Abstract and Introduction
Cure of chronic hepatitis C (CHC) can lead to improvement of health-related quality of life and other patient-reported outcomes (PROs). While extensive PRO data for CHC patients who were enrolled in clinical trials are available, similar data for patients seen in real-world practices are scarce. Our aim was to assess PROs of CHC patients enrolled from real-world practices from different regions and to compare them with those enrolled in clinical trials. CHC patients seen in clinical practices and not receiving treatment were enrolled in the Global Liver Registry (GLR). Clinical and PRO (FACIT-F, CLDQ-HCV, WPAI) data were collected and compared with the baseline data from CHC patients enrolled in clinical trials. N = 12,171 CHC patients were included (GLR n = 3146, clinical trial subjects n = 9025). Patients were from 30 countries from 6 out of 7 Global Burden of Disease (GBD) super-regions. Compared with clinical trial enrollees, patients from GLR were less commonly enrolled from High-Income GBD super-region, older, more commonly female, less employed, had more type 2 diabetes, anxiety and clinically overt fatigue but less cirrhosis (all p < 0.001). Out of 15 PRO domain and summary scores, 12 were lower in GLR patients than in subjects enrolled in clinical trials (p < 0.001). In multiple regression models, anxiety, depression, and fatigue were associated with significant PRO impairment in CHC patients (p < 0.05). After adjustment for the clinico-demographic confounders, the association of PRO scores of CHC patients with enrolment settings was no longer significant (all p > 0.05). In conclusion, hepatitis C patients seen in the real-world practices have PRO impairment driven by fatigue and psychiatric comorbidities.
In the past decade, novel curative treatment regimens for hepatitis C virus (HCV) have led to a complete change in the paradigm of chronic liver disease. These new treatments, direct-acting antivirals (DAAs), are now administered as an all-oral, interferon-free regimen covering all HCV genotypes.[1,2] The DAA regimens have also proven to be efficacious in multiple chronic hepatitis C (CHC) subpopulations including those with cirrhosis, HIV, and with other liver diseases.[1–7]
In addition to providing clinical benefit, DAA-based treatment for CHC has been shown to significantly improve health-related quality of life and other patient-reported outcomes (PROs) which can occur as early as 2–4 weeks after starting treatment even in the presence of advanced liver disease.[8–10] The economic benefit of treating all patients with DAAs, especially earlier in their disease course, is also substantial.[11–13] As a result, the United States Preventative Task Force (USPTF) recently updated their HCV screening guidelines to include all those 18 years and older, women with each pregnancy, and more frequent testing for those with high-risk behaviours. The World Health Organization also changed their recommendations to start treatment with pan-genotypic DAAs for all infected persons over the age of 12 years.[15,16]
Despite these tremendous advances, there is still some knowledge gap about the characteristics of patients with HCV seen in real-world practices and how they compare to HCV patients from clinical trials, especially in their reporting of PROs. Therefore, the aim of this study was to describe patients with HCV who were seen in clinics around the world and their respective PROs, and to compare this group to HCV patients who were enrolled in clinical trials.
J Viral Hepat. 2022;29(11):1015-1025. © 2022 Blackwell Publishing