Hepatitis C in Patients with Minimal or No Hepatic Fibrosis: The Impact of Treatment and Sustained Virologic Response on Patient-Reported Outcomes

• Published in: Clinical infectious diseases Vol. 66; no. 11; pp. 1742 - 1750
• Main Authors: Younossi, Zobair M, Stepanova, Maria, Asselah, Tarik, Foster, Graham, Patel, Keyur, Brau, Norbert, Swain, Mark, Tran, Tram, Esteban, Rafael, Colombo, Massimo, Pianko, Stephen, Henry, Linda, Bourliere, Marc
• Format: Journal Article
• Language: English
• Published: United States Oxford University Press 17.05.2018
• Subjects: Clinical outcomes; Clinical trials; Fibrosis; Hepatitis; Hepatitis C; Interferon; Liver; Liver diseases; Medical research; Patients; Ribavirin; Viruses; fatigue; healthy liver; work productivity; vitality; direct-acting antivirals
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1093/cid/cix1106

While the necessity of treatment of HCV patients with advanced liver disease is widely accepted, the benefit of treating HCV patients without significant liver disease is less well established. Our aim was to assess the effect of treating HCV in patients with no or minimal fibrosis (F0-F1) on patients-reported outcomes (PROs). HCV patients with F0-F1 from 16 clinical trials were included. PROs were collected before, during, and after treatment using SF-36V2, FACIT-F, CLDQ-HCV, and WPAI:SHP. 1,548 HCV patients with F0-F1 were included (age 46±11 years, 43% male, 82% Caucasian, 64% employed, 81% treatment-naïve, 57% genotype 1). Patients were treated with interferon+sofosbuvir+ribavirin (N=91) or sofosbuvir+ribavirin±ledipasvir (N=479) or interferon- and ribavirin-free regimens with sofosbuvir+ledipasvir or sofosbuvir+velpatasvir or sofosbuvir+velpatasvir+voxilaprevir (N=978). There were no PRO differences at baseline (all p>0.01). By the end of treatment, F0-F1 patients receiving interferon-containing regimens experienced significant decreases in most PRO domains (-4.5 to -28.7 on a 0-100 scale), while subjects treated with interferon-free ribavirin-containing regimens had a modest impairment of PROs (-2.3 to -8.9) (p≤0.01). In contrast, treatment with regimens without interferon and ribavirin led to PRO improvements (+1.2 to +10.9). Regardless of the regimen, SVR-12 and -24 were universally associated with PRO improvements (+2.1 to +14.7, all p<0.0001). In multivariate analysis, receiving interferon-containing (β=-5.3 to -28.5, p<0.01) or interferon-free ribavirin-containing (β=-2.8 to -10.6, p<0.01) regimens were predictive of PRO impairments during and after treatment. HCV subjects with none or minimal fibrosis treated with interferon- and ribavirin-free regimens experience on-treatment and post-SVR PRO improvements.