Publications by authors named "Mohamed Hassany"

52 Publications

Hepatic and gastrointestinal disturbances in Egyptian patients infected with coronavirus disease 2019: A multicentre cohort study.

World J Gastroenterol 2021 Oct;27(40):6951-6966

Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo 13544, Egypt.

Background: Various liver and gastrointestinal involvements occur in patients with coronavirus disease 2019 (COVID-19) at variable prevalence. Most studies report mild liver function disturbances correlated with COVID-19 severity, though liver failure is unusual.

Aim: To study liver and gastrointestinal dysfunctions in Egyptian patients with COVID-19 and their relation to disease outcomes.

Methods: This multicentre cohort study was conducted on 547 Egyptian patients from April 15, 2020 to July 29, 2020. Consecutive polymerase chain reaction-confirmed COVID-19 cases were included from four quarantine hospitals affiliated to the Egyptian ministry of health. Demographic information, laboratory characteristics, treatments, fibrosis-4 (FIB-4) index, COVID-19 severity, and outcomes were recorded and compared according to the degree of liver enzyme elevation and the presence of gastrointestinal symptoms. Follow-ups were conducted until discharge or death. Regression analyses were performed to determine the independent factors affecting mortality.

Results: This study included 547 patients, of whom 53 (9.68%) died during hospitalization and 1 was discharged upon his request. Patients' mean age was 45.04 ± 17.61 years, and 21.98% had severe or critical COVID-19. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were available for 430 and 428 patients, respectively. In total, 26% and 32% of patients had elevated ALT and AST, respectively. Significant liver injury with ALT or AST elevation exceeding 3-fold was recorded in 21 (4.91%) and 16 (3.73%) patients, respectively. Male gender, smoking, hypertension, chronic hepatitis C, and lung involvement were associated with elevated AST or ALT. AST was elevated in 50% of patients over 60-years-old. FIB-4 was significantly higher in patients admitted to the intensive care unit (ICU), those with more severe COVID-19, and non-survivors. The independent variables affecting outcome were supplementary vitamin C intake (1 g daily capsules) [odds ratio (OR): 0.05, 95% confidence interval (CI): 0.008-0.337]; lung consolidation (OR: 4.540, 95%CI: 1.155-17.840); ICU admission (OR: 25.032, 95%CI: 7.110-88.128); and FIB-4 score > 3.25 (OR: 10.393, 95%CI: 2.459-43.925). Among 60 (13.98%) patients with gastrointestinal symptoms, 52 (86.67%) had diarrhoea. Patients with gastrointestinal symptoms were predominantly females with higher body mass index, and 50 (83.40%) patients had non-severe COVID-19.

Conclusion: Few Egyptian patients with COVID-19 developed a significant liver injury. The independent variables affecting mortality were supplementary vitamin C intake, lung consolidation, ICU admission, and FIB-4 score.
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http://dx.doi.org/10.3748/wjg.v27.i40.6951DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8567470PMC
October 2021

COVID-19 outcomes among pregnant and nonpregnant women at reproductive age in Egypt.

J Public Health (Oxf) 2021 Nov 5. Epub 2021 Nov 5.

Preventive Sector, Ministry of Health and Population, Cairo 11516, Egypt.

Background: To describe demographic, clinical and epidemiological characteristics of pregnant and nonpregnant women with confirmed COVID-19 at reproductive age and determine risk factors of COVID-19 severe outcomes during pregnancy.

Methods: A retrospective study for females aged 18-49 with confirmed COVID-19 by RT-PCR in Egypt, February-July 2020. Data were obtained from Egypt National Surveillance, bivariate and multivariate analysis for demographic and clinical characteristics and outcomes of COVID-19 between pregnant and nonpregnant women including ICU admission, need for ventilator and death was performed.

Results: A total of 23 095 females were identified, with mean (SD) age of 35.1 (8.1) year. Of those, 408 (1.8%) were pregnant, with mean (SD) age of 29.3 (8.1) years. Compared to nonpregnant, pregnant patients were more likely to be admitted to hospital (OR = 1.7 CI = 1.4-2.1), ICU (OR = 2.4, CI = 1.3-4.3), need ventilator (OR = 3.9, CI = 2.1-7.4) and have severe outcome (OR = 3.0, CI = 1.9-4.7). Factors associated with severe outcome included: pregnancy, age > 30 years, underlying medical conditions, and living in rural areas.

Conclusion: Pregnant women with COVID-19 are at higher risk of severe symptoms and outcome including ICU admission, requiring ventilator and death. To reduce risk of severe outcome, counseling about for seeking medical care and health education about COVID-19 preventive measures should be performed.
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http://dx.doi.org/10.1093/pubmed/fdab376DOI Listing
November 2021

Clinical evaluation of pregnant women with SARS-COV2 pneumonia: a real-life study from Egypt.

J Egypt Public Health Assoc 2021 Nov 4;96(1):29. Epub 2021 Nov 4.

MOHP, Cairo, Egypt.

Background: Knowledge about the outcome of COVID-19 on pregnant women is so important. The published literature on the outcomes of pregnant women with COVID-19 is confusing. The aim of this study was to report our clinical experience about the effect of COVID-19 on pregnant women and to determine whether it was associated with increased mortality or an increase in the need for mechanical ventilation in this special category of patients.

Methods: This was a cohort study from some isolation hospitals of the Ministry of Health and Population, in eleven governorates, Egypt. The clinical data from the first 64 pregnant women with COVID-19 whose care was managed at some of the Egyptian hospitals from 14 March to 14 June 2020 as well as 114 non-pregnant women with COVID-19 was reviewed.

Results: The two groups did not show any significant difference regarding the main outcomes of the disease. Two cases in each group needed mechanical ventilation (p 0.617). Three cases (4.7%) died among the pregnant women and two (1.8%) died among the non-pregnant women (p 0.352).

Conclusions: The main clinical outcomes of COVID-19 were not different between pregnant and non-pregnant women with COVID-19. Based on our findings, pregnancy did not exacerbate the course or mortality of COVID-19 pneumonia.
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http://dx.doi.org/10.1186/s42506-021-00092-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8567119PMC
November 2021

Evaluation of factors affecting patients' refusal of HCV treatment in a cohort of Egyptian patients.

J Public Health (Oxf) 2021 Oct 14. Epub 2021 Oct 14.

Endemic medicine department, Faculty of Medicine, Cairo University, Cairo 11652, Egypt.

Background: Treatment refusal, defined as active refusal of a patient to receive treatment despite physician recommendations, has not been extensively evaluated before in hepatitis C virus in the era of direct acting antivirals.

Objective: To investigate the reasons for refusal to receive hepatitis C virus treatment in Egypt.

Methods: an observational study conducted between July 2018 and November 2019 in Egypt. Enrollment was done to all patients who refused to get hepatitis C virus treatment during the national screening and treatment campaign. Reasons for their refusal were identified using a questionnaire as an instrument for data collection.

Results: Out of the 220 280 Egyptian hepatitis C virus patients who did not show up to start treatment and were contacted to get therapy, only 84 patients (0.038%) refused to receive treatment. The main reason for their refusal was having concerns about treatment (82.14%) and their main concern was the fear of adverse events (85.5%). Other causes of refusal were non-satisfactory experience at treatment centers (13.09%) and patients preferred to receive complementary and alternative medicines (4.7%). Most patients (65.4%) trusted the efficacy of directly acting antivirals for hepatitis C. None of the study participants was found to suffer from any psychiatric morbidity and the average score of the GHQ-12 was 10.7155.

Conclusion: Proper health education and awareness regarding hepatitis C virus treatment safety and efficacy is needed to increase treatment acceptance rates.
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http://dx.doi.org/10.1093/pubmed/fdab363DOI Listing
October 2021

IL28B rs12979860 polymorphism and zinc supplementation affect treatment outcome and liver fibrosis after direct-acting antiviral hepatitis C therapy.

J Genet Eng Biotechnol 2021 Oct 8;19(1):150. Epub 2021 Oct 8.

Faculty of Medicine, Cairo University, Cairo, Egypt.

Background: Impact of interleukin 28B (IL28B) rs12979860 polymorphism on response to direct-acting antivirals agents in HCV genotype 4-infected patients is under investigation. Zinc may have an advantage in improvement of liver damage and treatment outcome. We aimed to evaluate IL28B polymorphism and zinc administration impact on patient response to treatment and amelioration of liver fibrosis.

Results: Three hundred patients on anti-HCV treatments were equally categorized into patients treated with dual therapy (sofosbuvir/ribavirin) for 24 weeks, triple therapy (sofosbuvir/ribavirin+pegylated interferon-alpha) for 12 weeks, dual therapy plus oral zinc and with triple therapy plus oral zinc. All patients were genotyped for IL28B. Sustained virologic response (SVR) was achieved in 100% of patients with CC genotypes while 15.5% of CT/TT carriers did not attain SVR. After treatment, patients with CC genotype showed improvement in liver-related parameters compared with CT/TT genotypes. Zinc supplementation was associated with improved SVR in CT/TT genotypes and liver parameters in both CC and CT/TT genotypes. Hepatic fibrosis was improved in higher percent of CC genotype (16.7%) compared with CT/TT genotypes (5.8%). Interestingly with zinc administration, improved fibrosis increased to 60.9% in CC genotype vs. 15.4% in CT/TT genotypes.

Conclusion: Absolute SVR rates in patients with IL28B CC genotype support their selection for shorter treatment duration and therefore associated with high economic value. IL28B polymorphism is associated with improvement of hepatic functions and fibrosis after antiviral treatments. Zinc is powerful supplement not only to increase SVR in non-responders but also to improve hepatic functions and fibrosis.
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http://dx.doi.org/10.1186/s43141-021-00250-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8501168PMC
October 2021

Anxiety, depression and coping strategies among chronic medical patients with coronavirus disease-2019: a multicenter follow-up cohort study.

J Ment Health 2021 Sep 30:1-9. Epub 2021 Sep 30.

Endemic medicine department, Faculty of Medicine, Helwan University, Helwan, Egypt.

Background: Studies have shown that COVID-19 patients experience high levels of anxiety, depression, and stress during the pandemic. Patients adopt different coping strategies to reduce their psychological distress.

Aim: To compare the immediate and long-term psychological impact of COVID-19 disease on patients with and without chronic medical illnesses (CMI) and identify coping styles of both groups during the peak of COVID-19 disease in Egypt.

Methods: This is a cohort follow-up study, that included an online survey consisting of General Health Questionnaire-12, Taylor Manifest Anxiety Scale, Beck Depression Inventory and Brief-COPE scale. The Post-Traumatic Stress Disorder (PTSD) Checklist was completed after 6 months. Questionnaires were distributed to adult patients with a confirmed diagnosis of SARS-CoV-2 virus infection during their quarantine in Egypt.

Results: There was no significant difference between the two groups regarding anxiety and depression during the acute infection. Patients without CMI relied significantly on the use of informational support to cope with COVID-19 disease. Patients with CMI continued to show significant depressive symptoms after 6 months without significant PTSD symptoms.

Conclusions: COVID-19 has similar immediate psychological impact on patients with and without CMI. However, patients with CMI continue to show depression on long-term follow-up.
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http://dx.doi.org/10.1080/09638237.2021.1979491DOI Listing
September 2021

Public health workers' knowledge, attitude and practice regarding COVID-19: the impact of Field Epidemiology Training Program in the Eastern Mediterranean Region.

J Public Health (Oxf) 2021 Sep 27. Epub 2021 Sep 27.

Directorate of Public Health, Ministry of Health, Baghdad, Iraq.

Background: This study aimed to compare knowledge, attitude and practice (KAP) regarding COVID-19 between public health workers (PHWs) attended field epidemiology training program (FETP-trained) and those who did not attend FETP (non-FETP trained).

Methods: Multi-country cross-sectional survey was conducted among PHWs who participated in COVID-19 pandemic in 10 countries at EMR. Online questionnaire that included demographic information, KAP regarding COVID-19 pandemic was distributed among HCWs. Scoring system was used to quantify the answers, bivariate and Multivariate analysis performed to compare FETP-trained with non-FETP trained PHWs.

Results: Overall, 1337 PHWs participated, with 835 (62.4%) < 40 years of age, and 851 (63.6%) males. Of them, 423 (31.6%) had FETP, including that 189 (44.7%) had advanced level, 155 (36.6%) intermediate and 79 (18.7%) basic level training. Compared with non-FETP trained, FETP trained were older, having higher KAP scores. FETP participation was low in infection control, and PH laboratories. KAP mean scores for intermediate level attendees are comparable to advanced level.

Conclusions: FETP-trained are having better KAP than non-FETP PHWs. Expanding the intermediate level, maintain the Rapid Response training and introduce the laboratory component are recommended to maximize the benefit from FETP. Infection control, antimicrobial resistance and coordination are areas where training should include.
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http://dx.doi.org/10.1093/pubmed/fdab240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8500047PMC
September 2021

Direct-acting antiviral regimens in Egyptian patients with chronic hepatitis C virus infection: A real-world single-center experience.

Arab J Gastroenterol 2021 Sep 13. Epub 2021 Sep 13.

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

Background And Study Aims: Chronic hepatitis C virus (HCV) infection has always been identified as a major health threat and a potential cause of liver cirrhosis, portal hypertension, and other associated problems. The introduction of direct-acting antiviral agents (DAAs) has represented a paradigm shift in HCV management. In this study, we aim to observe the rate of sustained virologic response (SVR12) in a large scale of patients at a single center as well as record the post-treatment changes in the hematologic, hepatic, and renal biochemical profiles.

Patients And Methods: In total, 1933 chronic HCV genotype 4 mono-infected non-HCC patients who completed the treatment with six different DAA regimens in the Faculty of Medicine, Ain Shams University Research Institute (MASRI), were retrospectively enrolled in this study. The rate of sustained virologic response after 12 weeks off-therapy (SVR12) was assessed. The baseline characteristics to predict the SVR12 were then analyzed. The post-treatment changes in many profiles were recorded and analyzed.

Results: The overall SVR12 rate was 96.2% (after excluding 84 cases who were lost to follow-up). It was achieved in 346/375 patients (92.3%), 466/477 patients (97.7%), 60/62 patients (96.8%), 11/11 patients (100%), 532/545 patients (97.6%), and 445/463 patients (96.1%) who received sofosbuvir/daclatasvir (SOF/DCV), sofosbuvir/daclatasvir/ribavirin (SOF/DCV/RBV), sofosbuvir/ledipasvir (SOF/LDV), sofosbuvir/ledipasvir/ribavirin (SOF/LDV/RBV), sofosbuvir/simeprevir (SOF/SMV), and ombitasvir/paritaprevir/ritonavir/ribavirin (OBV/PTV/r + RBV), respectively. In total, 73 patients (3.8%) failed to achieve SVR12. The baseline aspartate aminotransferase (AST), cirrhotic status, and treatment regimen were determined to have a significant impact on SVR12. In the overall treated population, the levels of serum AST, alanine aminotransferase, albumin, creatinine, bilirubin, and hemoglobin and platelet count improved significantly after treatment. Furthermore, sustained virologic response was strongly related to cirrhosis and its degree.

Conclusion: The interferon-free DAA regimens offered high SVR12 rates in Egyptian patients with chronic HCV infection. They were associated with a significant improvement in the hematologic, hepatic, and renal biochemical profiles. The baseline AST, liver cirrhosis, and treatment regimen might have an impact on achieving SVR.
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http://dx.doi.org/10.1016/j.ajg.2021.06.001DOI Listing
September 2021

Pattern and determinants of COVID-19 infection and mortality across countries: An ecological study.

Heliyon 2021 Jul 8;7(7):e07504. Epub 2021 Jul 8.

Ministry of Health and Population, Egypt.

Background: This work aimed to identify the mathematical model and ecological determinants of COVID-19 infection and mortality across different countries during the first six months of the pandemic.

Methodology: In this study, authors used the online available data sources of randomly selected 18 countries to figure out potential determinants of COVID-19 transmissibility and mortality. The studied variables were environmental factors (daily average temperature, daily humidity), socioeconomic attributes (population age structure, count and density, human development index, per capita income (PCI), gross domestic product, internet coverage) mobility trends and chronic diseases. Researchers used the linear and exponential time series analysis, and further utilized multivariate techniques to explain the variance in the monthly increase in cases and deaths.

Results: In the first two months, the R of linear models for the cases and deaths were higher than that of the corresponding R of the exponential model. Later one, R of the exponential model was occasionally relatively higher than that of the linear model. The exponential growth rate of new cases was significantly associated with mobility trends (β = 0.00398, = 0.002), temperature (β = 0.000679, = 0.011), humidity (β = 0.000249, < 0.001), and the proportion of population aged ≥65 years (β = -0.000959, = 0.012). Similarly, the exponential growth rate of deaths was significantly associated with mobility trends (β = 0.0027, = 0.049), temperature (β = 0.0014, P < 0.001), humidity (β = -0.0026, P < 0.001), and PCI of countries. During this period, COVID-19 transmissibility was evident to be controlled as soon as social mobility is decreased by about 40% of the baseline over 3 months controlling for the other predictors.

Conclusion: Controlling of COVID-19 pandemic is based mainly on controlling social mobility. Role of environmental determinants like temperature and humidity was well noticed on disease fatality and transmissibility. Socio-demographic determinants of COVID-19 spread and fatality included modifiable risk factors like PCI and non-modifiable risk factors like ageing.
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http://dx.doi.org/10.1016/j.heliyon.2021.e07504DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8264269PMC
July 2021

Impact of successful HCV treatment using direct acting antivirals on recurrence of well ablated hepatocellular carcinoma.

Expert Rev Anti Infect Ther 2021 Jul 15:1-8. Epub 2021 Jul 15.

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

Background: There are many contradictory studies that dealt with hepatocellular carcinoma (HCC) recurrence rate of well ablated hepatitis C virus (HCV) related HCC. We aim to assess the recurrence rate of previously ablated HCC in patients who received direct acting antiviral (DAA) for their HCV.

Research Design And Methods: This is a retrospective data analysis of 523 HCV patients who have a history of successfully ablated HCC and eligible for HCV treatment. Retrieval was done to demographic/clinical data, HCV pretreatment investigations, HCV treatment outcome. Follow up for survival and HCC recurrence was done every 3 months using abdominal ultrasound and alfa-fetoprotein.

Results: Mean age was 53.83 years. Sofosbuvir/daclatasvir/ribavirin was the most used regimen (35.4%) with 438 patients (83.7%) achieved sustained virologic response (SVR). The median duration for surveillance was 159 weeks. Hundred and five patients developed recurrent HCC, with a crude recurrence rate of 20.1%. There was no difference between HCV responders and non-responders in crude recurrence rate (p = 0.94) but HCC developed earlier in non-responders (p = <0.01).

Conclusion: Recurrence of HCC remains a threat in HCV patients even after achieving an SVR. Implementation of long-term surveillance programs is highly recommended.
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http://dx.doi.org/10.1080/14787210.2021.1951230DOI Listing
July 2021

Beta-thalassemia major alters sofosbuvir/ledipasvir exposure in Hepatitis C virus infected adolescent patients.

Clin Res Hepatol Gastroenterol 2021 09 26;45(5):101747. Epub 2021 Jun 26.

Department of Paediatrics and Paediatric Haematology/Oncology unit, Faculty of Medicine, Ain Shams University, Cairo, Egypt; Faculty of Medicine, Ain-Shams University Research Institute-Clinical Research Centre (MASRI-CRC), Egypt.

Background: Hepatitis C virus (HCV) infected adolescents with beta-thalassemia major (BTM) are considered a potential population for HCV micro-elimination model development where BTM may negatively impact the pharmacokinetic exposure parameters of sofosbuvir/ledipasvir (SOF/LED).

Objectives: The study aimed at studying the effect of BTM on SOF/LED and SOF metabolite (GS-331007) pharmacokinetics.

Methods: A prospective, controlled study recruiting BTM and control HCV infected adolescents (Clinicaltrials.gov identifier-NCT04353986). Pharmacokinetic exposure to GS-331007 and LED was the primary pharmacokinetic outcome. No-effect boundaries were set to 90% confidence interval (CI) of exposure geometric mean ratio (GMR) within 70-143%. Dose suitability was based on the 90% CI of exposure GMR within 50-200% compared to adults. The percentage of patients achieving sustained virologic response 12 weeks post-treatment (SVR12) was the primary efficacy endpoint.

Results: Thirteen patients were enrolled per study group. All patients were included in the pharmacokinetic analysis (n=26). BTM patients showed lower GS-331007 and LED exposure that could, respectively, be as low as 45.4% and 36.1% compared to their control group. GS-331007 exposure in BTM patients was nearly half (56.8%, 90% CI 45.3-71.2%) that observed in adults. Despite that low drug exposure in 46.2% of BTM patients may alert dose unsuitability, they achieved SVR12. Moreover, patients with total bilirubin ≥1.93 mg/dL were predicted to have low GS-331007 exposure (0.913 receiver operating characteristic area under the curve with sensitivity and specificity >80%).

Conclusion And Relevance: The identified systematically lower drug exposure in BTM patients might partially explain relapses or treatment failures among BTM patients reported in other studies. BTM may be a hurdle towards implementing HCV micro-elimination model that may necessitate dose-adjustment.
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http://dx.doi.org/10.1016/j.clinre.2021.101747DOI Listing
September 2021

Effect of disease stage and treatment outcomes on the dynamics of liver functions during and after treatment of hepatitis C with directly acting antivirals.

Eur J Gastroenterol Hepatol 2021 Jan 14. Epub 2021 Jan 14.

aEndemic Medicine Department, Faculty of Medicine, Helwan University bDepartment of Internal Medicine, Al-Azhar University cEndemic Medicine, Hepatology and Gastroenterology, Cairo University dInternal Medicine Department, Helwan University eTropical Medicine Department, Faculty of Medicine Ain Shams University, Cairo fEpidemiology and Preventive Medicine Department, National Liver Institute, Menoufia University, Menoufia gNew Cairo Viral Hepatitis, Treatment Unit, New Cairo Hospital, Cairo hTropical Medicine, Faculty of Medicine, Alexandria University, Alexandria iTropical Medicine Department, National Hepatology and Tropical Medicine Research Institute jGastroenterology and Hepatology Department, Theodor Bilharz Research Institute, Cairo, Egypt.

Background: Virus C infection is recently treated successfully with plenty of direct antiviral agents (DAAs). We aimed to evaluate the effect of disease stage and treatment outcome on the dynamics of liver functions during treatment of hepatitis C with DAAs.

Methods: We reported the liver function in 2354 subjects diagnosed as chronic hepatitis C before, during and after treatment with different DAAs regimens. Patients were classified into two groups according to treatment response with further subclassification according to the presence or absence of cirrhosis, and changes in liver functions were compared in each group and subgroup.

Results: Totally 2213 (94%) achieved sustained virological response (SVR) to DAAs therapy with significant improvement in all liver biochemistry. Also, there was an improvement in the non-SVR group's liver enzymes in relapsers during and after treatment; however, there was no improvement in serum albumin. We noticed a slight increase in serum bilirubin at weeks 4 and 8 for both groups.

Conclusion: DAAs therapy is associated with improvement of the liver biochemical profile and improved outcome in the majority of chronic hepatitis C virus patients due to suppression of viral replication. However, the long-term impact of DAAs therapy needs to be further evaluated.
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http://dx.doi.org/10.1097/MEG.0000000000002043DOI Listing
January 2021

Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial.

JAMA 2021 07;326(1):35-45

Beijing Key-Tech Statistical Consulting Co, Ltd, Beijing, China.

Importance: Although effective vaccines against COVID-19 have been developed, additional vaccines are still needed.

Objective: To evaluate the efficacy and adverse events of 2 inactivated COVID-19 vaccines.

Design, Setting, And Participants: Prespecified interim analysis of an ongoing randomized, double-blind, phase 3 trial in the United Arab Emirates and Bahrain among adults 18 years and older without known history of COVID-19. Study enrollment began on July 16, 2020. Data sets used for the interim analysis of efficacy and adverse events were locked on December 20, 2020, and December 31, 2020, respectively.

Interventions: Participants were randomized to receive 1 of 2 inactivated vaccines developed from SARS-CoV-2 WIV04 (5 µg/dose; n = 13 459) and HB02 (4 µg/dose; n = 13 465) strains or an aluminum hydroxide (alum)-only control (n = 13 458); they received 2 intramuscular injections 21 days apart.

Main Outcomes And Measures: The primary outcome was efficacy against laboratory-confirmed symptomatic COVID-19 14 days following a second vaccine dose among participants who had no virologic evidence of SARS-CoV-2 infection at randomization. The secondary outcome was efficacy against severe COVID-19. Incidence of adverse events and reactions was collected among participants who received at least 1 dose.

Results: Among 40 382 participants randomized to receive at least 1 dose of the 2 vaccines or alum-only control (mean age, 36.1 years; 32 261 [84.4%] men), 38 206 (94.6%) who received 2 doses, contributed at least 1 follow-up measure after day 14 following the second dose, and had negative reverse transcriptase-polymerase chain reaction test results at enrollment were included in the primary efficacy analysis. During a median (range) follow-up duration of 77 (1-121) days, symptomatic COVID-19 was identified in 26 participants in the WIV04 group (12.1 [95% CI, 8.3-17.8] per 1000 person-years), 21 in the HB02 group (9.8 [95% CI, 6.4-15.0] per 1000 person-years), and 95 in the alum-only group (44.7 [95% CI, 36.6-54.6] per 1000 person-years), resulting in a vaccine efficacy, compared with alum-only, of 72.8% (95% CI, 58.1%-82.4%) for WIV04 and 78.1% (95% CI, 64.8%-86.3%) for HB02 (P < .001 for both). Two severe cases of COVID-19 occurred in the alum-only group and none occurred in the vaccine groups. Adverse reactions 7 days after each injection occurred in 41.7% to 46.5% of participants in the 3 groups; serious adverse events were rare and similar in the 3 groups (WIV04: 64 [0.5%]; HB02: 59 [0.4%]; alum-only: 78 [0.6%]).

Conclusions And Relevance: In this prespecified interim analysis of a randomized clinical trial, treatment of adults with either of 2 inactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19, and serious adverse events were rare. Data collection for final analysis is pending.

Trial Registration: ClinicalTrials.gov Identifier: NCT04510207; Chinese Clinical Trial Registry: ChiCTR2000034780.
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http://dx.doi.org/10.1001/jama.2021.8565DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8156175PMC
July 2021

Utility of Lung Ultrasound in Decision making to prioritize hospital admission for COVID-19 patients: A Developing Country Perspective.

Curr Med Imaging 2021 May 6. Epub 2021 May 6.

Professor of Pulmonology, Cairo University, Cairo, Egypt.

Background & Aims: In healthcare settings with limited resources, it is crucial to make a plan to prioritize hospital admission for patients affected by COVID-19. So, we tried to develop a novel approach for triaging COVID-19 patients and deciding the priority for hospital admission using Lung Ultrasound. In this study, we aimed to evaluate the efficacy of lung ultrasound in triaging suspected COVID-19 patients and assessment of the severity of COVID-19 pneumonia and its comparison with CT chest as the gold standard.

Method: This was a multicenter cross-sectional study enrolled on 243 COVID-19 confirmed patients presented to the emergency department in three major University hospitals in Egypt. Lung ultrasound was done by an experienced emergency physician or chest physician according to the local protocol of each hospital. Demographic, clinical, and laboratory data were collected from each patient. Each patient was subjected to CT chest and lung ultrasound.

Results: A total of 243 confirmed COVID-19 patients were enrolled in this study, with a mean age of 46.7+10.4 years. Ground glass opacity (GGO), subpleural consolidation, trans-lobar consolidation, and crazy paving were reported in chest CT scans of 54.3%, 15.2%, 11.1%, and 8.6% of patients, respectively. B-line artifacts were found in 81.1% of COVID-19 patients, which was of confluent pattern in 18.9% of patients. The lung ultrasound findings of 197 patients (81.1%) were completely coincident with those of CT with a Kappa agreement value of 0.77, and this offered a diagnostic sensitivity of 74 %, a diagnostic specificity of 97.9 %, positive predictive value (PPV) of 90.2% and negative predictive value (NPV) of 93.6 % for lung ultrasound in triaging COVID-19 patients. Adding O2 saturation to the findings of lung imaging, the accuracy of evaluation of lung ultrasound to differentiate between severe and non-severe lung diseases showed that ultrasound had 100% sensitivity and specificity.

Conclusion: Lung Ultrasound with Oxygen saturation is a very efficient tool for decision-making to prioritize hospital admission for patients affected by COVID-19 in healthcare settings with limited resources.
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http://dx.doi.org/10.2174/1573405617666210506164243DOI Listing
May 2021

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

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

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

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

The Impact of Implementing the Egypt Pandemic Preparedness Plan for Acute Respiratory Infections in Combating the Early Stage of the COVID-19 Pandemic, February-July 2020: Viewpoint.

JMIR Public Health Surveill 2021 05 7;7(5):e27412. Epub 2021 May 7.

Preventive Sector, Ministry of Health and Population, Cairo, Egypt.

This article briefly describes Egypt's acute respiratory infection (ARI) epidemic preparedness and containment plan and illustrates the impact of implementation of the plan on combating the early stage of the COVID-19 epidemic in Egypt. Pillars of the plan include crisis management, enhancing surveillance systems and contact tracing, case and hospital management, raising community awareness, and quarantine and entry points. To identify the impact of the implementation of the plan on epidemic mitigation, a literature review was performed of studies published from Egypt in the early stage of the pandemic. In addition, data for patients with COVID-19 from February to July 2020 were obtained from the National Egyptian Surveillance system and studied to describe the situation in the early stage of the epidemic in Egypt. The lessons learned indicated that the single most important key to success in early-stage epidemic containment is the commitment of all partners to a predeveloped and agreed-upon preparedness plan. This information could be useful for other countries in the region and worldwide in mitigating future anticipated ARI epidemics and pandemics. Postepidemic evaluation is needed to better assess Egypt's national response to the COVID-19 epidemic.
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http://dx.doi.org/10.2196/27412DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108937PMC
May 2021

Coinfection With SARS-CoV-2 and Influenza A(H1N1) in a Patient Seen at an Influenza-like Illness Surveillance Site in Egypt: Case Report.

JMIR Public Health Surveill 2021 04 28;7(4):e27433. Epub 2021 Apr 28.

Preventive Sector, Cairo, Egypt.

Background: Sentinel surveillance of influenza-like illness (ILI) in Egypt started in 2000 at 8 sentinel sites geographically distributed all over the country. In response to the COVID-19 pandemic, SARS-CoV-2 was added to the panel of viral testing by polymerase chain reaction for the first 2 patients with ILI seen at one of the sentinel sites. We report the first SARS-CoV-2 and influenza A(H1N1) virus co-infection with mild symptoms detected through routine ILI surveillance in Egypt.

Objective: This report aims to describe how the case was identified and the demographic and clinical characteristics and outcomes of the patient.

Methods: The case was identified by Central Public Health Laboratory staff, who contacted the ILI sentinel surveillance officer at the Ministry of Health. The case patient was contacted through a telephone call. Detailed information about the patient's clinical picture, course of disease, and outcome was obtained. The contacts of the patient were investigated for acute respiratory symptoms, disease confirmation, and outcomes.

Results: Among 510 specimens collected from patients with ILI symptoms from October 2019 to August 2020, 61 (12.0%) were COVID-19-positive and 29 (5.7%) tested positive for influenza, including 15 (51.7%) A(H1N1), 11 (38.0%) A(H3N2), and 3 (10.3%) influenza B specimens. A 21-year-old woman was confirmed to have SARS-CoV-2 and influenza A(H1N1) virus coinfection. She had a high fever of 40.2 °C and mild respiratory symptoms that resolved within 2 days with symptomatic treatment. All five of her family contacts had mild respiratory symptoms 2-3 days after exposure to the confirmed case, and their symptoms resolved without treatment or investigation.

Conclusions: This case highlights the possible occurrence of SARS-CoV-2/influenza A(H1N1) coinfection in younger and healthy people, who may resolve the infection rapidly. We emphasize the usefulness of the surveillance system for detection of viral causative agents of ILI and recommend broadening of the testing panel, especially if it can guide case management.
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http://dx.doi.org/10.2196/27433DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8081026PMC
April 2021

The potential hepatoprotective effect of metformin in hepatitis C virus-infected adolescent patients with beta thalassemia major: Randomised clinical trial.

Int J Clin Pract 2021 Jun 17;75(6):e14104. Epub 2021 Mar 17.

Department of Pediatrics and Pediatric Hematology/Oncology Unit, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Background: Iron overload-induced oxidative stress and transfusion-acquired hepatitis C virus (HCV) infection are the main reasons of liver damage in beta thalassemia major (β-TM).

Objectives: Based on metformin's hepatic benefits in nondiabetic populations, the study aims to investigate the safety and the potential hepatoprotective effect of metformin in HCV-infected β-TM adolescent patients.

Methods: This was a prospective, randomised, parallel, controlled, open-label study in which 60 HCV-infected β-TM adolescent patients aged 11 to 18 years and receiving no antiviral therapy were selected and randomly assigned to treatment or control group in 1:1 allocation. Both groups were receiving β-TM standard-of-care regimen, whereas metformin (500 mg, twice daily) was added to the treatment group's regimen only. Patients were prospectively followed up for 6 months with assessment of liver biochemical profile, oxidative stress markers, liver fibrosis, clinical symptom improvement and metformin's adverse effects.

Results: Aspartate aminotransferase serum level decreased significantly over time in the treatment group only (P = .013). However, improvement was not clinically significant and did not attain normality. Change in total antioxidant capacity and malondialdehyde serum levels indicated significantly improved oxidative stress status in the treatment group versus significant deterioration in the control group (P < .001). Fibrosis grade improvement was observed in 14 patients in the treatment group versus one improved case in the control group.

Conclusion: The use of metformin in HCV-infected β-TM adolescent patients as an adjuvant antioxidant hepatoprotective agent is promising and can improve liver damage.
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http://dx.doi.org/10.1111/ijcp.14104DOI Listing
June 2021

Antiretroviral therapy under the wing of the COVID-19 epidemic: One look, and different solutions.

South Afr J HIV Med 2020 15;21(1):1167. Epub 2020 Dec 15.

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

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http://dx.doi.org/10.4102/sajhivmed.v21i1.1167DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756945PMC
December 2020

Clinical features and laboratory characteristics of patients hospitalized with COVID-19: single centre report from Egypt.

J Infect Dev Ctries 2020 12 31;14(12):1352-1360. Epub 2020 Dec 31.

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

Introduction: The recently discovered novel coronavirus disease (COVID-19) has emerged in Wuhan, China, since January 2020. Egypt reported a low incidence of infection when compared with other countries. The aim of the study was to assess the characterization of COVID-19 infection among the Egyptian population.

Methodology: Data were collected from a single COVID-19 quarantine hospital in Cairo. A total number of 195 cases were included with their clinical, laboratory, and radiological data.

Results: Three different age groups behaved differently for COVD-19 infection. The pediatric age group was asymptomatic entirely, the middle age group (18-50 years) were asymptomatic in 53.3% of cases, while 77.9% of those above 50 years were symptomatic (p ≤ 0.001). The latter group had a high incidence of COVID-pneumonia in (83.1%), and moderate to critical presentations were encountered in 66.3% of them. Neutrophil to lymphocyte (N/L) ratio correlated directly with the age and case severity. C-reactive protein (CRP) and computed tomography scan chest (CT-chest) had added value on COVID-19 diagnosis in suspected cases.

Conclusions: In Egypt, patients above 50 years are at a higher risk for symptomatic COVID-19 infection and leaner for moderate to critical COVID-19 presentation. The triad of CT-chest, CRP, and N/L ratio could be an integrated panel for assessing disease severity.
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http://dx.doi.org/10.3855/jidc.13156DOI Listing
December 2020

Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results.

N Engl J Med 2021 02 2;384(6):497-511. Epub 2020 Dec 2.

The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.

Background: World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19).

Methods: We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry.

Results: At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.

Conclusions: These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.).
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http://dx.doi.org/10.1056/NEJMoa2023184DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7727327PMC
February 2021

The interrelation between lipid profile in chronic HCV patients and their response to antiviral agents.

Expert Rev Gastroenterol Hepatol 2021 Jan 2;15(1):103-110. Epub 2020 Nov 2.

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

Objectives: This study aims to assess the changes of lipid profile in chronic HCV patients; before, during, and after treatment with DAAs and their association with treatment response.

Methods: 301 chronic HCV patients who received SOF-based therapy were included. Serum lipid profile was assessed at different check points; baseline, 6 weeks on treatment, end of treatment (EOT) and 12 weeks after EOT; and compared between SVR and non-SVR groups.

Results: SVR group had significantly higher baseline lipid parameters compared to non-SVR group with significant increase in lipid parameters at different time points apart from HDL-C. Non-SVR group showed non-significant change in lipid parameters apart from LDL-C. On week6 on treatment, cholesterol level > 125 mg/dl was 92.8% sensitive, 97.3% specific with 95.5% NPV, and AUC of 0.989 in prediction of SVR. Similarly, LDL > 57 mg/dl was 83.7% sensitive, 100% specific with 93.3%, NPV and AUC of 0.952. Baseline cholesterol and LDL were significantly associated with SVR.

Conclusion: Higher baseline lipid parameters and their further elevation starting from week 6 on treatment are good predictors of SVR in HCV patients. Successful HCV therapy with DAAs is associated with a significant increase in lipid parameters.
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http://dx.doi.org/10.1080/17474124.2020.1823831DOI Listing
January 2021

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

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

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

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

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

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

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

Pharmacokinetics of daclatasvir in Egyptian adolescents with genotype-4 HCV infection.

Antivir Ther 2020 ;25(2):101-110

Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Background: Daclatasvir has potent antiviral activity against HCV infection when used in combination with sofosbuvir, however, its pharmacokinetics have not been described in adolescents. The aim is to determine the pharmacokinetic parameters of daclatasvir in adolescents, and to develop a population pharmacokinetic (PopPK) model.

Methods: Seventeen adolescent patients with genotype-4 chronic HCV infection received once daily oral daclatasvir 60 mg in combination with 400 mg sofosbuvir for 12 weeks. Steady state concentrations were determined. Non-compartmental and population PK were determined.

Results: The average PK parameters calculated by non-compartmental analysis (NCA): maximum plasma concentration (C), area under the curve (AUC), apparent oral volume of distribution (V/F), apparent oral clearance (CL/F) and half-life (T) were 1,092 ng/ml, 11,178 ng/ml•h, 55 l, 4.5 l/h and 8.5 h, respectively. Daclatasvir was best described by one compartment structural PK model with zero order absorption and first-order elimination. The absorption rate constant (K), V/F, and CL/F of the final PopPK model of daclatasvir were 1.5/h, 52 l and 4.7 l/h, respectively. Body weight and serum albumin had significant effect on the V/F parameter.

Conclusions: Body weight and serum albumin were the major determinants of daclatasvir V/F in this population. PK parameters were comparable to those reported in adult HCV patients, demonstrating that 60 mg daclatasvir is an appropriate dose for adolescents. ClinicalTrials.gov NCT03540212.
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http://dx.doi.org/10.3851/IMP3357DOI Listing
October 2021

Estimation of COVID-19 burden in Egypt.

Lancet Infect Dis 2020 08 27;20(8):896-897. Epub 2020 Apr 27.

Ministry of Health and Population, Cairo, Egypt.

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http://dx.doi.org/10.1016/S1473-3099(20)30319-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7185947PMC
August 2020

Screening and Treatment Program to Eliminate Hepatitis C in Egypt.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Generic Ledipasvir-Sofosbuvir Treatment for Adolescents With Chronic Hepatitis C Virus Infection.

J Pediatric Infect Dis Soc 2020 Jul;9(3):386-389

Hepatology Department, Ain Shams University, Cairo, Egypt.

We assessed the safety and efficacy of a generic form of ledipasvir-sofosbuvir for the treatment of hepatitis C virus infection in Egyptian adolescents and compared the results with those of treatment with the brand-named form. The generic form resulted in a high response rate, significant improvement in liver function, and mild adverse effects. These results are comparable with those of the brand form at a reduced price.
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http://dx.doi.org/10.1093/jpids/piz041DOI Listing
July 2020
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