Publications by authors named "Aisha Elsharkawy"

49 Publications

Highly Sensitive Serum miRNA Panel for the Diagnosis of Hepatocellular Carcinoma in Egyptian Patients with HCV-Related HCC.

Lab Med 2022 Jun 22. Epub 2022 Jun 22.

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

Objective: This study aimed at exploring the potential role of a panel of serum micro-RNA (miRNA) markers in liver fibrosis and hepatocellular carcinoma (HCC) diagnosis in patients with chronic hepatitis C virus (HCV) infection.

Methods: The study included 157 chronic HCV patients and 62 HCC patients who presented to the Cairo University Center for Hepatic Fibrosis, Endemic Medicine Department, from 2015 to 2017. Relevant clinical and laboratory data were collected and sera were subjected to miRNA expression profiling. Eleven miRNA markers were studied and receiver operating characteristic curves were constructed to investigate the best cutoff values of the miRNAs that showed altered expression in HCC compared to HCV-associated advanced fibrosis.

Results: miRNA expression profiling revealed 5 miRNAs (miR-124, miR-141, miR-205, miR-208a, miR-499a) were significantly upregulated and 2 miRNAs were significantly downregulated (miR-103a, miR-15a) in HCC compared to advanced fibrosis patients. No significant difference was observed in miRNA expression between advanced fibrosis and early hepatic fibrosis apart from a significant downregulation of miR-155-5p in advanced fibrosis.

Conclusion: Serum miRNAs could serve as potential diagnostic tools for the diagnosis of HCC.
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http://dx.doi.org/10.1093/labmed/lmac045DOI Listing
June 2022

Perceived stigma and healthcare services in healthcare settings among people living with HIV in Egypt: a qualitative study.

Trans R Soc Trop Med Hyg 2022 Apr 22. Epub 2022 Apr 22.

Tropical Medicine Department, National Hepatology, and Tropical Medicine Research Institute, Cairo, 11516, Cairo, Egypt.

Background: The researchers conducted the current study to explore the perspectives of people living with HIV (PLHIV) on HIV-related discrimination and the delivery of healthcare services in healthcare settings.

Methods: An exploratory study using a qualitative approach was conducted among 46 PLHIV who were seeking HIV counselling and treatment from two HIV centres in the Cairo governorate using a purposive sampling technique.

Results: A thematic content analysis was used to examine the responses. Participants had a combination of positive and negative experiences. Some participants reported staff acceptance and friendliness towards HIV-positive patients on antiretroviral treatment. Most interviewees observed that staff took extra precautions when treating or caring for them. The majority stated that counselling about the effects of the treatment was inadequate and that testing was either too far from their homes or at overcrowded centres with long waiting times. All the interviewees recommended ongoing communication and HIV counselling skills for healthcare providers who are in contact with HIV patients.

Conclusion: Most of the study participants were not satisfied with HIV services in the participating centres, as well as experiencing stigma. More investment in enhancing the quality of HIV service delivery and reinforcement of health worker competencies, mainly in HIV counselling, may improve satisfaction, bearing in mind HIV-related stigma in the centres involved.
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http://dx.doi.org/10.1093/trstmh/trac028DOI 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 06 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

Current status of hepatitis C virus among people living with human immunodeficiency virus in Egypt.

Trans R Soc Trop Med Hyg 2022 Jun;116(6):571-578

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

Background: Human immunodeficiency virus (HIV)-hepatitis C virus (HCV) co-infection is increasing due to their similar routes of transmission. Co-infection poses a big challenge. Information on the prevalence of HCV infection in Egyptian HIV individuals is scarce.

Methods: A cross-sectional study was conducted on 1004 HIV individuals who were recruited from July 2018 to March 2019. Blood samples obtained from HIV individuals were subsequently screened for HCV antibodies using the Murex anti-HCV (version 4) enzyme-linked immunosorbent assay test. HCV RNA was performed only on anti-HCV antibody-positive samples. Logistic regression was used to identify factors associated with HCV seroprevalence using SPSS (IBM, Armonk, NY, USA).

Results: Among 1004 participants, 349 exhibited a positive result for anti-HCV antibodies (34.8% [95% confidence interval 31.81 to 37.8]). The most commonly self-reported risk factor of HIV infection by the co-infected participants was intravenous drug use (IDU) (303/349 [86.8%]). In multinomial analysis, risk factors identified as statistically associated with HCV seroprevalence include IDU, history of surgical operations and dental procedures and HIV viral load (p<0.001, 0.032, <0.001 and 0.006, respectively). Under combination antiretroviral therapy (cART), the proportion of HIV mono-infected individuals with an undetectable HIV viral load was significantly higher than those with co-infection (p<0.0007). We also found that HIV-HCV co-infected participants exhibited significantly higher CD4+ cell counts than those with HIV mono-infection (p=0.04).

Conclusions: The prevalence of HIV-HCV co-infection is higher in Egypt compared with other countries in Africa. It is essential to screen all HIV-infected patients for HCV infection for early identification, counselling and initiation of anti-HCV treatment.
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http://dx.doi.org/10.1093/trstmh/trab176DOI Listing
June 2022

The oral microbiome of treated and untreated chronic HCV infection: A preliminary study.

Oral Dis 2021 Aug 16. Epub 2021 Aug 16.

Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University, Cairo, Egypt.

Objectives: Chronic hepatitis C virus (HCV) infection is a debilitating disease that is lately treated using direct-acting antivirals (DAAs). Changes in the oral microbiome were detected in other liver diseases; however, oral microbiome was never investigated in patients having chronic HCV infection, whether pre- or post-treatment.

Materials And Methods: This case-control preliminary study enrolled three equal groups: Group (I): untreated HCV patients; group (II): HCV patients who achieved viral clearance after DAA administration; and group (III): healthy controls. For each participant, a buccal swab was harvested and its 16S rRNA was sequenced.

Results: The oral microbiome of chronic HCV patients had a significantly distinct bacterial community compared to healthy controls, characterized by high diversity and abundance of certain pathogenic species. These changes resemble that of oral lichen planus patients. After treatment by DAAs, the oral microbiome shifted to a community with partial similarity to both the diseased and the healthy ones.

Conclusions: Chronic HCV is associated with dysbiotic oral microbiome having abundant pathogenic bacteria. With HCV clearance by DAAs, the oral microbiome shifts to approach the healthy composition.
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http://dx.doi.org/10.1111/odi.14007DOI Listing
August 2021

HCV/HIV coinfected Egyptian patients: a cross-sectional study of their main characteristics and barriers to HCV treatment initiation.

Trans R Soc Trop Med Hyg 2022 03;116(3):227-232

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

Background: This study investigates different barriers preventing a cohort of Egyptian HIV/HCV coinfected patients from accessing HCV treatment, despite being available and free of charge, aiming to improve the long-term outcomes of coinfected patients and decreasing their liver-related morbidity and mortality.

Methods: This study included HIV patients who were referred to Kasr Alainy Viral Hepatitis Center to receive HCV treatment and who had to continue pretreatment assessment in order to receive direct acting antiviral agents free of charge. Patients who did not attend within 90 d were questioned via a telephone interview. Questions addressed sociodemographic status, HIV status and the main barriers to accessing healthcare.

Results: Overall, 474 HIV/HCV coinfected patients were eligible for HCV treatment and 223 (47.1%) patients did not complete work-up for HCV treatment. Fear of community stigma concerning HIV/HCV was the most important barrier to compliance with treatment (73.3%), followed by lack of a supportive work environment and employment opportunities (51.5%), whereas 39.3% stopped follow-up due to the lack of integrated services in the healthcare facility.

Conclusions: Managing HCV in HCV/HIV coinfected patients still represents a major challenge, not only for healthcare providers, but also at a community level, to improve community awareness and manage the major obstacle facing those patients regarding community stigma.
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http://dx.doi.org/10.1093/trstmh/trab106DOI Listing
March 2022

Long-term clinical outcomes in sustained responders with chronic hepatitis C after treatment with direct-acting antivirals.

Eur J Gastroenterol Hepatol 2021 12;33(1S Suppl 1):e746-e752

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

Objective: Little is known about how the achievement of sustained virological response (SVR) after treatment with direct-antiviral agents (DAAs) affects fibrosis and clinical outcomes in the long term. Our study aimed to evaluate the impact of achieving SVR on long-term changes in fibrosis and clinical outcomes in CHC patients treated with different DAAs-based regimens.

Methods: a prospective, 3-year follow-up study of 113 CHC patients who had achieved SVR after treatment with different DAAs-based regimens between January and June 2015 was conducted. The clinical outcomes of SVR on the biochemical profile, changes in fibrosis, ALBI score and grade and occurrence of liver-related events were analyzed.

Results: Overall, liver function parameters and serum alpha-fetoprotein level showed improvement from baseline to SVR12 and remained steady thereafter. Moreover, the ALBI score showed nonsignificant change at baseline to SVR12 (P = 0.2) but it was significantly better at 3-years follow-up than at SVR12 (P = 0.001). Regarding liver stiffness (LS) by transient elastography, a significant decrease in TE values was observed between baseline to SVR12 (P ≤ 0.0001) as well as between SVR12 to 3-years follow-up (P = 0.0005). Stratified by fibrosis stage, patients with advanced fibrosis and cirrhosis showed a more pronounced and significant improvement of LS during follow-up after SVR compared to patients with less advanced fibrosis stage. During the follow-up period, 3 (5.2%) cirrhotic patients developed liver-related events, including 2 (3.4%) patients with de novo HCC and one (1.7%) patient experienced ascites for the first time.

Conclusion: This 3-year follow-up study provides evidence for the durability of SVR, improvement of liver function parameters and ALBI score and grade in patients with an advanced stage of fibrosis, in particular, and reduction of the clinical events after successful treatment with DAAs.
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http://dx.doi.org/10.1097/MEG.0000000000002240DOI Listing
December 2021

Evaluation of red cell distribution width to platelet ratio as a novel non-invasive index for predicting hepatic fibrosis in patients with chronic hepatitis C.

Arab J Gastroenterol 2021 Mar 2;22(1):6-11. Epub 2021 Mar 2.

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

Background And Study Aims: Assessing the extent of fibrosis is an essential part of therapeutic decisions in patients with chronic hepatitis C (CHC). Liver biopsies are the "gold standard" for evaluating liver fibrosis but have many limitations. Thus, noninvasive predictors of fibrosis have been developed. This study aimed to determine the effectiveness of red cell distribution width (RDW) to platelet ratio as a simple noninvasive method for predicting the hepatic fibrosis stage in patients with CHC.

Patients And Methods: This cross-sectional study included 197 Egyptian patients with CHC. A routine pretreatment reference needle liver biopsy was performed. Fib-4, transient elastography (TE) by Fibroscan, AST to Platelet Ratio Index (APRI), and RDW to platelet ratio (RPR) were measured. Predictors of significant fibrosis (Metavir score ≥ F2) and advanced fibrosis (Metavir score ≥ F3) were identified.

Results: Fib-4, TE, APRI, and RPR values differed significantly when comparing different stages of fibrosis (p < 0.01). Fib-4, TE, APRI, and RPR were reliable diagnostic tools at cutoff values of 1.17, 7.75, 0.18, and 0.07, respectively, for predicting significant fibrosis and cutoff values of 1.99, 8, 1.77, and 0.08, respectively, for predicting advanced fibrosis. Using logistic regression analysis, TE was identified as an independent predictor associated with significant and advanced fibrosis. Fib-4 was significantly associated with advanced fibrosis only.

Conclusion: The use of Fib-4, TE, APRI, and RPR measurements may decrease the need for liver biopsies for predicting significant and advanced fibrosis. RPR showed fair sensitivity, specificity, positive and negative predictive values, and overall accuracy for predicting significant fibrosis in patients with CHC.
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http://dx.doi.org/10.1016/j.ajg.2020.12.003DOI Listing
March 2021

Renal profile of chronic hepatitis C patients with sofosbuvir-based therapy.

Infection 2020 Dec 20;48(6):913-922. Epub 2020 Aug 20.

Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Cairo, 11562, Egypt.

Purpose: The impact of SOF-based therapy on renal functions is quite controversial in clinical practice. Therefore, we aimed to evaluate the serial changes of renal indices during SOF-based therapy in CHC patients with normal kidney function or mild renal impairment.

Methods: We retrospectively reviewed all CHC patients who received different SOF-based regimens from January 2015 until December 2017, and presented with a baseline eGFR ≥ 30 ml/min/1.73m. Patients who didn't achieve SVR, with missing creatinine or eGFR data, and patients with eGFR less than 30 ml/min/1.73m at baseline were excluded. eGFR was calculated for each time of evaluation using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Results: A total of 1004 patients were finally included. The mean serum creatinine and eGFR levels varied between 0.84 mg/dl and 106.53 ml/min/1.73m for baseline and 0.87 mg/dl and 104.24 ml/min/1.73m for SVR12, respectively. The maximum increase of creatinine was 3.69 mg/dl and the maximum decrease of eGFR level was 83.30 ml/min/1.73m during treatment. Moreover, 74.4% of treated patients stayed in the same eGFR category, 14.3% progressed to a higher eGFR category, and 11.3% had an improvement eGFR category at EOT and continued to SVR12. Age > 65 years, baseline eGFR, and ribavirin-containing regimens were independent risk factors of eGFR decline during and after SOF-based treatment.

Conclusion: SOF-based therapies seem to be safe in CHC patients with baseline normal or slightly impaired renal function.
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http://dx.doi.org/10.1007/s15010-020-01505-5DOI Listing
December 2020

Emerging from the screening of 57 million citizens and treating 4 million patients: future strategies to eliminate hepatitis C from Egypt.

Expert Rev Anti Infect Ther 2020 07 23;18(7):637-642. Epub 2020 Apr 23.

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

Introduction: Egypt succeeded in establishing a successful model of care for hepatitis C virus (HCV) management in the country with the highest worldwide disease prevalence. The Egyptian ministry of health announced an optimistic goal of near disease elimination. More steps are still required to achieve such a goal.

Areas Covered: This review covers the efforts made in treatment and prevention of HCV by the Egyptian National Committee for the Control of Viral Hepatitis (NCCVH) with emphasis on the extensive screening program that was able to screen more than 57 million citizens, and future strategies implemented to ensure eradicating the virus from the country.

Expert Opinion: Despite the great efforts and the proven success in controlling the HCV epidemic in Egypt, some facets of the Egyptian program still need to be upgraded to reach the HCV elimination goal. A significant workload with follow up programs for those who were successfully treated, and treatment failure cases are existing. More enhancement for the currently performed prevention and control measure is missing. Also, we strongly recommend conducting a recent nationwide survey to document the actual infection rates of HCV after all these efforts.
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http://dx.doi.org/10.1080/14787210.2020.1758065DOI Listing
July 2020

Improvement of platelet in thrombocytopenic HCV patients after treatment with direct-acting antiviral agents and its relation to outcome.

Platelets 2021 Apr 6;32(3):383-390. Epub 2020 Apr 6.

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

Little is known about evolution of platelet count after treatment with direct-acting antiviral agents (DAAs). The study aimed to evaluate the changes in platelet count after treatment with DAAs among thrombocytopenic patients with HCV-related advanced fibrosis and cirrhosis. A total of 915 chronic HCV patients with advanced fibrosis and cirrhosis who were treated with different DAAs-based regimens were retrospectively enrolled in final analysis. Included patients were those with thrombocytopenia (TCP). Platelet count was recorded at baseline, end of treatment (EOT) and 24-weeks after EOT (SVR24). Changes in platelet count and its relation to SVR were analyzed. The overall SVR24 rate was 98.8%. The platelet count showed statistically significant improvement from baseline to EOT (107 (84-127) × 10/mm vs. 120 (87-153) × 10/mm( = <0.0001) but remained unchanged thereafter to SVR24. Among responders, the platelet count significantly increased at SVR24 compared to baseline (<0.0001) but in relapsers, there was improvement in platelet count that didn't reach statistical significance (0.9). Logistic regression analysis showed that higher Child-Pugh score and more advanced fibrosis at baseline were significant predictors of decreasing of platelet count and development of severe TCP at SVR24. Among thrombocytopenic patients with HCV-related advanced fibrosis and cirrhosis, the platelet count improved after treatment with DAAs regardless to treatment response.
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http://dx.doi.org/10.1080/09537104.2020.1742313DOI Listing
April 2021

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

Sustained virologic response and changes in liver fibrosis parameters following 12-wk administration of generic sofosbuvir and daclatasvir in HIV/HCV-coinfected patients with HCV genotype 4 infection.

Trans R Soc Trop Med Hyg 2020 04;114(4):232-240

Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Cairo 11562, Egypt.

Background: Novel direct-acting antiviral agents have shown great efficacy and tolerability in HCV-monoinfected patients. However, data are lacking regarding their efficacy and safety in HIV/HCV-genotype (GT) 4-coinfected patients.

Methods: A single-centre, prospective study including HIV/HCV-GT 4-coinfected patients who were treated with sofosbuvir and daclatasvir (SOF/DCV) was conducted for 12 wk. Sustained virological response (SVR) at week 12 post-treatment (SVR12), adverse events (AEs) and changes in liver stiffness measurement (LSM) at SVR12 in comparison with baseline were evaluated.

Results: SVR12 was achieved in 46 of 50 patients (92%). No significant difference in SVR12 was noticed among patients who received antiretroviral therapy (ART) regimens compared with those who did not receive ART regimens or between those with insignificant fibrosis (
Conclusion: SOF/DCV achieved a high SVR12 and was well-tolerated in HIV/HCV-GT 4-coinfected patients.
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http://dx.doi.org/10.1093/trstmh/trz120DOI Listing
April 2020

Serum visfatin level as a noninvasive marker for nonalcoholic fatty liver disease in children and adolescents with obesity: relation to transient elastography with controlled attenuation parameter.

Eur J Gastroenterol Hepatol 2020 08;32(8):1008-1016

Endemic medicine and medicine and hepatogastroentrology, Faculty of Medicine, Cairo University, Cairo, Egypt.

Background: Obesity is associated with an increased risk of nonalcoholic fatty liver disease (NAFLD). Visfatin is an adipokine produced by visceral fat tissue and liver cells. Transient elastography with controlled attenuation parameter (CAP) noninvasively assesses liver fibrosis and steatosis.

Aim: To measure visfatin level in 80 children and adolescents with obesity as a potential biomarker for NAFLD and assess its relation to transient elastography.

Methods: Abdominal ultrasound, liver stiffness and CAP measurements were performed for all patients. Fasting lipid profile, fasting blood glucose, insulin level, liver and kidney functions, coagulation profile and serum visfatin levels were assessed.

Results: Among patients with obesity, 31 (38.8%) had NAFLD and 16 (20%) patients had elevated alanine aminotransferase (ALT), while 9 (11.2%) had both NAFLD and elevated ALT. Transient elastography showed that 12.5% had fibrosis stage F1, 2.5% had F2 and another 2.5% had F3 while none had F4. Using CAP, 23.8, 13.8 and 17.5% had S1, S2 and S3, respectively. Serum visfatin levels were significantly elevated in all patients compared with nonobese controls. Higher visfatin levels were found among patients with dyslipidemia, NAFLD, elevated ALT and steatosis defined by CAP. Serum visfatin was related to the degree of fibrosis and steatosis. Visfatin cutoff value 18 ng/mL could significantly detect the presence of NAFLD with 83.9% sensitivity and 81.4% specificity. Serum visfatin was positively correlated to BMI, waist circumference, waist/hip ratio, ALT, total cholesterol, liver stiffness and CAP.

Conclusions: Visfatin could be a promising serum biomarker for monitoring liver disease among pediatric patients with obesity.
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http://dx.doi.org/10.1097/MEG.0000000000001608DOI Listing
August 2020

Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2017: A Systematic Analysis for the Global Burden of Disease Study.

JAMA Oncol 2019 12;5(12):1749-1768

Department of Family and Community Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.

Importance: Cancer and other noncommunicable diseases (NCDs) are now widely recognized as a threat to global development. The latest United Nations high-level meeting on NCDs reaffirmed this observation and also highlighted the slow progress in meeting the 2011 Political Declaration on the Prevention and Control of Noncommunicable Diseases and the third Sustainable Development Goal. Lack of situational analyses, priority setting, and budgeting have been identified as major obstacles in achieving these goals. All of these have in common that they require information on the local cancer epidemiology. The Global Burden of Disease (GBD) study is uniquely poised to provide these crucial data.

Objective: To describe cancer burden for 29 cancer groups in 195 countries from 1990 through 2017 to provide data needed for cancer control planning.

Evidence Review: We used the GBD study estimation methods to describe cancer incidence, mortality, years lived with disability, years of life lost, and disability-adjusted life-years (DALYs). Results are presented at the national level as well as by Socio-demographic Index (SDI), a composite indicator of income, educational attainment, and total fertility rate. We also analyzed the influence of the epidemiological vs the demographic transition on cancer incidence.

Findings: In 2017, there were 24.5 million incident cancer cases worldwide (16.8 million without nonmelanoma skin cancer [NMSC]) and 9.6 million cancer deaths. The majority of cancer DALYs came from years of life lost (97%), and only 3% came from years lived with disability. The odds of developing cancer were the lowest in the low SDI quintile (1 in 7) and the highest in the high SDI quintile (1 in 2) for both sexes. In 2017, the most common incident cancers in men were NMSC (4.3 million incident cases); tracheal, bronchus, and lung (TBL) cancer (1.5 million incident cases); and prostate cancer (1.3 million incident cases). The most common causes of cancer deaths and DALYs for men were TBL cancer (1.3 million deaths and 28.4 million DALYs), liver cancer (572 000 deaths and 15.2 million DALYs), and stomach cancer (542 000 deaths and 12.2 million DALYs). For women in 2017, the most common incident cancers were NMSC (3.3 million incident cases), breast cancer (1.9 million incident cases), and colorectal cancer (819 000 incident cases). The leading causes of cancer deaths and DALYs for women were breast cancer (601 000 deaths and 17.4 million DALYs), TBL cancer (596 000 deaths and 12.6 million DALYs), and colorectal cancer (414 000 deaths and 8.3 million DALYs).

Conclusions And Relevance: The national epidemiological profiles of cancer burden in the GBD study show large heterogeneities, which are a reflection of different exposures to risk factors, economic settings, lifestyles, and access to care and screening. The GBD study can be used by policy makers and other stakeholders to develop and improve national and local cancer control in order to achieve the global targets and improve equity in cancer care.
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http://dx.doi.org/10.1001/jamaoncol.2019.2996DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6777271PMC
December 2019

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

DAAs therapy associated with improved hepatic fibrosis in HCV-GT4 patients co-infected with HIV.

Expert Rev Gastroenterol Hepatol 2019 Jul 13;13(7):693-698. Epub 2019 May 13.

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

: 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. : 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. : 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. : 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.
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http://dx.doi.org/10.1080/17474124.2019.1614441DOI Listing
July 2019

Diagnostic accuracy of acoustic radiation force impulse elastography (ARFI) in comparison to other non-invasive modalities in staging of liver fibrosis in chronic HCV patients: single-center experience.

Abdom Radiol (NY) 2019 08;44(8):2751-2758

Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Cairo, 11562, Egypt.

Purpose: To evaluate the reliability of ARFI elastography for liver fibrosis staging and compare it to other non-invasive assessment of hepatic fibrosis (FIB-4 and APRI) in chronic HCV (CHC) patients.

Methods: A single-center, prospective study included 2103 CHC patients. Liver stiffness (LS) was evaluated by TE and ARFI elastography. FIB-4 and APRI were calculated. The area under the receiver-operating characteristic curve (AUROCs) was used to assess the diagnostic performance of ARFI elastography for staging of liver fibrosis using TE as a reference standard.

Results: The best cut off values of ARFI elastography for diagnosis of ≥ F2, ≥ F3and F4 were 1.36 m/s, 1.45 m/s, and 1.7 m/s with AUROCs of 0.89, 0.94 and 0.95, respectively. ARFI elastography cut offs are lower in patients with normal ALT level compared to those with ALT level (1.1-< 3 ULN) and those with ALT level ≥ 3ULN (1.35 m/s vs 1.39 m/s vs 1.54 for F ≥ 2, 1.44 m/s vs 1.58 m/s vs 1.6 m/s for F3, 1.69 m/s, 1.84 m/s, 1.86 m/s for F4). FIB-4 (0.82-0.86) and APRI (0.78-0.82) yielded lower AUC in prediction of significant fibrosis and cirrhosis than ARFI elastography (0.89-0.95).

Conclusion: ARFI elastography is a reliable method for non-invasive staging of liver fibrosis in CHC patients when compared to TE with a good diagnostic performance comparable to FIB-4 and APRI scores for the prediction of significant fibrosis and cirrhosis.
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http://dx.doi.org/10.1007/s00261-019-02031-1DOI Listing
August 2019

Clinical impact of serum α-fetoprotein and its relation on changes in liver fibrosis in hepatitis C virus patients receiving direct-acting antivirals.

Eur J Gastroenterol Hepatol 2019 Sep;31(9):1129-1134

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

Background: α-Fetoprotein (AFP) is used widely as a serological marker for hepatocellular carcinoma. However, the AFP value is elevated in chronic hepatitis C virus (HCV) patients without hepatocellular carcinoma. Yet, data on the impact of direct-acting antiviral agents (DAAs) therapy on AFP levels after viral eradication are still lacking.

Aim: The aim of this study was to elucidate the changes in the serum AFP level in chronic hepatitis C patients treated with DAA-based therapy and their relation to response and liver fibrosis parameters.

Patients And Methods: A total of 456 chronic HCV patients who received different DAAs-based treatment regimens were enrolled. Laboratory data including serum AFP, transient elastography values, and fibrosis scores were recorded at baseline and sustained virological response at 24 weeks after treatment (SVR24). The outcome was the changes in the AFP level from baseline to SVR24 and its relation to changes in liver fibrosis parameters at SVR24 using Spearman's rank correlation test.

Results: Overall, 96.9% of enrolled patients were responders. A statistically significant improvement in serum transaminases, albumin, transient elastography values, and fibrosis scores at SVR24 was reported. The AFP level was significantly decreased from a median (interquartile range) of 6 (3.2-10.8) ng/ml before DAAs to 4 (2.3-6) ng/ml at SVR24 (P < 0.0001). Only 22.6% of patients showed an increase in the AFP level after treatment. On multivariate analysis, the only independent baseline variable associated with an increase in the AFP level after treatment was baseline AFP (odds ratio: 0.95, 95% confidence interval: 0.91-0.99, P = 0.02). There is a significant correlation between changes in AFP and liver fibrosis parameters at SVR24.

Conclusion: DAAs-based regimens are a highly efficient antiviral therapy for chronic hepatitis C patients that resulted in improvements in the serum AFP level.
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http://dx.doi.org/10.1097/MEG.0000000000001400DOI Listing
September 2019

Liver stiffness measurement changes following hepatocellular carcinoma treatment with percutaneous microwave ablation or transarterial chemoembolization: a cohort study.

Eur J Gastroenterol Hepatol 2019 Jun;31(6):685-691

Endemic Medicine Department.

Background: Liver stiffness increases after the development of hepatocellular carcinoma (HCC). Transient elastography for liver stiffness measurement (LSM) using fibroscan is a simple noninvasive method of proven efficacy. This study aims to assess the changes in LSM following HCC treatment.

Patients And Methods: This study included 150 patients with hepatitis C virus related HCC attending the multidisciplinary HCC clinic, Kasr Al-Ainy Hospital between March 2014 and October 2015 who underwent either transarterial chemoembolization (TACE) or microwave ablation (MWA). Baseline LSM was carried out 3 and 6 months after treatment. The response rate was calculated according to the modified Response Evaluation Criteria in Solid Tumors criteria; overall survival and LSM changes were then compared between the two procedures.

Results: MWA showed higher rates of complete ablation (77.4%) than did TACE (31.7%) (P=0.004). Increase in LSM 3 and 6 months after treatment was statistically significant in the TACE group (P<0.001) but not in the MWA group (P=0.4). Patients who showed complete ablation had statistically significant lower baseline LSM than those with incomplete ablation, and their 6 months increase in LSM was also significantly lower. Logistic regression revealed that with each unit increase in baseline stiffness, 3% reduction in the odds of complete ablation is expected, and this did not change after controlling for the type of treatment. Child-Pugh class, number, and size of HCCs were our independent prognostic factors by Cox proportional analysis.

Conclusion: The increase in LSM is significant after TACE than after MWA. Moreover, lower pre-ablation LSM is a predictor of complete ablation.
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http://dx.doi.org/10.1097/MEG.0000000000001343DOI Listing
June 2019

Interferon gamma and interleukin 8 gene polymorphisms in patients with hepatitis C virus related oral lichen planus.

Arch Oral Biol 2018 Dec 26;96:189-194. Epub 2018 Sep 26.

Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University, Egypt.

Objectives: This study aimed to determine the association of rs2430561 and rs4073 polymorphisms in the Interferon gamma (IFN-ɤ) and Interleukin 8 (IL-8) genes, respectively, with hepatitis C virus-related oral lichen planus and disease severity.

Design: This is a case-control study. 60 subjects were equally divided into patients with and without oral lichen planus. They were further subdivided into hepatitis C virus seropositive and seronegative patients. All patients were genotyped for IFN-γ rs2430561 thymine to adenine (T > A) and IL-8 rs4073 adenine to thymine (A > T) polymorphisms. All patients with oral lichen planus had their lesions measured and documented using the Escudier scoring system.

Results: Disease activity was significantly higher in the "oral lichen planus/hepatitis C virus-positive" patients than in the "oral lichen planus/hepatitis C virus-negative" patients (P = 0.003). IFN-γ rs2430561 T > A and IL-8 rs4073 A > T genotypes and allele frequencies were not associated with the oral lichen planus group or the normal group. Stratification of the two groups into HCV and non-HCV-infected patients or into erosive and non-erosive types revealed no significant associations. The "A-allele-containing" genotypes of IL-8 rs4073 A > T were significantly more prevalent in the patients with oral lichen planus than in those without.

Conclusion: Hepatitis C virus infection is associated with the development of erosive oral lichen planus. The A-allele of IL-8 rs4073 A > T may have a role in the development and progression of oral lichen planus.
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http://dx.doi.org/10.1016/j.archoralbio.2018.09.015DOI Listing
December 2018

Genetic Variants in nicotinamide-N-methyltransferase (NNMT) gene are related to the stage of non-alcoholic fatty liver disease diagnosed by controlled attenuation parameter (CAP)-fibroscan.

J Gastrointestin Liver Dis 2018 Sep;27(3):265-272

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

Background And Aims: Various genetic polymorphisms play a key-role in the pathogenesis of NAFLD and progression to NASH with fibrosis to cirrhosis. We aimed to study the association between single-nucleotide polymorphisms (SNPs) in NNMT gene, namely rs694539 and the development of different stages of NAFLD diagnosed by controlled attenuation parameter (CAP) of FibroScan Echosens®.

Methods: Transient elastography (FibroScan®) with controlled attenuation parameter (CAP) measurement was performed in 81 NAFLD patients (35 of them with liver biopsy) and 80 non-NAFLD controls. The accuracy of CAP and FibroScan for the detection and quantification of hepatic steatosis/fibrosis, respectively, was assessed based on liver biopsy aspect. Genetic variants of NNMT gene rs694539 were analyzed using a polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP).

Results: According to BMI (kg/m2), among the patients, 17 (21%) were overweight, 56 (69.1%) obese, and 8 (9.9%) morbidly obese. CAP and FibroScan diagnosed steatosis/fibrosis correlated significantly with liver biopsy. There was a significant association between polymorphisms of rs694539-NNMT gene and NAFLD presence and stages. The mutant type (AA-genotype) was found in 33% NAFLD patients versus 1.2% controls (P<0.001), whereas the wild type (GG-genotype) was present in 21% versus 63.8% controls (P<0.001). Moreover, the AA-genotype significantly correlated with the steatosis degree by CAP but not the fibrosis degree by FibroScan. Multivariate regression analysis of all the independent risk factors showed non-significant correlations with the degree of steatosis on CAP. However, by using a stepwise approach, waist circumference showed significance as an independent predictor of NAFLD.

Conclusions: Polymorphisms in rs694539-NNMT gene (mutant AA-genotype) could be a genetic risk factor for developing NAFLD and NASH (indicating susceptibility for progression and complications). Individuals with wild type (GG-genotype) are at less risk of NAFLD development. CAP and FibroScan efficiently diagnosed steatosis and fibrosis.
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http://dx.doi.org/10.15403/jgld.2014.1121.273.wshDOI Listing
September 2018

High sustained virologic response rate using generic directly acting antivirals in the treatment of chronic hepatitis C virus Egyptian patients: single-center experience.

Eur J Gastroenterol Hepatol 2018 10;30(10):1194-1199

Endemic Medicine and Hepatogastroentrology Department, Faculty of Medicine.

Background: Hepatitis C virus (HCV) is a major health problem in Egypt, with a high prevalence of genotype 4.

Aim: This study aimed to evaluate the safety and efficacy of generic sofosbuvir (SOF) plus generic daclatasvir (DAC) with or without ribavirin in the treatment of Egyptian chronic HCV patients compared with the use of brand drugs.

Materials And Methods: An observational study that included 234 Egyptian chronic HCV patients was carried out. Patients were classified into two groups: group A (101 patients) received brand SOF 400 mg plus brand DAC 60 mg and group B (134 patients) received generic SOF 400 mg plus generic DAC 60 mg with or without ribavirin for 12 weeks. The end point was a sustained virological response at 12 weeks after treatment.

Results: Thirty-eight (37.2%) patients in group A were treatment experienced compared with 12 (9.02%) patients in group B; there were 39 (38%) cirrhotic patients in group A and 22 (16.5%) cirrhotic patients in group B. In group A, 50% of patients received ribavirin, while in group B, 42.1% of patients received ribavirin. All patients were followed up; all of them attended their week 12 post-treatment visit with negative HCV RNA, with achievement of sustained virological response at 12 in 100% of patients receiving generic drugs (group B) and 99% of patients receiving brand drugs (group A). Generic SOF and DAC were well tolerated, with mild adverse events including fatigue and headache.

Conclusion: Use of generic SOF and DAC with or without ribavirin is an extremely effective and a well-tolerated treatment for Egyptian chronic HCV patients.
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http://dx.doi.org/10.1097/MEG.0000000000001228DOI Listing
October 2018

Hepatitis C virus treatment by direct-acting antivirals in successfully treated hepatocellular carcinoma and possible mutual impact.

Eur J Gastroenterol Hepatol 2018 08;30(8):876-881

Endemic Medicine and Hepatogastroentrology Department.

Background And Aims: Treatment of hepatitis C virus (HCV) after successfully treated hepatocellular carcinoma (HCC) becomes possible with the introduction of direct-acting antivirals because of their favorable efficacy, safety, and short period of treatment. Few data are available on the results of treatment using different direct-acting antiviral regimens in successfully treated HCC and a lot of debate about its role in tumor recurrence.

Methods: Sixty-two HCV-related HCC patients were enrolled in the study after successfully treated HCC; the studied population included either Child-Pugh 'A' or 'B7'. The patients were subcategorized to receive one of the following regimens: group 1: sofosbuvir (SOF)+ribavirin (RBV) for 24 weeks, group 2: SOF+simeprevir for 12 weeks, group 3: SOF+daclatasvir for 24 weeks, and group 4: SOF+daclatasvir+RBV for 12 weeks. The overall median follow-up period is 12 months after treatment initiation.

Results: All treatment regimens were tolerable for all patients, with no reported major adverse events during treatment. The overall sustained virologic response rate was 64.5%, with the highest result in group 4 and the lowest result in group 1; 87.5 and 26.7%, respectively. HCC recurrence was observed in 42% of patients; 80.7% of these patients developed recurrence within 6 months of treatment initiation.

Conclusion: Treatment of HCV in successfully treated HCC is feasible, with the best results achieved using multiple direct-acting antivirals and RBV; a high rate of HCC recurrence was observed, especially within the first 6 months of treatment initiation (ClinicalTrials.gov no: NCT02771405).
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http://dx.doi.org/10.1097/MEG.0000000000001152DOI Listing
August 2018

Evaluation of accuracy of elastography point quantification versus other noninvasive modalities in staging of fibrosis in chronic hepatitis C virus patients.

Eur J Gastroenterol Hepatol 2018 08;30(8):882-887

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

Background: Elastography point quantification (ElastPQ) is a newly noninvasive method incorporated into a conventional ultrasound system for staging of liver fibrosis in patients with chronic liver diseases.

Aim: The aim was to evaluate ElastPQ reproducibility and its accuracy in staging of liver fibrosis in hepatitis C virus (HCV) patients in comparison with transient elastography (TE) and fibrosis scores [FIB-4 and aspartate aminotransferase-to-platelet ratio index (APRI)] using liver biopsy as a reference standard and also to predict the sensitivity and specificity of ElastPQ as well as proposing a cut-off for advanced fibrosis.

Patients And Methods: A single-center, cross-sectional study enrolled 72 chronic HCV patients. Baseline demographic and laboratory data were recorded. ElastPQ and TE were performed. Fibrosis scores were calculated. The performance of ElastPQ was compared with that of TE and noninvasive methods (FIB-4, APRI) using liver biopsy as a reference standard using receiver operating characteristic curve analysis.

Results: ElastPQ is a valuable diagnostic tool for the diagnosis of F≥1, F≥2, and F≥3, with area under the receiver operating characteristic curve of 0.79, 0.74, and 0.83, respectively. The best cut-off values for ElastPQ were 4.9, 6.6, and 10.7 kPa for mild fibrosis, significant fibrosis, and advanced fibrosis, respectively. ElastPQ correlated positively with all other fibrosis indices (TE, APRI, and FIB-4) as well as liver biopsy. Area under the curve for the diagnosis of advanced fibrosis (F3/F4) using ElastPQ was 0.83 at a cut-off value of 10.7 kPa (P<0.01).

Conclusion: ElastPQ is a promising noninvasive US-based method for assessing liver fibrosis in HCV-related chronic liver disease patients with good diagnostic performance comparable to that of liver biopsy and TE.
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http://dx.doi.org/10.1097/MEG.0000000000001151DOI Listing
August 2018

Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt.

Gut 2019 04 17;68(4):721-728. Epub 2018 Apr 17.

National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.

Objective: We evaluated the efficacy and safety of ledipasvir/sofosbuvir alone and with ribavirin for 8 and 12 weeks in Egyptian patients with and without cirrhosis, who were infected with hepatitis C virus (HCV) genotype 4, including those who had failed previous treatment with sofosbuvir regimens.

Design: In this open-label, multicentre, phase III study, treatment-naive patients were randomised to receive 8 or 12 weeks of ledipasvir/sofosbuvir±ribavirin. Interferon treatment-experienced patients were randomised to receive 12 weeks of ledipasvir/sofosbuvir±ribavirin, while sofosbuvir-experienced or ledipasvir/sofosbuvir-experienced patients received 12 weeks of ledipasvir/sofosbuvir+ribavirin. Randomisation was stratified by cirrhosis status. The primary endpoint was sustained virological response 12 weeks post-treatment (SVR12).

Results: We enrolled 255 patients from four centres in Egypt. Among treatment-naive patients, SVR12 rates were 95% and 90% for those receiving 8 weeks of ledipasvir/sofosbuvir alone and with ribavirin, respectively, and 98% for those receiving 12 weeks of ledipasvir/sofosbuvir both alone and with ribavirin. Among interferon-experienced patients, SVR rates were 94% for those receiving 12 weeks of ledipasvir/sofosbuvir and 100% for those receiving 12 weeks of ledipasvir/sofosbuvir plus ribavirin. All patients previously treated with sofosbuvir regimens who received ledipasvir/sofosbuvir plus ribavirin achieved SVR12. The most common adverse events, headache and fatigue, were more common among patients receiving ribavirin.

Conclusion: Among non-cirrhotic treatment-naive patients with HCV genotype 4, 8 weeks of ledipasvir/sofosbuvir±ribavirin was highly effective. Twelve weeks of ledipasvir/sofosbuvir±ribavirin was highly effective regardless of presence of cirrhosis or prior treatment experience, including previous treatment with sofosbuvir or ledipasvir/sofosbuvir.

Trial Registration Number: NCT02487030.
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http://dx.doi.org/10.1136/gutjnl-2017-315906DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6580781PMC
April 2019

Effect of Direct-Acting Agents on Fibrosis Regression in Chronic Hepatitis C Virus Patients' Treatment Compared with Interferon-Containing Regimens.

J Interferon Cytokine Res 2018 03 12;38(3):129-136. Epub 2018 Mar 12.

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

Hepatitis C virus (HCV) treatment is aiming to cure and prevent the development, progression of fibrosis, and related complications. Interferon-based therapy was claimed to reduce or even reverse fibrosis. Although direct-acting agents have a better cure rate, we still lack the knowledge of their effect on fibrosis regression. We aim to assess fibrosis regression in direct-acting agents compared with interferon-based treatment regimens in the treatment of chronic HCV patients. The 204 chronic HCV patients were divided into 3 groups; group 1(N = 68) received Peg-IFN and ribavirin, group 2 (N = 69) received sofosbuvir and ribavirin, and group 3 (N = 67) received Peg-IFN, ribavirin, and sofosbuvir. Fibrosis assessment was performed by transient elastography (TE), APRI and FIB 4, in the pretreatment and at least 3 months after end of treatment. Of these, 66.2% of the patients did not show significant fibrosis changes, 6.4% fibrosis progressed, and 27.5% of fibrosis regressed (P < 0.0001) by TE. Similar results were detected in the different treatment regimens with no statistically significant difference between the regimens. Fibrosis regression was detected in 43.3% of cirrhotic patients who achieved sustained virological response (SVR) and only in 27.4% with significant fibrosis. Significant improvement of posttreatment aspartate transaminase, alanine transaminase, and alpha fetoprotein as well as APRI and FIB 4 scores were detected. Fibrosis regression (TE, APRI and FIB 4) was detected with direct-acting agents and interferon-based therapy. Treated patients with significant fibrosis will benefit of fibrosis regression irrespective to their treatment response, whereas fibrosis regression was associated with SVR in cirrhotic patients.
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http://dx.doi.org/10.1089/jir.2017.0137DOI Listing
March 2018

HCV in Egypt, prevention, treatment and key barriers to elimination.

Expert Rev Anti Infect Ther 2018 04 11;16(4):345-350. Epub 2018 Mar 11.

b Endemic Hepatogastroenterology, Faculty of Medicine , Cairo University , Cairo , Egypt.

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.
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http://dx.doi.org/10.1080/14787210.2018.1448709DOI Listing
April 2018

Comparing the efficiency of Fib-4, Egy-score, APRI, and GUCI in liver fibrosis staging in Egyptians with chronic hepatitis C.

J Med Virol 2018 06 12;90(6):1106-1111. Epub 2018 Mar 12.

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

Assessment of hepatic fibrosis in chronic hepatitis C virus patients by liver biopsy is not widely accepted despite its accuracy, being invasive, carrying complications, and adding cost. This paved the way to development and use of non-invasive markers of fibrosis in diagnosis of hepatic fibrosis. We aimed at evaluating the efficiency of Fib-4, Egy-score, Aspartate-to-platelet ratio index (APRI), and Göteborg University Cirrhosis Index (GUCI) in comparison to liver biopsy, in the assessment of hepatic fibrosis in chronic hepatitis C patients. This was a cross sectional study including 200 chronic HCV patients were divided into two groups according to stage of fibrosis (Metavir score) into non-significant fibrosis (1.27, APRI >0.48, Egy-score >0.73, and GUCI >0.57 significantly predict significant fibrosis (P < 0.01). Fib-4 carries the best performance and significant reliability with AUROC 0.783, sensitivity 74%, specificity 69%, PPV 0.55, and NPV 0.86. The addition of BMI to Fib-4 improved the significant fibrosis AUROC curve performance but did not reach statistical significant improvement. We concluded that age and BMI are good predictors of hepatic fibrosis. Fib-4 (>1.27) is the best method of prediction of significant fibrosis compared to Egy-score, APRI, and GUCI. Addition of BMI to Fib-4 did not improve diagnostic value of Fib-4.
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http://dx.doi.org/10.1002/jmv.25064DOI Listing
June 2018

Novel scores combining AFP with non-invasive markers for prediction of liver fibrosis in chronic hepatitis C patients.

J Med Virol 2018 06 12;90(6):1080-1086. Epub 2018 Mar 12.

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

Serum levels of alpha-fetoprotein (AFP) were reported to increase in patients with significant or advanced hepatic fibrosis. Combination of non-invasive tests decreases the use of liver biopsy in large proportion of chronic HCV patients. The aim of the study was to compare and combine AFP with commonly used non-invasive fibrosis tests in novel scores for prediction of different stages of hepatic fibrosis. Six hundred and fifty two treatment naïve chronic hepatitis C patients were enrolled. Demographic data, basic pre-treatment laboratory tests including complete blood count (CBC), liver biochemical profile and renal functions test, international normalized ratio (INR) in addition to AFP, liver stiffness measurement (LSM) by Fibroscan and liver biopsies were retrospectively analyzed. AST to Platelet Ratio Index (APRI) and FIB-4 scores were calculated. Different predictive models using multivariate logistic regression analysis were generated and presented in equations (scores) composed of a combination of AFP, LSM plus FIB-4/APRI scores. AFP was correlating significantly with LSM, FIB-4, and APRI scores. Areas under receiver operating characteristic curves (AUROCs) for predicting significant hepatic fibrosis, advanced hepatic fibrosis, and cirrhosis were 0.897, 0.931, and 0.955, respectively, for equations (scores) containing AFP, LSM, and FIB-4. AUROCs for predicting significant hepatic fibrosis, advanced hepatic fibrosis and cirrhosis were 0.897, 0.929, and 0.959, respectively, for equations (scores) containing AFP, LSM, and APRI. The study shows that combining AFP to serum biomarkers and LSM increases their diagnostic performance for prediction of different stages of liver fibrosis.
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http://dx.doi.org/10.1002/jmv.25026DOI Listing
June 2018
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