THE IMPROVEMENT OR REGRESSION OF FIBROSIS AFTER TREATMENT WITH SOFOSBUVIR PLUS RIBAVIRIN FOR HCV GENOTYPE 2 INFECTION

Abstract

Background: Sofosbuvir (SOF) and ribavirin (RBV) for 12 or 16 weeks is recommended for treatment of patients with HCV genotype (GT) 2 infected patients in KASL guideline based on clinical trials.Whether sustained virological response of HCV infection has any beneficial effect on improvement of liver fibrosis associated with chronic HCV infection remains unclear. We investigated to assess the effects on liver fibrosis of at least 2 years through follow-up liver biopsy and fibroelastography after treatment with sofosbuvir plus ribavirin for HCV G2 infection.

Methods: Three tertiary center, prospective observational cohort study evaluates clinical practice data (Korea university Anam, Guro, and Ansan) between January 2015 and December 2019.Clinical data were centrally collected from medical records. The efficacy outcome was sustained virological response 12 weeks after therapy (SVR12). The degree of liver fibrosis was evaluated by APRI score, FIB-4, fibroelestography and paired liver tissue biopsy.

Results: 146 patients were visited and 131 patients were treated SOF plus RBV during 12 weeks (n=122) or 16 weeks (n=9). Overall, EVR, ETR, and SVR12 by ITT analysis were 90.0%, 96.2% and 87%. In addition, EVR, ETR, and SVR12 by PP analysis 97.5%, 99.2% and 96.3%, respectively. In subgroup analysis, SVR12 in patients with treatment-naïve and treatment-experience were 97.2% or 94.7%, respectively. SVR12 in patients with and without cirrhosis were 94.4% and 97.4%, respectively. Finally 106 patients showed sutained virological response and follow up 2 year after treatment.The mean APRI score was 0.57 before treatment, but improved to 0.27 at 2 year after treatment (p=0.004). The mean FIB-4 score was 2.15 before treatment, but improved to 1.53 at 2 year after treatment (p=0.004). The mean fibroelastography value was 10.81 kPa before treatment, but improved to 4.75 kPa at 2 year after treatment (p=0.008). Follow-up liver tissue biopsies were done in 8 patients and fibrosis was evaluated by Metavir score (F0-4). Almost all patient except one showed improvement of cirrhosis (≥1 unit decrease in Metavir score, p=0.031).

Conclusion: SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection.In patients with sustained virological response 2 year after SOF and RBV, the improvement or regression of liver fibrosis could be observed in biochemical and histological aspect.