PIN3 SOFOSBUVIR/VELPATASVIR VS GLECAPREVIR/PIBRENTASVIR IN GENOTYPE 3 HEPATITIS C VIRUS INFECTED PATIENTS

Abstract

Genotype 3 (G3) is the second most prevalent hepatitis C virus (HCV) genotype in Europe, and causes a faster progression to liver cirrhosis. Sofosbuvir/Velpatasvir (SOF/VEL) or Glecaprevir/Pibrentasvir (GLE/PIB) are the recommended therapies for most G3-HCV patients. The objective of this study is to analyze the effectiveness and safety of 8-24 weeks treatment regimens of SOF/VEL vs GLE/PIB in a cohort of G3-HCV infected patients in real clinical practice. Prospective, observational, comparative study in G3-HCV infected patients, who initiated treatment with SOF/VEL or GLE/PIB during 2017 and 2018. Exclusion criteria: patients from penitentiary centers and pediatrics. Effectiveness main variable: sustained virological response 12 weeks post-treatment (SVR12). Safety variable: treatment withdrawal secondary to severe adverse events (AE). Covariates: gender, age, HIV co-infection, previous treatment, liver transplantation, cirrhosis, fibrosis, and previous antiviral treatment. Statistical method: intention-to-treat analysis; statistical signification calculated with Fisher exact or Mann-Whitney tests. Study authorized by the Health System Investigation Committee. 76 patients included, 46 treated with SOF/VEL±RBV and 30 with GLE/PIB. No basal differences between groups observed related with age, gender, HIV co-infection, fibrosis stage, cirrhosis and previous antiviral treatment (p>0.1). 95.7% treated with SOF/VEL±RBV vs 96.7% treated with GLE/PIB reached SVR12 (p=0.7). 83.3% cirrhotic vs 98.4% non-cirrhotic patients reached SVR12 (0.09). 100% patients with low fibrosis (F0-2) compared to 85.7% patients with advanced fibrosis (F3-4) reached SVR12 (p=0.03). SVR12 in treatment-naïve vs treatment-experienced was 95.7% vs 100.0% respectively (p=0.57), without statistically significant differences independent of the treatment group (p=0.28 for SOF/VEL±RBV; p=0.18 for GLE/PIB). Any degree AEs rate was 21.1% (11.3%-30.9%, 95%CI); no patient presented serious AE, so none of the patients in both cohorts required antiviral treatment withdrawal. SOF/VEL or GLE/PIB are highly effective and safe for G3-HCV infected patients, with a lower effectiveness in patients with advanced fibrosis F3-4.