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1. Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection

Author

Rosenthal, Philip, Schwarz, Kathleen B, Gonzalez‐Peralta, Regino P, Lin, Chuan‐Hao, Kelly, Deidre A, Nightingale, Scott, Balistreri, William F, Bansal, Sanjay, Jonas, Maureen M, Massetto, Benedetta, Brainard, Diana M, Hsueh, Chia‐Hsiang, Shao, Jiang, Parhy, Bandita, Davison, Suzanne, Feiterna‐Sperling, Cornelia, Gillis, Lynette A, Indolfi, Giuseppe, Sokal, Etienne M, Murray, Karen F, and Wirth, Stefan

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Hepatitis - C, Hepatitis, Liver Disease, Clinical Trials and Supportive Activities, Infectious Diseases, Chronic Liver Disease and Cirrhosis, Clinical Research, Emerging Infectious Diseases, Pediatric, Digestive Diseases, Management of diseases and conditions, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 7.1 Individual care needs, Infection, Good Health and Well Being, Antiviral Agents, Child, Child, Preschool, Drug Combinations, Female, Genotype, Hepacivirus, Hepatitis C, Chronic, Humans, Male, Ribavirin, Sofosbuvir, Sustained Virologic Response, Treatment Outcome, Medical Biochemistry and Metabolomics, Immunology, Gastroenterology & Hepatology, Clinical sciences
Abstract

Currently, the only approved hepatitis C virus (HCV) treatment for children aged

Published
2020

2. Neutralizing antibodies to interferon alfa arising during peginterferon therapy of chronic hepatitis B in children and adults: Results from the HBRN trials

Author

Zahoor, Muhammad Atif, primary, Feld, Joshua B., additional, Lin, Hsing-Hua Sylvia, additional, Mosa, Alexander I., additional, Salimzadeh, Loghman, additional, Perrillo, Robert P., additional, Chung, Raymond T., additional, Schwarz, Kathleen B., additional, Janssen, Harry LA, additional, Gehring, Adam J., additional, and Feld, Jordan J., additional

Published
2024
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3. Extrahepatic Anomalies in Infants With Biliary Atresia: Results of a Large Prospective North American Multicenter Study

Author

Schwarz, Kathleen B, Haber, Barbara H, Rosenthal, Philip, Mack, Cara L, Moore, Jeffrey, Bove, Kevin, Bezerra, Jorge A, Karpen, Saul J, Kerkar, Nanda, Shneider, Benjamin L, Turmelle, Yumirle P, Whitington, Peter F, Molleston, Jean P, Murray, Karen F, Ng, Vicky L, Romero, René, Wang, Kasper S, Sokol, Ronald J, Magee, John C, and Network, Childhood Liver Disease Research and Education

Subjects
Perinatal Period - Conditions Originating in Perinatal Period, Congenital Structural Anomalies, Chronic Liver Disease and Cirrhosis, Liver Disease, Prevention, Pediatric, Clinical Research, Cardiovascular, Rare Diseases, Digestive Diseases, 2.1 Biological and endogenous factors, Aetiology, Abnormalities, Multiple, Adult, Biliary Atresia, Female, Humans, Male, Prospective Studies, United States, Childhood Liver Disease Research and Education Network, Medical Biochemistry and Metabolomics, Clinical Sciences, Immunology, Gastroenterology & Hepatology
Abstract

UnlabelledThe etiology of biliary atresia (BA) is unknown. Given that patterns of anomalies might provide etiopathogenetic clues, we used data from the North American Childhood Liver Disease Research and Education Network to analyze patterns of anomalies in infants with BA. In all, 289 infants who were enrolled in the prospective database prior to surgery at any of 15 participating centers were evaluated. Group 1 was nonsyndromic, isolated BA (without major malformations) (n = 242, 84%), Group 2 was BA and at least one malformation considered major as defined by the National Birth Defects Prevention Study but without laterality defects (n = 17, 6%). Group 3 was syndromic, with laterality defects (n = 30, 10%). In the population as a whole, anomalies (either major or minor) were most prevalent in the cardiovascular (16%) and gastrointestinal (14%) systems. Group 3 patients accounted for the majority of subjects with cardiac, gastrointestinal, and splenic anomalies. Group 2 subjects also frequently displayed cardiovascular (71%) and gastrointestinal (24%) anomalies; interestingly, this group had genitourinary anomalies more frequently (47%) compared to Group 3 subjects (10%).ConclusionThis study identified a group of BA (Group 2) that differed from the classical syndromic and nonsyndromic groups and that was defined by multiple malformations without laterality defects. Careful phenotyping of the patterns of anomalies may be critical to the interpretation of both genetic and environmental risk factors associated with BA, allowing new insight into pathogenesis and/or outcome.

Published
2013

4. Evaluating progression of liver disease from repeat liver biopsies in children with chronic hepatitis C: A retrospective study

Author

Mohan, Parvathi, Barton, Bruce A, Narkewicz, Michael R, Molleston, Jean P, Gonzalez‐Peralta, Regino P, Rosenthal, Philip, Murray, Karen F, Haber, Barbara, Schwarz, Kathleen B, and Goodman, Zachary D

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Chronic Liver Disease and Cirrhosis, Hepatitis - C, Pediatric, Emerging Infectious Diseases, Infectious Diseases, Hepatitis, Clinical Research, Liver Disease, Digestive Diseases, Aetiology, 2.1 Biological and endogenous factors, Infection, Oral and gastrointestinal, Good Health and Well Being, Adolescent, Alanine Transaminase, Biopsy, Child, Child, Preschool, Disease Progression, Female, Hepatitis C, Chronic, Humans, Infant, Liver, Liver Cirrhosis, Male, Retrospective Studies, Severity of Illness Index, Medical Biochemistry and Metabolomics, Immunology, Gastroenterology & Hepatology, Clinical sciences
Abstract

UnlabelledClinical and histologic progression of liver disease in untreated children with chronic hepatitis C virus (HCV) infection is poorly documented. The aim of this retrospective study was to characterize changes in liver histology over time in a cohort of HCV-infected children who had more than one liver biopsy separated by over 1 year. Forty-four untreated children without concurrent liver diseases, who had repeat liver biopsies at eight U.S.-based medical centers, were included. Biopsies were scored by a single pathologist for inflammation, fibrosis, and steatosis and were correlated with demographic data including age at biopsy, time from infection to biopsies, and laboratory values such as serum alanine aminotransferase (ALT). Mode of transmission was vertical in 25 (57%) and from transfusions in 17 children (39%). Genotype 1 was present in 30/35 (84%) children. The mean age at first and final biopsy was 8.6 and 14.5 years, respectively, and the mean interval between biopsies was 5.8 ± 3.5 years. Duration of infection to biopsy was 7.7 and 13.5 years, respectively. Laboratory values did not change significantly between the biopsies. Inflammation was minimal in about 50% at both timepoints. Fibrosis was absent in 16% in both biopsies, limited to portal/periportal in 73% in the first biopsy, and 64% in the final biopsy. Between the two biopsies, the proportion of patients with bridging fibrosis/cirrhosis increased from 11% to 20% (P = 0.005).ConclusionAlthough in aggregate this cohort did not show significant histologic progression of liver disease over 5 years, 29.5% (n = 13) of children showed an increase in severity of fibrosis. These findings may have long-term implications for the timing of follow-up biopsies and treatment decisions.

Published
2013

5. Intravenous N‐acetylcysteine in pediatric patients with nonacetaminophen acute liver failure: A placebo‐controlled clinical trial

Author

Squires, Robert H, Dhawan, Anil, Alonso, Estella, Narkewicz, Michael R, Shneider, Benjamin L, Rodriguez‐Baez, Norberto, Olio, Dominic Dell, Karpen, Saul, Bucuvalas, John, Lobritto, Steven, Rand, Elizabeth, Rosenthal, Philip, Horslen, Simon, Ng, Vicky, Subbarao, Girish, Kerkar, Nanda, Rudnick, David, Lopez, M James, Schwarz, Kathleen, Romero, Rene, Elisofon, Scott, Doo, Edward, Robuck, Patricia R, Lawlor, Sharon, Belle, Steven H, and Group, for the Pediatric Acute Liver Failure Study

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Patient Safety, Clinical Research, Clinical Trials and Supportive Activities, Complementary and Integrative Health, Digestive Diseases, Transplantation, Liver Disease, Pediatric, 6.1 Pharmaceuticals, Oral and gastrointestinal, Acetylcysteine, Adolescent, Child, Child, Preschool, Double-Blind Method, Female, Free Radical Scavengers, Hepatic Encephalopathy, Humans, Infant, Infant, Newborn, Infusions, Intravenous, Liver Failure, Acute, Liver Transplantation, Male, Severity of Illness Index, Survival Rate, Treatment Outcome, Pediatric Acute Liver Failure Study Group, Medical Biochemistry and Metabolomics, Immunology, Gastroenterology & Hepatology, Clinical sciences
Abstract

UnlabelledN-acetylcysteine (NAC) was found to improve transplantation-free survival in only those adults with nonacetaminophen (non-APAP) acute liver failure (ALF) and grade 1-2 hepatic encephalopathy (HE). Because non-APAP ALF differs significantly between children and adults, the Pediatric Acute Liver Failure (PALF) Study Group evaluated NAC in non-APAP PALF. Children from birth through age 17 years with non-APAP ALF enrolled in the PALF registry were eligible to enter an adaptively allocated, doubly masked, placebo-controlled trial using a continuous intravenous infusion of NAC (150 mg/kg/day in 5% dextrose in water [D5W]) or placebo (D5W) for up to 7 days. The primary outcome was 1-year survival. Secondary outcomes included liver transplantation-free survival, liver transplantation (LTx), length of intensive care unit (ICU) and hospital stays, organ system failure, and maximum HE score. A total of 184 participants were enrolled in the trial with 92 in each arm. The 1-year survival did not differ significantly (P = 0.19) between the NAC (73%) and placebo (82%) treatment groups. The 1-year LTx-free survival was significantly lower (P = 0.03) in those who received NAC (35%) than those who received placebo (53%), particularly, but not significantly so, among those less than 2 years old with HE grade 0-1 (NAC 25%; placebo 60%; P = 0.0493). There were no significant differences between treatment arms for hospital or ICU length of stay, organ systems failing, or highest recorded grade of HE.ConclusionNAC did not improve 1-year survival in non-APAP PALF. One-year LTx-free survival was significantly lower with NAC, particularly among those

Published
2013

6. Pegylated interferon for chronic hepatitis C in children affects growth and body composition: Results from the pediatric study of hepatitis C (PEDS‐C) trial

Author

Jonas, Maureen M, Balistreri, William, Gonzalez‐Peralta, Regino P, Haber, Barbara, Lobritto, Steven, Mohan, Parvathi, Molleston, Jean P, Murray, Karen F, Narkewicz, Michael R, Rosenthal, Philip, Schwarz, Kathleen B, Barton, Bruce A, Shepherd, John A, Mitchell, Paul D, and Duggan, Christopher

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Hepatitis, Clinical Trials and Supportive Activities, Pediatric, Nutrition, Chronic Liver Disease and Cirrhosis, Liver Disease, Obesity, Clinical Research, Hepatitis - C, Digestive Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Antiviral Agents, Body Composition, Body Height, Body Mass Index, Body Weight, Child, Child, Preschool, Cohort Studies, Drug Therapy, Combination, Eating, Fatty Liver, Female, Growth Disorders, Hepatitis C, Chronic, Humans, Interferon-alpha, Liver Cirrhosis, Male, Polyethylene Glycols, Recombinant Proteins, Ribavirin, Medical Biochemistry and Metabolomics, Immunology, Gastroenterology & Hepatology, Clinical sciences
Abstract

UnlabelledWeight loss and changes in growth are noted in children treated with interferon alpha (IFN-α). The aim of this study was to prospectively determine changes in weight, height, body mass index (BMI), and body composition during and after treatment of children with hepatitis C virus (HCV). Children treated with pegylated interferon alpha-2a (Peg-IFN-α2a) ± ribavirin in the Pediatric Study of Hepatitis C (PEDS-C) trial underwent anthropometric measurements, dual-energy X-ray absorptiometry scan, as well as dietary and activity assessments during and after treatment. One hundred and fourteen (55% male) children, with a mean age of 11 ± 3 years, were randomized, and 107 received treatment for at least 24 weeks. Subjects were divided into three groups according to duration of treatment: 24 (N = 14), 48 (N = 82), or 72 (N = 11) weeks. Decrements of up to 0.50 z score were observed for weight, height, and BMI while on therapy among all groups (P ≤ 0.01, compared to baseline). In the group treated for 48 weeks, 29 (33%) subjects had greater than 0.5-unit decrement in height-for-age z (HAZ) score. Though weight-for-age and BMI z scores returned to baseline after cessation of therapy, mean HAZ score was slower to rebound, still lower than baseline at 96 weeks post-therapy for the long-treatment duration group (P = 0.03) and lower than baseline in most children treated for 48 weeks. Percent body fat, fat-free mass z scores, and triceps skinfold z scores decreased with therapy. Dietary energy intake and levels of physical activity did not change during treatment.ConclusionsPeg-IFN-α2a was associated with significant changes in body weight, linear growth, BMI, and body composition in children. These effects were generally reversible with cessation of therapy, although HAZ scores had not returned to baseline after 2 years of observation in many. Longer term growth data are needed among children treated for chronic HCV.

Published
2012

9. Recurrence of Primary Sclerosing Cholangitis After Liver Transplant in Children: An International Observational Study

Author

Martinez, Mercedes, primary, Perito, Emily R., additional, Valentino, Pamela, additional, Mack, Cara L, additional, Aumar, Madeleine, additional, Broderick, Annemarie, additional, Draijer, Laura G., additional, Fagundes, Eleonora D.T., additional, Furuya, Katryn N., additional, Gupta, Nitika, additional, Horslen, Simon, additional, Jonas, Maureen M., additional, Kamath, Binita M., additional, Kerkar, Nanda, additional, Kim, Kyung Mo, additional, Kolho, Kaija‐Leena, additional, Koot, Bart G.P., additional, Laborda, Trevor J., additional, Lee, Christine K., additional, Loomes, Kathleen M., additional, Miloh, Tamir, additional, Mogul, Douglas, additional, Mohammed, Saeed, additional, Ovchinsky, Nadia, additional, Rao, Girish, additional, Ricciuto, Amanda, additional, Rodrigues Ferreira, Alexandre, additional, Schwarz, Kathleen B., additional, Smolka, Vratislav, additional, Tanaka, Atsushi, additional, Tessier, Mary E.M., additional, Venkat, Venna L., additional, Vitola, Bernadette E., additional, Woynarowski, Marek, additional, Zerofsky, Melissa, additional, and Deneau, Mark R., additional

Published
2021
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10. Oral Vancomycin, Ursodeoxycholic Acid, or No Therapy for Pediatric Primary Sclerosing Cholangitis: A Matched Analysis

Author

Deneau, Mark R., primary, Mack, Cara, additional, Mogul, Douglas, additional, Perito, Emily R., additional, Valentino, Pamela L., additional, Amir, Achiya Z., additional, DiGuglielmo, Matthew, additional, Draijer, Laura G., additional, El‐Matary, Wael, additional, Furuya, Katryn N., additional, Gupta, Nitika, additional, Hochberg, Jessica T., additional, Horslen, Simon, additional, Jensen, M. Kyle, additional, Jonas, Maureen M., additional, Kerkar, Nanda, additional, Koot, Bart G.P., additional, Laborda, Trevor J., additional, Lee, Christine K., additional, Loomes, Kathleen M., additional, Martinez, Mercedes, additional, Miethke, Alexander, additional, Miloh, Tamir, additional, Mohammad, Saeed, additional, Ovchinsky, Nadia, additional, Rao, Girish, additional, Ricciuto, Amanda, additional, Sathya, Pushpa, additional, Schwarz, Kathleen B., additional, Shah, Uzma, additional, Singh, Ruchi, additional, Vitola, Bernadette, additional, Zizzo, Andréanne, additional, and Guthery, Stephen L., additional

Published
2021
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15. The Sclerosing Cholangitis Outcomes in Pediatrics (SCOPE) Index: A Prognostic Tool for Children

Author

Deneau, Mark R., primary, Mack, Cara, additional, Perito, Emily R., additional, Ricciuto, Amanda, additional, Valentino, Pamela L., additional, Amin, Mansi, additional, Amir, Achiya Z., additional, Aumar, Madeleine, additional, Auth, Marcus, additional, Broderick, Annemarie, additional, DiGuglielmo, Matthew, additional, Draijer, Laura G., additional, Tavares Fagundes, Eleonora Druve, additional, El‐Matary, Wael, additional, Ferrari, Federica, additional, Furuya, Katryn N., additional, Gupta, Nitika, additional, Hochberg, Jessica T., additional, Homan, Matjaz, additional, Horslen, Simon, additional, Iorio, Raffaele, additional, Jensen, M. Kyle, additional, Jonas, Maureen M., additional, Kamath, Binita M., additional, Kerkar, Nanda, additional, Kim, Kyung Mo, additional, Kolho, Kaija‐Leena, additional, Koot, Bart G.P., additional, Laborda, Trevor J., additional, Lee, Christine K., additional, Loomes, Kathleen M., additional, Martinez, Mercedes, additional, Miethke, Alexander, additional, Miloh, Tamir, additional, Mogul, Douglas, additional, Mohammad, Saeed, additional, Mohan, Parvathi, additional, Moroz, Stacy, additional, Ovchinsky, Nadia, additional, Palle, Sirish, additional, Papadopoulou, Alexandra, additional, Rao, Girish, additional, Rodrigues Ferreira, Alexandre, additional, Sathya, Pushpa, additional, Schwarz, Kathleen B., additional, Shah, Uzma, additional, Shteyer, Eyal, additional, Singh, Ruchi, additional, Smolka, Vratislav, additional, Soufi, Nisreen, additional, Tanaka, Atsushi, additional, Varier, Raghu, additional, Vitola, Bernadette, additional, Woynarowski, Marek, additional, Zerofsky, Melissa, additional, Zizzo, Andréanne, additional, and Guthery, Stephen L., additional

Published
2020
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20. Ledipasvir‐Sofosbuvir for 12 Weeks in Children 3 to <6 Years Old With Chronic Hepatitis C

Author

Schwarz, Kathleen B., primary, Rosenthal, Philip, additional, Murray, Karen F., additional, Honegger, Jonathan R., additional, Hardikar, Winita, additional, Hague, Rosie, additional, Mittal, Naveen, additional, Massetto, Benedetta, additional, Brainard, Diana M., additional, Hsueh, Chia‐Hsiang, additional, Shao, Jiang, additional, Parhy, Bandita, additional, Narkewicz, Michael R., additional, Rao, Girish S., additional, Whitworth, Suzanne, additional, Bansal, Sanjay, additional, and Balistreri, William F., additional

Published
2019
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21. Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection

Author

Rosenthal, Philip, primary, Schwarz, Kathleen B., additional, Gonzalez‐Peralta, Regino P., additional, Lin, Chuan‐Hao, additional, Kelly, Deidre A., additional, Nightingale, Scott, additional, Balistreri, William F., additional, Bansal, Sanjay, additional, Jonas, Maureen M., additional, Massetto, Benedetta, additional, Brainard, Diana M., additional, Hsueh, Chia‐Hsiang, additional, Shao, Jiang, additional, Parhy, Bandita, additional, Davison, Suzanne, additional, Feiterna‐Sperling, Cornelia, additional, Gillis, Lynette A., additional, Indolfi, Giuseppe, additional, Sokal, Etienne M., additional, Murray, Karen F., additional, and Wirth, Stefan, additional

Published
2019
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22. Safety and Efficacy of Ledipasvir–Sofosbuvir With or Without Ribavirin for Chronic Hepatitis C in Children Ages 6‐11

Author

Murray, Karen F., primary, Balistreri, William F., additional, Bansal, Sanjay, additional, Whitworth, Suzanne, additional, Evans, Helen M., additional, Gonzalez‐Peralta, Regino P., additional, Wen, Jessica, additional, Massetto, Benedetta, additional, Kersey, Kathryn, additional, Shao, Jiang, additional, Garrison, Kimberly L., additional, Parhy, Bandita, additional, Brainard, Diana M., additional, Arnon, Ronen, additional, Gillis, Lynette A., additional, Jonas, Maureen M., additional, Lin, Chuan‐Hao, additional, Narkewicz, Michael R., additional, Schwarz, Kathleen, additional, and Rosenthal, Philip, additional

Published
2018
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23. Efficacy and Safety of Peginterferon Alfa‐2a (40KD) in Children With Chronic Hepatitis B: The PEG‐B‐ACTIVE Study

Author

Wirth, Stefan, primary, Zhang, Hongfei, additional, Hardikar, Winita, additional, Schwarz, Kathleen B., additional, Sokal, Etienne, additional, Yang, Weibo, additional, Fan, Huimin, additional, Morozov, Vyacheslav, additional, Mao, Qing, additional, Deng, Hong, additional, Huang, Yang, additional, Yang, Lei, additional, Frey, Nicolas, additional, Nasmyth‐Miller, Clare, additional, Pavlovic, Vedran, additional, and Wat, Cynthia, additional

Published
2018
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24. The safety and effectiveness of ledipasvir−sofosbuvir in adolescents 12‐17 years old with hepatitis C virus genotype 1 infection

Author

Balistreri, William F., primary, Murray, Karen F., additional, Rosenthal, Philip, additional, Bansal, Sanjay, additional, Lin, Chuan‐Hao, additional, Kersey, Kathryn, additional, Massetto, Benedetta, additional, Zhu, Yanni, additional, Kanwar, Bittoo, additional, German, Polina, additional, Svarovskaia, Evguenia, additional, Brainard, Diana M., additional, Wen, Jessica, additional, Gonzalez‐Peralta, Regino P., additional, Jonas, Maureen M., additional, and Schwarz, Kathleen, additional

Published
2017
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25. Randomized, controlled trial of entecavir versus placebo in children with hepatitis B envelope antigen-positive chronic hepatitis B

Author

Jonas, Maureen M., primary, Chang, Mei-Hwei, additional, Sokal, Etienne, additional, Schwarz, Kathleen B., additional, Kelly, Deirdre, additional, Kim, Kyung Mo, additional, Ling, Simon C., additional, Rosenthal, Philip, additional, Oraseanu, Dumitru, additional, Reynolds, Laurie, additional, Thiry, Alexandra, additional, and Ackerman, Peter, additional

Published
2015
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27. Reply

Author

Goodman, Zachary D., primary, Makhlouf, Hala R., additional, Liu, Lea, additional, Balistreri, William, additional, Gonzalez-Peralta, Regino P., additional, Haber, Barbara, additional, Jonas, Maureen M., additional, Mohan, Parvathi, additional, Molleston, Jean P., additional, Murray, Karen F., additional, Narkewicz, Michael R., additional, Rosenthal, Philip, additional, Smith, Lesley J., additional, and Schwarz, Kathleen B., additional

Published
2008
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28. Pathology of chronic hepatitis C in children: Liver biopsy findings in the Peds-C Trial

Author

Goodman, Zachary D., primary, Makhlouf, Hala R., additional, Liu, Lea, additional, Balistreri, William, additional, Gonzalez-Peralta, Regino P., additional, Haber, Barbara, additional, Jonas, Maureen M., additional, Mohan, Parvathi, additional, Molleston, Jean P., additional, Murray, Karen F., additional, Narkewicz, Michael R., additional, Rosenthal, Philip, additional, Smith, Lesley J., additional, Robuck, Patricia R., additional, and Schwarz, Kathleen B., additional

Published
2007
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