Retrospective Cohort Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jun 16, 2022; 10(17): 5566-5576
Published online Jun 16, 2022. doi: 10.12998/wjcc.v10.i17.5566
Longitudinal assessment of liver stiffness by transient elastography for chronic hepatitis C patients
Anya Mezina, Arunkumar Krishnan, Tinsay A Woreta, Kevin B Rubenstein, Eric Watson, Po-Hung Chen, Carla Rodriguez-Watson
Anya Mezina, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21287, United States
Arunkumar Krishnan, Tinsay A Woreta, Po-Hung Chen, Division of Gastroenterology and Hepatology, Johns Hopkins School of Medicine, Baltimore, MD 21231, United States
Kevin B Rubenstein, Eric Watson, Carla Rodriguez-Watson, Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, Rockville 20852, United States
Carla Rodriguez-Watson, Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21287, United States
Carla Rodriguez-Watson, Innovation in Medical Evidence Development and Surveillance (IMEDS) Program, Reagan-Udall Foundation for the FDA, Washington, 20036, United States
Author contributions: Tinsay A Woreta and Po-Hung Chen conceptualized the study; Anya Mezina, Tinsay A Woreta and Po-Hung Chen investigated the study; Anya Mezina, Tinsay A Woreta, Kevin B Rubenstein Po-Hung Chen and Carla Rodriguez-Watson did the methodology; Anya Mezina did the writing - original draft; Arunkumar Krishnan, Tinsay A Woreta, Kevin B Rubenstein Po-Hung Chen and Carla Rodriguez-Watson did the writing-review and editing; Kevin B Rubenstein did the software and visualization; Tinsay A Woreta and Eric Watson did the data curation; Arunkumar Krishnan did the validation.
Supported by the National Center for Advancing Translational Sciences, No. 5KL2TR001077-05 (to Po-Hung Chen).
Institutional review board statement: The study was reviewed and approved for publication by the Institutional Review Board of Johns Hopkins Medicine and Kaiser Permanente Mid-Atlantic States.
Informed consent statement: The need for informed consent was waived due to the retrospective nature of the study.
Conflict-of-interest statement: All the Authors have no conflict of interest related to the manuscript.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Carla Rodriguez-Watson, PhD, Senior Researcher, Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, 2101 E Jefferson Street, Rockville 20852, United States. crodriguezwatson@reaganudall.org
Received: August 10, 2021
Peer-review started: August 10, 2021
First decision: November 17, 2021
Revised: December 16, 2021
Accepted: April 21, 2022
Article in press: April 21, 2022
Published online: June 16, 2022
Processing time: 302 Days and 19.3 Hours
ARTICLE HIGHLIGHTS
Research background

Liver fibrosis is a common pathway of liver injury and is a feature of most chronic liver diseases. Fibrosis progression varies markedly in patients with hepatitis C virus (HCV), and the severity of liver fibrosis is associated with the prognosis of liver disease. Liver stiffness has been recommended as a parameter of fibrosis progression/regression in patients with HCV.

Research motivation

To investigate the changes in liver stiffness measured by transient elastography (TE) in a large, racially diverse cohort of U.S. patients with chronic hepatitis C (CHC).

Research objectives

We evaluated the differences in liver stiffness between patients treated with direct-acting antiviral (DAA) therapy and untreated patients. In addition, we performed a longitudinal, retrospective observational study investigating changes in liver stiffness measured by TE in a racially diverse cohort of United States patients with CHC.

Research methods

We conducted a longitudinal retrospective study of patients with confirmed CHC infection seen at Johns Hopkins Health System (JHHS) and Kaiser Permanente Mid-Atlantic States (KPMAS). Patients had ≥ 2 TE measurements and no prior DAA exposure. We used linear regression to measure the change in liver stiffness between first and last TE in response to treatment, controlling for age, sex, race, diabetes, smoking status, HIV status, baseline ALT, and baseline liver stiffness.

Research results

Of 813 patients, 84% were at least 50 years of age, 79% were Black, 79% were current or former smokers, 37% were coinfected with HIV, 3% were coinfected with HBV, 19% had diabetes, and 52% initiated treatment with a DAA. The median time between first and last TE was 11.7 and 12.7 mo among treated and untreated patients, respectively. There was no significant change in liver stiffness observed over time in either the group initiating DAA treatment (0.016 kPa/month; CI: -0.051, 0.084) or in the untreated group (0.001 kPa/month; CI: -0.090, 0.092), controlling for covariates. A higher baseline kPa score was independently associated with decreased liver stiffness.

Research conclusions

DAA treatment was not associated with a differential change in liver stiffness over time, as measured by TE, in patients with CHC compared to untreated patients. Our study underscores the imperfect characteristics of any single noninvasive test for assessing liver fibrosis, which continues to be compared to the gold standard of liver biopsy and histopathology, despite the impetus to avoid invasive testing for CHC infection in clinical practice.

Research perspectives

Direct-acting antiviral therapy was not associated with a differential change in liver stiffness over time in patients with CHC compared to untreated patients. Further longitudinal prospective studies are needed to evaluate the clinical utility of obtaining TE measurements in patients with CHC who have achieved sustained virologic response and assess liver fibrosis progression in diverse populations.