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2. A Real‐World Observational Cohort of Patients with Hepatocellular Carcinoma: Design and Rationale for TARGET‐HCC

Author

Cabrera, Roniel, Singal, Amit G, Colombo, Massimo, Kelley, R Kate, Lee, Hannah, Mospan, Andrea R, Meyer, Tim, Newell, Pippa, Parikh, Neehar D, Sangro, Bruno, Reddy, K Rajender, Watkins, Stephanie, Zink, Richard C, and Di Bisceglie, Adrian M

Subjects
Cancer, Hepatitis, Liver Disease, Liver Cancer, Chronic Liver Disease and Cirrhosis, Clinical Research, Clinical Trials and Supportive Activities, Digestive Diseases, Rare Diseases, Good Health and Well Being, Adult, Aged, Carcinoma, Hepatocellular, Europe, Female, Health Services Research, Humans, Liver Neoplasms, Longitudinal Studies, Male, Middle Aged, Outcome Assessment, Health Care, Prospective Studies, Research Design, United States
Abstract

This study describes the design of the TARGET-hepatocellular carcinoma (HCC) cohort and descriptive characteristics of the patient population at diagnosis among those who were enrolled in the cohort across academic and community clinical centers. TARGET-HCC is a 5-year, longitudinal, observational cohort of patients with HCC receiving care in usual clinical practice. Redacted clinical information, obtained from medical records, captures the natural history and management of the disease, including the safety and efficacy of treatment interventions used in usual clinical practice. Patients can complete patient-reported outcome measures and provide biological specimens for future translational studies. The TARGET-HCC study includes adults with histologic, cytologic, or radiologic diagnosis of HCC from academic and community centers in both the United States and Europe. A total of 1,841 participants were enrolled between January 9, 2017, and July 23, 2019, at 67 sites in the United States and Europe. To date, the most common liver disease etiology in the cohort continues to be hepatitis C, although nearly half had a nonviral etiology, including alcohol-related liver disease or nonalcoholic steatohepatitis. Most included patients were diagnosed at an early stage (Barcelona Clinic Liver Cancer Stage [BCLC] 0/A), but only approximately one third underwent curative treatment. Systemic therapy has been used in 7.3% of enrolled patients, including 45.7% of those with BCLC stage C tumors. Conclusion: Overall, the TARGET-HCC cohort allows for the assessment of patient characteristics and investigation of new treatment paradigms and sequencing with existing agents as well as novel regimens for HCC.

Published
2021

3. Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study

Author

Evon, Donna M, Sarkar, Souvik, Amador, Jipcy, Lok, Anna S, Sterling, Richard K, Stewart, Paul W, Reeve, Bryce B, Serper, Marina, Reau, Nancy, Reddy, K Rajender, Di Bisceglie, Adrian M, Nelson, David R, Golin, Carol E, Lim, Joseph K, and Fried, Michael W

Subjects
Behavioral and Social Science, Infectious Diseases, Emerging Infectious Diseases, Clinical Research, Brain Disorders, Hepatitis - C, Hepatitis, Chronic Liver Disease and Cirrhosis, Liver Disease, Digestive Diseases, Mental Health, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, 2-Naphthylamine, Adult, Aged, Aged, 80 and over, Amides, Anilides, Antiviral Agents, Benzimidazoles, Benzofurans, Carbamates, Cyclopropanes, Drug Therapy, Combination, Female, Fluorenes, Hepacivirus, Hepatitis C, Chronic, Heterocyclic Compounds, 4 or More Rings, Humans, Imidazoles, Lactams, Macrocyclic, Macrocyclic Compounds, Male, Middle Aged, Patient Reported Outcome Measures, Proline, Prospective Studies, Quinoxalines, Ritonavir, Sofosbuvir, Sulfonamides, Sustained Virologic Response, Uracil, Valine, Young Adult, HCV, Liver, PRO, Patient-reported outcome, Quality of life, Treatment, Sleep, Pain, Functioning, Symptom, Clinical Sciences, Public Health and Health Services, Gastroenterology & Hepatology
Abstract

Background & aimsA comprehensive analysis of changes in symptoms and functioning during and after direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection has not been conducted for patients treated in real-world clinical settings. Therefore, we evaluated patient-reported outcomes (PROs) in a diverse cohort of patients with HCV treated with commonly prescribed DAAs.MethodsPROP UP is a US multicenter observational study of 1,601 patients with HCV treated with DAAs in 2016-2017. PRO data were collected at baseline (T1), early on-treatment (T2), late on-treatment (T3) and 3-months post-treatment (T4). PRO mean change scores were calculated from baseline and a minimally important change (MIC) threshold was set at 5%. Regression analyses investigated patient and treatment characteristics independently associated with PRO changes on-treatment and post-treatment.ResultsOf 1,564 patients, 55% were male, 39% non-white, 47% had cirrhosis. Sofosbuvir/ledipasvir was prescribed to 63%, sofosbuvir/velpatasvir to 21%, grazoprevir/elbasvir to 11%, and paritaprevir/ombitasvir/ritonavir + dasabuvir to 5%. During DAA therapy, mean PRO scores improved slightly in the overall cohort, but did not reach the 5% MIC threshold. Between 21-53% of patients experienced >5% improved PROs while 23-36% experienced >5% worse symptoms. Of 1,410 patients with evaluable sustained virologic response (SVR) data, 95% achieved SVR. Among those with SVR, all mean PRO scores improved, with the 5% MIC threshold met for fatigue, sleep disturbance, and functioning well-being. Regression analyses identified subgroups, defined by age 35-55, baseline mental health issues and a higher number of health comorbidities as predictors of PRO improvements.ConclusionsIn real-world clinical practices, we observed heterogeneous patient experiences during and after DAA treatment. Symptom improvements were more pronounced in younger patients, those with baseline mental health issues and multiple comorbidities.Lay summaryPatients who received direct-acting antiviral medications for hepatitis C at several liver centers in the US did not generally experience significant changes in baseline symptoms during treatment. We observed a full range of patient experiences with some patients experiencing substantial symptom improvements, yet others experiencing less improvements and some even experiencing a worsening of symptoms. The 1,346 patients who were cured of hepatitis C experienced improvements in fatigue, sleep disturbance, and functional well-being, and trends for improved pain and depression; whereas the 64 who were not cured experienced minimal improvements. Clinicaltrial.gov: NCT02601820.

Published
2019

4. Age, race and viral genotype are associated with the prevalence of hepatitis B e antigen in children and adults with chronic hepatitis B

Author

Di Bisceglie, Adrian M, King, Wendy C, Lisker‐Melman, Mauricio, Khalili, Mandana, Belle, Steven H, Feld, Jordan J, Ghany, Marc G, Janssen, Harry LA, Lau, Daryl, Lee, William M, Ling, Simon C, Cooper, Stewart, Rosenthal, Philip, Schwarz, Kathleen B, Sterling, Richard K, Teckman, Jeffrey H, Terrault, Norah, and Network, the Hepatitis B Research

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Digestive Diseases, Infectious Diseases, Cancer, Genetics, Chronic Liver Disease and Cirrhosis, Clinical Research, Pediatric, Hepatitis, Liver Disease, Hepatitis - B, 2.1 Biological and endogenous factors, Infection, Good Health and Well Being, Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Child, Child, Preschool, DNA, Viral, Female, Genotype, Hepatitis B e Antigens, Hepatitis B virus, Hepatitis B, Chronic, Humans, Infant, Male, Middle Aged, Population Groups, Public Health Surveillance, Seroepidemiologic Studies, Viral Load, Young Adult, e antigen, hepatitis B, natural history, Hepatitis B Research Network, Microbiology, Medical Microbiology, Gastroenterology & Hepatology, Clinical sciences, Medical microbiology
Abstract

Hepatitis B e antigen (HBeAg) is an important serological marker of hepatitis B virus (HBV) infection and is associated with higher levels of viraemia, increased risk of infectivity to others and increased risk of hepatocellular carcinoma. We analysed HBeAg status in a large cohort of adults and children enrolled in Cohort Studies of the Hepatitis B Research Network, long-term natural history studies of chronic HBV infection. A cross-sectional analysis examined factors associated with HBeAg positivity, including demographic and virologic data, across the age spectrum. Among 2241 enrolled participants who met criteria for this analysis, 825 (37%) were seropositive for HBeAg. The prevalence of HBeAg was lower in those with older age, ranging from 85% among those up to 10 years of age to only 12% among those older than 50 years. In addition to age, both race and HBV genotype were independently associated with HBeAg positivity. There was a significant interaction between age and race; the prevalence of HBeAg was significantly higher among Asians > 10-30 years old vs Whites or Blacks who were >10 to 30 years old and those infected with HBV genotype C. Conversely, the presence of the basal core promoter and precore variants was associated with significantly lower prevalence of HBeAg, even when adjusted for age, race and genotype. These data will provide a better understanding of factors associated with seropositivity for HBeAg and may lead to better strategies for preventing HBV infection and broader indications for antiviral therapy.

Published
2019

5. Review article: Recommendations for detection, assessment and management of suspected drug‐induced liver injury during clinical trials in oncology patients.

Author

Fettiplace, Anna, Marcinak, John, Merz, Michael, Zhang, Hui‐Talia, Kikuchi, Luciana, Regev, Arie, Palmer, Melissa, Rockey, Don, Fontana, Robert, Hayashi, Paul H., Tillmann, Hans L., Di Bisceglie, Adrian M., and Lewis, James H.

Subjects
LITERATURE reviews, CANCER patients, ANTINEOPLASTIC agents, CONSORTIA, CLINICAL trials
Abstract

Summary: Background: Drug‐induced liver injury (DILI) is a major concern for oncology drugs in clinical practice and under development. Monitoring cancer patients for hepatotoxicity is challenging as these patients may have abnormal liver tests pre‐treatment or on‐study for many reasons including liver injury due to past oncology treatments, hepatic metastases, medical co‐morbidities such as heart failure, and concomitant medications. At present, there are no regulatory guidelines or position papers that systematically address best practices pertaining to DILI detection, assessment and management in oncology patients. Aims: The goals of this review are (1) to examine and interpret the available evidence and (2) to make recommendations for detection, monitoring, adjudication, and management of suspected hepatocellular DILI during oncology clinical trials. Methods: This manuscript was developed by the IQ Consortium (International Consortium for Innovation and Quality in pharmaceutical development) DILI Initiative that consists of members from 17 pharmaceutical companies, in collaboration with academic and regulatory DILI experts. The manuscript is based on extensive literature review, expert interpretation of the literature, and several rounds of consensus discussions. Results: This review highlights recommendations for patient eligibility for clinical trials with or without primary/metastatic liver involvement, as well as changes in liver tests that should trigger increased monitoring and/or discontinuation of study drug. Guidance regarding causality assessment for suspected DILI events, rechallenge and dose‐modification is provided. Conclusions: This review brings together evidence‐based recommendations and expert opinion to provide the first dedicated consensus for best practices in detection, assessment, and management of DILI in oncology clinical trials. [ABSTRACT FROM AUTHOR]

Published
2024
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7. A comprehensive assessment of patient reported symptom burden, medical comorbidities, and functional well being in patients initiating direct acting antiviral therapy for chronic hepatitis C: Results from a large US multi-center observational study

Author

Evon, Donna M, Stewart, Paul W, Amador, Jipcy, Serper, Marina, Lok, Anna S, Sterling, Richard K, Sarkar, Souvik, Golin, Carol E, Reeve, Bryce B, Nelson, David R, Reau, Nancy, Lim, Joseph K, Reddy, K Rajender, Di Bisceglie, Adrian M, and Fried, Michael W

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Digestive Diseases, Pain Research, Hepatitis, Infectious Diseases, Chronic Liver Disease and Cirrhosis, Hepatitis - C, Patient Safety, Emerging Infectious Diseases, Chronic Pain, Clinical Research, Clinical Trials and Supportive Activities, Liver Disease, Substance Misuse, Good Health and Well Being, Adult, Aged, Aged, 80 and over, Antiviral Agents, Cohort Studies, Comorbidity, Female, Hepatitis C, Chronic, Humans, Insurance, Major Medical, International Normalized Ratio, Liver, Liver Cirrhosis, Male, Mental Disorders, Middle Aged, Patient Reported Outcome Measures, RNA, Viral, United States, Young Adult, General Science & Technology
Abstract

BackgroundSymptom burden, medical comorbidities, and functional well-being of patients with chronic hepatitis C virus (HCV) initiating direct acting antiviral (DAA) therapy in real-world clinical settings are not known. We characterized these patient-reported outcomes (PROs) among HCV-infected patients and explored associations with sociodemographic, liver disease, and psychiatric/substance abuse variables.Methods and findingsPROP UP is a large US multicenter observational study that enrolled 1,600 patients with chronic HCV in 2016-2017. Data collected prior to initiating DAA therapy assessed the following PROs: number of medical comorbidities; neuropsychiatric, somatic, gastrointestinal symptoms (PROMIS surveys); overall symptom burden (Memorial Symptom Assessment Scale); and functional well-being (HCV-PRO). Candidate predictors included liver disease markers and patient-reported sociodemographic, psychiatric, and alcohol/drug use features. Predictive models were explored using a random selection of 700 participants; models were then validated with data from the remaining 900 participants. The cohort was 55% male, 39% non-white, 48% had cirrhosis (12% with advanced cirrhosis); 52% were disabled or unemployed; 63% were on public health insurance or uninsured; and over 40% had markers of psychiatric illness. The median number of medical comorbidities was 4 (range: 0-15), with sleep disorders, chronic pain, diabetes, joint pain and muscle aches being present in 20-50%. Fatigue, sleep disturbance, pain and neuropsychiatric symptoms were present in over 60% and gastrointestinal symptoms in 40-50%. In multivariable validation models, the strongest and most frequent predictors of worse PROs were disability, unemployment, and use of psychiatric medications, while liver markers generally were not.ConclusionsThis large multi-center cohort study provides a comprehensive and contemporary assessment of the symptom burden and comorbid medical conditions in patients with HCV treated in real world settings. Pain, fatigue, and sleep disturbance were common and often severe. Sociodemographic and psychiatric markers were the most robust predictors of PROs. Future research that includes a rapidly changing population of HCV-infected individuals needs to evaluate how DAA therapy affects PROs and elucidate which symptoms resolve with viral eradication.Trial registration(Clinicaltrial.gov: NCT02601820).

Published
2018

8. Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment

Author

Evon, Donna M, Golin, Carol E, Stewart, Paul, Fried, Michael W, Alston, Shani, Reeve, Bryce, Lok, Anna S, Sterling, Richard K, Lim, Joseph K, Reau, Nancy, Sarkar, Souvik, Nelson, David R, Reddy, KR, and Di Bisceglie, Adrian M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Digestive Diseases, Hepatitis, Clinical Trials and Supportive Activities, Substance Misuse, Liver Disease, Hepatitis - C, Infectious Diseases, Chronic Liver Disease and Cirrhosis, Behavioral and Social Science, Comparative Effectiveness Research, Drug Abuse (NIDA only), Clinical Research, Emerging Infectious Diseases, Good Health and Well Being, Adult, Antiviral Agents, Benzimidazoles, Benzofurans, Carbamates, Drug Combinations, Female, Fluorenes, Hepatitis C, Chronic, Heterocyclic Compounds, 4 or More Rings, Humans, Imidazoles, Macrocyclic Compounds, Male, Patient Participation, Patient-Centered Care, Prospective Studies, Pyrrolidines, Quinoxalines, Ritonavir, Sofosbuvir, Sulfonamides, Treatment Outcome, Uracil, Uridine Monophosphate, Valine, Liver, Patient-reported outcomes, Patient-centered outcomes research, Direct acting antiviral, Medical and Health Sciences, General Clinical Medicine, Public Health, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundNew highly efficacious direct-acting antiviral (DAA) therapies are available to treat chronic hepatitis C viral (HCV) infection. Real-world, patient-centered data on harms and benefits associated with these therapies are needed.MethodsPROP UP is a multi-center prospective observational study that plans to enroll 1600 patients starting treatment with recently-approved DAA regimens. Informed by extensive input from a HCV patient engagement group who prioritized outcomes most important to them, patient-reported outcomes will be characterized using surveys at five time points: Baseline (T1), treatment week 4 (T2), end of treatment (T3), 12weeks post-treatment (T4), 12months post-treatment (T5).Outcomes(1) Changes in side effects, functioning, pre-existing conditions, and out-of-pocket costs during therapy (T1 vs T2/T3); (2) Medication adherence in relation to a history of mental health/substance abuse, treatment regimens, pill burden, reasons for missed doses, and cure rates; (3) Short term impact of cure on functioning and amelioration of symptoms (T1 vs T4); (4) Long-term treatment harms or benefits of cure on symptoms, side effects, pre-existing conditions, and functioning (T1 vs T5). Similarities between regimens will be examined where comparisons are appropriate and meaningful.ConclusionPROP UP complements previous clinical trials by focusing on patient-reported outcomes in a representative sample of patients treated in clinical practice, by collaborating with a patient engagement group, by characterizing the experiences of vulnerable subgroups, and by investigating long-term harms and benefits of treatments. PROP UP is designed to provide novel and detailed information to support informed decision-making for patients and providers contemplating HCV treatment (PCORI CER-1408-20,660; NCT02601820).

Published
2017

9. Best practices for detection, assessment and management of suspected immune-mediated liver injury caused by immune checkpoint inhibitors during drug development

Author

Regev, Arie, Avigan, Mark I., Kiazand, Alexandre, Vierling, John M., Lewis, James H., Omokaro, Stephanie O., Di Bisceglie, Adrian M., Fontana, Robert J., Bonkovsky, Herbert L., Freston, James W., Uetrecht, Jack P., Miller, Ethan D., Pehlivanov, Nonko D., Haque, Syed Asif, Harrison, Melanie J., Kullak-Ublick, Gerd A., Li, Hewei, Patel, Niti N., Patwardhan, Meenal, Price, Karen D., Watkins, Paul B., and Chalasani, Naga P.

Published
2020
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11. Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated With Sustained Virologic Response

Author

Terrault, Norah A, Zeuzem, Stefan, Di Bisceglie, Adrian M, Lim, Joseph K, Pockros, Paul J, Frazier, Lynn M, Kuo, Alexander, Lok, Anna S, Shiffman, Mitchell L, Ari, Ziv Ben, Akushevich, Lucy, Vainorius, Monika, Sulkowski, Mark S, Fried, Michael W, Nelson, David R, and Group, HCV-TARGET Study

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Hepatitis - C, Infectious Diseases, Chronic Liver Disease and Cirrhosis, Emerging Infectious Diseases, Digestive Diseases, Liver Disease, Hepatitis, Clinical Research, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Antiviral Agents, Benzimidazoles, Bilirubin, Drug Therapy, Combination, Female, Fluorenes, Genotype, Hepacivirus, Hepatitis C, Chronic, Humans, Liver Cirrhosis, Longitudinal Studies, Male, Middle Aged, Prospective Studies, Proton Pump Inhibitors, Ribavirin, Risk Factors, Serum Albumin, Sofosbuvir, Sustained Virologic Response, Time Factors, Treatment Failure, Uridine Monophosphate, Young Adult, DAA, NS5A Inhibitor, NS5B Inhibitor, Antiviral, HCV-TARGET Study Group, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology, Clinical sciences, Nutrition and dietetics
Abstract

Background & aimsThe combination of ledipasvir and sofosbuvir has been approved for treatment of genotype 1 hepatitis C virus (HCV) infection, including an 8-week regimen for treatment-naïve patients without cirrhosis and a baseline level of HCV RNA

Published
2016

12. Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis

Author

Treem, William R., Palmer, Melissa, Lonjon-Domanec, Isabelle, Seekins, Daniel, Dimick-Santos, Lara, Avigan, Mark I., Marcinak, John F., Dash, Ajit, Regev, Arie, Maller, Eric, Patwardhan, Meenal, Lewis, James H., Rockey, Don C., Di Bisceglie, Adrian M., Freston, James W., Andrade, Raul J., and Chalasani, Naga

Published
2021
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13. HBV Genotype-Specific Levels of Hepatitis B Surface Antigen Improve HBV Phenotype Definition

Author

Niu, Jianghe, Javaid, Asad, Nasir, Bilal, Susheela, Ammu, Nasser, Imad, Rusibamayila, Nifasha, Foley, Cara, Stahler, Alisha C., Stadheim, Linda, Lake, John, Lacher, Philip, Rushing, Kathryn, Nagy, Rosemary A., Cerkoski, Jacki, DeMarco Shaw, Debra, Kessels, Lisa, Klebert, Michael K., Noureldin, Seham, La, Danie, Liu, Lucie, Kaznowski, Diana, Chen, Jiayun, Vladutu, Doinita, Cerocchi, Orlando, Rowan, Debra, Bass, Sheila, Lilly, Barbara, French, Samuel, Peacock, Velma, Shobe, Ashley, Davis, Rayshawnda, Kuras, Romuald, Ayala, Claudia, Lau, Ivy, Podolskaya, Veronika, von Bakonyi, Anna, DeVole, Nata, McKenna, Barbara, Choi, Karen, Oberhelman, Kelly, Kaza, Sravanthi, Bowen, Abigail, Kalathil, Sumodh, Huddleston, Leslie, Wong, Richmond, Barritt, A. Sidney, Marsh, Tiffany, Metheny, Vikki, Cardona, Danielle, Luketic, Velimir A., Smith, Paula G., Hofmann, Charlotte, Wolfstone, Alycia, Mooney, Jody, Cardona-Gonzalez, Lupita, Fryzek, Nancy, Rivera, Elenita, Morris, Nevitt, Haynes-Williams, Vanessa, Huang, Amy, Sherker, Averell H., Torrance, Rebecca J., Hall, Sherry R., Valiga, Mary E., Torrey, Keith, Levine, Danielle, Keith, James, Betts, Michael, Montaner, Luis J., Averbach, Frani, Haller, Tamara, Hardison, Regina, Kelley, Stephanie, Lawlor, Sharon, Lin, Hsing-Hua (Sylvia), Liu, Stephen, Lombardero, Manuel, Pelesko, Andrew, Stoliker, Donna, Weiner, Melissa, Zadorozny, Ella, Brouwer, Willem P., Zhao, Qian, Hansen, Bettina E., Lau, Daryl, Khalili, Mandana, Terrault, Norah A., Di Bisceglie, Adrian M., Perrillo, Robert P., Fried, Michael W., Wong, David, Feld, Jordan J., Belle, Steven H., and Janssen, Harry L.A.

Published
2020
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16. Association Between Severe Serum Alanine Aminotransferase Flares and Hepatitis B e Antigen Seroconversion and HBV DNA Decrease in Untreated Patients With Chronic HBV Infection

Author

Lau, Daryl T-Y., Chung, Raymond T., Roberts, Lewis R., Hassan, Mohamed A., Lisker-Melman, Mauricio, Wong, David K., Juan, Joshua, Yim, Colina, Patel, Keyur, Murakami, Carol S., Do, Son, Han, Steven-Huy B., Tran, Tram T., Khalili, Mandana, Cooper, Stewart L., Fontana, Robert J., Tsai, Naoky, Younoszai, Barak, Muir, Andrew, Evon, Donna, Darling, Jama M., Carithers, Robert C., Shuhart, Margaret, Kowdley, Kris V., Wang, Chia C., Sterling, Richard K., Ghany, Marc G., Liang, T. Jake, Hoofnagle, Jay H., Doo, Edward, Chang, Kyong-Mi, Park, Jang-June, Wahed, Abdus, Cloonan, Yona, Kleiner, David, Brahmania, Mayur, Lombardero, Manuel, Hansen, Bettina E., Terrault, Norah A., Lok, Anna S., Perrillo, Robert P., Belle, Steven H., Di Bisceglie, Adrian M., Feld, Jordan J., Lee, William M., Fried, Michael W., and Janssen, Harry L.A.

Published
2019
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17. Characteristics of Adults in the Hepatitis B Research Network in North America Reflect Their Country of Origin and Hepatitis B Virus Genotype

Author

Ghany, Marc G, Perrillo, Robert, Li, Ruosha, Belle, Steven H, Janssen, Harry LA, Terrault, Norah A, Shuhart, Margaret C, Lau, Daryl T-Y, Kim, W Ray, Fried, Michael W, Sterling, Richard K, Di Bisceglie, Adrian M, Han, Steven-Huy B, Ganova-Raeva, Lilia Milkova, Chang, Kyong-Mi, Lok, Anna Suk-Fong, Network, Hepatitis B Research, Chung, Raymond T, Roberts, Lewis R, Smith, Coleman I, Lisker-Melman, Mauricio, Wong, David K, Juan, Joshua, Feld, Jordan, Yim, Colina, Heathcoate, Jenny, Lee, William M, Do, Son, Tran, Tram T, Khalili, Mandana, Cooper, Stewart L, Fontana, Robert J, Tsai, Naoky, Patel, Keyur, Evon, Donna, Carithers, Robert C, Kowdley, Kris V, Wang, Chia C, Liang, T Jake, Park, Jang-June, Wahed, Abdus, Kleiner, David, Afdhal, Nezam, Javaid, Asad, Niu, Jianghe, Han, Johanna, Nasser, Imad, Stahler, Alisha C, Stadheim, Linda, Hassan, Mohamed, King, Debra L, Nagy, Rosemary A, La, Danie, Liu, Lucie, Minshall, Stacey, Bass, Sheila, French, Samuel, Peacock, Velma, Ungermann, Ashley, Ayala, Claudia, Olson, Emma, Lau, Ivy, Podolskaya, Veronika, DeVole, Nata, McKenna, Barbara, Oberhelman, Kelly, Kaza, Sravanthi, Rodd, Cassandra, Huddleston, Leslie, Poerzgen, Peter, Darling, Jama M, Barritt, A Sidney, Marsh, Tiffany, Metheny, Vikki, Cardona, Danielle, Luketic, Velimir A, Smith, Paula G, Hofmann, Charlotte, Mathisen, Terri, Strom, Susan, Mooney, Jody, Cardona-Gonzalez, Lupita, Fryzek, Nancy, Rivera, Elenita, Morris, Nevitt, Haynes-Williams, Vanessa, Valiga, Mary E, Torrey, Keith, Levine, Danielle, Keith, James, Betts, Michael, Montaner, Luis J, Teo, Chong-Gee, Khudyakov, Yury, Punkova, Lili T, Cloonan, Yona, Danielson, Michelle, Haller, Tamara, Johnson, Geoffrey, and Kelley, Stephanie

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Chronic Liver Disease and Cirrhosis, Hepatitis - B, Liver Disease, Digestive Diseases, Infectious Diseases, Hepatitis, Infection, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Canada, Emigrants and Immigrants, Female, Genotype, Hepatitis B virus, Hepatitis B, Chronic, Humans, Male, Middle Aged, United States, Young Adult, HBeAg, Chronic Hepatitis B Virus Infection, USA, ALT, Hepatitis B Research Network, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsChronic hepatitis B virus (HBV) infection is an important cause of cirrhosis and hepatocellular carcinoma worldwide; populations that migrate to the United States and Canada might be affected disproportionately. The Hepatitis B Research Network (HBRN) is a cooperative network of investigators from the United States and Canada, created to facilitate clinical, therapeutic, and translational research in adults and children with hepatitis B. We describe the structure of the network and baseline characteristics of adults with hepatitis B enrolled in the network.MethodsThe HBRN collected data on the clinical characteristics of 1625 adults with chronic HBV infection who are not receiving antiviral therapy from 21 clinical centers in North America.ResultsHalf of the subjects in the HBRN are men, and the median age is 42 years; 72% are Asian, 15% are black, and 11% are white; with 82% born outside of North America. The most common HBV genotype was B (39%); 74% of subjects were negative for the hepatitis B e antigen. The median serum level of HBV DNA when the study began was 3.6 log10 IU/mL; 68% of male subjects and 67% of female subjects had alanine aminotransferase levels higher than the normal range.ConclusionsThe HBRN cohort is used to address important clinical and therapeutic questions for North Americans infected with chronic HBV and to guide health policies on HBV prevention and management in North America.

Published
2015

20. Frequency of elevated hepatocellular carcinoma (HCC) biomarkers in patients with advanced hepatitis C.

Author

Sterling, Richard K, Wright, Elizabeth C, Morgan, Timothy R, Seeff, Leonard B, Hoefs, John C, Di Bisceglie, Adrian M, Dienstag, Jules L, and Lok, Anna S

Subjects
Biomarkers: blood, Carcinoma, Hepatocellular: blood, complications, Disease Progression, Female, Hepatitis C: complications, Humans, Liver Neoplasms: blood, complications, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Protein Isoforms: blood, Protein Precursors: blood, Prothrombin, alpha-Fetoproteins: analysis
Abstract

Prospective studies of serum hepatocellular carcinoma (HCC) biomarkers in patients with advanced hepatitis C are lacking. The aim of this study was to determine the frequencies and performance of elevated α-fetoprotein (AFP), AFP-L3, and des-γ-carboxy prothrombin (DCP) levels as HCC biomarkers in advanced hepatitis C.Patients in the HALT-C Trial were tested every 3 months for 42 months. Screening ultrasound was performed every 12 months. Levels of biomarkers were compared in patients in whom HCC did or did not develop.In all, 855 patients were evaluated; HCC developed in 46. Among patients without HCC, 73.2% had AFP consistently

Published
2012

27. Hepatitis B Virus–Specific and Global T-Cell Dysfunction in Chronic Hepatitis B

Author

Chung, Raymond T., Roberts, Lewis R., Di Bisceglie, Adrian M., Lisker-Melman, Mauricio, Janssen, Harry L.A., Juan, Joshua, Yim, Colina, Heathcote, Jenny, Perrillo, Robert, Do, Son, Han, Steven-Huy B., Tran, Tram T., Cooper, Stewart L., Fontana, Robert J., Tsai, Naoky, Fried, Michael W., Patel, Keyur, Evon, Donna, Shuhart, Margaret, Wang, Chia C., Ghany, Marc G., Liang, T. Jake, Belle, Steven, Cloonan, Yona, Kleiner, David, Park, Jang-June, Wong, David K., Wahed, Abdus S., Lee, William M., Feld, Jordan J., Terrault, Norah, Khalili, Mandana, Sterling, Richard K., Kowdley, Kris V., Bzowej, Natalie, Lau, Daryl T., Kim, W. Ray, Smith, Coleman, Carithers, Robert L., Torrey, Keith W., Keith, James W., Levine, Danielle L., Traum, Daniel, Ho, Suzanne, Valiga, Mary E., Johnson, Geoffrey S., Doo, Edward, Lok, Anna S.F., and Chang, Kyong-Mi

Published
2016
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28. Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection

Author

Afdhal, N., Alam, I., Ben-Ari, Z., Bredfeldt, J., Brown, R.S., Chung, R.T., Darling, J., Harlan, W., Di Bisceglie, A.M., Dickson, R.C., Elbeshbeshy, H.A., Everson, G., Feld, J., Fenkel, J.M., Fried, M.W., Galati, J., Gordon, S.C., Hassan, M., Hawkins, T.N., Hinestrosa, F., Jacobson, I.M., Kerr, C.A., Kuo, A., Kwo, P.Y., Levitsky, J., Lim, J., Lok, A.S., Mailliard, M., Manns, M.P., Morelli, G., Muir, A.J., Nelson, D., O’Leary, J.G., Pearlman, B.L., Pockros, P., Ramani, A., Reau, N., Reddy, K.R., Schiff, E.R., Sherman, K.E., Shiffman, M.L., Smith, C., Spivey, J.R., Sterling, R.K., Sulkowski, M.S., Szabo, G., Terrault, N.A., Trautwein, C., Vargas, H.E., Watts, K., Williams, A., Zeuzem, S., Sulkowski, Mark S., Vargas, Hugo E., Di Bisceglie, Adrian M., Kuo, Alexander, Reddy, K. Rajender, Lim, Joseph K., Morelli, Giuseppe, Darling, Jama M., Feld, Jordan J., Brown, Robert S., Frazier, Lynn M., Stewart, Thomas G., Fried, Michael W., Nelson, David R., and Jacobson, Ira M.

Published
2016
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32. Immunostaining for Hepatitis B Viral Antigens in Liver: Association with Clinical, Biochemical and Virologic Features of Disease

Author

Kleiner, David E., primary, Lisker‐Melman, Mauricio, additional, Wahed, Abdus S., additional, Bhan, Atul K., additional, Nalesnik, Michael A., additional, Choi, Eun‐Young K., additional, Leonard, Kelsey K., additional, Ghany, Marc G., additional, Chung, Raymond T., additional, and Di Bisceglie, Adrian M., additional

Published
2023
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33. Characteristics of Adults in the Hepatitis B Research Network in North America Reflect Their Country of Origin and Hepatitis B Virus Genotype

Author

Chung, Raymond T., Roberts, Lewis R., Smith, Coleman I., Lisker-Melman, Mauricio, Wong, David K., Juan, Joshua, Feld, Jordan, Yim, Colina, Heathcoate, Jenny, Lee, William M., Do, Son, Tran, Tram T., Khalili, Mandana, Cooper, Stewart L., Fontana, Robert J., Tsai, Naoky, Patel, Keyur, Evon, Donna, Carithers, Robert C., Kowdley, Kris V., Wang, Chia C., Liang, T. Jake, Park, Jang-June, Wahed, Abdus, Kleiner, David, Afdhal, Nezam, Javaid, Asad, Niu, Jianghe, Han, Johanna, Nasser, Imad, Stahler, Alisha C., Stadheim, Linda, Hassan, Mohamed, King, Debra L., Nagy, Rosemary A., La, Danie, Liu, Lucie, Minshall, Stacey, Bass, Sheila, French, Samuel, Peacock, Velma, Ungermann, Ashley, Ayala, Claudia, Olson, Emma, Lau, Ivy, Podolskaya, Veronika, DeVole, Nata, McKenna, Barbara, Oberhelman, Kelly, Kaza, Sravanthi, Rodd, Cassandra, Huddleston, Leslie, Poerzgen, Peter, Darling, Jama M., Barritt, A. Sidney, Marsh, Tiffany, Metheny, Vikki, Cardona, Danielle, Luketic, Velimir A., Smith, Paula G., Hofmann, Charlotte, Mathisen, Terri, Strom, Susan, Mooney, Jody, Cardona-Gonzalez, Lupita, Fryzek, Nancy, Rivera, Elenita, Morris, Nevitt, Haynes-Williams, Vanessa, Valiga, Mary E., Torrey, Keith, Levine, Danielle, Keith, James, Betts, Michael, Montaner, Luis J., Teo, Chong-Gee, Khudyakov, Yury, Punkova, Lili T., Cloonan, Yona, Danielson, Michelle, Haller, Tamara, Johnson, Geoffrey, Kelley, Stephanie, Lawlor, Sharon, Li, Ruosha, Lombardero, Manuel, MacGregor, Joan M., Pelesko, Andrew, Stoliker, Donna, Walters, Barbara, Zadorozny, Ella, Ghany, Marc G., Perrillo, Robert, Belle, Steven H., Janssen, Harry L.A., Terrault, Norah A., Shuhart, Margaret C., Lau, Daryl T.-Y., Kim, W. Ray, Fried, Michael W., Sterling, Richard K., Di Bisceglie, Adrian M., Han, Steven-Huy B., Ganova-Raeva, Lilia Milkova, Chang, Kyong-Mi, and Lok, Anna Suk-Fong

Published
2015
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34. Randomized Trial of Tenofovir With or Without Peginterferon Alfa Followed by Protocolized Treatment Withdrawal in Adults With Chronic Hepatitis B

Author

Terrault, Norah A., primary, Lok, Anna S., additional, Wahed, Abdus S., additional, Ghany, Marc G., additional, Perrillo, Robert P., additional, Fried, Michael W., additional, Wong, David K., additional, Khalili, Mandana, additional, Lau, Daryl T.Y., additional, Sterling, Richard K., additional, Di Bisceglie, Adrian M., additional, Lisker-Melman, M., additional, Cooper, Stewart L., additional, Chung, Ray T., additional, Patel, Keyur, additional, Roberts, Lewis R., additional, Belle, Steven H., additional, and Janssen, Harry L.A., additional

Published
2022
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35. Efficacy of Immunotherapy With TG4040, Peg-Interferon, and Ribavirin in a Phase 2 Study of Patients With Chronic HCV Infection

Author

Di Bisceglie, Adrian M., Janczweska–Kazek, Ewa, Habersetzer, François, Mazur, Wlodzimierz, Stanciu, Carol, Carreno, Vicente, Tanasescu, Coman, Flisiak, Robert, Romero–Gomez, Manuel, Fich, Alexander, Bataille, Vincent, Toh, Myew–Ling, Hennequi, Marie, Zerr, Patricia, Honnet, Géraldine, Inchauspé, Geneviève, Agathon, Delphine, Limacher, Jean–Marc, and Wedemeyer, Heiner

Published
2014
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36. Contributors

Author

Allampati, Sanath, primary, Ayles, Helen M., additional, Bacon, Bruce R., additional, Bailey, Sarah Lou, additional, Balistreri, William F., additional, Bang, Ji Young, additional, Benias, Petros C., additional, Berenguer, Marina, additional, Bethea, Emily D., additional, Bhamidimarri, Kalyan Ram, additional, Bowlus, Christopher L., additional, Cardenas, Andres, additional, Carrion, Andres F., additional, Choi, Steve S., additional, Chopra, Sanjiv, additional, Chung, Raymond T., additional, Cobbold, Jeremy F.L., additional, Curry, Michael P., additional, Czaja, Albert J., additional, de Castro, Teresita Gomez, additional, deLemos, Andrew S., additional, Di Bisceglie, Adrian M., additional, Diehl, Anna Mae, additional, Fontana, Robert J., additional, Friedman, Lawrence S., additional, Ginès, Pere, additional, Grace, Norman D., additional, Han, Steven-Huy B., additional, Hirschfield, Gideon M., additional, House, Michael G., additional, Waasdorp Hurtado, Christine E., additional, Jacobson, Ira M., additional, Kowdley, Kris V., additional, Lai, Michelle, additional, Lefkowitch, Jay H., additional, Lertudomphonwanit, Chatmanee, additional, Lewis, James H., additional, Lillemoe, Keith D., additional, Lo Re, Vincent, additional, Manickavasagan, Hanisha, additional, Martin, Paul, additional, Mayo, Marlyn J., additional, Mitchell, Mack C., additional, Mullen, Kevin D., additional, Muñoz, Santiago J., additional, Neuschwander-Tetri, Brent A., additional, Nguyen, Kelvin T., additional, Patidar, Kavish R., additional, Pringle, Patricia, additional, Procaccini, Nicholas J., additional, Puleo, James, additional, Reddy, K. Rajender, additional, Rosen, Hugo R., additional, Sanyal, Arun J., additional, Schilsky, Michael L., additional, Sherman, Stuart, additional, Sokol, Ronald J., additional, Spengler, Erin, additional, Stoffel, Elena M., additional, Summerfield, John A., additional, Tapper, Elliot B., additional, Tran, Tram T., additional, Vinaixa, Carmen, additional, Webb, Gwilym J., additional, Weine, Douglas M., additional, Wolf, Jacqueline L., additional, Wong, Florence S., additional, and Zhang, Wei, additional

Published
2018
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41. Prevalence of hepatitis B antiviral drug resistance variants in North American patients with chronic hepatitis B not receiving antiviral treatment

Author

Lok, A. S., Ganova‐Raeva, L., Cloonan, Y., Punkova, L., Lin, H.‐H. S., Lee, W. M., Ghany, M. G., Lau, Daryl T‐Y, Chung, Raymond T., Roberts, Lewis R., Smith, Coleman I., Di Bisceglie, Adrian M., ‐Melman, Mauricio, Janssen, L. A., Wong, David K., Juan, Joshua, Feld, Jordan, Yim, Colina, Heathcote, Jenny, Perrillo, Robert, Do, Son, Han, Steven‐Huy B., Tran, Tram T., Terrault, Norah A., Khalili, Mandana, Cooper, Stewart L., Fontana, Robert J., Tsai, Naoky, Fried, Michael W., Patel, Keyur, Evon, Donna, Carithers, Robert C., Shuhart, Margaret, Kowdley, Kris V., Wang, Chia C., Sterling, Richard K., Jake Liang, T., Hoofnagle, Jay H., Doo, Edward, Chang, Kyong‐Mi, Park, Jang‐June, Belle, Steven H., Wahed, Abdus, and Kleiner, David

Published
2017
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43. Randomized Trial of Tenofovir With or Without Peginterferon Alfa Followed by Protocolized Treatment Withdrawal in Adults With Chronic Hepatitis B.

Author

Terrault, Norah A., Lok, Anna S., Wahed, Abdus S., Ghany, Marc G., Perrillo, Robert P., Fried, Michael W., Wong, David K., Khalili, Mandana, Lau, Daryl T. Y., Sterling, Richard K., Di Bisceglie, Adrian M., Lisker-Melman, Mauricio, Cooper, Stewart L., Chung, Ray T., Patel, Keyur, Roberts, Lewis R., Belle, Steven H., and Janssen, Harry L. A.

Published
2023
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47. Hepatitis C Virus-Specific Immune Responses and Quasi-Species Variability at Baseline Are Associated with Nonresponse to Antiviral Therapy during Advanced Hepatitis C

Author

Hepatitis C Antiviral Long-Term Treatment against Cirrhosis Trial Group, Morishima, Chihiro, Polyak, Stephen J., Ray, Ranjit, Doherty, Michael C., Di Bisceglie, Adrian M., Malet, Peter F., Bonkovsky, Herbert L., Sullivan, Daniel G., Gretch, David R., Rothman, Alan L., Koziel, Margaret James, and Lindsay, Karen L.

Published
2006

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