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Redefinition of Fatty Liver Disease from NAFLD to MAFLD through the Lens of Drug Development and Regulatory Science

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Journal of Clinical and Translational Hepatology 2022年第2期10卷 374-382页

作者： Yasser Fouad Melissa Palmer Minjun Chen Arie Regev Rajarshi Banerjee Rob Myers Robert Riccio Richard Torstenson Ramy Younes Puneet SArora Henrik Landgren Morten A.Karsdal Martin Blake David A.Shapiro Hans-Juergen Gruss Muhammad Y.Sheikh dina attia Steven Bollipo Alastair D.Smith Bradley Freilich Robert G.Gish Detlef Schuppan Department of Gastroenterology Hepatologyand Endemic MedicineFaculty of MedicineMinia UniversityMiniaEgypt Gan-nex/Ascletis Pharma Co Ltd BeijingChina Liver Consulting LLC New YorkNYUSA Division of Bioinformatics and Biostatis-tics National Center for Toxicological ResearchUS Food and Drug AdministrationJeffersonARUSA Eli Lilly and Company IndianapolisINUSA Perspectum Diagnostics Ltd OxfordUK Gilead Sciences Inc Foster CityCAUSA Syneos Health LLC MorrisvilleNCUSA Allergan Marlow International BuckinghamshireUKAstraZenecaCambridgeUK Boehringer Ingel-heim International GmbHIngelheimGermany Genentech IncSouth San FranciscoCAUSA AbbVie MarlowBuck-inghamshireUK Nordic Bioscience A/S HerlevDenmark Resonance Health BurswoodWAAustralia Intercept Phar-maceuticals Inc San DiegoCAUSA Fresno Clinical Research Center FresnoCAUSA Gastroenterology and Hepatology Department Beni-Suef UniversityBeni SuefEgypt Department of Gastroenterology and Endoscopy John Hunter HospitalNewcastleNSWAustralia School of Medicine and Public Health University of NewcastleNewcastleNSWAustralia Kan-sas City Research Institute Kansas CityMOUSA Division of Gastroenterology and Hepatology Loma Linda UniversityLoma LindaCAUSA Institute of Translational Immunology and Research Center for Immune Therapy University Medical CenterMainzGermany Division of Gastroenterology Beth Israel Deaconess Medical CenterHarvard Medical SchoolBostonMAUSA

Metabolic(dysfunction)-associated fatty liver disease(MAFLD)affects a third of the population and is a leading cause of liver-related *** no effective treatments exist,novel approaches to drug development are ***,outdated terminology and definitions of the disease are hampering efforts to develop new drugs and *** international consensus panel has put forth an influential proposal for the disease to be renamed from nonalcoholic fatty liver disease(NAFLD)to MAFLD,includ-ing a proposal for how the disease should be *** allies with the many stakeholders in MAFLD care―including patients,patients’advocates,clinicians,researchers,nurse and allied health groups,regional societies,and others―we are aware of the negative consequences of the NAFLD term and *** share the sense of urgency for change and will act in new ways to achieve our *** there is much work to be done to overcome clinical inertia and reverse worrisome recent trends,the MAFLD initiative provides a firm foundation to build *** provides a roadmap for moving for-ward toward more efficient care and affordable,sustainable drug and device innovation in MAFLD *** hope it will bring promising new opportunities for a brighter future for MAFLD care and improve care and outcomes for patients of one of the globe’s largest and costliest public health *** this viewpoint,we have revisited this initiative through the perspectives of drug development and regulatory science.

关键词： NAFLD MAFLD NASH Fatty liver disease Liver Fibrosis

Effects of dual sofosbuvir/daclatasvir therapy on, chronic hepatitis C infected, survivors of childhood malignancy

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World Journal of Clinical Cases 2019年第16期7卷 2247-2255页

作者： Mortada HF El-Shabrawi Laila M Sherief Mostafa Yakoot Naglaa M Kamal Mohamed A Almalky Manal M AbdElgawad Aml A Mahfouz Sherine Helmy Enas M Kamal dina attia Hisham R El-Khayat Paediatric Hepatology Department Cairo Faculty of MedicineCairo 11559Egypt Paediatric Hematology-Oncology Department Zagazig Faculty of MedicineZagazig 21121Egypt Internal medicine Pediatrics and HepatologyGreen Clinic and Research CenterAlexandria UniversityAlexandria 21121Egypt Paediatric Hepatology Department Alexandria Faculty of medicineAlexandria 21121Egypt Innovations & Research Pharco CorporationAlexandria 21121Egypt Endemic medicine and Hepatology Department Minia UniversityMinia 22233Egypt Endemic medicine and Hepatology Department Beni-suef UniversityBeni-suef 62511Egypt Gastroenterology and Endemic Medicine Department Theodore Research InstituteCairo 23323Egypt

BACKGROUND Childhood cancer survivors are potentially at a higher risk of infection with hepatitis C virus (HCV).The effects of all-oral direct-acting antiviral therapy (DAA) on both the HCV infection as well as the state of cancer remission have not been well investigated in this *** To test the effects of dual sofosbuvir/daclatasvir (SOF/DCV) therapy in the treatment of chronic HCV in survivors of hematologic malignancy in pediatric age *** We conducted a prospective,uncontrolled,open-label multicenter study.A total of 20 eligible,chronic HCV,genotype-4,infected children who had been in continuous complete remission from hematologic cancer (leukemia/lymphoma) for at least one year were included in the *** patients were treated with combined SOF/DCV for 12 *** were monitored throughout the study till 12 wk after end of treatment for safety and efficacy outcomes including the sustained virologic response 12 (SVR12) rate,hematological indices,liver and kidney *** The intent-to-treat SVR12 rate was 20 of 20 (100%;95%CI: 84%-100%).All patients showed normalized liver enzymes from *** hematological indices,liver and kidney functions were kept normal throughout the *** fatalities or treatment-emergent serious or severe adverse events were reported throughout the *** SOF/DCV combined therapy could be used safely and effectively in the treatment of chronic HCV genotype-4 infection in leukemia/lymphoma treated *** relapses were detected during treatment and throughout the follow up period for either the original malignant disease or the HCV infection.

关键词： Chronic hepatitis C Survivors of childhood cancer Sofosbuvir Daclatasvir Efficacy

The combination of endoglin and FIB-4 increases the accuracy of detection of hepatic fibrosis in chronic hepatitis C patients

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Open Journal of Gastroenterology 2012年第2期2卷 62-67页

作者： Dawlat Salem Magdy El-Serafy Eman Obeida Wafaa Al-Akel Maissa El-Raziki dina attia Mostafa Hassan Biochemistry Department Faculty of Medicine Cairo University Cairo Egypt Endemic Medicine Department Faculty of Medicine Beni-Suef University Beni-Suef Egypt Endemic Medicine Department Faculty of Medicine Cairo University Cairo Egypt

Background and aim: In patients infected with chronic hepatitis C virus, liver biopsy is the gold standard method of staging fibrosis. Different combinations of serum markers attempted to correlate with hepatic fibrosis in place of liver biopsy and have shown encouraging results. The aim of our study is to evaluate the diagnostic value of endoglin and FIB-4 as non-invasive markers of hepatic fibrosis in HCV patients. Methods: We estimated serum endoglin & FIB-4 index in 40 infected chronic hepatitis C patients. Histological staging of hepatic fibrosis was done according to the METAVIR scoring system. Results: Both endoglin and FIB-4 index showed positive correlation with age and aspartate transaminase and inverse correlation with albumin. The diagnostic performance determined by AUROCs for early fibrosis (≤F2), was 0.868 for endoglin and 0.887 for FIB-4, at cut off va- lues of 5.5 & 0.98 with sensitivity of 64.3% & 82.1%, and specificity of 100% & 85% respectively. For ad-vanced fibrosis (>F2), the AUROC was 0.98 for endoglin and 0.967 for FIB-4, obtained at cut off values of 6.29 & 1.6, with sensitivity of 100% & 91.7%, and specificity of 89.3% & 92.9%, respectively. Conclusion: Both serum endoglin and FIB-4 index are fairly accurate in differentiating stages of hepatic fibrosis;their combination in a single equation enhanced the accuracy of fibrosis detection in chronic HCV patients.

关键词： Hepatitis C Virus Hepatic Fibrosis Liver Biopsy Non-Invasive Marker Endoglin FIB-4

Predictors of Complete Early Virological Response to Pegylated Interferon and Ribavirin in Egyptian Patients with Chronic Hepatitis C Genotype 4

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Advances in Infectious Diseases 2013年第2期3卷 78-83页

作者： Gamal El Din Esmat Gamil Maissa El Said El Raziky Rabab Maamoun Salama Wafaa Ahmed El Akel Waleed Fouad Fathalah dina Ismail attia Endemic Medicine and Hepatology Department Faculty of Medicine Cairo University Cairo Egypt

We aim to determine the baseline factors associated with partial and cEVR by analyzing the data of 1861 Egyptian patients treated for 12 weeks with a course of Peg-IFN plus RBV. Base line data of 1861 Egyptian patients with chronic hepatitis C coming at Cairo-Fatemic Hospital for HCV treatment were studied including full clinical, Ultrasonographic examination, laboratory evaluation and liver biopsy. The most significant variables in relation to complete early virological response were low Hb level (13 gm/dl) with p 0.01, the stage of fibrosis p value < 0.05 and the grades of inflammation p value were associated with less achievement of c EVR. We conclude that identifying the most significant predictors of response such as Hb, stage of fibrosis F, at baseline before initiating treatment is mandatory to predict which patient will be more expected to achieve a cEVR and thus reducing the side-effects and healthcare costs associated with interferon therapies.

关键词： Predictors of Response cEVR HCV Treatment Peg IFN/Ribavirin

The Glenn Shunt Revisited, A Single Center Registry in Ain Shams University Cardiology Department

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Congenital Heart Disease 2022年第1期17卷 71-85页

作者： Mina Tewfik Maiy El-Sayed Alaa Roushdy Soha Romeih dina Ezzeldin Hebatalla attia Cardiology Department Ain Shams UniversityCairoEgypt Prof.Magdy Yacoub Aswan Heart Centre AswanEgypt Cardiology Department Tanta UniversityTantaEgypt

Background:Bidirectional Glenn shunts have long been available as palliative procedures for patients with single ventricle physiology that is,patients unsuitable for biventricular *** our country they are performed at an older age than that recommended by the ***,we aim to assess post bidirectional Glenn shunt patients to detect the presence of any complications and to evaluate their functional ***:This was a descriptive study that included all patients who underwent a bidirectional Glenn shunt and were referred for follow up in Ain shams university *** taking including NYHA class and physical activity,clinical examination,six-minutes-walk test,laboratory investigations,full echocardiographic assessment were done for all *** patients needed invasive cardiac ***:Our registry included 178 patients who underwent bidirectional Glenn procedure referred for follow up in Ain Shams university hospital from January 2019 till July *** mean age of the registry was 18.7±8.26 years(range between 5 and 37 years),85 males(48%)and 93 females(52%).Regarding the basic anatomy,double outlet right ventricle with hypoplastic left ventricle was the ***,our descriptive study confirmed many characteristic similarities between our patients and patients in developing *** patients underwent bidirectional Glenn shunt at a median age of 6 years which is considered a relatively old age but similar to other studies that have been made in developing countries like Pakistan,India and *** is a significant delay in the operation in Egyptian patients due to lack of patients’awareness,few numbers of primary health care facilities and high economic ***:Although the presence of slight systemic desaturation,our study demonstrated a satisfactory functional capacity among our patients;thus,bidirectional Glenn can be considered an acceptable definite univentricular repair in patients

关键词： Bidirectional Glenn shunt single ventricle univentricular repair