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2020
Said, M., R. E. Etreby, H. Omar, H. Dabees, R. Abdelghafour, M. El-Serafy, and W. Doss, "Fibro-indices versus liver stiffness for prediction of significant fibrosis in hepatitis B virus-infected Egyptian patients; a single-center experience.", Expert review of gastroenterology & hepatology, pp. 1-7, 2020. Abstract

: 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.

2019
Darweesh, S. K., H. Omar, E. medhat, R. A. Abd-Al Aziz, H. Ayman, Y. Saad, and A. Yosry, "The clinical usefulness of elastography in the evaluation of nonalcoholic fatty liver disease patients: A biopsy-controlled study.", European journal of gastroenterology & hepatology, 2019. Abstract

BACKGROUND: We aimed at determination of the usefulness of elastography [acoustic radiation force impulse (ARFI) and FibroScan] for evaluation of nonalcoholic fatty liver disease (NAFLD) patients.

PATIENTS AND METHODS: A prospective cross-sectional study included 60 biopsy-proven NAFLD patients (mean age: 45 years) was carried out. All patients were subjected to lab works, liver biopsy, and measurement of liver stiffness by ARFI and FibroScan and steatosis by controlled attenuation parameter (CAP). CAP measurements were adjusted for the presence of NAFLD and presence or absence of diabetes and according to BMI.

RESULTS: Linear regression analysis showed that CAP is an independent predictor for significant hepatic steatosis (P<0.001). No significant difference was found in diagnostic accuracy between adjusted and nonadjusted CAP values for diagnosis of mild (>S1) or significant (>S2) hepatic steatosis (P=0.17 and 0.29 respectively). The median ARFI velocities for F1, F2, F3, and F4 were 0.92, 1.08, 1.07, and 2.58 m/s, respectively. Although there was an overall significant increase in ARFI values across the fibrosis grades (P<0.04), the difference in ARFI values was only significant between fibrosis grades F1 and F4 (P=0.02).

CONCLUSION: Elastography is a promising noninvasive tool for diagnosis and grading of hepatic steatosis and fibrosis in patients with NAFLD/nonalcoholic steatohepatitis with good sensitivity and specificity, especially in moderate to marked grades.

El-Garem, H., M. Abdallah, H. Omar, A. Cordie, S. A. Alem, M. A. Mohey Eldin Elzahry, doaa ghaith, N. H. Abou El-Soud, W. Kamal, A. Elsharkawy, et al., "DAAs therapy associated with improved hepatic fibrosis in HCV-GT4 patients co-infected with HIV.", Expert review of gastroenterology & hepatology, pp. 1-6, 2019. Abstract

BACKGROUND: The present work aimed at evaluation of the potential dynamic changes in hepatic fibrosis following treatment of chronic HCV using DAAs in patients coinfected with HIV.

PATIENTS AND METHODS: In total, 50 HCV/HIV coinfected patients [age; 34.68 ± 10.38 years, 82% men] were included. For all included patients, liver stiffness measured using transient elastography as well as serum liver fibrosis scores; [fibrosis-4 (FIB-4) score and the aspartate aminotransferase to platelet ratio index (APRI)] were calculated at baseline and at 12 and 24-weeks following 12 weeks therapy of HCV with once daily sofosbuvir 400 mg plus daclatasvir 60 mg.

RESULTS: Most of the included patients (70%, n = 35) were on anti-retroviral therapy. SVR24 was achieved by 93.48% of the patients. There was significant serial improvement in baseline liver stiffness measurement (LSM), FIB-4 and APRI among responders; [LSM: baseline, 7.05 ± 4.84 kPa vs. 5.66 ± 2.63 kPa at SVR24, p < 0.001], [FIB-4: baseline, 1.24 ± 1.08 vs. 0.93 ± 0.64 at SVR24, p 0.001) and (APRI: baseline, 0.725 ± 0.66 vs. 0.36 ± 0.19at SVR24, p 0.001) respectively.

CONCLUSION: Treatment of HCV patients coinfected with HIV using DAAs is associated with a rapid significant regression in hepatic fibrosis, as evaluated by FibroScan, FIB-4, and APRI scores.

Elbaz, T., M. Abdo, H. Omar, E. A. Hassan, A. M. Zaghloul, M. Abdel-Samiee, A. Moustafa, A. Qawzae, M. Gamil, and G. Esmat, "Efficacy and safety of sofosbuvir and daclatasvir with or without ribavirin in elderly patients with chronic hepatitis C virus infection.", Journal of medical virology, vol. 91, issue 2, pp. 272-277, 2019. Abstract

Hepatitis C virus (HCV) infection is considered as a major public health problem that, worldwide, chronically affects 170 million people. Elderly patients are more likely than younger patients to have increased duration of infection, increased rate of disease progression, and subsequently increased incidence of advanced liver disease. Natural history models predicted that the prevalence of HCV infection and its chronic sequelae as well as extrahepatic manifestations will eventually increase through the next decade and will mostly affect those who are greater than 60 years of age. Moreover, polytherapy and polypharmacy are frequent in elderly patients due to associated comorbidities. As advanced age is associated with increasing risk of development of cirrhosis and hepatocellular carcinoma, elderly patients are in special need of safe and effective antiviral therapies. Achievement of sustained viral responses (SVR) is associated with reduced liver-related complications and overall mortality in such patients with the advanced liver disease. With the recent introduction of interferon-free direct-acting antivirals, successful treatment for chronic HCV infection had dramatically improved, with overall cure rates that exceed 90% SVR. In our study, we aimed to study the efficacy and safety of combined sofosbuvir and daclatasvir, with or without ribavirin, in management of chronically infected HCV elderly patients who are more than 60 years old.

Alboraie, M., N. Youssef, A. F. Sherief, shimaa afify, M. - N. Wifi, D. Omran, E. Hafez, H. Omar, M. Eltabbakh, M. Abdellah, et al., "Egyptian liver library: An indexed database for liver disease evidence in Egypt.", Arab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology, 2019. Abstract

Liver diseases are among the most challenging health care problems worldwide. In Egypt, we established different care programs to combat liver diseases including schistosomiasis and viral hepatitides. A lot of research work addressing liver diseases in Egypt have been published with special focus on these two major fields. Other liver disease seems to be neglected although present and contributing to the liver disease burden in Egypt. In this report we reviewed the available evidence published from Egypt and elucidate areas of weakness and future research needs. Our search for Egyptian liver disease evidence retrieved 4683 articles, 67% of them were relevant to the topic. Out of the relevant articles; 1646/3265 (50.4%) were discussing clinical science, 1131 (34.7%) were discussing basic science and 488 (14.9%) were discussing both basic and clinical sciences. Cairo university (16.8%, n = 513) and Mansoura university (9.3%, n = 285) had the largest number of publications related to liver disease in Egypt respectively. The most commonly reported diseases were hepatitis C in 719/3361 articles (21.4%), parasitic liver infestations in 663 articles (19.7%), hepatocellular carcinoma in 544 articles (16.2%), liver fibrosis or cirrhosis in 537 articles (16%), and drug induced liver injury in 516 articles (15.4%). Most of the reviewed articles (36%) were discussing treatment of chronic liver diseases (n = 1201) followed by diagnostics (28%, n = 940), pathogenesis and pathophysiology (21%, n = 706). This review will direct attention to areas with less research like hepatitis B related liver disease, HIV/HCV co-infections, and non-alcoholic fatty liver disease (NAFLD) to encourage future research in these topics. In conclusion; our results ring a bell inviting the development of a roadmap for liver research in Egypt targeting to put future policies to cover areas of weakness in liver research with an ultimate goal of tackling liver disease and its overwhelming socioeconomic burden in our developing country.

El Kassas, M., M. Alboraie, H. Omar, Y. A. E. Latif, M. A. Algaber, adel el tahan, H. El Halwagy, shimaa afify, M. E. Serafy, K. Elsaeed, et al., "High success rates for the use of ombitasvir/paritaprevir/ritonavir containing regimens in treatment of naïve and experienced chronic hepatitis C genotype 4: Real world results.", Journal of medical virology, 2019. Abstract

INTRODUCTION AND AIMS: Treatment of hepatitis C virus (HCV) genotype 4 patient with fixed dose combination of ombitasvir-paritaprevir-ritonavir plus ribavirin (OBV/rPTV/RBV) has been proven efficacy and safety in many clinical trials. The current study reports the efficacy and safety of OBV/rPTV/RBV (for treatment-naïve), and OBV/rPTV/RBV/sofosbuvir (SOF) (for treatment-experienced), in chronic HCV genotype 4 patients in real life settings.

METHODS: Prospective cohort study including all adult chronic HCV genotype 4 patients who were scheduled to receive OBV/rPTV/RBV ± SOF for 12 or 24 weeks in New Cairo Viral Hepatitis Treatment Center. The primary efficacy endpoint was a virologic response at posttreatment week 12 (SVR12). Changes in hematological parameters, liver biochemical profile and fibrosis-4 index (FIB-4), as well as clinical and laboratory adverse events (AEs) across follow up visits (week 4, end of treatment [EOT], and SVR12), were recorded.

RESULTS: Our study included 325 patients (age; 47.63 ± 12.63 years, 55.38% [n = 180] men). Most of the included patients (89.85%, n = 292) were treatment naïve and only 7% (n = 23) had liver cirrhosis. Overall, SVR12 was attained by 98.44% (316 of 321) of the patients; 97.15% (307 of 316) of patients who received 12 weeks of OBV/rPTV/RBV ± SOF and 100% (9 of 9) of patients who received 24 weeks of OBV/rPTV/RBV as assessed by modified intention to treat analysis. There was a significant improvement of baseline alanine aminotransferase, aspartate aminotransferase, hemoglobin, FIB-4 at SVR12 (P < 0.05). The most common reported AEs were anemia (n = 106), fatigue (n = 41) and elevated indirect bilirubin (n = 37).

CONCLUSION: OBV/rPTV/RBV (±SOF) is a highly effective therapy for chronic HCV patients in real life settings.

Darweesh, S. K., K. Elsaeed, H. Omar, M. E. Raziky, W. elakel, M. E. Serafy, S. Ismail, A. A. Gomaa, M. Mehrez, M. Elkassas, et al., "High SVR rate following retreatment of non-sustained virological responders to sofosbuvir based anti-HCV therapies regardless RAS testing: A real-life multicenter study.", Expert review of gastroenterology & hepatology, 2019. Abstract

: we aimed at evaluating efficacy and safety of sofosbuvir/daclatasvir/ribavirin (SOF/DCV/RBV) in treating non-sustained virological responders (non-SVR12) to prior sofosbuvir-based therapy, in the setting of absence of RAS testing in mass treatment, and to determine the optimal timing to start re-treatment. : Real-life prospective observational study including 1,014 non-SVR12 who failed prior treatment with 24-weeks SOF-RBV (n=679, 67%) or 12-weeks SOF- RBV- PEG (n=335, 33%). Patients were retreated with daily sofosbuvir, daclatasvir plus ribavirin for 12 (n=270) or 24 weeks (n=744). The primary efficacy endpoint was SVR12. Safety endpoint was regimen adverse events. : The mean age was 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 adverse events occurred in 5.13% and 32 (3.1%) discontinued treatment; with eight (0.78%) on-treatment mortalities. Multivariate regression revealed that higher baseline FIB4 and shorter interval before starting re-treatment (<6 months) were the independent predictors of non-SVR12. : SOF/DCV/RBV is an effective and safe treatment option for non-responders to prior sofosbuvir-based therapy. Six months after end of initial therapy is an optimum interval before starting retreatment to achieve favorable SVR.

Said, M., H. Omar, Z. Soliman, Y. Saad, H. Dabes, S. Hamed, K. ElSaeed, Y. ElShazly, and M. ElSerafy, "Ritonavir-boosted paritaprevir, ombitasvir plus ribavirin could improve eGFR in patients with renal impairment and HCV: an Egyptian cohort.", Expert review of gastroenterology & hepatology, vol. 13, issue 1, pp. 89-93, 2019. Abstract

BACKGROUND: The present study aimed at evaluation of changes in estimated glomerular filtration rate (eGFR) among chronic Hepatitis C virus (HCV) patients with chronic kidney disease (CKD) Stages 3-5 who were treated with 12 weeks of ritonavir-boosted paritaprevir, ombitasvir plus ribavirin.

METHODS: Changes in renal functions were compared across follow up time points (baseline, SVR4, and SVR8). Data on on-treatment adverse events (AEs), serious AEs, laboratory abnormalities, treatment discontinuation were collected.

RESULTS: 171 patients were included (females 35%, mean age 53 years). 29 patients had liver cirrhosis. The most common etiologies of CKD were diabetes and/or hypertension (n = 67). All included patient reached the end of treatment (EOT) with no treatment discontinuations. The overall EOT response was 100%. 122/122 (100%) patients who reached 4 weeks post-treatment have achieved SVR4, and 80/80 (100%) have achieved SVR12. No reported SAEs. Ribavirin therapy was interrupted in 25% (43/171) of patients due to anemia; 16 patients required blood transfusions. The median eGFR improved from 33.5 (15) mL/min/1.73 m at baseline to 35 (36) mL/min/1.73 m2 at SVR8 (p = 0.0003).

CONCLUSIONS: The use of ombitasvir, paritaprevir, and ritonavir for treatment of HCV-infected patients with advanced renal disease was safe and effective, moreover, it was associated with significantly improved eGFR.

El Kassas, M., M. Alboraie, mervat naguib, H. Omar, adel el tahan, I. Moaz, M. Abdellah, S. Ezzat, M. - N. Wifi, A. F. Sherief, et al., "A significant upsurge of body mass index in patients with chronic hepatitis C successfully treated with direct-acting antiviral regimens.", The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology, vol. 30, issue 8, pp. 708-713, 2019. Abstract

BACKGROUND/AIMS: There is less data regarding the changes in body mass index (BMI) after treating hepatitis C virus (HCV) patients with new direct-acting antiviral agents (DAAs). This study aimed to assess the changes in BMI in chronic HCV patients treated with DAAs in Egypt and to explore other factors influencing this change.

MATERIALS AND METHODS: The data of chronic HCV patients who received antiviral therapy with new DAAs in one of Egypt's specialized viral hepatitis treatment centers were retrospectively analyzed. In addition to the routine clinical and laboratory workup, changes in body weight during and after treatment were monitored and BMI was calculated. Viral load was measured at 12 weeks post-treatment to assess a sustained virological response. Patients with documented thyroid abnormalities, bariatric surgery, or ensuing special diets were excluded. BMI of >30 was taken as the cutoff for pa¬tients with obesity.

RESULTS: The study included 162 patients with a mean age of 48.56±11.49 years, of whom 61.1% were males, 16% were treatment-experienced, 12% were diabetic, and 29% were obese. Treatment duration was 12 weeks in 84% of patients and 24 weeks in 16% of patients. There was a significant increase in BMI post-treatment as compared to pretreatment measures (28.68±5.35 vs 28.18±4.55) (p=0.03). BMI changes were constant regardless of cirrhosis or previous treatment experience.

CONCLUSION: Treatment of chronic HCV with DAAs was associated with increased body mass index. Further studies are needed to explore if this effect is secondary to treatment with DAAs or is an improvement in the liver function and lifestyle of treated patients.

Mohamed, A. A., H. Omar, M. A. F. Ghaffar, M. S. Marie, M. E. E. A. Ramadan, S. M. Talima, M. E. L. Daly, and S. Mahmoud, "Single Nucleotide Polymorphism in Adiponectin Gene and Risk of Pancreatic Adenocarcinoma", Asian Pacific journal of cancer prevention : APJCP, vol. 20, issue 1, pp. 139-143, 2019. Abstract

Introduction: Adiponectin is anti-inflammatory and anti-tumor cytokine secreted exclusively from adipocytes. There
is a growing evidence of association between adiponectin gene polymorphism and development of pancreatic cancer.
The current study aimed at evaluation of the possible association between selected adiponectin gene polymorphism and
the risk of pancreatic cancer. Methods: Prospective case-control study included 77 patients (29 women and 48 men)
with biopsy-proven pancreatic adenocarcinoma and 97 healthy control. Blood samples from all included participants
were genotyped for 3 single nucleotide polymorphism (SNPs) of adiponectin genes (rs1501299C>A, rs266729C>G and
rs2241766G>T) by PCR. Clinical, biochemical, and radiological data analyzed. Results: We demonstrated a significant
association between the three studied SNPs (rs1501299, rs266729, and rs2241766) and increased risk of pancreatic
adenocarcinoma (p<0.001). Furthermore, in clinical correlation analysis, Patients with rs2241766 polymorphism
have a lower frequency of lymph node involvement (p 0.05). Smoking and older age were independent predictors of
pancreatic adenocarcinoma. Conclusion: We provided evidence that variants in adiponectin gene might influence the
development and progression of pancreatic cancer.

2018
Darweesh, S. K., R. A. Abd Alziz, H. Omar, D. Sabry, and W. Fathy, "Secreted protein acidic and rich in cysteine gene variants: Impact on susceptibility and survival of hepatocellular carcinoma patients.", Journal of gastroenterology and hepatology, 2018 Nov 13. Abstract

BACKGROUND AND AIM: Secreted protein acidic and rich in cysteine (SPARC) is a glycoprotein involved in extracellular matrix remodeling, which regulates cell growth. It could be involved in hepatic fibrogenesis related to chronic inflammations, hepatocellular carcinoma (HCC) angiogenesis, and tumor progression. We aimed to study the expressions of single nucleotide polymorphisms in the SPARC gene and their impact on susceptibility and survival of HCC patients.

METHODS: We conducted a case-control study on 200 HCC patients and 50 matched healthy controls. All patients were subjected to laboratory investigations, ultrasound, and real-time polymerase chain reaction to detect the genetic polymorphisms (rs3210714, rs11950384, and rs7719521) in the SPARC gene in the blood.

RESULTS: One hundred sixty (80%) patients were men with a mean age of 43 years. The SPARC gene showed a significant higher prevalence of rs3210714 mutation (i.e. AA or AG) and a significant lower prevalence of rs11950384 mutation (i.e. AA or AC) among HCC patients in comparison with controls (83% vs 22%, P ≤ 0.001) and (65.5 vs 86%, P = 0.005), respectively, while rs7719521 mutation did not reach significance. On univariate and multivariate analyses, elder age and having at least one copy of the mutant rs3210714 were associated with a significantly increased risk of HCC (P < 0.001 for both), whereas the presence of at least one copy of the mutant rs11950384 carried a significantly reduced risk of having HCC (P < 0.01). Overall survival did not differ significantly between any of the SPARC gene mutation groups.

CONCLUSIONS: The SPARC gene polymorphisms had a diverse impact on the susceptibility of HCC due to its ability to inhibit or promote tumor progression. SPARC gene polymorphisms were not related to survival of our HCC patients, and probably, this needs further analysis of other SPARC gene nucleotides.

El Kassas, M., M. Alboraie, D. Omran, M. Salaheldin, M. N. Wifi, M. Elbadry, adel el tahan, S. Ezzat, E. Moaz, A. M. Farid, et al., "An account of the real-life hepatitis C management in a single specialized viral hepatitis treatment centre in Egypt: results of treating 7042 patients with 7 different direct acting antiviral regimens.", Expert review of gastroenterology & hepatology, pp. 1-8, 2018 May 24. Abstract

BACKGROUND: A large Egyptian treatment program for HCV was launched in2014 after the introduction of direct-acting antiviral agents (DAAs). This program depended mainly on establishing specialized independent centres for HCV treatment. These centres represent the major strengths in the Egyptian model of care, as they provide integrated care for HCV patients and have enabled Egypt to treat more than one million patients in 3 years. The New Cairo Viral Hepatitis Treatment Center (NCVHTC) is an example of these specialized centres.

METHODS: The Egyptian experience in the management of HCV was evaluated by analysing the data of real-life HCV management in the NCVHTC from 2014 to 2017. Results of different treatment regimens in addition to their strengths, limitations and areas for improvement are discussed in this report.

RESULTS: A total of 7042 HCV patients have been evaluated for treatment in the NCVHTC. Among them, 5517 patients received treatment by seven different DAA regimens with excellent results.

CONCLUSIONS: All regimens were highly effective at treating HCV in a real-life setting, apart from SOF/RBV, which was the least effective. A nationwide screening program and enhancing the follow-up of treated patients are the main missing pillars in the Egyptian model.

Omar, H., W. Elakel, T. Elbaz, M. El Kassas, K. Elsaeed, H. El Shazly, M. Said, M. Yousif, A. A. Gomaa, A. Nasr, et al., "Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt.", Alimentary pharmacology & therapeutics, vol. 47, issue 3, pp. 421-431, 2018 Feb. Abstract

BACKGROUND: Treatment of chronic hepatitis C using combination of sofosbuvir (SOF) and daclatasvir (DCV) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1-3. The national program in Egypt is using SOF-DCV combination for large scale treatment.

AIM: To assess the efficacy and safety of combined SOF-DCV in treating patients with HCV-G4 in a real-world setting.

METHODS: Data and outcome of chronic HCV patients who were treated for 12 weeks with generic medications: DCV 60 mg plus SOF 400 mg ± ribavirin (RBV) within the national hepatitis C treatment program in Egypt are presented. Treatment-naïve patients without cirrhosis were treated without RBV, and those who had cirrhosis or were treatment-experienced (interferon experienced or SOF experienced) received RBV. Efficacy and safety were assessed, and baseline factors associated with sustained virological response at post-treatment week 12 (SVR12) were explored.

RESULTS: During the first 2 months of the programme, 18 378 patients with HCV-G4 started treatment with SOF-DCV with or without RBV. Overall, 95.1% achieved SVR12 (95.4% among patients treated without RBV and 94.7% for patients treated with RBV, P = .32). Treatment was prematurely discontinued in only 1.5% of patients. The most common events leading to discontinuation were patient withdrawal (n = 76) and pregnancy (n = 5). Five deaths occurred within this group.

CONCLUSIONS: Real-world experience of generic SOF-DCV in patients with chronic HCV-G4 proved to be safe and associated with a high SVR12 rate, in patients with different stages of fibrosis.

Hasaballah, M., R. M. Salama, M. S. Marie, A. A. Mandur, and H. Omar, "Utility of point shear wave elastography in characterisation of focal liver lesions.", Expert review of gastroenterology & hepatology, vol. 12, issue 2, pp. 201-207, 2018 Feb. Abstract

BACKGROUND: The present study aimed at evaluation of the usefulness of point shear wave elastography (pSWE) in characterization of FLL(s) by quantifying their stiffness.

METHODS: In total, 197 patients (mean age was 56.57 years) with FLL(s) on conventional ultrasound were included. Final diagnoses, confirmed by imaging and/or biopsy whenever possible, included hepatocellular carcinoma (HCC) (n = 143), metastasis (n = 36), hemangioma (n = 16), and focal nodular hyperplasia (n = 2). Stiffness evaluation was performed by pSWE. Stiffness ratio (lesion to background liver) was calculated. ROC analysis was performed to evaluate the diagnostic accuracy of the stiffness value and stiffness ratio and to extract the optimal cutoff values for characterisation of FLL(s).

RESULTS: HCC was significantly softer than its surrounding liver parenchyma [5.43 (3.03) vs. 17.05 (8.53) kPa, p <0.001]. However, the stiffness values for the other examined FLLs were comparable to their surrounding liver parenchyma. No significant difference was detected across different types of metastases or between metastases and surrounding liver (p>0.05). Stiffness ratio was superior to stiffness value in discrimination of HCC from metastasis (AUROC, 0.91 vs. 0.51 respectively).

CONCLUSION: pSWE could provide a complementary information about FLLs especially in differentiation between HCCs from metastases.

Omar, H., M. Said, R. E. Etreby, M. Mehrez, M. Bassam, Z. abdellatif, A. Hosny, S. Megawer, M. Elamir, and A. Yosry, "Longitudinal assessment of hepatic fibrosis in responders to direct-acting antivirals for recurrent hepatitis C after liver transplantation using noninvasive methods.", Clinical transplantation, vol. 32, issue 8, pp. e13334, 2018 Aug. Abstract

Successful eradication of recurrent hepatitis C virus (HCV) infection following liver transplantation (HCV) improves graft survival. This study aimed at evaluation of hepatic fibrosis changes among long-term responders to DAA therapy for recurrent HCV after liver transplantation using noninvasive methods. Patients with significant hepatic fibrosis (≥F2) who achieved SVR12 after treatment with DAAs for recurrent HCV were included (n = 52). Hepatic fibrosis status was assessed, noninvasively, by calculation of fibrosis-4 score (FIB-4) and Aspartate Aminotransferase Platelet Ratio Index (APRI) and by measurement of graft stiffness using FibroScan at baseline and 12 and 18 months post-treatment. Acoustic radiation force imaging (ARFI) was done for all patients 12 and 18 months post-treatment. Patients were classified into two groups based on baseline liver stiffness measurement (LSM) by FibroScan; significant fibrosis (F2; n = 28) and advanced fibrosis groups (≥F3). Over 18-month follow-up period, there was serial improvement of FIB-4, APRI, and LSM by FibroScan in both groups. Higher baseline LSM and delayed initiation of antiviral therapy were significant predictors of lack of fibrosis regression (P-value 0.01 and 0.04, respectively). Fibroindices and LSM improved over time in liver transplant recipients who responded to DAAs. Baseline LSM can predict post-treatment fibrosis regression.

El Kassas, M., T. Elbaz, A. Elsharkawy, H. Omar, and G. Esmat, "HCV in Egypt, prevention, treatment and key barriers to elimination.", Expert review of anti-infective therapy, vol. 16, issue 4, pp. 345-350, 2018 04. Abstract

INTRODUCTION: Currently, direct-acting antivirals (DAAs) are considered the ideal choice for the treatment of chronic HCV patients due to their proven efficacy (SVR> 90%), and minimal adverse effects. Egypt launched a large treatment program aimed at providing treatment coverage for Egyptian HCV- infected patients. Areas covered: This review covers the treatment and prevention efforts made by the Egyptian National Committee for the Control of Viral Hepatitis (NCCVH) with the available model of care for HCV patients in Egypt, in addition to the barriers that prevent elimination of HCV from Egypt. Expert commentary: Egypt could provide a model for establishing the largest HCV management system aimed at eliminating HCV from the country with the highest worldwide prevalence. Despite the huge efforts and achieved results in combating the HCV epidemic in Egypt, certain improvements are needed in order to attain HCV elimination, such as the development of an enhanced screening program working in parallel to the present treatment options.

Waked, I., H. Omar, T. Elbaz, and G. Esmat, "Ravidasvir. Second-generation NS5A inhibitor, Treatment of hepatitis C virus infection", Drugs of the Future, 2018.
Omar, H., W. Elakel, T. Elbaz, M. El Kassas, K. Elsaeed, H. El Shazly, M. Said, M. Yousif, A. A. Gomaa, A. Nasr, et al., "Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt.", Alimentary pharmacology & therapeutics, vol. 47, issue 3, pp. 421-431, 2018. Abstract

BACKGROUND: Treatment of chronic hepatitis C using combination of sofosbuvir (SOF) and daclatasvir (DCV) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1-3. The national program in Egypt is using SOF-DCV combination for large scale treatment.

AIM: To assess the efficacy and safety of combined SOF-DCV in treating patients with HCV-G4 in a real-world setting.

METHODS: Data and outcome of chronic HCV patients who were treated for 12 weeks with generic medications: DCV 60 mg plus SOF 400 mg ± ribavirin (RBV) within the national hepatitis C treatment program in Egypt are presented. Treatment-naïve patients without cirrhosis were treated without RBV, and those who had cirrhosis or were treatment-experienced (interferon experienced or SOF experienced) received RBV. Efficacy and safety were assessed, and baseline factors associated with sustained virological response at post-treatment week 12 (SVR12) were explored.

RESULTS: During the first 2 months of the programme, 18 378 patients with HCV-G4 started treatment with SOF-DCV with or without RBV. Overall, 95.1% achieved SVR12 (95.4% among patients treated without RBV and 94.7% for patients treated with RBV, P = .32). Treatment was prematurely discontinued in only 1.5% of patients. The most common events leading to discontinuation were patient withdrawal (n = 76) and pregnancy (n = 5). Five deaths occurred within this group.

CONCLUSIONS: Real-world experience of generic SOF-DCV in patients with chronic HCV-G4 proved to be safe and associated with a high SVR12 rate, in patients with different stages of fibrosis.

2017
Al Maani, A., A. Al Qayoudhi, H. F. Nazir, H. Omar, A. Al Jardani, Z. Al Muharrmi, and Y. Wali, "Pertussis and Pertussis like Illness: Pediatric Experience in Oman.", Oman medical journal, vol. 32, issue 5, pp. 396-402, 2017 Sep. Abstract

OBJECTIVES: A resurgence of pertussis or whooping cough has been observed worldwide despite broad vaccination coverage. Pertussis like illness (PLI) refers to a clinical syndrome compatible with pertussis infection but lacking laboratory confirmation or an epidemiological link to a confirmed case. Our study aimed to estimate the contribution of Bordetella pertussis infection and identifying predictors of its diagnosis in a cohort of children with PLI.

METHODS: Demographic and clinical information were retrospectively collected from the medical records of children < 13 years old and hospitalized for PLI in two pediatric units in Oman from 1 January 2012 to 31 December 2013. The laboratory data of all cases were reviewed and confirmed cases of pertussis were identified, analyzed, and compared with non-confirmed cases.

RESULTS: A total of 131 patients were enrolled in this study. The majority (95.4% [125/131]) were infants. Only 54.1% (71/131) of admitted children with PLI were tested for pertussis. The incidence of pertussis infection among the tested group was 16.9% (12/71) with a 95% confidence interval 8.2-25.6. Severe illness occurred in 56.4% (74/131) of patients, and six were confirmed to have pertussis. Pediatric intensive care unit admission was required for one confirmed case of pertussis and eight cases from the PLI group (three were negative for pertussis, and five were not tested). Receiver operator characteristic curve analysis revealed that a white blood cell count 3 23.5 × 109/L had 96.6% specificity and lymphocytes 3 17 × 109/L had 98.3% specificity.

CONCLUSIONS: Taking into consideration that the number tested for pertussis was limited, the incidence of pertussis was 16.9% (12 out of 71 patients). Lymphocytosis can be used as a reliable predictor for the diagnosis of pertussis especially in the absence of specific confirmatory tests or until their results are available.

Al-Busafi, S. A., H. Al-Shuaili, H. Omar, H. Al-Zuhaibi, L. Jeyaseelan, and K. Al-Naamani, "Epidemiology of Chronic Hepatitis C Infections at a Tertiary Care Centre in Oman.", Sultan Qaboos University medical journal, vol. 17, issue 4, pp. e404-e410, 2017 Nov. Abstract

Objectives: Chronic hepatitis C (CHC) is a leading cause of liver cirrhosis and hepatocellular carcinoma (HCC) worldwide. However, there is a lack of data regarding the epidemiology of CHC in Oman. This study aimed to describe the clinicopathological characteristics and outcomes of CHC-infected patients at a tertiary care hospital in Oman.

Methods: This retrospective descriptive hospital-based study included all CHC-infected patients who presented to the Sultan Qaboos University Hospital (SQUH) in Muscat, Oman, between January 2010 and December 2015. The baseline demographic, clinical, laboratory and radiological data of the patients were analysed.

Results: A total of 603 CHC-infected patients were identified during the study period; of these, 65.8% were male and the mean age was 44.8 ± 16.5 years. The main risk factors associated with CHC infection were intravenous drug abuse (23.9%) and a history of blood transfusions (20.7%). The most prevalent virus genotypes were 1 and 3 (44.0% and 35.1%, respectively). Upon initial presentation, 33.0% of the cohort had liver cirrhosis; of these, 48.7% had decompensated cirrhosis and 23.1% had HCCs. Liver transplantation was only performed for 7.5% of the cirrhosis patients, mostly as a curative treatment for HCC.

Conclusion: The implementation of national policies to prevent hepatitis C transmission and encourage the early screening of at-risk patients is recommended to reduce the burden and consequences of this disease in Oman.

El Serafy, M. A., A. M. Kassem, H. Omar, M. S. Mahfouz, and M. E. S. El Raziky, "APRI test and hyaluronic acid as non-invasive diagnostic tools for post HCV liver fibrosis: Systematic review and meta-analysis.", Arab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology, vol. 18, issue 2, pp. 51-57, 2017 Jun. Abstract

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.

Al-Busafi, S. A., and H. Omar, "Towards supporting greater and lower cost access to direct acting antiviral treatment for hepatitis C for all patients.", Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association, vol. 23, issue 4, pp. 263-264, 2017 Jul-Aug.
El-Nawawy, A., D. Khater, H. Omar, and Y. Wali, "Evaluation of Early Corticosteroid Therapy in Management of Pediatric Septic Shock in Pediatric Intensive Care Patients: A Randomized Clinical Study.", The Pediatric infectious disease journal, vol. 36, issue 2, pp. 155-159, 2017 Feb. Abstract

BACKGROUND: Septic shock is a major healthcare problem. Adrenal insufficiency (AI) in children with septic shock is a recognized complication, yet is controversial regarding its management and effect on mortality. According to the current guidelines, children with risk factors for AI should receive a stress dose of steroids in step 3 of treatment. This study aimed to evaluate and compare early corticosteroid therapy with the traditional use of steroids among pediatric septic shock patients.

METHODS: This prospective randomized interventional clinical study included 3 groups of patients (32 each) and was conducted in Alexandria University pediatric intensive care unit. By protocol, the first group received steroids in step 3 of the treatment according to the current international guidelines (group A), and the second group was managed as group A and was tested for AI by adrenal stimulation test using intramuscular adrenocorticotropic hormone (cosyntropin) (group B). The third group received steroids at the start of fluid therapy (group C). A fourth group (group D) was created by adding patients from groups A and B who needed corticosteroids in the third stage of therapy according to the international protocol in 1 group. All patients were evaluated for basal serum cortisol and plasma adrenocorticotropic hormone concentrations.

RESULTS: The data showed a statistically significant shorter shock reversal time among patients receiving corticosteroids at the start of treatment compared with those who received it at the third step of treatment (P = 0.046); however, mortality was not statistically different among the groups. In addition, there was no superinfection in cases receiving early steroid therapy.

CONCLUSIONS: Early use of corticosteroid in patients with septic shock might shorten the shock reversal time without increase in mortality or superinfection.

Yosry, A., D. Omran, M. Yousef, M. Salah, H. Omar, S. Hamdy, O. Shaker, Y. Elsherif, and M. S. Marie, "SNPs in the Insulin-Like Growth Factor Gene and Obesity Impact on Colorectal Cancer in Egyptians", Asian Pacific journal of cancer prevention : APJCP, vol. 18, issue 11, pp. 2959-2964, 2017 11 26. Abstract

Background and aims: The insulin pathway may play a role in development of colorectal cancer (CRC). In this study, we investigated associations between CRC and obesity in Egyptians with reference to single nucleotide polymorphisms (SNPs) in the insulin-like growth factor-1 (IGF-I) gene. We also studied serum levels of IGF-1in Egyptian CRC patients with different BMI values. Methods: This prospective study included 66 CRC patients and 30 healthy individuals, for whom body mass index (BMI) was estimated, patients and controls being categorized into overweight or obese in one group and average weight in the other. Serum levels of IGF-1 were assessed by ELISA and SNPs in the IGF-I gene at rs6214C/T, rs6220 T/C and rs35767 C/T were examined by PCR- RFLP. Results: Serum levels of IGF-1 were significantly lower in both CRC average weight and overweight cases. IGF-1 could negatively predict CRC at a cut-off of 154 ng/ml with 87.5% sensitivity and 72.6 specificity. IGF-1 rs6214 CT and TT (T allele) genotypes were associated with a significantly increased risk of CRC. Univariate logistic regression showed that CRC risk significantly decreases by 0.14 for each one unit increase in IGF1. Conclusion: BMI could be considered as effect modifier for CRC risk. IGF-1 SNP rs6214 (TT and CT) are significantly associated with risk regardless of the BMI.

Mohamed, A. A., S. Sabry, A. S. M. A. A. M. A. H. M. O. U. D. ABDALLAH, N. A. A. Elazeem, D. Refaey, H. A. F. Algebaly, G. A. E. Fath, and H. Omar, "Circulating adipokines in children with nonalcoholic fatty liver disease: possible noninvasive diagnostic markers.", Annals of gastroenterology, vol. 30, issue 4, pp. 457-463, 2017. Abstract

BACKGROUND: The growing obesity pandemic is the leading cause for increasing prevalence of nonalcoholic fatty liver disease (NAFLD) in children. Histopathological evaluation of the liver remains the gold standard for NAFLD diagnosis, but it is an invasive procedure with a low but real risk of morbidity and mortality. The current study evaluated circulating chemerin and adiponectin as possible noninvasive diagnostic markers for NAFLD in obese non-diabetic children.

METHODS: A prospective case-control study was conducted, which included 101 obese children with biopsy-proven NAFLD and 57 age- and sex-matched controls. The overall mean age of the children was 10.08±3.12 years. All underwent a full clinical assessment, routine laboratory investigation, and abdominal ultrasound. Homeostatic model assessment-insulin resistance was calculated and circulating chemerin and adiponectin were evaluated using ELISA.

RESULTS: Elevated serum chemerin and decreased serum adiponectin were significantly associated with an increased likelihood of exhibiting NAFLD. Receiver operator characteristic curve analysis for differentiation of NAFLD patients from those in the control group demonstrated that chemerin, at a cutoff value of 186.7 ng/mL, yielded a sensitivity and specificity of 56.44% and 87.72% respectively (P<0.001), whereas adiponectin, at a cutoff value of 2.4 µg/mL, had a sensitivity and specificity of 74.26% and 3.51% respectively (P<0.001). Furthermore, body mass index, aspartate transaminase, alanine transaminase, triglycerides, and gamma-glutamyl transferase had significant positive correlations with chemerin and significant negative correlations with adiponectin (P≤0.001).

CONCLUSION: Circulating chemerin and adiponectin could serve as simple noninvasive diagnostic markers for NAFLD in non-diabetic obese children.