Patient-reported outcomes in a large North American cohort living with chronic hepatitis B virus: a cross-sectional analysis

for the Hepatitis B Research Network (HBRN)

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Patient-reported outcomes (PROs) such as health-related quality of life (HRQoL) and symptoms associated with chronic hepatitis B viral (HBV) infection have not been well-described in North American cohorts. Aims: To evaluate several PROs and associations with HBV disease activity markers. Methods: Cross-sectional analysis including 876 adults who completed PRO measures during the Hepatitis B Research Network Adult Cohort Study. Participants on HBV treatment were excluded. Outcomes included: HRQoL using the SF-36 mental component summary and physical component summary scores; symptom burden using a 10-item Total Symptom Checklist and fatigue using an instrument from the Patient-Reported Outcomes Measurement Information System®. Covariates included laboratory markers of disease severity, virological status, comorbidities and medications. Results: Median age was 42 (range: 19-79), 51% were female, 73% Asian, 19% HBeAg (+), 2% had AST-platelet ratio index (APRI) ≥1.5 and 74% without comorbidities. Mean mental component summary T-score = 52, physical component summary T-score = 54 and PROMIS Fatigue T-score = 47. On a scale from 0 (none) to 40 (extreme), the mean Symptom Checklist score = 3 and 25% reported no symptoms. The most frequent symptoms were fatigue (60%), irritability (32%) and itching (32%). Most symptoms were ‘a little bit’ bothersome. In multivariable regressions, APRI ≥1.50 and more comorbidities were associated with worse patient-reported outcomes; virological markers were not. Adding the Total Symptom Checklist score to original regression models increased explanation of variation in the mental component summary score from 4% to 44% and the Physical Component Summary Score from 17% to 34%. Conclusions: Untreated North American HBV patients with mild liver disease report favourable health-related quality of life and minimal symptoms. HBV does not impact health-related quality of life unless advanced liver disease or comorbidities are present. High symptom burden explains substantial variation in health-related quality of life. (CT.gov identifier: NCT01263587).

Original languageEnglish (US)
Pages (from-to)457-468
Number of pages12
JournalAlimentary Pharmacology and Therapeutics
Volume51
Issue number4
DOIs
StatePublished - Feb 1 2020

Bibliographical note

Funding Information:
In addition to the authors, the HBRN acknowledge the contributions of the following: Harvard Consortium : Jianghe Niu, PhD, Asad Javaid, MBBS, Bilal Nasir, MBBS, Ammu Susheela, MBBS, Imad Nasser, MD (Beth Israel Deaconess Medical Center, Boston, MA), Arley Donovan, Nifasha Rusibamayila, Cara Foley (Massachusetts General Hospital, Boston, MA). Minnesota Alliance for Research in Chronic Hepatitis B : Alisha C. Stahler, Linda Stadheim, RN (Mayo Clinic Rochester, Rochester, MN), John Lake, MD, Philip Lacher (University of Minnesota, Minneapolis, MN). Midwest Hepatitis B Consortium : Kathryn Rushing, RN (Saint Louis University School of Medicine, St Louis, MO), Debra DeMarco Shaw, RN, BSN, Lisa Kessels, RN, Michael K. Klebert, PhD, RN, ANP‐BC (Washington University School of Medicine, St. Louis, MO). University of Toronto Consortium : Seham Noureldin, PhD, Danie La, RN, Lucie Liu, MSc, CCRP, Diana Kaznowski, RN, Jiayun Chen, Fengfei Huang, Doinita Vladutu, Orlando Cerocchi (Toronto General Hospital, Toronto, Ontario). HBV CRN North Texas Consortium : Debra Rowan, LVN (Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center at Dallas, Dallas, TX), Sheila Bass (University of Texas Southwestern, Dallas, TX), Barbara Lilly, BS (Baylor University Medical Center, Dallas, TX). Los Angeles Hepatitis B Consortium : Samuel French, MD, Velma Peacock, RN (David Geffen School of Med, UCLA, Los Angeles, CA). San Francisco Hepatitis B Research Group Consortium : Marion Peters, MD, Ashley Shobe, MS, Rayshawnda Davis, Romuald Kuras, Claudia Ayala, MS, Ivy Lau, BS (University of California‐San Francisco, San Francisco, CA), Veronika Podolskaya, BS, NCPT, Anna von Bakonyi, LVN, CCRC, Nata DeVole, RN (California Pacific Medical Center Research Institute, San Francisco, CA). Michigan Hawaii Consortium : Barbara McKenna, MD, Karen Choi, MD, Kelly Oberhelman, PAC, Sravanthi Kaza, Bpharm, Isabel Moran (University of Michigan, Ann Arbor, MI), Leslie Huddleston, NP, Richmond Wong (The Queen's Medical Center, University of Hawaii, Honolulu, HI). Chapel Hill, NC Consortium : A. Sidney Barritt, M.D. , Tiffany Marsh, BA , Vikki Metheny, ANP, Danielle Cardona, PA‐C (University of North Carolina at Chapel Hill, Chapel Hill, NC). Virginia Commonwealth University Medical Center : Paula G. Smith, RN, BSN, Charlotte Hofmann, RN (Virginia Commonwealth University Health System, Richmond, VA). PNW/Alaska Clinical Center Consortium : Alycia Wolfstone, RN, MN (University of Washington Medical Center, Seattle, WA) Jody Mooney, Lupita Cardona‐Gonzalez (Virginia Mason Medical Center, Seattle, WA). : Nancy Fryzek, RN, BSN, Elenita Rivera, BSN, Nevitt Morris, Vanessa Haynes‐Williams, Amy Huang, RN, Catherine Nadal, RN, MS, Jaha Norman‐Wheeler, RN, BA (National Institutes of Health, Bethesda, MD). Averell H. Sherker, MD, Rebecca J. Torrance, RN, MS, Sherry R. Hall, MS (National Institutes of Health, Bethesda, MD). Liver Diseases Branch, NIDDK, NIH Liver Disease Research Branch, NIDDK, NIH: Immunology Center : Mary E. Valiga, RN, Keith Torrey, BS, Danielle Levine, BS, James Keith, BS, Michael Betts, PhD (University of Pennsylvania, Philadelphia, PA), Luis J. Montaner, DVM, DPhil (Wistar Institute, Philadelphia, PA). Data Coordinating Center : Frani Averbach, MPH, Tamara Haller, Regina Hardison, MS, Stephanie Kelley, MS, Christina Lalama, MS, Sharon Lawlor, MBA, Manuel Lombardero, MS, Andrew Pelesko, BS, Donna Stoliker, Melissa Weiner, MPH, Ella Zadorozny, MS, Qian Zhao, PhD (Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA). Declaration of personal Interests: Donna M. Evon receives research grant funding (to UNC) from Gilead Sciences Inc and Merck Sharp and Dohme. Michael Fried has received research funding from and served as a consultant for AbbVie, BMS, Gilead and Merck, and TARGET PharmaSolutions. Stock in TARGET PharmaSolutions is held in an independently managed trust. Mandana Khalili received research grant funding (to her institution) from Gilead Sciences Inc and Intercept Pharmaceutical and has served as a scientific consultant for Gilead Science. Robert Fontana has received research support from Gilead, BMS and Abbvie and provides consulting to Alynam. Colina Yim has received speakers honorarium from Abbvie Canada, and consulting fees from Abbvie Canada and Lupin Pharma Canada. Hsing‐Hua S. Lin, Abdus S. Wahed and Jay H. Hoofnagle have no conflict of interests to disclose.

Funding Information:
Funding information The HBRN was funded as a Cooperative Agreement between the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the following investigators: Lewis R. Roberts, MB, ChB, PhD (U01-DK082843), Anna Suk-Fong Lok, MD (U01-DK082863), Steven H. Belle, PhD, MScHyg (U01-DK082864), Kyong-Mi Chang, MD (U01-DK082866), Michael W. Fried, MD (U01-DK082867), Adrian M. Di Bisceglie, MD (U01-DK082871), William M. Lee, MD (U01-DK082872), Harry L. A. Janssen, MD, PhD (U01-DK082874), Daryl T-Y Lau, MD, MPH (U01-DK082919), Richard K. Sterling, MD, MSc (U01-DK082923), Steven-Huy B. Han, MD (U01-DK082927), Robert C. Carithers, MD (U01-DK082943), Mandana Khalili, MD (U01-DK082944), an interagency agreement with NIDDK: Lilia M. Ganova-Raeva, PhD (A-DK-3002-001) and support from the intramural program, NIDDK, NIH: Marc G. Ghany, MD. Additional funding to support this study was provided to Kyong-Mi Chang, MD, the Immunology Center, (NIH/NIDDK Center of Molecular Studies in Digestive and Liver Diseases P30DK50306, NIH Public Health Service Research Grant M01-RR00040), Richard K. Sterling, MD, MSc (UL1TR000058, NCATS (National Center for Advancing Translational Sciences, NIH), Norah A. Terrault, MD, MPH (CTSA Grant Number UL1TR000004), Michael W. Fried, MD (CTSA Grant Number UL1TR001111) and Anna Suk-Fong Lok (CTSA Grant Number UL1RR024986, U54TR001959.) Additional support was provided by Gilead Sciences, Inc. and Roche Molecular Systems via a CRADA through the NIDDK. In addition to the authors, the HBRN acknowledge the contributions of the following: Harvard Consortium: Jianghe Niu, PhD, Asad Javaid, MBBS, Bilal Nasir, MBBS, Ammu Susheela, MBBS, Imad Nasser, MD (Beth Israel Deaconess Medical Center, Boston, MA), Arley Donovan, Nifasha Rusibamayila, Cara Foley (Massachusetts General Hospital, Boston, MA). Minnesota Alliance for Research in Chronic Hepatitis B: Alisha C. Stahler, Linda Stadheim, RN (Mayo Clinic Rochester, Rochester, MN), John Lake, MD, Philip Lacher (University of Minnesota, Minneapolis, MN). Midwest Hepatitis B Consortium: Kathryn Rushing, RN (Saint Louis University School of Medicine, St Louis, MO), Debra DeMarco Shaw, RN, BSN, Lisa Kessels, RN, Michael K. Klebert, PhD, RN, ANP-BC (Washington University School of Medicine, St. Louis, MO). University of Toronto Consortium: Seham Noureldin, PhD, Danie La, RN, Lucie Liu, MSc, CCRP, Diana Kaznowski, RN, Jiayun Chen, Fengfei Huang, Doinita Vladutu, Orlando Cerocchi (Toronto General Hospital, Toronto, Ontario). HBV CRN North Texas Consortium: Debra Rowan, LVN (Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center at Dallas, Dallas, TX), Sheila Bass (University of Texas Southwestern, Dallas, TX), Barbara Lilly, BS (Baylor University Medical Center, Dallas, TX). Los Angeles Hepatitis B Consortium: Samuel French, MD, Velma Peacock, RN (David Geffen School of Med, UCLA, Los Angeles, CA). San Francisco Hepatitis B Research Group Consortium: Marion Peters, MD, Ashley Shobe, MS, Rayshawnda Davis, Romuald Kuras, Claudia Ayala, MS, Ivy Lau, BS (University of California-San Francisco, San Francisco, CA), Veronika Podolskaya, BS, NCPT, Anna von Bakonyi, LVN, CCRC, Nata DeVole, RN (California Pacific Medical Center Research Institute, San Francisco, CA). Michigan Hawaii Consortium: Barbara McKenna, MD, Karen Choi, MD, Kelly Oberhelman, PAC, Sravanthi Kaza, Bpharm, Isabel Moran (University of Michigan, Ann Arbor, MI), Leslie Huddleston, NP, Richmond Wong (The Queen's Medical Center, University of Hawaii, Honolulu, HI). Chapel Hill, NC Consortium: A. Sidney Barritt, M.D, Tiffany Marsh, BA, Vikki Metheny, ANP, Danielle Cardona, PA-C (University of North Carolina at Chapel Hill, Chapel Hill, NC). Virginia Commonwealth University Medical Center: Paula G. Smith, RN, BSN, Charlotte Hofmann, RN (Virginia Commonwealth University Health System, Richmond, VA).

Publisher Copyright:
© 2020 John Wiley & Sons Ltd

Keywords

  • SF-36
  • fatigue
  • functioning
  • liver
  • quality of life
  • symptom

PubMed: MeSH publication types

  • Journal Article
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

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