Chronic Hepatitis C and comorbidities: real-world study to evaluate impact in outcomes after treatment with sofosbuvir-based regimens

Abstract

Background and Aims: Risk of liver-related morbidity and mortality is not eliminated in cirrhotic patients following direct-acting antiviral treatment. This study aimed to assess virologic and clinical outcomes among chronic hepatitis C patients who received sofosbuvir (SOF)-based regimens. Methods: Non-interventional, multicenter,retrospective, single-cohort study of 1,724 patients who started treatment with (SOF)-based regimens between February 2015 and August 2016. SVR12, liver fibrosis, mortality and progression disease risks scores were evaluated. Results: Patients median age was 51.9 years and 71.7% were male. Most patients (67.2%) were genotype (GT) 1. Cirrhosis was found in 35.5% of patients being 94.8% compensated. Ledipasvir/SOF was the most common regimen (76.1%) and 20.2% of patients received ribavirin (RBV).SVR12 was 97.7%, higher among females (99.0%; p=0.0298) and patients withoutRBV (98.8%; p=0.0002). SVR12 were approximately 97% among patients with and without extra-hepatic comorbidities (EHC) and in cirrhotic patients. At 24 weeks after treatment cessation, liver fibrosis stage improvement was observed in 45.2% of patients and was higher in SVR12 patients without EHC than with EHC (53.8% vs 37.9%, p=0.0227). At baseline, the 2.5 years median mortality risk was lower among patients without EHC than with EHC (1.6% vs 1.8%; p=0.0043). Same trend was found regarding 5 and 7.5-year risk at baseline and at 12 weeks follow up. Discussion/Conclusion: SOF-based regimens showed high SVR rates in all genotypes, being higher among females and those not receiving RBV. Nearly half of patients improved liver fibrosis stage over time. Presence of EHC may lead to poorer prognosis in terms of liver fibrosis, morbidity and all-cause mortality risk.