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2021
Sabry, A. M., Mortada HF El-Shabrawi, Ola El-Sisi, A. A. Abdelrazek, and M. F. Ali, "Efficacy of single phototherapy with low-cost reflective sheets versus single phototherapy alone in mild-to-moderate unconjugated hyperbilirubinaemia in full-term neonates.", Paediatrics and international child health, pp. 1-5, 2021. Abstract

BACKGROUND: An economical alternative method of increasing the light intensity of phototherapy for neonatal jaundice is the use of reflective sheets placed on the sides of the incubator.

AIM: To determine whether reflective sheets in addition to phototherapy increase the reduction of bilirubin levels and the duration of hospital stay.

METHODS: The study was undertaken in the neonatal intensive care unit of Cairo University Children's Hospital. There were two groups: a study group of 90 full-term neonates with neonatal jaundice who received single phototherapy in incubators covered with white plastic reflective sheets and a control group of 90 full-term neonates with neonatal jaundice who received single phototherapy without the reflective sheets.

RESULTS: The mean (SD) rate of bilirubin decline in the first 24 hours of phototherapy was greater in the study group [3.7 (0.86) µmol/L/hr] than in the control group [2.2 (0.14) µmol/L/hr] (<0.001).

CONCLUSION: Use of reflective sheets decreases the total duration of phototherapy and the cost and duration of hospitalisation without any added complications. AAP: American Academy of Pediatrics; HIDS: high-intensity double-surface; LMIC: low- and middle-income countries; MCTP: mirror-covered tunnel phototherapy; NICU: neonatal intensive care unit; TSB: total serum bilirubin.

El-Shabrawi, M. H., S. R. Baroudy, F. S. Hassanin, and A. E. Farag, "A pilot study of the value of a stool color card as a diagnostic tool for extrahepatic biliary atresia at a single tertiary referral center in a low/middle income country.", Arab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology, vol. 22, issue 1, pp. 61-65, 2021. Abstract

BACKGROUND AND STUDY AIMS: Biliary atresia (BA) is a major cause of hepatic failure and consequent liver transplantation in pediatrics. If BA is not diagnosed early and the proper surgical intervention is not performed before the age of 3 months, the survival of the affected infant is significantly reduced. In 1994, a stool color card (SCC) for early detection of BA was developed and used in Japan, a country where the parents' socioeconomic and education levels are high. We aimed to assess the value of using the SCC as a screening tool for early diagnosis of BA at a tertiary referral center in Egypt (a low/middle-income country).

PATIENTS AND METHODS: This prospective study enrolled 108 infants (56 females) aged 1 day to 4 months who presented with cholestasis to the Hepatology Unit of Cairo University Children's Hospital from January 2018 to August 2019. In most of our patients, the mothers were the main caregivers and the parents' socioeconomic and education levels were generally modest or low. We utilized the SCC courtesy of the Perinatal Services BC (Vancouver, Canada) with an Arabic translation. This SCC contains nine colored stool photos: the first six are ranked as abnormal colors and the last three are ranked as normal.

RESULTS: We found that almost all referring physicians were unfamiliar with or unaware of the SCC concept. Twenty-six of our babies' mothers were illiterate and 36 had not completed their primary school education. In spite of this low education level, 43 mothers of babies who were finally confirmed to have BA correctly matched a stool color of BA on the SCC with their babies' stools, and 56 mothers of babies who were finally confirmed not to have BA correctly matched a stool color not of BA with their babies' stools. Only nine mothers made a wrong match. Therefore, the overall "lay" mothers' sensitivity and specificity in diagnosis of BA using the SCC were 93.48% (95% confidence interval [CI] 82.1%-98.63%) and 90.32% (95% CI 80.12%-96.37%), respectively.

CONCLUSION: To the best of our knowledge, this is the first study reporting the use of the SCC (with an Arabic translation) in a low/middle-income country. Despite the referring physicians' unfamiliarity with the SCC and the mothers' relatively low education level at our center; SCC proved to be a simple, efficient, highly sensitive, specific, and applicable method for early diagnosis of BA. Therefore, SCC screening might increase motherś (as well as physicianś) awareness of BA, and we recommend that it be more publicized and used as a mass neonatal screening tool in low/middle-income countries such as Egypt.

El-Shabrawi, M. H., S. R. Baroudy, F. S. Hassanin, and A. E. Farag, "A pilot study of the value of a stool color card as a diagnostic tool for extrahepatic biliary atresia at a single tertiary referral center in a low/middle income country.", Arab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology, vol. 22, issue 1, pp. 61-65, 2021. Abstract

BACKGROUND AND STUDY AIMS: Biliary atresia (BA) is a major cause of hepatic failure and consequent liver transplantation in pediatrics. If BA is not diagnosed early and the proper surgical intervention is not performed before the age of 3 months, the survival of the affected infant is significantly reduced. In 1994, a stool color card (SCC) for early detection of BA was developed and used in Japan, a country where the parents' socioeconomic and education levels are high. We aimed to assess the value of using the SCC as a screening tool for early diagnosis of BA at a tertiary referral center in Egypt (a low/middle-income country).

PATIENTS AND METHODS: This prospective study enrolled 108 infants (56 females) aged 1 day to 4 months who presented with cholestasis to the Hepatology Unit of Cairo University Children's Hospital from January 2018 to August 2019. In most of our patients, the mothers were the main caregivers and the parents' socioeconomic and education levels were generally modest or low. We utilized the SCC courtesy of the Perinatal Services BC (Vancouver, Canada) with an Arabic translation. This SCC contains nine colored stool photos: the first six are ranked as abnormal colors and the last three are ranked as normal.

RESULTS: We found that almost all referring physicians were unfamiliar with or unaware of the SCC concept. Twenty-six of our babies' mothers were illiterate and 36 had not completed their primary school education. In spite of this low education level, 43 mothers of babies who were finally confirmed to have BA correctly matched a stool color of BA on the SCC with their babies' stools, and 56 mothers of babies who were finally confirmed not to have BA correctly matched a stool color not of BA with their babies' stools. Only nine mothers made a wrong match. Therefore, the overall "lay" mothers' sensitivity and specificity in diagnosis of BA using the SCC were 93.48% (95% confidence interval [CI] 82.1%-98.63%) and 90.32% (95% CI 80.12%-96.37%), respectively.

CONCLUSION: To the best of our knowledge, this is the first study reporting the use of the SCC (with an Arabic translation) in a low/middle-income country. Despite the referring physicians' unfamiliarity with the SCC and the mothers' relatively low education level at our center; SCC proved to be a simple, efficient, highly sensitive, specific, and applicable method for early diagnosis of BA. Therefore, SCC screening might increase motherś (as well as physicianś) awareness of BA, and we recommend that it be more publicized and used as a mass neonatal screening tool in low/middle-income countries such as Egypt.

El-Khayat, H., M. Yakoot, M. El-Shabrawi, Y. Fouad, D. Attia, and E. M. Kamal, "Treatment of Chronic Hepatitis C in Adolescent Patients With Positive HBsAg or With Occult Hepatitis B: Is the Risk of Hepatitis B Reactivation Significant?", The Pediatric infectious disease journal, vol. 40, issue 1, pp. 11-15, 2021. Abstract

BACKGROUND: Reactivation of hepatitis B virus (HBV) infection in patients treated for chronic hepatitis C (HCV) with direct-acting antiviral agents has emerged recently as an important safety issue; however, it has not been adequately studied in pediatric age groups. We aimed to evaluate this risk in adolescent patients infected with chronic HCV and positive for HBsAg and HBcAbs.

PATIENTS AND METHODS: One hundred and fifteen adolescent patients from 12 to 17 years of age, infected with chronic HCV and positive for HBcAbs with or without HBsAg were included in this study. All patients were treated with 1 tablet daily of the fixed-dose combination sofosbuvir/ledipasvir for 12 weeks. Patients were closely monitored throughout the study for virus load, liver functions, and other safety and efficacy outcome measures.

RESULTS: The sustained virologic response 12 (SVR12) rates were 96.7% (95% confidence interval: 88.6-99.1%) in HBsAg positive group and 98.2% (95% confidence interval: 90.4-99.7%) in HBsAg negative with HBcAbs positive group. Throughout the treatment period and the 12 weeks follow-up after treatment, there has been no single case in both HBsAg negative or positive that showed any manifestation of reactivation of hepatitis B, detected levels of HBV-DNA, or deterioration of liver functions.

CONCLUSION: No HBV reactivation was observed in adolescents treated for chronic HCV with direct-acting antiviral agents in our study, in both HBsAg positive or occult hepatitis B. Although results are reassuring, we still recommend close monitoring of liver functions to not miss even rare cases of such a potentially serious condition.

El-Khayat, H., M. Yakoot, M. El-Shabrawi, Y. Fouad, D. Attia, and E. M. Kamal, "Treatment of Chronic Hepatitis C in Adolescent Patients With Positive HBsAg or With Occult Hepatitis B: Is the Risk of Hepatitis B Reactivation Significant?", The Pediatric infectious disease journal, vol. 40, issue 1, pp. 11-15, 2021. Abstract

BACKGROUND: Reactivation of hepatitis B virus (HBV) infection in patients treated for chronic hepatitis C (HCV) with direct-acting antiviral agents has emerged recently as an important safety issue; however, it has not been adequately studied in pediatric age groups. We aimed to evaluate this risk in adolescent patients infected with chronic HCV and positive for HBsAg and HBcAbs.

PATIENTS AND METHODS: One hundred and fifteen adolescent patients from 12 to 17 years of age, infected with chronic HCV and positive for HBcAbs with or without HBsAg were included in this study. All patients were treated with 1 tablet daily of the fixed-dose combination sofosbuvir/ledipasvir for 12 weeks. Patients were closely monitored throughout the study for virus load, liver functions, and other safety and efficacy outcome measures.

RESULTS: The sustained virologic response 12 (SVR12) rates were 96.7% (95% confidence interval: 88.6-99.1%) in HBsAg positive group and 98.2% (95% confidence interval: 90.4-99.7%) in HBsAg negative with HBcAbs positive group. Throughout the treatment period and the 12 weeks follow-up after treatment, there has been no single case in both HBsAg negative or positive that showed any manifestation of reactivation of hepatitis B, detected levels of HBV-DNA, or deterioration of liver functions.

CONCLUSION: No HBV reactivation was observed in adolescents treated for chronic HCV with direct-acting antiviral agents in our study, in both HBsAg positive or occult hepatitis B. Although results are reassuring, we still recommend close monitoring of liver functions to not miss even rare cases of such a potentially serious condition.

2020
Kamal, E. M., M. El-Shabrawi, H. El-Khayat, M. Yakoot, Y. Sameh, Y. Fouad, and D. Attia, "Effects of sofosbuvir/ledipasvir therapy on chronic hepatitis C virus genotype 4, infected children of 3-6 years of age.", Liver international : official journal of the International Association for the Study of the Liver, vol. 40, issue 2, pp. 319-323, 2020. Abstract

BACKGROUND & AIMS: Treatment of children aged 3-6 genotype 4 is still limited by the interferon side effects. We aimed in this study to evaluate the effectiveness and safety of sofosbuvir/ledipasvir in children (3-6 years) genotype 4 chronic HCV-infected patients.

METHODS: In total, 22 consecutive chronic HCV-infected patients (mean age 4.8 ± 0.9years, 19 males) were included in this prospective study. All patients received sofosbuvir 200 mg/ledipasvir 45 mg in a single oral daily dose. Patients were randomly subdivided into two groups according the duration of treatment into 8 and 12 weeks. All the clinical and laboratory data were collected. All the side effects were recorded from the patients or their parents. Follow-up were made at Week 4, 8 and 12 and 12 weeks after the end of treatment (SVR12).

RESULTS: The overall SVR12 rate was 100%. At Week 4, 9/11 patients in the 12-week group (81.8%; 95% CI: 52.3%-94.7%) achieved virologic negativity, vs 10/11 (90.9%; 95% CI: 62.3%-98.4%) in the 8-week group. At Week 8, 10/11 (90.8%; 95% CI: 62.3%-98.4%) in the 12-week group vs 11/11 (100%; 95% CI: 74.1%-100%) in the 8-week group were virologically negative. The reported side effects were cough, abdominal pain, nausea, vomiting and diarrhoea especially early in the treatment. The main complaint was difficulty in swallowing the tablets in the youngest patient at the beginning of the course of treatment. All patients were compliant to treatment.

CONCLUSION: Sofosbuvir/ledipasvir combination is safe and tolerable in the chronic infected HCV genotype 4 infected children (3-6 years). The 8-week treatment duration is similarly effective as the 12-week duration.

El-Shabrawi, M., W. Lotfy, R. Hegazy, O. AbdElAziz, R. Sobhy, GaserAbdelmohsen, H. Ibrahim, and A. M. Dohain, "Evolution of ventricular function in children with permanent right ventricular pacing after tetralogy of Fallot repair: A midterm follow-up.", Journal of cardiac surgery, 2020. Abstract

OBJECTIVE: We aim to evaluate the midterm effect of chronic apical right ventricular (RV) pacing on right and left ventricular (LV) function using different modalities of echocardiography including conventional echocardiography, tissue Doppler imaging and two-dimension speckle tracking echocardiography.

METHODS: This case-control study enrolled 49 patients divided into two groups: a paced group and a nonpaced group. The paced group included 23 patients that underwent tetralogy of Fallot (TOF) repair and required permanent pacemaker insertion for postoperative complete heart block. The nonpaced group included 26 patients that had TOF repair at the same period.

RESULTS: The median age for the paced and nonpaced groups was 6 and 8 years, respectively (P = .169). The follow-up duration after TOF surgical repair was 4 years for the paced patients and 5 years for nonpaced patients (P = .411). In the nonpaced group, the QRS duration increased and LV global longitudinal strain (GLS) decreased significantly with increasing duration after TOF repair, P value was .006 and .042, respectively. In the paced group, tricuspid annular systolic plane excursion (TAPSE) was significantly correlated with age (r = .578; P = .004) and duration following TOF correction (r = .724; P < .001).

CONCLUSION: Chronic RV apical pacing in children after TOF repair was associated with better clinical status, preservation of RV systolic function, and prevention of progressive QRS prolongation. RV pacing was not associated with progressive deterioration of LV systolic function with increasing the time interval following TOF repair. Therefore, RV pacing can be beneficial in corrected TOF patients presenting with RV failure.

El-Shabrawi, M., W. Lotfy, R. Hegazy, O. AbdElAziz, R. Sobhy, GaserAbdelmohsen, H. Ibrahim, and A. M. Dohain, "Evolution of ventricular function in children with permanent right ventricular pacing after tetralogy of Fallot repair: A midterm follow-up.", Journal of cardiac surgery, vol. 35, issue 4, pp. 831-839, 2020. Abstract

OBJECTIVE: We aim to evaluate the midterm effect of chronic apical right ventricular (RV) pacing on right and left ventricular (LV) function using different modalities of echocardiography including conventional echocardiography, tissue Doppler imaging and two-dimension speckle tracking echocardiography.

METHODS: This case-control study enrolled 49 patients divided into two groups: a paced group and a nonpaced group. The paced group included 23 patients that underwent tetralogy of Fallot (TOF) repair and required permanent pacemaker insertion for postoperative complete heart block. The nonpaced group included 26 patients that had TOF repair at the same period.

RESULTS: The median age for the paced and nonpaced groups was 6 and 8 years, respectively (P = .169). The follow-up duration after TOF surgical repair was 4 years for the paced patients and 5 years for nonpaced patients (P = .411). In the nonpaced group, the QRS duration increased and LV global longitudinal strain (GLS) decreased significantly with increasing duration after TOF repair, P value was .006 and .042, respectively. In the paced group, tricuspid annular systolic plane excursion (TAPSE) was significantly correlated with age (r = .578; P = .004) and duration following TOF correction (r = .724; P < .001).

CONCLUSION: Chronic RV apical pacing in children after TOF repair was associated with better clinical status, preservation of RV systolic function, and prevention of progressive QRS prolongation. RV pacing was not associated with progressive deterioration of LV systolic function with increasing the time interval following TOF repair. Therefore, RV pacing can be beneficial in corrected TOF patients presenting with RV failure.

El-Shabrawi, M., sherif Baroudy, F. Hassanin, A. S. Behairy, M. Yakoot, and A. Ahmed, "Follow-up of chronic paediatric hepatitis C virus in a low-/middle-income country.", Acta paediatrica (Oslo, Norway : 1992), vol. 109, issue 12, pp. 2699-2705, 2020. Abstract

AIM: Follow-up of chronic hepatitis C virus (HCV) infection following Interferon (IFN) plus Ribavirin (RBV) or direct-acting antiviral (DAA) drug therapy in a cohort of paediatric outpatients as confirmed by a sustained virologic response (SVR).

METHODS: This study included a cohort of 60 patients (6-18 years), divided into 2 groups: Group 1:21 patients who completed treatment with IFN/RBV. Group 2:39 treated with dual DAA therapy: 19 with Sofosbuvir/Ledipasvir (SOF/LED) and 20 with Sofosbuvir/Daclatasvir (SOF/DCV).

RESULTS: Group 1:12 (57.1%) were cured, six were IFN/RBV treatment failure then subsequently treated with DAAs successfully, and three had liver transplants. IFN/RBV side effects were reported in all patients; however, fibrosis regressed in two cured patients. Group 2: all were cured. HCV RNA became negative in all DAAs-treated patients at weeks 2, 4 and 12 of treatment (100%) as well as SVR after 12 weeks (100%). Thirty patients reported no adverse side effects whereas only nine suffered minor side effects.

CONCLUSIONS: In our cohort, SOF/LED therapy and SOF/DCV therapy were extremely safe and effective with 100% SVR and negligible short-term side effects. IFN/RBV therapy was much less effective (SVR 57.1%) and accompanied with short-term side effects. Fibrosis might stop and even regress with successful treatment.

El-Shabrawi, M., sherif Baroudy, F. Hassanin, A. S. Behairy, M. Yakoot, and A. Ahmed, "Follow-up of chronic paediatric hepatitis C virus in a low-/middle-income country.", Acta paediatrica (Oslo, Norway : 1992), vol. 109, issue 12, pp. 2699-2705, 2020. Abstract

AIM: Follow-up of chronic hepatitis C virus (HCV) infection following Interferon (IFN) plus Ribavirin (RBV) or direct-acting antiviral (DAA) drug therapy in a cohort of paediatric outpatients as confirmed by a sustained virologic response (SVR).

METHODS: This study included a cohort of 60 patients (6-18 years), divided into 2 groups: Group 1:21 patients who completed treatment with IFN/RBV. Group 2:39 treated with dual DAA therapy: 19 with Sofosbuvir/Ledipasvir (SOF/LED) and 20 with Sofosbuvir/Daclatasvir (SOF/DCV).

RESULTS: Group 1:12 (57.1%) were cured, six were IFN/RBV treatment failure then subsequently treated with DAAs successfully, and three had liver transplants. IFN/RBV side effects were reported in all patients; however, fibrosis regressed in two cured patients. Group 2: all were cured. HCV RNA became negative in all DAAs-treated patients at weeks 2, 4 and 12 of treatment (100%) as well as SVR after 12 weeks (100%). Thirty patients reported no adverse side effects whereas only nine suffered minor side effects.

CONCLUSIONS: In our cohort, SOF/LED therapy and SOF/DCV therapy were extremely safe and effective with 100% SVR and negligible short-term side effects. IFN/RBV therapy was much less effective (SVR 57.1%) and accompanied with short-term side effects. Fibrosis might stop and even regress with successful treatment.

Mortada HF El-Shabrawi, Ola El-Sisi, S. Tarek, maha Abou-Zekri, S. Meshaal, A. Enayet, and E. A. Mogahed, "Hepatobiliary manifestations in children with inflammatory bowel disease: A single-center experience in a low/middle income country.", World journal of gastrointestinal pharmacology and therapeutics, vol. 11, issue 3, pp. 48-58, 2020. Abstract

BACKGROUND: There has been a worldwide increase in the reported incidence of inflammatory bowel disease (IBD) in children over the past 2-3 decades. The hepatobiliary (HB) manifestations of IBD have been well-studied in children in industrialized and developed countries but are infrequently reported in low- and middle-income countries (LMIC) such as Egypt.

AIM: To determine the prevalence of the HB manifestations in a cohort of Egyptian children with IBD.

METHODS: This cross-sectional observational study was carried out over a period of 6 mo (between June 2013 to December 2013) at the Paediatric Hepatology and Gastroenterology Units of Cairo University Children's Hospital, which is the largest paediatric tertiary care centre in the country.

RESULTS: The study included 48 patients with confirmed IBD based upon clinical, laboratory, endoscopic and histopathological features, 29 (60.4%) were male. Twenty-four patients (50%) had ulcerative colitis (UC), 11 (22.9%) had Crohn's disease (CD) and 13 (27.1%) had unclassified-IBD (IBD-U), which was formerly known as indeterminate colitis. The mean age of the patients at the time of presentation was 8.14 (± SD 4.02) years and the mean age at the time of study enrolment was 10.16 (± SD 4.19) years. All patients were screened for HB manifestations by physical examination, liver function tests, imaging and liver biopsy when indicated. HB disorders were confirmed in 13 patients (27.1%). Transaminases were elevated in 3 patients (6.3%). Two patients (4.2%) had elevated biliary enzymes (one was diagnosed as primary sclerosing cholangitis (PSC) and the other was diagnosed with PSC/autoimmune hepatitis overlap syndrome and the third patient had hepatitis C virus infection. Ten patients (20.8%) had bright echogenic liver on ultrasound suggesting fatty infiltration as a sequel of malnutrition or medication toxicity.

CONCLUSION: The commonest HB disorders in Egyptian children with IBD were abnormal liver function tests, fatty infiltration and PSC. These HB manifestations in paediatric patients in LMIC may be relatively more common than in industrialized countries. Therefore, IBD patients in LMIC should be meticulously screened for liver disease to allow prompt diagnosis and management.

Mortada HF El-Shabrawi, Ola El-Sisi, S. Tarek, maha Abou-Zekri, S. Meshaal, A. Enayet, and E. A. Mogahed, "Hepatobiliary manifestations in children with inflammatory bowel disease: A single-center experience in a low/middle income country.", World journal of gastrointestinal pharmacology and therapeutics, vol. 11, issue 3, pp. 48-58, 2020. Abstract

BACKGROUND: There has been a worldwide increase in the reported incidence of inflammatory bowel disease (IBD) in children over the past 2-3 decades. The hepatobiliary (HB) manifestations of IBD have been well-studied in children in industrialized and developed countries but are infrequently reported in low- and middle-income countries (LMIC) such as Egypt.

AIM: To determine the prevalence of the HB manifestations in a cohort of Egyptian children with IBD.

METHODS: This cross-sectional observational study was carried out over a period of 6 mo (between June 2013 to December 2013) at the Paediatric Hepatology and Gastroenterology Units of Cairo University Children's Hospital, which is the largest paediatric tertiary care centre in the country.

RESULTS: The study included 48 patients with confirmed IBD based upon clinical, laboratory, endoscopic and histopathological features, 29 (60.4%) were male. Twenty-four patients (50%) had ulcerative colitis (UC), 11 (22.9%) had Crohn's disease (CD) and 13 (27.1%) had unclassified-IBD (IBD-U), which was formerly known as indeterminate colitis. The mean age of the patients at the time of presentation was 8.14 (± SD 4.02) years and the mean age at the time of study enrolment was 10.16 (± SD 4.19) years. All patients were screened for HB manifestations by physical examination, liver function tests, imaging and liver biopsy when indicated. HB disorders were confirmed in 13 patients (27.1%). Transaminases were elevated in 3 patients (6.3%). Two patients (4.2%) had elevated biliary enzymes (one was diagnosed as primary sclerosing cholangitis (PSC) and the other was diagnosed with PSC/autoimmune hepatitis overlap syndrome and the third patient had hepatitis C virus infection. Ten patients (20.8%) had bright echogenic liver on ultrasound suggesting fatty infiltration as a sequel of malnutrition or medication toxicity.

CONCLUSION: The commonest HB disorders in Egyptian children with IBD were abnormal liver function tests, fatty infiltration and PSC. These HB manifestations in paediatric patients in LMIC may be relatively more common than in industrialized countries. Therefore, IBD patients in LMIC should be meticulously screened for liver disease to allow prompt diagnosis and management.

Klein, J. D., B. Koletzko, M. H. El-Shabrawi, A. Hadjipanayis, N. Thacker, and Z. Bhutta, "Promoting and supporting children's health and healthcare during COVID-19 - International Paediatric Association Position Statement.", Archives of disease in childhood, vol. 105, issue 7, pp. 620-624, 2020.
Klein, J. D., B. Koletzko, M. H. El-Shabrawi, A. Hadjipanayis, N. Thacker, and Z. Bhutta, "Promoting and supporting children's health and healthcare during COVID-19 - International Paediatric Association Position Statement.", Archives of disease in childhood, vol. 105, issue 7, pp. 620-624, 2020.
2019
El-Khayat, H., E. M. Kamal, M. Yakoot, M. A. Gawad, N. Kamal, M. E. Shabrawi, Y. Sameh, A. Haseeb, Y. Fouad, and D. Attia, "Effectiveness of 8-week sofosbuvir/ledipasvir in the adolescent chronic hepatitis C-infected patients.", European journal of gastroenterology & hepatology, 2019 Jan 22. Abstract

BACKGROUND: The sustained virological response (SVR) rate for the 12-week sofosbuvir (SOF)/ledipasvir (LVD) treatment of adolescent genotype-4 patients is high. The aim of this study is to evaluate 8 versus 12-week treatment efficacy and safety in adolescent genotype-4 patients.

PATIENTS AND METHODS: In total, 157 chronic hepatitis C-infected adolescent patients (mean age 14±2 years, 62% males) were included in this study. All patients received a morning dose of SOF (400 mg)/LVD (90 mg) as a single tablet for 8 and 12 weeks. Laboratory and biochemical monitoring were performed at weeks 4 and 8, end of treatment (8/12) and 12 weeks after the end of treatment (SVR12).

RESULTS: In total, SVR12 was 98% [95% confidence interval (CI): 96-100] for all treated patients. For patients treated for 12 weeks, SVR12 was 97.6% (95% CI: 96-101) (82/84 patients), and 98.6% (95% CI: 93-101) (72/73) patients for those treated for 8 weeks. For both regimens, no serious adverse effects, treatment discontinuation or cases of death were detected. The main adverse effects for the 8-week patient group were fatigue (2.8%), headache (1.4%), nausea (1.4%) and epigastric tenderness (1.4%). For the 12-week-treated group, adverse events were epigastric tenderness (1.2%), nausea (1.2%), diarrhoea (2.4%) and rash (2.4%). Three patients were lost to follow-up: two were in the 12-week treatment group and one was in the 8-week group. All of them reached end of treatment but were lost before SVR12. No relapsers were observed in either group.

CONCLUSION: Eight weeks of treatment of SOF/LVD combination is equally effective and safe as 12 weeks in adolescent genotype-4 patients.

Kamal, N. M., H. Y. Khan, Mortada HF El-Shabrawi, Ola El-Sisi, and L. M. Sherief, "Congenital chloride losing diarrhea: A single center experience in a highly consanguineous population.", Medicine, vol. 98, issue 22, pp. e15928, 2019. Abstract

Congenital chloride losing diarrhea (CCLD) is a rare type of chronic watery diarrhea due to mutations in SLC26A3 gene leading to defective chloride-bicarbonate exchanges with the resultant loss of chloride and retention of bicarbonate.We aim to define pediatric Saudi CCLD patients' characteristics to achieve prompt diagnosis, management, follow up with good quality of life, and prevention of complications in these patients.We carried retrospective data review of demographic, clinical, laboratory, radiographic, and outcome of all pediatric patients fulfilling the criteria of CCLD over 10 years from 2004 to 2014 from a single center in Taif region, Saudi Arabia.Forty-nine patients fulfilled the criteria of CCLD from 21 families with more than one affected patient in the same family in 90% of them and positive consanguinity in 91% of the cohort. Most patients were born preterm with intrauterine growth restriction and usually neonatal intensive care unit (NICU) admissions with prematurity and its complications. Thirteen patients were discharged without diagnosis of CCLD and 3 were misdiagnosed as intestinal obstruction with unnecessary surgical intervention. Many complications do existed with renal complications being the most common with three patients received renal transplantation.Prematurity with abdominal distension and stool like urine were the commonest presentation of CCLD in Saudi children. Positive consanguinity and more than one affected sibling are present in most of our cohort.High index of suspicion by clinicians is a cornerstone for early diagnosis with subsequent favorable outcome.A multicenter national incidence study of CCLD in KSA and its genetic attributes is recommended. Premarital screening should be implemented specially for consanguineous marriage.

El-Khayat, H., E. M. Kamal, M. Yakoot, M. A. Gawad, N. Kamal, M. E. Shabrawi, Y. Sameh, A. Haseeb, Y. Fouad, and D. Attia, "Effectiveness of 8-week sofosbuvir/ledipasvir in the adolescent chronic hepatitis C-infected patients.", European journal of gastroenterology & hepatology, vol. 31, issue 8, pp. 1004-1009, 2019. Abstract

BACKGROUND: The sustained virological response (SVR) rate for the 12-week sofosbuvir (SOF)/ledipasvir (LVD) treatment of adolescent genotype-4 patients is high. The aim of this study is to evaluate 8 versus 12-week treatment efficacy and safety in adolescent genotype-4 patients.

PATIENTS AND METHODS: In total, 157 chronic hepatitis C-infected adolescent patients (mean age 14±2 years, 62% males) were included in this study. All patients received a morning dose of SOF (400 mg)/LVD (90 mg) as a single tablet for 8 and 12 weeks. Laboratory and biochemical monitoring were performed at weeks 4 and 8, end of treatment (8/12) and 12 weeks after the end of treatment (SVR12).

RESULTS: In total, SVR12 was 98% [95% confidence interval (CI): 96-100] for all treated patients. For patients treated for 12 weeks, SVR12 was 97.6% (95% CI: 96-101) (82/84 patients), and 98.6% (95% CI: 93-101) (72/73) patients for those treated for 8 weeks. For both regimens, no serious adverse effects, treatment discontinuation or cases of death were detected. The main adverse effects for the 8-week patient group were fatigue (2.8%), headache (1.4%), nausea (1.4%) and epigastric tenderness (1.4%). For the 12-week-treated group, adverse events were epigastric tenderness (1.2%), nausea (1.2%), diarrhoea (2.4%) and rash (2.4%). Three patients were lost to follow-up: two were in the 12-week treatment group and one was in the 8-week group. All of them reached end of treatment but were lost before SVR12. No relapsers were observed in either group.

CONCLUSION: Eight weeks of treatment of SOF/LVD combination is equally effective and safe as 12 weeks in adolescent genotype-4 patients.

Yakoot, M., M. H. El-Shabrawi, M. M. AbdElgawad, A. A. Mahfouz, A. F. Khalil, N. M. Kamal, S. Helmy, A. M. Abdo, E. M. Kamal, and H. R. El-Khayat, "Effects of Dual Sofosbuvir/Daclatasvir Therapy on Weight and Linear Growth in Adolescent Patients with Chronic Hepatitis C Virus Infection.", The Pediatric infectious disease journal, vol. 38, issue 7, pp. e154-e157, 2019. Abstract

Negative effects on growth indices had been reported in children treated with interferon for chronic viral hepatitis. Forty chronic hepatitis C virus-infected adolescents, 12-17 years of age, were treated with sofosbuvir/daclatasvir therapy for 12 weeks. The intent-to-treat sustained virologic response rate at 12 weeks after end of treatment was 39/40 (97.5%). Unlike interferon-based therapy, we did not detect significant negative effects on linear growth or weight. Contrarily, a trend to increased appetite and insignificant weight gain was observed, but further larger studies are needed to confirm. See Video-Abstract, http://links.lww.com/ASAIO/A381.

Mortada HF El-Shabrawi, Ola El-Sisi, L. M. Sherief, M. Yakoot, N. M. Kamal, M. A. Almalky, M. M. AbdElgawad, A. A. Mahfouz, S. Helmy, E. M. Kamal, D. Attia, et al., "Effects of dual sofosbuvir/daclatasvir therapy on, chronic hepatitis C infected, survivors of childhood malignancy.", World journal of clinical cases, vol. 7, issue 16, pp. 2247-2255, 2019. Abstract

BACKGROUND: Childhood cancer survivors are potentially at a higher risk of infection with hepatitis C virus (HCV). The effects of all-oral direct-acting antiviral therapy (DAA) on both the HCV infection as well as the state of cancer remission have not been well investigated in this population.

AIM: To test the effects of dual sofosbuvir/daclatasvir (SOF/DCV) therapy in the treatment of chronic HCV in survivors of hematologic malignancy in pediatric age group.

METHODS: We conducted a prospective, uncontrolled, open-label multicenter study. A total of 20 eligible, chronic HCV, genotype-4, infected children who had been in continuous complete remission from hematologic cancer (leukemia/lymphoma) for at least one year were included in the study. All patients were treated with combined SOF/DCV for 12 wk. Patients were monitored throughout the study till 12 wk after end of treatment for safety and efficacy outcomes including the sustained virologic response 12 (SVR12) rate, hematological indices, liver and kidney functions.

RESULTS: The intent-to-treat SVR12 rate was 20 of 20 (100%; 95%CI: 84%-100%). All patients showed normalized liver enzymes from week-4. All hematological indices, liver and kidney functions were kept normal throughout the study. No fatalities or treatment-emergent serious or severe adverse events were reported throughout the study.

CONCLUSION: SOF/DCV combined therapy could be used safely and effectively in the treatment of chronic HCV genotype-4 infection in leukemia/lymphoma treated children. No relapses were detected during treatment and throughout the follow up period for either the original malignant disease or the HCV infection.

Eskander, A., C. Ghobrial, N. A. Mohsen, B. Mounir, D. Abd El-Kareem, S. Tarek, and Mortada HF El-Shabrawi, Ola El-Sisi, "Histopathological changes in the oesophageal mucosa in Egyptian children with corrosive strictures: A single-centre vast experience.", World journal of gastroenterology, vol. 25, issue 7, pp. 870-879, 2019. Abstract

BACKGROUND: The caustic ingestion continues to be a major problem worldwide especially in developing countries. The long-term complications include stricture and increased life time risk of oesophageal carcinoma. Patients suffered from corrosive induced oesophageal strictures have more than a 1000-fold risk of developing carcinoma of the oesophagus.

AIM: To determine the possibility of oesophageal mucosal dysplasia after prolonged dilatation in post corrosive stricture.

METHODS: This observational study was conducted at the Paediatric Endoscopy Unit in Cairo University Children's Hospital. It included children of both sexes older than 2 years of age who had an established diagnosis of post-corrosive oesophageal stricture and repeated endoscopic dilatation sessions for more than 6 mo. All patients were biopsied at the stricture site after 6 mo of endoscopic dilatation. A histopathological examination of an oesophageal mucosal biopsy was performed for the detection of chronic oesophagitis, inflammatory cellular infiltration and dysplasia.

RESULTS: The mean age of the enrolled children was 5.9 ± 2.6 years; 90% of the patients had ingested an alkaline corrosive substance (potash). The total number of endoscopic dilatation sessions were ranging from 16 to 100 with mean number of sessions was 37.2 ± 14.9. Histopathological examination of the specimens showed that 85% of patients had evidence of chronic oesophagitis (group A) in the form of basal cell hyperplasia, hyperkeratosis and subepithelial fibrosis. Thirteen percent of the patients had evidence of reactive atypia (group B) in the form of severe neutrophilic intraepithelial inflammatory cellular infiltration, and 2 patients (2%) had mild squamous dysplasia (group C); we rebiopsied these two patients 6 mo after the initial pathological assessment, guided by chromoendoscopy by Lugol's iodine.

CONCLUSION: The histopathology of oesophageal mucosal biopsies in post-corrosive patients demonstrates evidence of chronic oesophagitis, intraepithelial inflammatory cellular infiltration and dysplasia. Dysplasia is one of the complications of post-corrosive oesophageal stricture.

El-Shabrawi, M., and F. Hassanin, "Paediatric hepatitis C virus infection and its treatment: Present, past, and future.", Arab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology, 2019. Abstract

Hepatitis C virus (HCV) infection is a major cause of chronic liver disease in the world. It is a challenging medico-social problem in the paediatric population. High HCV infection rates are reported in low and middle incomes countries. From the health economic point of view treatment of hepatitis C virus (HCV) with subsequent virus eradication is very effective as it eliminates the long-term sequelae of untreated or maltreated HCV. In this review we summarize the updates and highlight the historical approach of treatment of chronic HCV infection in children in the new era of directly acting antiviral (DAA) agents.

Mortada HF El-Shabrawi, Ola El-Sisi, and N. M. Kamal, "Pediatric Liver Disease in the African Continent", Pediatric Hepatology and Liver Transplantation: Springer Publisher, 2019.
2018
El-Karaksy, H., E. A. Mogahed, H. Abdullatif, C. Ghobrial, M. S. El-Raziky, N. El-Koofy, M. El-Shabrawi, H. Ghita, sherif Baroudy, and Sawsan Okasha, Mona Isa, "Sustained Viral Response in Genotype 4 Chronic Hepatitis C Virus-infected Children and Adolescents Treated With Sofosbuvir/Ledipasvir.", Journal of pediatric gastroenterology and nutrition, vol. 67, issue 5, pp. 626-630, 2018 Nov. Abstract

OBJECTIVES: Recently, direct acting antivirals (DAAs), sofosbuvir (SOF) combined with ledipasvir (LED), were approved for treatment of hepatitis C virus (HCV)-infected children 12 years of age and older or weighting at least 35 kg for all HCV genotypes. The aim of this study was to assess the safety and efficacy of SOF/LED in genotype 4 HCV-infected Egyptian children and adolescents.

METHODS: This observational study included 40 consecutive HCV-infected children of age 12 to <18 years old or weighing >35 kg, both treatment-naive and treatment-experienced. All of the children were hepatitis B virus-negative and had normal renal functions and heart rate. Patients received oral, fixed-dose combination tablet of SOF/LED (400 mg SOF, 90 mg LED [Harvoni]) once daily for 12 weeks. Potential side effects were recorded at weeks 4, 8, and 12 weeks of treatment. The study primary outcome was sustained virological response 12 weeks (SVR12) after end-of-treatment.

RESULTS: The study included 40 children and adolescents, 24 were boys (60%); their age ranged between 11.5 and 17.5 years (mean 13.9 ± 1.5). Baseline viral load ranged between 9630 and 24,600,000 IU/mL. HCV RNA became negative in 39 patients (97.5%) at 4 weeks and in all patients (100%) at weeks 8, 12, and SVR12. Asthenia was the commonest side effect, reported in 52.5% followed by headache in 47.5%.

CONCLUSIONS: Treatment with all-oral DAAs (SOF/LED) for 12 weeks was well tolerated in Egyptian children and adolescents infected with genotype 4 HCV, with 100% SVR12 and negligible side effects.

Yakoot, M., M. H. El-Shabrawi, M. M. AbdElgawad, A. A. Mahfouz, S. Helmy, A. M. Abdo, and H. R. El-Khayat, "Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients With Chronic Hepatitis C Infection.", Journal of pediatric gastroenterology and nutrition, 2018 Mar 22. Abstract

OBJECTIVES: Dual sofosbuvir/daclatasvir (SOF/DCV) therapy is currently recommended by The European Association for Study of Liver (EASL) as an option for the treatment of chronic hepatitis C virus infection (HCV) in adults for all genotypes; however it is still not considered for patients younger than 18 years old. We aimed to test safety and efficacy of SOF/DCV in adolescent patients 12 to 17 years old with chronic HCV, genotype 4 infection.

METHODS: We conducted a prospective, uncontrolled, open-label multicenter study. A total of 30 chronic HCV infected adolescents, aged from 12 to 17 years old were included and treated with dual SOF/DCV for 12 weeks. Patients were monitored throughout the treatment and follow-up period for safety and efficacy outcome measures including the sustained virologic response 12 (SVR12) rate.

RESULTS: The Intention to treat (ITT) SVR12 rate was 29/30 (96.7%; 95% confidence interval (CI): 83.3 - 99.4%). The only patient who did not achieve SVR12 was lost to follow up after showing viral negativity at the end of treatment visit. While all the remaining 29 patients (100%, 95% CI: 88.3 - 100%) who completed the follow up visits achieved SVR12. All patients showed normalized liver enzymes with normal hematological, liver and renal function tests at the end of the study. No fatalities or treatment-emergent serious or severe adverse events were reported throughout the study.

CONCLUSIONS: Sofosbuvir/Daclatasvir combined therapy could be a safe and effective treatment in adolescent patients 12 to 17 years old with chronic HCV genotype 4 infection.

El-Khayat, H. R., E. M. Kamal, M. H. El-Sayed, M. El-Shabrawi, H. Ayoub, A. Rizk, M. Maher, R. Y. El Sheemy, Y. M. Fouad, and D. Attia, "The effectiveness and safety of ledipasvir plus sofosbuvir in adolescents with chronic hepatitis C virus genotype 4 infection: a real-world experience.", Alimentary pharmacology & therapeutics, vol. 47, issue 6, pp. 838-844, 2018 Mar. Abstract

BACKGROUND: The combination of ledipasvir plus sofosbuvir was recently approved for treatment of adolescent (12-17 years) HCV genotype 1, 4, 5 & 6 patients. However, few clinical trials have been performed in genotype 1 patients.

AIM: To investigate the effectiveness and safety of ledipasvir plus sofosbuvir in chronic HCV adolescent patients with genotype 4 in the real world.

METHODS: This prospective multicentre (six centres) open-label study included 144 adolescent chronic HCV patients with genotype 4 (mean age 14 ± 2, 69% males). All patients received a combination tablet containing 400 mg sofosbuvir and 90 mg ledipasvir once daily for 12 weeks. Laboratory and virological markers were evaluated at baseline, week 4, week 8 and week 12 (EOT), and 12 weeks after end of treatment (SVR12).

RESULTS: SVR12 was observed in 142/144 patients (99%). The relapsers occurred in previous naïve patients (n = 2/128, 2%), while the experienced patients showed 100% SVR12. SVR12 was 98% in F0/F1 patients in comparison to 100% in F2 patients (P = 0.552). No serious side effects were observed, nor was treatment discontinuation or death. Headache was the most common side effect in all patients (20%). In experienced patients, pruritus (31%, P = 0.007), diarrhoea (44%, P < 0.001) and skin rash (19%, P = 0.002) were higher than in naïve patients.

CONCLUSIONS: A ledipasvir plus sofosbuvir regimen is well tolerated and effective, and can be used safely in treating adolescent patients with chronic hepatitis C genotype 4.

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