Author information
1
Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, United States of America.
2
Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina, United States of America.
3
Division of Gastroenterology and Hepatology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.
4
Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, United States of America.
5
Division of Gastroenterology, Hepatology & Nutrition, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia, United States of America.
6
Division of Gastroenterology and Hepatology, Department of Medicine, University of California Davis, Davis, California, United States of America.
7
Division of General Medicine and Clinical Epidemiology, Department of Medicine, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, United States of America.
8
Department of Health Behaviors, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, United States of America.
9
Department of Population Health Sciences, Duke University, Durham, North Carolina, United States of America.
10
Division of Gastroenterology, Hepatology & Nutrition, Department of Medicine, University of Florida, Gainesville, Florida, United States of America.
11
Department of Internal Medicine, Section of Hepatology, Rush University, Chicago, Illinois, United States of America.
12
Digestive Diseases, Department of Internal Medicine, Yale University, New Haven, Connecticut, United States of America.
13
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Saint Louis University, St. Louis, Missouri, United States of America.
Abstract
BACKGROUND:
Symptom 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 FINDINGS:
PROP 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.
CONCLUSIONS:
This 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).