Publications by authors named "Wafaa Elakel"

18 Publications

  • Page 1 of 1

Egyptian revalidation of non-invasive parameters for predicting esophageal varices in cirrhotic patients: A retrospective study.

Arab J Gastroenterol 2022 Apr 23. Epub 2022 Apr 23.

National Committee for Control of Viral Hepatitis, Egypt; Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.

Background And Study Aims: In resource-limited countries, non-invasive tests for assessing liver fibrosis are a potential alternative to costly endoscopic screening for esophageal varices. We aimed to validate several non-invasive parameters for predicting the presence of varices.

Patients And Methods: Between September 2006 and August 2017, a total of 46,014 patients who underwent upper gastrointestinal endoscopy as one of the perquisites for receiving hepatitis C virus (HCV) therapy were enrolled and divided into group I (without varices) and group II (with varices). Non-invasive parameters of fibrosis, namely Lok index, Bonacini score, liver stiffness, FIB-4, Baveno, and extended Baveno criteria, were validated.

Results: Lok index, Bonacini score, liver stiffness, and FIB-4 had areas under the receiver operating characteristic curve (AUCs) of >0.6 (all P < 0.01 for the null hypothesis that the AUC was 0.5) for determination of the presence/absence of varices, with cutoff values of 0.80, 6.5, 21.9 kPa, and 2.94, and sensitivities of 74%, 74%, 66%, and 83%, respectively. The expanded Baveno VI criteria performed better than the Baveno VI criteria (spared endoscopy rate 81% versus 63%).

Conclusion: The use of non-invasive methods is of limited value in predicting esophageal varices. The limited accuracy of ≤60% may delay the use of appropriate primary prophylaxis against variceal bleeding in a large proportion of cirrhotic patients.
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http://dx.doi.org/10.1016/j.ajg.2022.04.003DOI Listing
April 2022

Determining the lower limit of detection required for HCV viral load assay for test of cure following direct-acting antiviral-based treatment regimens: Evidence from a global data set.

J Viral Hepat 2022 Jun 30;29(6):474-486. Epub 2022 Mar 30.

Department of Medicine, Section of Infectious Diseases, Boston Medical Center, Boston, Massachusetts, USA.

Achieving global elimination of hepatitis C virus requires a substantial scale-up of testing. Point-of-care HCV viral load assays are available as an alternative to laboratory-based assays to promote access in hard to reach or marginalized populations. The diagnostic performance and lower limit of detection are important attributes of these new assays for both diagnosis and test of cure. Therefore, our objective was to determine an acceptable LLoD for detectable HCV viraemia as a test for cure, 12 weeks post-treatment (SVR12). We assembled a global data set of patients with detectable viraemia at SVR12 from observational databases from 9 countries (Egypt, the United States, United Kingdom, Georgia, Ukraine, Myanmar, Cambodia, Pakistan, Mozambique) and two pharmaceutical-sponsored clinical trial registries. We examined the distribution of HCV viral load at SVR12 and presented the 90th, 95th, 97th and 99th percentiles. We used logistic regression to assess characteristics associated with low-level virological treatment failure (defined as <1000 IU/mL). There were 5973 cases of detectable viraemia at SVR12 from the combined data set. Median detectable HCV RNA at SVR12 was 287,986 IU/mL. The level of detection for the 95th percentile was 227 IU/mL (95% CI 170-276). Females and those with minimal fibrosis were more likely to experience low-level viraemia at SVR12 compared to men (adjusted odds ratio AOR = 1.60 95% confidence interval [CI] 1.30-1.97 and those with cirrhosis (AOR = 1.49 95% CI 1.15-1.93). In conclusion, an assay with a level of detection of 1000 IU/mL or greater may miss a proportion of those with low-level treatment failure.
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http://dx.doi.org/10.1111/jvh.13672DOI Listing
June 2022

Covid-19 pandemic in Egyptian children with liver diseases: Incidence and impact on health care service delivery in a low/middle income country.

Arab J Gastroenterol 2022 Feb 14;23(1):1-6. Epub 2022 Jan 14.

Department of Paediatrics, Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address:

Background And Study Aims: The coronavirus disease 2019 (COVID-19) pandemic has had considerable effects on health care services given the need for re-allocation of resources and interruption of medical care. COVID-19 poses a challenge to patients with liver disease who are at risk of infection and more severe disease course. The current study aimed to assess the incidence of COVID-19 in children with liver diseases and evaluate the extent to which health care delivery was affected during lockdown.

Patients And Methods: This cross-sectional analytical study conducted at the Pediatric Hepatology Unit, Cairo University Children's Hospital utilized a questionnaire to determine the incidence of COVID-19 in patients with liver diseases and the impact of COVID-19 on the patients' liver condition and health care service delivery. A presumed score was implemented to identify patients with probable COVID-19.

Results: Data from 349 children with liver diseases were analyzed. The overall incidence of COVID-19 was 8%. Patients with documented and probable COVID-19 were compared to improbable COVID-19 cases. Notably, COVID-19 cases were younger and had higher incidence rates of cholestatic liver diseases. COVID-19 patients experienced significantly higher rates of hepatic complications (43%) and had significantly greater need for medical services during the lockdown. All COVID-19 patients recovered after a median (IQR) duration of 3 (4) days, except for one patient who succumbed to COVID-19 and hepatic complications.

Conclusions: COVID-19 affected the younger hepatic patients with cholestatic disorders of infancy. Hepatic complications were more common among COVID-19 infected children. Alternative ways of communication require development to prioritize patients who needs a hospital visit and monitoring. Clinical scores may help diagnosis of COVID-19 in low/middle income countries like Egypt to compensate for the deficient laboratory diagnostic facilities.
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http://dx.doi.org/10.1016/j.ajg.2022.01.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8758320PMC
February 2022

Derivation of "Egyptian varices prediction (EVP) index": A novel noninvasive index for diagnosing esophageal varices in HCV Patients.

J Adv Res 2022 01 24;35:87-97. Epub 2021 Feb 24.

Systems and Information Department, Engineering Research Division, National Research Centre, Giza, Egypt.

Introduction: Esophageal Varices (EVs) is one of the major dangerous complications of liver fibrosis. Upper Gastrointestinal (UGI) Endoscopy is necessary for its diagnosis. Repeated examinations for EVs screening severely burden endoscopic units in terms of cost and other side implications; moreover, the lack of public health resources in rural areas and primary hospitals should be considered, particularly in developing countries. So, an accurate noninvasive marker for EV is highly needed for liver disease patients.

Objectives: This study sought to evaluate the values of several indices to determine how adequate are they in predicting EV and build a novel accurate prediction index.

Methods: Five thousand and thirteen patients were enrolled. The laboratory tests, abdominal ultrasonography, liver stiffness measurement using Fibro-scan, and UGI endoscopy were performed. Ten common indices: Fib-4 score, AST-to-platelet ratio index, Fibrosis index, AST/ALT ratio Varices Prediction Rule, Baveno VI, APRI-Fib4 Combo, King score, "Model for End-Stage Liver Disease", and Lok Score were calculated. The significant predictors for EVs were identified by using "P-value Correlation-based Filter Selection" method, where a novel Egyptian Varices Prediction (EVP) index was developed using binary logistic regression. The diagnostic performance was evaluated by some parameters and the Area Under Curve (AUC).

Results: EVP Index was correlated to EVs at 0.5; it achieved higher performance (AUC 0.788, accuracy 73.3%, and sensitivity 78%) than the other indices at a cutoff point of 0.423.

Conclusion: EVP Index was a good noninvasive predictor. It had an acceptable performance for diagnosing EVs and it was only required regular laboratory tests and imaging data. It can provide a tool for classifying or arranging the patients according to the degree pre-emptive for selective endoscopy and the degree of severity. Also, it will enable clinicians to concentrate on one marker instead of a wide set of parameters.
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http://dx.doi.org/10.1016/j.jare.2021.02.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8721354PMC
January 2022

Evaluation of the role of bile acids and serotonin as markers of pruritus in children with chronic cholestatic liver disease.

Arab J Gastroenterol 2021 Sep 3;22(3):199-202. Epub 2021 Jun 3.

Cairo University, Department Clinical & Chemical Pathology, Cairo, Egypt. Electronic address:

Background And Study Aims: Pruritus is an annoying symptom with an unclear pathogenesis accompanied by chronic cholestasis. This cross-sectional study was conducted to define the relationship between serum levels of presumed pruritogens (bile acids (BAs) and serotonin) and severity of pruritus in pediatric patients with chronic cholestatic liver disease.

Patients And Methods: A total of 28 children suffering from pruritus due to chronic cholestatic liver disease and 29 age- and sex-matched healthy control subjects were examined. Scores obtained used the 5-D itch scale were evaluated among patients. Serum levels of BAs and serotonin were determined using enzymatic assays and high-performance liquid chromatography, respectively.

Results: Patients had higher serum BA levels and lower serotonin levels than control subjects. Serum BA levels were significantly elevated in 61% of patients. The 5-D itch scale scores were significantly higher in cholestatic individuals with normal γ-glutamyl transpeptidase levels. Neither BA nor serotonin levels correlated with the severity of the 5-Ditch scale score.

Conclusion: Neither BA nor serotonin levels correlated with the severity of pruritus, indicating that they may not be good laboratory markers for the intensity of itch in children with cholestasis. Our findings suggest that it is necessary to identify another potential pruritogenic mediator, most probably of a biliary origin.
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http://dx.doi.org/10.1016/j.ajg.2021.04.001DOI Listing
September 2021

Machine Learning Prediction Models for Diagnosing Hepatocellular Carcinoma with HCV-related Chronic Liver Disease.

Comput Methods Programs Biomed 2020 Nov 23;196:105551. Epub 2020 May 23.

Endemic Hepatogastroenterology Department, Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address:

Background And Objective: Considered as one of the most recurrent types of liver malignancy, Hepatocellular Carcinoma (HCC) needs to be assessed in a non-invasive way. The objective of the current study is to develop prediction models for Chronic Hepatitis C (CHC)-related HCC using machine learning techniques.

Methods: A dataset, for 4423 CHC patients, was investigated to identify the significant parameters for predicting HCC presence. In this study, several machine learning techniques (Classification and regression tree, alternating decision tree, reduce pruning error tree and linear regression algorithm) were used to build HCC classification models for prediction of HCC presence.

Results: Age, alpha-fetoprotein (AFP), alkaline phosphate (ALP), albumin, and total bilirubin attributes were statistically found to be associated with HCC presence. Several HCC classification models were constructed using several machine learning algorithms. The proposed HCC classification models provide adequate area under the receiver operating characteristic curve (AUROC) and high accuracy of HCC diagnosis. AUROC ranges between 95.5% and 99%, plus overall accuracy between 93.2% and 95.6%.

Conclusion: Models with simplistic factors have the power to predict the existence of HCC with outstanding performance.
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http://dx.doi.org/10.1016/j.cmpb.2020.105551DOI Listing
November 2020

Assessment of facility performance during mass treatment of chronic hepatitis C in Egypt: Enablers and obstacles.

J Infect Public Health 2020 Sep 27;13(9):1322-1329. Epub 2020 May 27.

Endemic Medicine and Hepato-Gastroenterology Department, Cairo University, Cairo, Egypt; National Committee for Control of Viral Hepatitis, MOH, Cairo, Egypt.

Background: The national committee for control of viral hepatitis (NCCVH) in Egypt, settled by the Ministry of health, treated over one million patients in around 60 centers with chronological changes in drug combinations. This research aims to study the health care facilities and services provided by NCCVH treatment centers in Egypt and explore hinders faced.

Methods: A cross-sectional operational research study. Multistage random sampling technique was applied for Egyptian governorates. From each stratum one governorate was chosen from which one center was randomly selected. Quality of recorded data for each center in the central server (Data-oriented parameter), newly designed score to assess the overall performance of the centers was retrieved from computer based recording system. A self-administered questionnaire was completed by the centers head.

Results: This study included 24 treatment centers from urban, rural areas, Upper and Lower Egypt. The Upper centers showed the best completeness of follow-up records and the least compliance rates. None of the centers had 100% completeness of follow-up data. Proportion of SVR is minimally less than proportion of patient with known outcome in all treatment centers. A novel indicator standardizing the comparisons of performance of different facilities was introduced: Total number of physicians/total number of SVR patients with completed records. The highest response rate: Monfiya Governorate (Lower Egypt), Aswan (Upper Egypt), Completeness of follow-up records: Kalyoubia (Lower Egypt), Sohag governorate (Upper Egypt). The average administrative score was 64%.

Conclusion: Challenges of NCCVH program: overcrowdings, resistant sociocultural background among rural patients, limited accessibility for internal migrants and incompleteness of data entry are system lacking points. Strengths include, clear patient pathway, well-established database online application, well-trained physicians and treatment availability.
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http://dx.doi.org/10.1016/j.jiph.2020.05.008DOI Listing
September 2020

High SVR rate following retreatment of non-sustained virological responders to sofosbuvir based anti-HCV therapies regardless of RAS testing: A real-life multicenter study.

Expert Rev Gastroenterol Hepatol 2019 Sep 23;13(9):907-914. Epub 2019 Jun 23.

Hepatology Department, National Liver Institute, Menoufiya University , Shebeen EL Kom , Egypt.

Evaluation of the efficacy and safety of sofosbuvir/daclatasvir/ribavirin (SOF/DCV/RBV) in treating non-sustained virological responders (non-SVR12) to prior sofosbuvir-based therapy, in absence of RAS testing in mass treatment, and determination of the optimal timing to start re-treatment. Real-life prospective observational study included prior non-responders to 24-weeks SOF-RBV (n = 679, 67%) or 12-weeks SOF- RBV- PEG (n = 335, 33%). Patients were re-treated with daily SOF/DCV/RBV for 12 (n = 270) or 24 weeks (n = 744). The primary efficacy endpoint was SVR12. The primary safety endpoints were reported adverse events (AEs) from baseline to SVR12 time point. We included 1,014 patients [age 52 ± 9 years, 58.48% men]. Cirrhosis was documented in 46.98% and 27.5% of SOF-RBV and SOF-RBV-PEG non-responders respectively. Overall, SVR12 was 90.6% [92.2% for 12 weeks therapy and 90.05% for 24 weeks therapy]. Mild AEs occurred in 5.13% (n=52) and 3.1% (n=32) discontinued treatment including eight on-treatment mortalities. Higher baseline FIB-4 and shorter interval before starting retreatment (<6 months) were independent predictors of non-SVR12 on multivariate regression analysis. SOF/DCV/RBV is an effective and safe treatment option for non-responders to prior sofosbuvir-based therapy. Six months interval before retreatment is optimal for achieving favorable SVR.
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http://dx.doi.org/10.1080/17474124.2019.1629287DOI Listing
September 2019

Efficacy and safety of sofosbuvir-based therapy in hepatitis C virus recurrence post living donor liver transplant: A real life egyptian experience.

J Med Virol 2019 04 14;91(4):668-676. Epub 2018 Dec 14.

Department of Endemic Medicine and Hepatology, Faculty of Medicine, Cairo University, Cairo, Egypt.

Background And Aim: Direct acting antiviral has offered treatment of hepatitis C virus (HCV) recurrence post liver transplantation (LT) with an all-oral regimen for short duration, excellent safety profile, and high sustained virological response (SVR). The aim of this study was to evaluate the efficacy and safety of sofosbuvir (SOF)-based regimens in the real world among a cohort of Egyptian patients with recurrent HCV post living donor LT (LDLT).

Methods: Patients with HCV-G4 recurrence post-LDLT were recruited from National Committee of Control of Viral Hepatitis, Egypt, from November 2014 to May 2017. They received different SOF-based regimens according to the treatment protocols available during this period. Patients' outcome and Adverse effects (AE) were evaluated.

Results: One hundred ninety patients (170 males, mean age 56.8 ± 7.9 years) were included. Calcineurin inhibitors were the main immunosuppression used (173 patients). Out of 190, 119 (62.6%) received SOF/ribavirin (RBV), 38 (20%) SOF/simeprevir (SMV), 22 (11.6%) SOF/daclatasvir (DSV)/ ± RBV, and 11 (5.8%) received SOF/LDV/ ± RBV. Overall SVR12 was 89.5%, 84.9% in SOF/RBV group, 94.7% in SOF/SMV, 100% in SOF/DCV, and 100% in SOF/LDV with no statistically significant difference ( P = 0.104). The AE reported were as follows: anemia (n = 65, 34.4%) mainly in SOF/RBV group, transient hyperbilirubinemia during SOF/SMV in 13 patients (34%), mild Acute cellular rejection in eight patients (4.2%), and hepatocellular carcinoma in two patients (1%) mainly driven by underlying liver condition. Two deaths were unlikely related to HCV therapy.

Conclusion: Different SOF-based regimens were effective with high SVR12 rates in a difficult-to-treat population, recurrent HCV post LDLT.
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http://dx.doi.org/10.1002/jmv.25362DOI Listing
April 2019

Evaluation of acoustic radiation force impulse (ARFI) elastography as non-invasive diagnostic tool in living donor liver transplantation.

Abdom Radiol (NY) 2019 02;44(2):464-472

Department of Endemic Medicine and Liver Unit, Faculty of Medicine, Kasr Al-Aini Hospital, Cairo University, Cairo, 11562, Egypt.

Background And Aims: Role of acoustic radiation force impulse (ARFI) elastography, in transplant setting, is not well established. We aimed to define the normal mean values of the liver stiffness by ARFI Elastography in healthy liver donors and to evaluate ARFI elastography as predictor of graft fibrosis post living donor liver transplant (LDLT) in comparison to other non-invasive methods (transient elastography [TE], APRI and FIB4).

Patients And Methods: A total of 100 subjects (70 recipients and 30 donors) were recruited. APRI and FIB4 scores were calculated for all recipients. TE and ARFI elastography (Siemens Acuson S2000 Ultrasound System, Germany) were performed to all subjects. All donors and only 30 recipients had liver biopsy. Significant fibrosis was defined as ≥ F2.

Results: The mean ARFI velocity among the donors was 1.05 ± 0.09 m/s. Regarding the recipients: mean age was 49.5 ± 8.49 years, 85.7% males, fibrosis stages < F2 were the most frequent stages by liver biopsy (86.7%) and TE (67.1%). ARFI median was significantly correlated with TE median, APRI and FIB-4 (r = 0.888, p = 0.000; r = 0.62, p = 0.000, and r = 0.585, p = 0.000, respectively). ARFI performed well in discriminating patients with ≥ F2 (AUROC = 0.93, 95% CI 0.86-0.99, p < 0.01) with best cutoff median value of 1.34 m/s (sensitivity 90%, specificity 82%).

Conclusion: ARFI can be used as a reliable method in assessment of significant fibrosis post-LDLT.
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http://dx.doi.org/10.1007/s00261-018-1732-8DOI Listing
February 2019

Spur-of-the-Moment Modification in National Treatment Policies Leads to a Surprising HCV Viral Suppression in All Treated Patients: Real-Life Egyptian Experience.

J Interferon Cytokine Res 2018 02 22;38(2):81-85. Epub 2018 Jan 22.

2 Endemic Medicine and Hepato-Gastroenterology Department, Faculty of Medicine, Cairo University , Cairo, Egypt .

The aim of this study was to retrospectively analyze the outcome of an unscheduled change in national Egyptian policies for the treatment of hepatitis C virus (HCV), which was transpired as a result of a reduction in interferon supplies, and to manage patients who already started interferon-based therapy. After completing a priming 4-weeks course of sofosbuvir/pegylated interferon/ribavirin (SOF/PEG IFN/RBV), a 12-weeks course of sofosbuvir/daclatasvir (SOF/DCV) combination was initiated. We evaluated the sustained virologic response at 12 weeks posttreatment (SVR12) for 2 groups of patients; Group 1, which included patients who had the previous regimen with IFN priming, and group 2, which included the first consecutive group of patients who received SOF/DCV for 12 weeks from the start without IFN priming. All group 1 patients (1,214 patients) achieved SVR12 (100%) and this was statistically significant when compared with the overall SVR12 in group 2 [8,869 patients with sustained virologic response [SVR] of 98.9%] (P value <0.001). No serious adverse events were reported in both groups. In this real-life treatment experience, interferon-based directly acting antiviral treatment with SOF/PEG IFN/RBV as a priming for 4 weeks, followed by SOF/DCV combination for 12 weeks, led to HCV viral suppression in all treated patients.
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http://dx.doi.org/10.1089/jir.2017.0121DOI Listing
February 2018

Serious Adverse Events with Sofosbuvir Combined with Interferon and Ribavirin: Real-Life Egyptian Experience.

J Interferon Cytokine Res 2017 08;37(8):348-353

1 Faculty of Medicine, Endemic Medicine and Hepatology Department, Cairo University , Cairo, Egypt .

Viral hepatitis is a serious problem worldwide that was under-recognized till recently. The prevalence of chronic hepatitis C virus (HCV) is estimated to be 180 million people worldwide. Treatment of chronic HCV using combined pegylated interferon and ribavirin (PEG/RIBA) has long been the standard of care with modest response. In our study, we will report the real-life experience of serious adverse events (SAEs) that were reported by the National Committee for Control of Viral Hepatitis (NCCVH, Cairo, Egypt) program while treating chronic HCV using the triple therapy, sofosbuvir combined with pegylated interferon and ribavirin (PEG/RIBA/SOF), which led to premature discontinuation of treatment. This retrospective analysis included a total of 6,989 chronic HCV patients who were treated by the NCCVH. They received the triple antiviral therapy in 26 treatment centers in Egypt using PEG/RIBA/SOF for 12 weeks. Among 6,989 patients who were treated in 26 treatment centers related to NCCVH, 406 cases (5.9%) reported SAEs and prematurely stopped their treatment. Triple therapy PEG/RIBA/SOF was an important intermediate milestone between interferon-based therapy and the interferon-free all-oral direct acting antiviral agents (DAAs). Results of this study were the leading cause of discontinuation of interferon-based therapy and introduction of interferon-free all-oral treatment protocols, incorporating DAAs from different classes as soon as they gain approval.
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http://dx.doi.org/10.1089/jir.2016.0131DOI Listing
August 2017

Response to Real life Egyptian experience of efficacy / safety of Simeprevir\ Sofosbuvir in HCV genotype IV.

Liver Int 2017 05;37(5):766

Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.

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http://dx.doi.org/10.1111/liv.13319DOI Listing
May 2017

Comparison of Machine Learning Approaches for Prediction of Advanced Liver Fibrosis in Chronic Hepatitis C Patients.

IEEE/ACM Trans Comput Biol Bioinform 2018 May-Jun;15(3):861-868. Epub 2017 Apr 4.

Background/aim: Using machine learning approaches as non-invasive methods have been used recently as an alternative method in staging chronic liver diseases for avoiding the drawbacks of biopsy. This study aims to evaluate different machine learning techniques in prediction of advanced fibrosis by combining the serum bio-markers and clinical information to develop the classification models.

Methods: A prospective cohort of 39,567 patients with chronic hepatitis C was divided into two sets-one categorized as mild to moderate fibrosis (F0-F2), and the other categorized as advanced fibrosis (F3-F4) according to METAVIR score. Decision tree, genetic algorithm, particle swarm optimization, and multi-linear regression models for advanced fibrosis risk prediction were developed. Receiver operating characteristic curve analysis was performed to evaluate the performance of the proposed models.

Results: Age, platelet count, AST, and albumin were found to be statistically significant to advanced fibrosis. The machine learning algorithms under study were able to predict advanced fibrosis in patients with HCC with AUROC ranging between 0.73 and 0.76 and accuracy between 66.3 and 84.4 percent.

Conclusions: Machine-learning approaches could be used as alternative methods in prediction of the risk of advanced liver fibrosis due to chronic hepatitis C.
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http://dx.doi.org/10.1109/TCBB.2017.2690848DOI Listing
May 2019

Real life Egyptian experience of efficacy and safety of Simeprevir/Sofosbuvir therapy in 6211 chronic HCV genotype IV infected patients.

Liver Int 2017 04 4;37(4):534-541. Epub 2016 Nov 4.

Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.

Background & Aims: Major changes have emerged during the last few years in the therapy of chronic HCV. Several direct acting antiviral agents have been developed showing potent activity with higher rates of sustained virological response, even in difficult-to-treat patients. This study explores real life experience concerning efficacy, safety and possible predictors of response for the first cohort of Egyptian patients with chronic HCV genotype IV treated with Sofosbuvir/Simprevir combination therapy.

Methods: This real life study recruited the first (6211) chronic HCV genotype IV Egyptian patients, who received antiviral therapy in viral hepatitis specialized treatment centres affiliated to the National committee for control of viral hepatitis. All enrolled patients received 12 weeks course of daily combination of sofosbuvir (400 mg) and simeprevir (150 mg). Patients were closely monitored for treatment safety and efficacy.

Results: Overall sustained virological response 12 rate was 94.0% while the end of treatment response rate was 97.6%. sustained virological response 12 rates in easy and difficult-to-treat groups were 96% and 93% respectively. Univariate and multivariate logistic regression analysis revealed significant association of low albumin (<3.5), cirrhosis and Fib-4 score (>3.25) with treatment failure. Fatal adverse events occurred in 23/6211 cases (0.37%) due to liver cell failure adverse events or SAEs leading to treatment discontinuation occurred in 97 patients (1.6%).

Conclusion: Sofosbuvir/Simeprevir combination is an effective and well tolerated regimen for patients with chronic HCV genotype IV.
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http://dx.doi.org/10.1111/liv.13266DOI Listing
April 2017

Accurate Prediction of Advanced Liver Fibrosis Using the Decision Tree Learning Algorithm in Chronic Hepatitis C Egyptian Patients.

Gastroenterol Res Pract 2016 6;2016:2636390. Epub 2016 Jan 6.

Informatics and Systems Department and Biomedical Informatics and Chemo Informatics Group, Engineering Research Division and Centre of Excellence for Advanced Sciences, National Research Centre, Giza, Egypt; Center for Informatics, Nile University, Giza, Egypt.

Background/Aim. Respectively with the prevalence of chronic hepatitis C in the world, using noninvasive methods as an alternative method in staging chronic liver diseases for avoiding the drawbacks of biopsy is significantly increasing. The aim of this study is to combine the serum biomarkers and clinical information to develop a classification model that can predict advanced liver fibrosis. Methods. 39,567 patients with chronic hepatitis C were included and randomly divided into two separate sets. Liver fibrosis was assessed via METAVIR score; patients were categorized as mild to moderate (F0-F2) or advanced (F3-F4) fibrosis stages. Two models were developed using alternating decision tree algorithm. Model 1 uses six parameters, while model 2 uses four, which are similar to FIB-4 features except alpha-fetoprotein instead of alanine aminotransferase. Sensitivity and receiver operating characteristic curve were performed to evaluate the performance of the proposed models. Results. The best model achieved 86.2% negative predictive value and 0.78 ROC with 84.8% accuracy which is better than FIB-4. Conclusions. The risk of advanced liver fibrosis, due to chronic hepatitis C, could be predicted with high accuracy using decision tree learning algorithm that could be used to reduce the need to assess the liver biopsy.
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http://dx.doi.org/10.1155/2016/2636390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4736594PMC
February 2016

Epstein-Barr virus and Interleukin-28B polymorphism in the prediction of response to interferon therapy in hepatitis C patients.

Arab J Gastroenterol 2015 Sep-Dec;16(3-4):84-9. Epub 2015 Oct 31.

Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.

Background And Study Aims: In chronic hepatitis C virus (HCV), viral and host factors are known to be predictors for anti-viral therapy. IL-28B genotype strongly influences treatment outcome, while Epstein-Barr virus (EBV) co-infection could accelerate the course of chronic HCV infection. This study was conducted to assess whether EBV co-infection adds to the predictive value of IL-28B.

Patients And Methods: A total of 105 patients with chronic HCV were classified according to their response to treatment into two groups: 38 sustained virological responders (SVRs) and 67 nonresponders (NRs). Collected sera at baseline and follow-up (FUP) were used for assessing EBV antibodies by enzyme-linked immunosorbent assay (ELISA) and the expression of EBV genes (BNLF-1, BZLF-1, and EBER-2) by polymerase chain reaction (PCR). Collected peripheral blood was used for detecting IL-28B rs.12979860 single-nucleotide polymorphism.

Results: Regarding IL-28B genotype frequencies, a significant difference (p=0.003) was observed between SVRs (C/C=51.4%, C/T=48.6%, T/T=0%) and NRs (C/C=25%, C/T=55%, T/T=20%). On assessing EBV infection at baseline and FUP, it was found that 61% and 55% were positive, respectively, with no significant difference between SVRs and NRs. As for anti-viral capsid antigen (VCA) antibodies, the NRs had significantly higher baseline anti-VCA immunoglobulin M (IgM) levels than SVRs (p=0.01). While FUP anti-Epstein-Barr nuclear antigen-1 (EBNA-1) IgG reported a significant decline within SVR patients (p=0.02), neither baseline nor FUP anti-VCA IgG levels showed a statistically significant viral response. Finally, on comparing EBV markers with CC versus CT and TT genotypes, it was found that FUP anti-VCA IgG levels were significantly increased in CC genotype (p=0.003).

Conclusion: Interleukin-28B polymorphism could be a possible predictor of response to pegylated interferon/ribavirin therapy (PEG-IFN/RBV). Furthermore, co-infection with EBV did not affect the response to IFN-based therapy in HCV-infected patients.
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http://dx.doi.org/10.1016/j.ajg.2015.09.013DOI Listing
September 2016

Liver fibrosis staging through a stepwise analysis of non-invasive markers (FibroSteps) in patients with chronic hepatitis C infection.

Liver Int 2013 Aug 20;33(7):982-90. Epub 2013 Mar 20.

Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.

Background: Non-invasive fibrosis markers can distinguish between liver fibrosis stages in lieu of liver biopsy or imaging elastography.

Aims: To develop a sensitive, non-invasive, freely-available algorithm that differentiates between individual liver fibrosis stages in chronic hepatitis C virus (HCV) patients.

Methods: Chronic HCV patients (n = 355) at Cairo University Hospital, Egypt, with liver biopsy to determine fibrosis stage (METAVIR), were tested for preselected fibrosis markers. A novel multistage stepwise fibrosis classification algorithm (FibroSteps) was developed using random forest analysis for biomarker selection, and logistic regression for modelling. FibroSteps predicted fibrosis stage using four steps: Step 1 distinguished no(F0)/mild fibrosis(F1) vs. moderate(F2)/severe fibrosis(F3)/cirrhosis(F4); Step 2a distinguished F0 vs. F1; Step 2b distinguished F2 vs. F3/F4; and Step 3 distinguished F3 vs. F4. FibroSteps was developed using a randomly-selected training set (n = 234) and evaluated using the remaining patients (n = 118) as a validation set.

Results: Hyaluronic Acid, TGF-β1, α2-macroglobulin, MMP-2, Apolipoprotein-A1, Urea, MMP-1, alpha-fetoprotein, haptoglobin, RBCs, haemoglobin and TIMP-1 were selected into the models, which had areas under the receiver operating curve (AUC) of 0.973, 0.923 (Step 1); 0.943, 0.872 (Step 2a); 0.916, 0.883 (Step 2b) and 0.944, 0.946 (Step 3), in the training and validation sets respectively. The final classification had accuracies of 94.9% (95% CI: 91.3-97.4%) and 89.8% (95% CI: 82.9-94.6%) for the training and validation sets respectively.

Conclusions: FibroSteps, a freely available, non-invasive liver fibrosis classification, is accurate and can assist clinicians in making prognostic and therapeutic decisions. The statistical code for FibroSteps using R software is provided in the supplementary materials.
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http://dx.doi.org/10.1111/liv.12139DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3793639PMC
August 2013
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