Tu1024 Plasma Interferon-γ-Inducible Protein 10 (Ip-10) and Response to Interferon-Free Direct-Acting Antiviral Therapy in HCV Genotype 1-Infected Patients With and Without Cirrhosis

Abstract

Rationale: Newly approved direct acting antiviral (DAA) regimens for Chronic Hepatitis C (HCV) achieve excellent response rates with unprecedented attainment of sustained virologic response (SVR12) in clinical trials. Real world effectiveness of HCV DAA therapy in special populations, particularly minority populations, is lacking. Aim: To assess SVR12 rates and identify pre treatment predictors of SVR12 in a non-Caucasian cohort.Methods: A prospective cohort study consecutively enrolled mono-infected, non-Caucasian patients undergoing DAA treatment for HCV. Enrolled subjects (N=54) were treated with one of the following: 1) pegylated interferon alfa-2a (IFN) + sofosbuvir (SOF) + ribavirin (RBV) for 12 weeks; 2) SOF + RBV for 12 or 24 weeks; and 3) SOF + simeprevir (SMV) for 12 weeks in accordance with AASLD guidelines and genotype. End of treatment response and SVR12 were defined as HCV RNA undetectable or below the lower limit of detection at regimen completion and at 12 weeks post therapy, respectively. Multivariate logistic regression was conducted to identify significant predictors of SVR12 controlling for age, gender, and BMI. Results: The majority of participants were Hispanic (64.8%) followed by Asian (18.5%) and African American (16.7%). Baseline clinical and viral demographics were recorded [Table 1] and included: 59.3% cirrhotic, 57.5% genotype 1, mean viral load 2,703,207 IU/mL and previous interferon experience: naive, 57.4%; non response 33.3%; and relapse 9.3%. DAA regimens utilized: IFN + SOF + RBV, 27.8%; SOF + RBV, 48.1%; and SOF + SMV, 24.1%. End of treatment response was 96% (52/54). SVR 12 rate was 81.5% (8 relapsers, 2 non responders to DAA therapy). Patients with pretreatment fasting glucose <=126 were 9.8 times (OR= 9.8; 95% CI=1.3-76.4) more likely to achieve SVR12 controlling for age, gender and BMI. Patients without hyperlipidemia were 6.9 times (OR=6.9; 95% CI=1.4-34.0) more likely to achieve SVR12 controlling for age, gender and BMI. Conclusions: Pre-existing diabetes and hyperlipidemia may explain the discrepancy between practical SVR12 and those reported in clinical trials. Optimization of diabetes and lipid control should be considered prior to DAA HCV therapy, particularly in minority populations with HCV.