Publications by authors named "Magdy El-Serafy"

27 Publications

  • Page 1 of 1

Real-life experience of treating HCV co-infection among HIV-infected population in Egypt: single-center experience.

Expert Rev Anti Infect Ther 2021 Nov 25:1-7. Epub 2021 Nov 25.

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

Background: Liver disease has emerged as a leading cause of death among PLHIV coinfected with HCV.

Methods: A retrospective study involving all HCV viremic patients coinfected with HIV who presented to HCV/HIV multidisciplinary clinics located at Embaba fever hospital. Patients were assigned to receive DAAs according to the national treatment guidelines. The primary endpoint was SVR12.

Results: Of the 519 patients enrolled, 38.73% LTFU; either not initiated (n = 170) or did not complete the treatment (n = 31). The main identified reasons behind LTFU were schedule conflict (19%) or hospitalization (13%). Among 318 patients who completed their DAAs course, nine patients had a relapse after the end of treatment and 97% had attained SVR12. There were significant differences among different virological response groups in baseline factors including smoking (p = 0.005), history of dental procedure (p = 0.007), CD4 count (p = 0.007), and HIV viral load (p = <0.001). Among responders (n = 309), there was a significant reduction of baseline hemoglobin and significant improvement of baseline platelets (p = 0.005) at on-treatment week 8. Baseline necro-inflammatory markers showed significant improvement across follow-up time points (p < 0.001).

Conclusions: DAAs are an effective and safe choice to treat HCV in PLHIV. Social stigma could be a major cause for lacking adherence to follow-up visits. ALT: Alanine Aminotransferase; ARV: Antiretroviral treatment; AST: Aspartate Aminotransferase; DAAs: Direct acting antivirals; ARVs: antiretroviral therapy; EMR: Eastern Mediterranean region; HCV: Hepatitis C virus; kPa: Kilopascal; LTFU: Patient lost to follow up; NCCVH: The National Committee for Control of Viral Hepatitis; PWID: People who inject drugs; SVR: Sustained virological response;UNAIDS: The Joint United Nations Programme on HIV/AIDS.
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http://dx.doi.org/10.1080/14787210.2022.2004117DOI Listing
November 2021

The outcome of re-treatment of relapsed hepatitis C virus infection in a resource-limited setting.

Virusdisease 2021 Sep 27;32(3):582-588. Epub 2021 Jul 27.

Department of Pediatrics and Clinical Research Center, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

The aim of this study was to compare efficacy and safety of different combination regimens in re-treatment of HCV in the setting of inaccessibility of resistance testing. This real-life prospective study included 86 chronic HCV infected patients who experienced failure of treatment treated at Faculty of Medicine Ain shams Research Institute (MASRI) since 2018. 64% of the patients were males, with median age 50.2 years. They were re-treated using 1 of 3 proposed regimens of DAA combinations. One group received PAR/OMB/SOF/RBV for 12 weeks, another group received SOF/DAC/SIM/RBV for 12 weeks and a third received SOF/DAC/RBV for 24 weeks. Response to different regimens was assessed by comparing sustained virologic response (SVR) of each. Monitoring the occurrence of adverse events was performed. SVR was achieved in all but 3 patients (96.5% SVR), one in the SOF/DAC/SIM/RBV group and two in the SOF/DAC/RBV group. The group receiving RBV had more anaemia and hyperbilirubinemia. The first treatment regimen used was a significant predictor to SVR achievement. This study presents alternative treatment regimens for re-treatment of HCV patients in areas with limited resources in the case of non-availability of other regimens as velpatasvir, voxilaprevir, grazoprevir, elbasvir.
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http://dx.doi.org/10.1007/s13337-021-00712-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8473466PMC
September 2021

Pregnancy outcome of anti-HCV direct-acting antivirals: Real-life data from an Egyptian cohort.

Liver Int 2021 07 11;41(7):1494-1497. Epub 2021 May 11.

Department of Pediatrics and Clinical Research Center, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

We aimed to assess the pregnancy outcome in women with chronic HCV who had negative pregnancy test prior to the anti-HCV course and had unintended pregnancy while on HCV treatment. Hundred patients with a mean age of 30 ± 6.7 y were included and advised to withhold antivirals and continue follow-up in viral hepatitis and obstetrics centres till delivery. All patients received a 12-weeks regimen of anti-HCV [sofosbuvir plus daclatasvir (SOF/DCV): n = 95, SOF/DCV plus ribavirin: n = 3, and paritaprevir/ritonavir/ombitasvir plus ribavirin: n = 2]. Only nine patients completed the full antiviral course against medical advice, and 91 stopped between on-treatment weeks 4 and 8. Eighty-eight patients delivered full-term babies, eight had preterm babies and two had abortions. Of the nine patients who completed the full course of DAAs, seven (77.8%) delivered normal babies, attended their post-treatment week 12 visit, and all (100%) achieved sustained virological response. No major antiviral-related adverse events were reported.
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http://dx.doi.org/10.1111/liv.14913DOI Listing
July 2021

Hepatitis C virus infection and global kidney health: the consensus proceedings of the International Federation of Kidney Foundations.

Afr J Nephrol 2020 ;23(1):159-168

Nephrology Department, Cliniques universitaires Saint-Luc and Université catholique de Louvain, Brussels, Belgium.

Hepatitis C virus (HCV) infection is an important cause of major morbidities including chronic liver disease, liver cancer, and acute kidney injury (AKI) as well as chronic kidney disease (CKD). HCV can affect kidney health; among CKD and AKI patients with HCV infection, the clinical outcomes are worse. The prevalence of HCV infection is exceptionally high among dialysis and kidney transplant patients throughout the globe. It is estimated that 5% to 25% or more of dialysis dependent patients are affected by chronic HCV, based on the region of the world. Almost half of all deaths in CKD patients, including HCV-infected patients, are due to cardiovascular disease, and HCV infected patients have higher mortality. Given the importance and impact of the HCV epidemic on CKD and global kidney health, and the status of Egypt as the nation with highest prevalence of HCV infection in the world along with its leading initiatives to eradicate HCV, the International Federation of Kidney Foundations (IFKF) convened a consensus conference in Cairo in December 2017. This article reflects the opinions and recommendations of the contributing experts and reiterates that with the current availability of highly effective and well tolerated pharmacotherapy; CKD patients should be given priority for treatment of HCV, as an important step towards the elimination of viral hepatitis as a public health problem by 2030 according to World Health Organization and IFKF. Every country should have an action plan with the goal to improve kidney health and CKD patient outcomes.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7751950PMC
January 2020

Screening and Treatment Program to Eliminate Hepatitis C in Egypt.

N Engl J Med 2020 03;382(12):1166-1174

From the Hepatology Department, National Liver Institute, Menoufia University, Shebeen El Kom (I.W., W.A.-R.), and the Endemic Medicine Department, Faculty of Medicine, Cairo University (G. Esmat, A.E., M.E.-S., A.C., W.E.A., W.D.), the Ministry of Health and Population (R.G., G. Elshishiney, A.S., S.A.M., M.A.S., K.A.H., S.A.G., N.E.N., A.E.S., S.E.S., H.E.T., E.E., H.G., A. Hashem, N.H., A.N.H., A.K., K.L., F.M., S. Mamoun, T.M., S. Mekky, A.M., A.O., O.R., E.R., A.R., T.S., R.S., M. Sharshar, H. Shawky, M. Shawky, W.S., H. Soror, M. Taha, M. Talha, A.T., M.Z., H.Z.), the National Committee for Control of Viral Hepatitis (K.K.), the Pediatrics Department (M.H.E.-S.), the Hepatology and Tropical Medicine Department (H.D.), and the Department of Medicine (Y.E.S., Y.O.), Ain Shams University, the Hepatology Department, National Hepatology and Tropical Medicine Research Institute (M.H.), the Communicable Diseases Control Cluster, World Health Organization (A. Hashish), the Medical Research Division, National Research Center (E.K., M.A.), and the Tropical Medicine Department, Al-Azhar University (I.A.), Cairo - all in Egypt.

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http://dx.doi.org/10.1056/NEJMsr1912628DOI Listing
March 2020

Fibro-indices versus liver stiffness for prediction of significant fibrosis in hepatitis B virus-infected Egyptian patients; a single-center experience.

Expert Rev Gastroenterol Hepatol 2020 Mar 7;14(3):221-227. Epub 2020 Feb 7.

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

: Liver fibrosis assessment is a key factor for disease management in hepatitis B virus (HBV). Several serum biomarkers have been introduced for noninvasive fibrosis assessment. This study aims to evaluate the validity of simple noninvasive indices, namely Fibrosis-4 score (FIB4), aspartate aminotransferase (AST) to Platelet Ratio Index (APRI), Goteborg University Cirrhosis Index (GUCI), and fibrosis index in evaluation of liver fibrosis in chronic HBV.: 226 patients with chronic HBV genotype D were included. FIB4, APRI, GUCI, and fibrosis index were performed. Receiver operating characteristic (ROC) curves were used to predict ≥F2 fibrosis.: The mean age of patients was 39.00 years and 72.27% of patients were treatment naïve. Patients with ≥F2 hepatic fibrosis had significantly higher FIB-4 (1.58 ± 1.46 vs. 1.15 ± 1.09), APRI (0.68 ± 0.71 vs. 0.43 ± 0.37), GUCI score (0.75 ± 0.94 vs. 0.42 ± 0.29) and Fibrosis index (2.18 ± 0.84 vs. 1.84 ± 0.69). All studied indices were able to diagnose ≥F2 fibrosis. APRI had the highest area under the ROC (AUROC) of 0.67. Predictivity of all indices was higher in on-treatment vs naive patients.: FIB4, APRI, and GUCI scores are acceptable, noninvasive, and cheap simple indices that can be helpful on treatment follow-up of fibrosis regression in the setting of low socioeconomic conditions compared to the relatively expensive fibroscan modality.
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http://dx.doi.org/10.1080/17474124.2020.1723415DOI Listing
March 2020

Hepatitis C Virus in Egypt: Interim Report From the World's Largest National Program.

Clin Liver Dis (Hoboken) 2019 Dec 29;14(6):203-206. Epub 2020 Jan 29.

Hepatology Department National Liver Institute, Menoufia University Shebeen El Kom Egypt.

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http://dx.doi.org/10.1002/cld.868DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988418PMC
December 2019

Sofosbuvir-containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment.

Liver Int 2020 04 20;40(4):797-805. Epub 2019 Dec 20.

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

Background And Aims: This study aimed to assess the safety and efficacy of sofosbuvir (SOF)-based regimens in patients with moderate to severe renal impairment; a subject which has been questioned by many investigators with conflicting results.

Methods: This is a real-life multicentre retrospective cohort study on 4944 chronic Hepatitis C virus (HCV) patients with chronic kidney disease (CKD) (eGFR <60 mL/min/1.73 m ) who received SOF-based therapy in specialized treatment centres affiliated to the National Committee for the Control of Viral Hepatitis in Egypt. The efficacy and safety of SOF-based regimens was assessed.

Results: Week 12 virological response rates were 97.5%, 96.7%, 85.7% and 80% in the total cohort, patients with eGFR <30 mL/min/1.73 m , patients with associated hepatic decompensation and patients on dialysis respectively. Various treatment regimens did not statistically affect the response rates. Treatment experience, cirrhosis and diabetes were predictors of treatment failure on multivariate analysis. Serious adverse events occurred in 0.1% of cases. Forty patients (0.8%) discontinued treatment.

Conclusion: Sofosbuvir-based regimens are effective and safe for treating patients with chronic HCV and moderate to severe CKD, and in those with associated hepatic decompensation.
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http://dx.doi.org/10.1111/liv.14299DOI Listing
April 2020

Real life application of FIB-4 & APRI during mass treatment of HCV genotype 4 with directly acting anti-viral agents in Egyptian patients, an observational study.

Expert Rev Gastroenterol Hepatol 2019 Dec 20;13(12):1189-1195. Epub 2019 Nov 20.

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

: Non-invasive prediction of significant liver fibrosis and gastro-esophageal varices during mass treatment for HCV is crucial.The aim is to validate the accuracy of FIB-4 & APRI for predicting significant fibrosis in chronic HCV patients during mass treatment with directly acting anti-viral agents (DAAs) & their validity for predicting varices.: We did a search in a database of 21,617 patients with chronic HCV infection recruited to one of the national HCV treatment centers to find out those with fibrosis assessment by recent liver biopsies &/or liver stiffness to serve as a gold standard. The diagnostic accuracy of FIB-4 and APRI values were assessed against the gold standard. Demographics and relevant laboratory data of 3144 patients (14.5%) were retrieved.: Significant fibrosis (F3-F4) was detected in 1585 (50.4%). AUROCs for detecting significant fibrosis (F3-F4) were 0.76 (0.75-0.78) for FIB-4 and 0.72 (0.72-0.75) for APRI. To diagnose liver cirrhosis, AUROCs were higher; 0.82 (0.80-0.83) for FIB-4 and 0.78 (0.76-0.79) for APRI, p < 0.001. Prediction of gastro-oesophageal varices; AUROC for FIB-4 and APRI, were 0.65 and 0.62 respectively.: FIB-4 and APRI are reliable methods in predicting cirrhosis during mass HCV treatment. Their role in predicting gastro-oesophageal varices is less remarkable.
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http://dx.doi.org/10.1080/17474124.2019.1690990DOI Listing
December 2019

Retreatment of chronic hepatitis C virus genotype-4 patients after non-structural protein 5A inhibitors' failure: efficacy and safety of different regimens.

Eur J Gastroenterol Hepatol 2020 03;32(3):440-446

Department of Gastroenterology, Hepatology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef.

Background: Nonstructural protein 5A (NS5A) is an important regimen for the treatment of chronic hepatitis C virus (HCV) genotype-4 infected patients. Retreatments for NS5A virologic failure are limited. The aim of this study is to provide real-life data regarding the effectiveness and safety of retreatment with different regimens after NS5A regimen virologic failure in GT4 patients.

Patients And Methods: A total of 524 HCV patients (mean age 48 ± 11 years, 71% males), with virologic failure to sofosbuvir+daclatasvir, n = 450 and sofosbuvir/ledipasvir, n = 74 were included in this study. Patients were retreated with sofosbuvir + ombitasvir/paritaprevir/ritonavir + ribavirin, n = 278 and sofosbuvir + simeprevir + daclatasvir + ribavirin, n = 246. Response was evaluated 12 weeks after the end of treatment (SVR12).

Results: Overall, SVR12 was 95.2% [95% confidence interval (CI) 93.3%-97.1%]. In sofosbuvir + ombitasvir/paritaprevir/ritonavir + ribavirin and sofosbuvir + simeprevir + daclatasvir + ribavirin, SVR12s were 94.9% (95% CI 92.5%-97.4%) and 95.5% (95% CI 92.8%-98%), respectively. In liver cirrhosis patients, SVR12s were 96.4% (95% CI 90.7%-100%) and 98% (95% CI 94.9%-100%), respectively. Relapse in the sofosbuvir + ombitasvir/paritaprevir/ritonavir + ribavirin was n = 14 patients, and n = 11 patients in sofosbuvir + simeprevir + daclatasvir + ribavirin. Three patients developed hepatic encephalopathy, haematemesis, lower limb oedema, and one patient died in the SOF + OBV/PTV/RTV + RIB. In the sofosbuvir + simeprevir + daclatasvir + ribavirin, three patients developed hepatocellular carcinoma and one patient died. No treatment discontinuation due to anaemia.

Conclusion: Salvage treatment for NS5A-treatment failure is effective and well tolerated in genotype-4 patients, in both noncirrhotic and compensated cirrhotic groups.
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http://dx.doi.org/10.1097/MEG.0000000000001581DOI Listing
March 2020

Liver stiffness measurements and FIB-4 are predictors of response to sofosbuvir-based treatment regimens in 7256 chronic HCV patients.

Expert Rev Gastroenterol Hepatol 2019 Oct 16;13(10):1009-1016. Epub 2019 Aug 16.

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

: To assess the role of baseline liver stiffness (LS) by Transient elastography (TE) and FIB-4 in the prediction of virological response to sofosbuvir - based regimens in chronic HCV patients.: A retrospective, multicenter study including 7256 chronic HCV patients who received different sofosbuvir-based regimens. Baseline demographic and laboratory data were recorded. TE was performed with FIB-4 calculation at baseline.: Sustained virological response at week 12 post-treatment (SVR12) was 91.4%. Pretreatment TE values and FIB-4 were significantly lower among sustained responders (17.8 ± 11.5 kPa, 2.66 ± 1.98, respectively) versus relapsers (24.5 ± 13.9 kPa, 4.02 ± 3.3, respectively). Best cutoff levels for LS by TE and FIB-4 score for prediction of failure to treatment response were 16.7 kPa and 2.4, respectively. Among different treatment protocol, patients with FIB-4 > 2.4, TE values >16.7 kPa are more prone to treatment failure except when using SOF/SIM treatment regimens.: Baseline LS by TE and FIB-4 score may be useful for predicting treatment outcome in the new era of DAAs and could be integrated into pretreatment assessment of chronic HCV patients for better optimization of patient management.
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http://dx.doi.org/10.1080/17474124.2019.1653183DOI Listing
October 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

Improvement of liver stiffness measurement, acoustic radiation force impulse measurements, and noninvasive fibrosis markers after direct-acting antivirals for hepatitis C virus G4 recurrence post living donor liver transplantation: Egyptian cohort.

J Med Virol 2018 09 25;90(9):1508-1515. Epub 2018 May 25.

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

Progression of recurrent hepatitis C is accelerated in liver transplant (LT) recipients. Direct-acting antivirals (DAAs) have recently emerged as a promising therapeutic regimen for the treatment of hepatitis C virus infection. Rates of sustained virological response (SVR) have drastically improved since the introduction of DAAs. The aim is to elucidate the changes in liver stiffness measurement (LSM) by transient elastography (TE) as well as acoustic radiation force impulse (ARFI) elastography and fibrosis scores after DAA treatment in LT recipients with hepatitis C virus recurrence. A single-center, prospective study including 58 LT recipients with hepatitis C recurrence who received different sofosbuvir-based treatment regimens. Transient elastography and ARFI elastography values were recorded as well as fibrosis 4 score (FIB-4) and aspartate aminotransferase-to-platelet ratio index were calculated at baseline and SVR at week 24 (SVR24). The outcome was improvement in LSM and at least a 20% decrease in LSM at SVR24 compared with baseline. The sustained virological response was 98.1%. There was improvement of platelet counts, alanine aminotransferase, and aspartate aminotransferase, which in turn caused improvement in fibrosis scores at SVR24. LSM by TE and ARFI elastography decreased from the baseline median value of 6.3 kPa (interquartile range [IQR]; 4.6 to 8.8 kPa) and 1.28 m/s (IQR; 1.07 to 1.53 m/s) to an SVR24 median value of 6.2 kPa (IQR; 4.85 to 8.9 kPa) and 1.12 (IQR; 0.97 to 1.30 m/s), respectively. Logistic regression analysis showed that baseline viral load was the only significant predictor of improvement in LS after DAA therapy at SVR24. Sofosbuvir-based treatment resulted in an early improvement in parameters of liver fibrosis in post-LT patients with hepatitis C recurrence.
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http://dx.doi.org/10.1002/jmv.25210DOI Listing
September 2018

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

Planning and prioritizing direct-acting antivirals treatment for HCV patients in countries with limited resources: Lessons from the Egyptian experience.

J Hepatol 2018 04 6;68(4):691-698. Epub 2017 Dec 6.

Department of Hepatology, National Liver Institute, Menoufiya University, Menoufiya, Egypt.

Background And Aims: The introduction of direct-acting antivirals for hepatitis C virus (HCV) in Egypt led to massive treatment uptake, with Egypt's national HCV treatment program becoming the largest in the world. The aim of this paper is to present the Egyptian experience in planning and prioritizing mass treatment for patients with HCV, highlighting the difficulties and limitations of the program, as a guide for other countries of similarly limited resources.

Methods: Baseline data of 337,042 patients, treated between October 2014 to March 2016 in specialized viral hepatitis treatment centers, were grouped into three equal time intervals of six months each. Patients were treated with different combinations of direct-acting antivirals, with or without ribavirin and pegylated interferon. Baseline data, percentage of patients with known outcome, and sustained virological response at week 12 (SVR12) were analyzed for the three cohorts. The outcomes of 94,258 patients treated in the subsequent two months are also included.

Results: For cohort-1, treatment was prioritized for patients with advanced fibrosis (F3-F4 fibrosis, liver stiffness ≥9.5 kPa, or Fibrosis-4 ≥3.25). Starting cohort-2, all stages of fibrosis were included (F0-F4). The prioritization strategy in the initial phase caused delays in enrollment and massive backlogs. Cohort-1 patients were significantly older, and more had advanced fibrosis compared to subsequent cohorts. The percentage of patients with known SVR12 results were low initially, and increased with each cohort, as several methods to capture patient results were adopted. Sofosbuvir-ribavirin therapy for 24 weeks had the lowest SVR12 rate (82.7%); while other therapies were associated with SVR12 rates between 94% and 98%.

Conclusion: Prioritization based on fibrosis stage was not effective and enrollment increased greatly only after including all stages of fibrosis. The availability of generic drugs reduced costs, and helped massively increase uptake of the program. Post-treatment follow-up was initially very low, and although this has increased, further improvement is still needed.

Lay Summary: We are presenting the largest national program for HCV treatment in the world. We clearly demonstrate that hepatitis C can be cured efficiently in large scale real-life programs. This is a clear statement that global HCV eradication is foreseeable, providing a model for other countries with limited resources and prevalent HCV. Moreover, the availability of generic products has influenced the success of this program.
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http://dx.doi.org/10.1016/j.jhep.2017.11.034DOI Listing
April 2018

MicroRNAs and clinical implications in hepatocellular carcinoma.

World J Hepatol 2017 Aug;9(23):1001-1007

Department of Internal Medicine, Faculty of Medicine, Ain Shams University, Cairo 11331, Egypt.

Aim: To assess the role of some circulating miRNAs (miR-23a, miR-203, miR338, miR-34, and miR-16) as tumor markers for diagnosis of hepatocellular carcinoma (HCC).

Methods: One hundred and seventy-one subjects were enrolled, 57 patients with HCC, 57 patients with liver cirrhosis (LC) and 57 healthy subjects as control group. Severity of liver disease was assessed by Child Pugh score. Tumor staging was done using Okuda staging system. Quantification of Micro RNA (miR-23a, miR-203, miR338, miR-34, and miR-16) was performed.

Results: All studied miRNA showed significant difference between HCC and cirrhotic patients in comparison to healthy control. miR-23a showed statistically significant difference between HCC and cirrhotic patients being higher in HCC group than cirrhotic. miR-23a is significantly higher in HCC patients with focal lesion size equal or more than 5 cm, patients with multiple focal lesions and Okuda stage III. At cutoff value ≥ 2, miR-23a showed accuracy 79.3% to diagnose HCC patients with sensitivity 89.47% and specificity about 64.91%. At cut off level ≥ 200 ng/mL, serum alpha fetoprotein had 73.68% sensitivity, 52.63% specificity, 43.75% PPV, 80% NPV for diagnosis of HCC.

Conclusion: MicroRNA 23a can be used as a screening test for early detection of HCC. Also, it is related to larger size of tumour, late Okuda staging and multiple hepatic focal lesions, so it might be a prognostic biomarker.
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http://dx.doi.org/10.4254/wjh.v9.i23.1001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569275PMC
August 2017

APRI test and hyaluronic acid as non-invasive diagnostic tools for post HCV liver fibrosis: Systematic review and meta-analysis.

Arab J Gastroenterol 2017 Jun 1;18(2):51-57. Epub 2017 Jun 1.

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

Background And Study Aims: Hepatitis C virus (HCV) accounts for a sizable proportion of chronic liver disease cases and represents the most common indication for liver transplantation. Precise diagnosis of hepatic fibrosis stage is considered a funnel-neck in proper management and follow-up of HCV-infected patients. Given the possible complications of liver biopsy, a non-invasive method for assessing hepatic fibrosis is needed. This study aimed to evaluate the diagnostic accuracy of APRI and hyaluronic acid as non-invasive diagnostic assessment tools for post HCV liver fibrosis.

Patients And Methods: Systematic literature searching identified studies performed on Egyptian territory to evaluate APRI and hyaluronic acid as non-invasive tests of fibrosis and using liver biopsy as the reference standard. Meta-analysis was performed for areas with an adequate number of publications. Validation of meta- analysis on APRI was done on a subset of 150 treatment-naïve post-hepatitis C patients.

Results: Both APRI and hyaluronic acid have superior predictive power for hepatic cirrhosis (F4) than for significant fibrosis (F2-F3). The pooled estimate for sensitivities and specificities of APRI and hyaluronic acid to diagnose F4 were (84% and 82%) and (83% and 89%) respectively. In the subgroup of treatment naïve post-hepatitis C patients, APRI had higher diagnostic performance to diagnose liver cirrhosis with 93.8% sensitivity and 72.4% specificity (AUC; 0.908, 95%CI; 0.851-0.965, p-value; <0.001) compared to its accuracy to diagnose significant hepatic fibrosis with 65.1% sensitivity and 77.8% (AUC; 0.685, 95% CI; 0.59-0.78, p-value; 0.001).

Conclusion: APRI score and hyaluronic acid levels are simple and reliable non-invasive markers to detect advanced fibrosis among post-hepatitis C patients.
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http://dx.doi.org/10.1016/j.ajg.2017.05.005DOI Listing
June 2017

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

Hepatitis C virus: A global view.

World J Hepatol 2015 Nov;7(26):2676-80

Amal Ahmed Mohamed, Biochemistry Department, National Hepatology and Tropical Medicine Institute, Cairo 11796, Egypt.

Hepatitis C virus (HCV) is a global challenge; 130-175 million are chronically infected. Over 350000 die each year from HCV. Chronic HCV is the primary cause of cirrhosis, hepatocellular carcinoma (HCC), and end-stage liver disease. Management of chronic HCV is aimed at preventing cirrhosis, reducing the risk of HCC, and treating extra hepatic complications. New treatments for chronic HCV has been devoted based on direct-acting antivirals, as pegylated interferon (peginterferon) is responsible for many side effects and limits treatment access. Sofosbuvir is the first compound to enter the market with Peginterferon-free combination regimens.
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http://dx.doi.org/10.4254/wjh.v7.i26.2676DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4651911PMC
November 2015

New genetic markers for diagnosis of hepatitis C related hepatocellular carcinoma in Egyptian patients.

J Gastrointestin Liver Dis 2013 Dec;22(4):419-25

Endemic Medicine and Hepatogastroenterology, Cairo University, Cairo, Egypt;

Background And Aim: Early detection of hepatocellular carcinoma (HCC) enhances effective and curative management. New genetic markers with distinct diagnostic ability are required.

Aim: determine the expression of GPC3, PEG10, SERPINI1, MK and QP-C in the peripheral blood of HCC patients.

Methods: 74 HCV patients were recruited and divided into three groups; chronic hepatitis (I), liver cirrhosis (II) and HCC (III). Demographics, laboratory and imaging data were collected. Child score and metastatic work up were completed. The expression of the five candidate genes in the peripheral blood was performed by qRT-PCR assay.

Results: Groups were gender matched, age in group I was significantly lower than in groups II and III (37.7 vs 50.4 and 55.6, p value <0.005). CHILD score; group II and III A/B/C = (7/5/6) and (20/6/3). AFP was significantly higher in group III than I and II (204 vs 3.9 and 6.9, p < 0.01). In HCC group 69% of the lesions were < 5 cm, and had 1-2 nodules; 14% had metastases. GPC3, PEG10, SERPINI1 and MK mRNA were significantly higher in the HCC group compared to the other groups while QP-C mRNA was higher in chronic hepatitis C group compared to other groups. The gene expression values in HCC patients were independent of the tumor size, AFP levels or extrahepatic metastasis. Combined measurement of the five gene markers showed 100% sensitivity and 33% specificity, 48% PPV and 100% NPV.

Conclusion: GPC3, PEG10, SERPINI1 and MK are genetic markers that can represent a useful tool for detection of HCC.
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December 2013

Health-related quality of life in Egyptian patients after liver transplantation.

Ann Hepatol 2012 Nov-Dec;11(6):882-90

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

Unlabelled: INTRODUCTION-AIM: Health-Related Quality of Life (HRQOL) has become an important focus of patient care and clinical outcomes research with the improvement in patient and graft survival after liver transplantation (LT). The current study was designed to evaluate the post-transplant HRQOL profiles using the Liver Disease Quality of Life 1.0 (LDQOL 1.0) Questionnaire and demonstrate the possible effect of peri-transplant clinical covariates on these profiles.

Material And Methods: Participants included pre-transplant group (waiting-list patients n = 50) and post-transplant group (mean 5 ± 4 years after deceased or living donor LT n = 103) who were recruited from 3 specialized centers in Egypt. We applied the LDQOL 1.0 questionnaire; a 111-item containing the Short Form-36 version 2.0 (SF-36v2) as a generic component supplemented by 75 disease-specific items. The etiology of cirrhosis, co-morbidities, model for end-stage liver disease (MELD), Child-Pugh class and post-operative complications were analyzed.

Results: All recipients had significant higher HRQOL scores than patients in waiting-list using both questionnaire components. Recipients with pre-LT MELD ≥ 15, Child-Pugh class C, history of hepatocellular carcinoma (HCC) demonstrated low HRQOL scores. Recipients without post-operative surgical complications had a statistically better HRQOL using the disease-specific, but not the SF-36v2 component. On the other hand, both components demonstrated non-significant lower scores in recipients with rejection episodes, cytomegalovirus (CMV) infection and hepatitis C recurrence had compared to those without medical complications.

Conclusion: Generally HRQOL improves dramatically after LT as assessed by LDQOL questionnaire. Moreover, combined questionnaires can provide accurate information about the possible impaired HRQOL post-LT due to pre-transplant disease severity and post-operative complications.
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April 2013

Recurrence of hepatitis C virus (genotype 4) infection after living-donor liver transplant in Egyptian patients.

Exp Clin Transplant 2009 Sep;7(3):157-63

Liver Transplantation Center, Dar Al-Fouad Hospital, Giza, Egypt.

Objectives: The recurrence of hepatitis C virus infection after liver transplant is common and may endanger both graft and patient survival. We investigated the frequency and outcome of and risk factors for the recurrence of that virus after living-donor liver transplant in hepatitis C virus positive recipients.

Materials And Methods: Seventy-four adult hepatitis C virus positive subjects were monitored for 36 months after living-donor liver transplant and demographic and laboratory data for the recipients and donors were evaluated. Recurrent hepatitis C virus infection was diagnosed on the basis of viral replication revealed by polymerase chain reaction after transplant, elevated levels of transaminases, and the results of liver biopsy.

Results: Hepatitis C virus recurrence was identified in 31.1% of the patients studied. Histopathologic recurrence was mild, and 91% of the subjects had a fibrosis score of < or = F2. No recipient exhibited cirrhosis or clinical decompensation during followup. Recurrent hepatitis C virus infection was associated with pretransplant and posttransplant viral load and antibody positive to hepatitis B core antigen. No other risk factors (sex, donor or recipient age, pretransplant Child-Pugh or Model for End-Stage Liver Disease scores, immunosuppressive drug therapy, and treatment with pulse steroids) were significantly correlated with the frequency of hepatitis C virus recurrence, the grade of the histologic activity index, or the stage of fibrosis.

Conclusions: In living-donor liver transplant recipients, patient and graft survival rates associated with hepatitis C virus (genotype 4) related cirrhosis were comparable to those in deceased-donor liver transplant recipients reported in the literature. Recurrent infection with hepatitic C virus after living-donor liver transplant was mild. After transplant, a higher viral load and the presence of antibody to hepatitis B core antigen could be risk factors for hepatitis C virus recurrence. Long-term follow-up in a large number of patients is required.
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September 2009

Quality of life of Egyptian donors after living-related liver transplantation.

Arab J Gastroenterol 2009 Mar 3;10(1):21-4. Epub 2009 May 3.

Department of Tropical Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

Background And Study Aim: Quality of life after liver donation must remain a primary outcome measure when we consider the utility of living donor liver transplants. In making clinical decisions on the use of transplantation for chronic liver diseases, consideration should be given to the key factors likely to affect subsequent health related quality of life. It would be beneficial for donors, if factors predicting good quality of life are identified. The aim of this study was to assess the health related quality of life changes experienced by donors following living related liver transplantation using the Short Form 36 (SF-36) questionnaire.

Patients And Methods: Between August 2001 and December 2006, 125 adults received liver grafts from living donors at Dar Al-Fouad Hospital, Cairo, Egypt. The SF-36v2 questionnaire was applied to 30 donors after at least 6 months following donation and maximally 4 years after donation (mean±STD:3.28±1.56 years). Furthermore, 30 healthy volunteers were taken as a control group.

Results: None of the donors required re-surgery and no deaths were reported. Only 4 (13.3%) donors experienced minor complications, which did not affect their quality of life and had no long term effects. No significant difference was found between donors and control group when means of the Physical and Mental Component Summary were compared. The physical functioning domain was the only domain of health which showed a statistically significant difference between both groups.

Conclusion: Health related quality of life of donors was not compromised after full recovery. All donors had good recovery and returned to regular activities within 2-4 months post donation.
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http://dx.doi.org/10.1016/j.ajg.2009.03.004DOI Listing
March 2009

Evaluation of liver tissue by polymerase chain reaction for hepatitis B virus in patients with negative viremia.

World J Gastroenterol 2005 Nov;11(43):6853-7

Tropical Medicine Department, Cairo University, Cairo, Egypt.

Aim: To assess the clinical significance of Hepatitis B virus (HBV) DNA localization in the liver tissue of patients with positive HBsAg and negative viremia.

Methods: HBV virological parameters of 33 HBsAg positive chronic hepatitis patients, including seromarkers and HBV DNA amplification in both sera and liver biopsies, were evaluated.

Results: Ten patients had negative viremia and positive HBV DNA in their liver biopsies. Most of them had HBeAg-negative/HBeAb-positive chronic hepatitis. Their liver biochemical and histopathological profiles were different from the viremic patients. Their disease pattern was designated as "hepatitis B in situ".

Conclusion: Hepatitis B in situ is a consequential entity which can be missed in clinical practice. It is a new clinical pattern of chronic HBV infection that considers HBV in liver biopsy and adds a new indication for antiviral therapy.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4725047PMC
http://dx.doi.org/10.3748/wjg.v11.i43.6853DOI Listing
November 2005
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