiac arrhythmias, including brady-cardia, when sofosbuvir is combined with certain direct-acting antivirals or with amiodarone. Pharmacovigilance data are starting to accumulate for sofosbuvir, and the EMA and Gilead are the first to be informed.Thus, the European SPC for sofosbuvir (Sovaldi0), a drug also marketed by Gilead, since 2014, mentions more than 20 frequent or very frequent adverse effects, including insomnia, neutropenia, headache, fatigue, muscle pain, mood disorders and skin disorders (2). In the US, prescribing information for Epclusa0 states that some of these adverse effects also occurred during clinical development of the sofosbuvir + velpatasvir combination, including irritability, insomnia, rash and depression. Gilead is therefore fully aware of them (3).

机译：没有知名的不利影响？奇迹般地，既不是Sofosbuvir和VelpataSvir是否都没有产生任何不良反应的意思是，患者应该被警告？欧洲产品特征（SPC）概述的不良反应部分对EPClusa0提到的少数不良影响：头痛，疲劳和恶心，以及贫血与利巴韦林相结合，仅基于EPClusa0（1）的临床试验期间观察到的情况。当Sofosbuvir与某些直接作用抗病毒或胺碘酮相结合时，SPC还提到了心脏心律失常的风险，包括Brady-Cardia。药物知识数据开始积累Sofosbuvir，而EMA和GILEAD是第一个被告知的.thus，欧洲SPC为Sofosbuvir（SOVAlodi0），这是一种由Gilead销售的药物，自2014年以来，提到20多频繁或非常频繁不良反应，包括失眠，中性粒细胞病，头痛，疲劳，肌肉疼痛，情绪障碍和皮肤病（2）。在美国，EPClusa0的规定信息表明，在Sofosbuvir + Velpatasvir组合的临床开发过程中也发生了这些不利影响，包括烦躁，失眠，皮疹和抑郁症。因此，Gilead完全了解它们（3）。

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《Prescrire international》 |2018年第192期|共1页
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1. Gilead and the EMA are hiding adverse effects from patients [J] . Prescrire international . 2018,第192期

机译：Gilead和EMA正在隐藏患者的不利影响
2. Sources of patients' knowledge of the adverse effects of psychotropic medication and the perceived influence of adverse effects on compliance among service users attending community mental health services. [J] . Agyapong VI, Nwankwo V, Bangaru Journal of clinical psychopharmacology . 2009,第6期

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3. Adverse drug effects in elderly people - a disparity between clinical examination and adverse effects self-reported by the patient. [J] . Lampela P, Hartikainen S, Sulkava R, European journal of clinical pharmacology . 2007,第5期

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4. Analysis of adverse effects of stimulation during DBS surgery by patient-specific FEM simulations [C] . Ashesh A. Shah, Fabiola Alonso, Dorian Vogel, Annual International Conference of the IEEE Engineering in Medicine and Biology Society . 2018

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5. Adverse effects of asparaginase in pediatric patients with acute lymphoblastic leukemia. [D] . Liu, Chengcheng. 2015

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6. Postoperative pain and patient-controlled epidural analgesia-related adverse effects in young and elderly patients: a retrospective analysis of 2435 patients [O] . Jae Chul Koh, Young Song, So Yeon Kim, 2017

机译：老年和老年患者的术后疼痛和患者控制的硬膜外镇痛相关不良反应：2435例患者的回顾性分析
7. MODERATED EPOSTERS1385Longitudinal strain assessment in dilated cardiomyopathy patients using a novel accelerated DENSE sequence1407Simultaneous T1 and T2 cardiac quantification with CABIRIA: initial clinical experience1423Head-to-head comparison of acceleration algorithms in 4-dimensional flow CMR1502Left ventricular function and size evaluated by hybrid cardiac positron emission tomography-magnetic resonance: Intraindividual comparison of left ventricular ejection fraction and ventricular volumes derived by two modalities1510Left Atrium assessed by Cardiovascular Magnetic Resonance at 1.5 and 3 Tesla – age and gender effects1514Comparison of Free Breathing Cardiac MRI Radial technique to the Standard Multi breath-hold cine SSFP CMR technique for the assessment of LV Volumes and Function1536Self-navigated free-breathing isotropic 3D whole heart phase sensitive inversion recovery magnetic resonance without navigator for detection of myocardial infarction1547Assessment of Right Ventricular Strain Using Myocardial Deformation Recovery Semi Automated Technique: Initial Experience and Normal Values1586Tissue tracking myocardial deformation analysis and prediction of left ventricular remodeling in acute myocardial infarction1589Investigating strategies for optimal 31P MRS clinical cardiac at 3T: Initial Results1620Quantitative Criteria for the Diagnosis of the Congenital Absence of Pericardium by Cardiac Magnetic Resonance1632Widespread tissue injury during acute myocardial infarction: evidence from advanced CMR relaxometry1322Computed tomography coronary angiography verSus sTRess cArdiac magneTic rEsonance for the manaGement of sYmptomatic revascularized patients: a cost effectiveness study (STRATEGY study)1339Comparison of low- versus high-dose of gadobutrol for late gadolinium enhancement imaging at 1.5 Tesla: a clinical feasibility study1347Multi-parametric Cardiac Magnetic Resonance for Prediction of Cardiac Complications in Thalassemia Intermedia: a Prospective Multicenter Study1461Prognostic value of Cardiovascular Magnetic Resonance derived indexes of myocardial fibrosis in heart transplant recipients1523The role of CMR in the acute phase of hospitalization: changing paradigms1542Preoperative CMR-based score predict ventricular response after surgical left ventricular reconstruction in ischemic heart failure patients1555Excellent response rate to cardiac resynchronization therapy guided with magnetic resonance imaging1626The ECG as a predictor of arrhythmogenic substrate on Cardiac Magnetic Resonance Imaging in patients undergoing ablation for premature ventricular contractions1649Comparison of T1-mapping at 3.0T CMR and angiographic APPROACH score for area at risk assessment in ST-segment elevation myocardial infarction1340Pathological correlates of left bundle branch disease in patients with non-ischemic cardiomyopathy: a cardiovascular magnetic resonance study1342Myocardial remodelling and fibrosis in nonischaemic dilated cardiomyopathy: insights from cardiovascular magnetic resonance1411The association between fibrosis and contractile dysfunction in hypertrophic cardiomyopathy assessed by cardiovascular magnetic resonance1622Persistent myocardial inflammation due to intramyocardial haemorrhage in reperfused STEMI as a precursor to adverse LV remodelling - insights from multi-parametric mapping1566Semiquantitative analysis of low and high b value DWI for detecting myocardial edema in acute myocarditis1567Value of Cardiac MRI In Detecting Coronary Artery Disease In Newly Diagnosed Systolic Dysfunction1570Usefulness of cardiac magnetic resonance in tuberous sclerosis complex1578Papillary muscles offer further insight into hypertrophied hearts: a cardiovascular magnetic resonance study1627Diagnostic and clinical implications of CMR timing (early versus late) in patients with troponin positive acute coronary syndromes and unobstructed coronary arteries: Table 1. [O] . Upasana Tayal, Alexandros Kallifatidis, P. Garg, 2016

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机译：红细胞储存年龄对危重患者的炎症，免疫功能和输血相关微嵌合体的敏感性是什么？重症患者红细胞储存的不良影响。

Gilead and the EMA are hiding adverse effects from patients

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