Effectiveness of 8-week Treatment with Glecaprevir/Pibrentasvir in Treatment-naïve or -experienced HCV Patients: Results from an Observational Retrospective Study in Real-life Settings (ODYSSEY).

Background and aims: Pan-genotypic ribavirin-free oral direct-acting antivirals, including the glecaprevir/pibrentasvir combination, are recommended for the treatment of most patients with chronic hepatitis C virus (HCV) infection. In Romania, the HCV-infected patient population receiving glecaprevir/pibrentasvir is not well characterized and data on treatment effectiveness is lacking. The ODYSSEY study aimed to provide insights into the characteristics and treatment outcomes of HCV-infected Romanian patients receiving 8-week therapy with glecaprevir/pibrentasvir.

Methods: This observational, retrospective medical chart review study was based on a Patient Support Program for HCV-infected patients (HCV-PSP) attending clinical practices in Romania and initiating glecaprevir/pibrentasvir between 01 February 2022 and 11 July 2023. Patients ≥18 years of age with compensated liver disease F0-F4 fibrosis grade treatment-naïve or F0-F3 fibrosis grade treatment-experienced on previous interferon-based regimens from the HCV-PSP were included in the ODYSSEY study. Patients received glecaprevir/pibrentasvir for at least 8 weeks. Sustained virological response (SVR) was assessed at 12 weeks after the 8-week treatment (SVR12). Analyses were conducted on the core population (CP) and the CP with sufficient follow-up data (CPSFU).

Results: The CP and CPSFU included 2,240 and 2,165 patients, respectively. In both populations, most patients were female (≥67.57%), aged >50 years (≥73.62%), and treatment-naïve (≥96.47%). F4 fibrosis was reported in 19% of patients. Hypertension was the most common relevant comorbidity, reported for 21% of patients; comorbidity rates increased with age. Overall SVR12 rates were 96.1% [95% confidence interval (CI): 95.2-96.8%) and 99.3% (95%CI: 98.9-99.6) in the CP and CPSFU, respectively. When stratified by gender, age category, comorbidities or fibrosis grade, SVR12 rates were >92% in the CP [except for the subgroups of patients with chronic kidney disease (87.5%) and depressive-/anxiety disorders (86.2%)] and ≥97.0% in the CPSFU. SVR12 rates were higher in female patients. In an exploratory analysis, in the CPSFU, the presence of diabetes mellitus [odds ratio (OR)=3.840; 95%CI: 1.093-13.495] and cardiovascular diseases (OR=7.904; 95%CI: 1.719-36.346) were associated with an increased probability to detect HCV RNA at 12 weeks post-treatment.

Conclusions: The 8-week treatment with glecaprevir/pibrentasvir resulted in high SVR12 rates for multiple HCV-infected patient profiles encountered in real-life settings in Romania.