A comparison of clinical and patient-reported treatment outcomes in chronic hepatitis C patients treated with direct-acting antivirals with and without cirrhosis: a prospective cohort study

Abstract

Managing patients with chronic hepatitis C and progressive liver conditions poses significant challenges for healthcare professionals. This research sought to evaluate and compare the clinical outcomes and patient-reported treatment experiences of individuals with chronic hepatitis C, differentiating between those with and without cirrhosis, all of whom were receiving standard direct-acting antiviral (DAA) therapy. This prospective cohort study enrolled outpatients who were diagnosed with hepatitis C virus (HCV) infection and who were recruited from a major public tertiary care hospital. The participants received a standard 12-week antiviral regimen consisting of 400 mg of sofosbuvir (SOF) and 60 mg of daclatasvir (DCV) once daily, with or without ribavirin (RBV) at a dose of 400 mg taken two to three times daily. The primary outcome was the cure rate, which was defined as an undetectable viral load at the end of the 12-week treatment period. The secondary outcomes included patient-reported outcomes (PROs), such as health-related quality of life (HRQoL), which were measured via the EuroQol 5-Dimensions 3-Levels (EQ-5D-3 L) questionnaire, and work productivity loss, which was assessed via the Work Productivity and Activity Impairment (WPAI) questionnaire. A total of 300 participants were assessed, comprising 150 cirrhotic and 150 noncirrhotic patients. Group B (cirrhosis) had a greater proportion of treatment-experienced patients and elevated aspartate aminotransferase (AST) levels (48 ± 22 vs. 131 ± 165, p < 0.001), along with significantly lower platelet counts (p = 0.024). An end-of-treatment response (ETR) was observed in 92.7% of patients without cirrhosis, compared to a significantly lower rate of 52.7% in those with cirrhosis (p < 0.001). A significant increase in HRQoL was noted in both groups across all the EQ-5D-3 L domains (p < 0.001); however, patients with cirrhosis experienced relatively smaller improvements in the areas of pain/discomfort and anxiety/depression. A small subset of noncirrhotic patients showed no improvement in mobility (−0.59 ± 0.62). Regarding work productivity, both groups experienced substantial reductions in overall impairment (43.0% in noncirrhotic patients, 32.3% in cirrhotic patients), absenteeism, and activity limitations (p < 0.001). However, presenteeism increased slightly in both groups, suggesting a return to work with residual functional limitations. The study concluded that SOF-based regimens were highly effective in noncirrhotic patients, who showed greater improvements in virological response, quality of life, and work productivity. In contrast, cirrhotic patients demonstrated lower treatment response rates and smaller gains in patient-reported outcomes despite receiving similar therapies