Results of Interferon-Free HCV Therapy in a Clinical Practice Setting

Abstract

Introduction: To assess the rapid virological response (RVR), end of treatment, sustained virological response (SVR) 4, SVR 12, and relapse rate in all HCV patients treated at our center with all oral, non-IFN therapy, and to assess side effects of therapy and tolerance in this difficult-to-treat population. Methods: This observational study describes our clinical practice experience of these medications in a more challenging patient population that have not qualified for clinical trials or have failed a previous treatment with experimental direct-acting antiviral (DAA) agents or standard interferon and ribavirin therapy. Results: All HCV patients on non-IFN therapy at our center were included. Total number of patients was 15 (6 female; 9 male). Age range was 25-66 (mean 55±9.9) years. Race was 11 white (73%) and 4 black (27%). Fibrosis stage was stage 1-2 in 2 patients (18%), stage 3 in 2 patients (18%), and stage 4 in 11 patients (73%). Genotype was 2 in 2 patients (18%) and 1 in 13 patients (82%). Prior treatment was none, IFN/RBV only, IFN/RBV with DAA, and DAA only in 3, 5, 5, and 2 patients, respectively. The average time to undetected HCV RNA was 4.3±2 weeks. ALT normalization occurred in all but 2 patients on treatment, 1 prior to treatment (7%), 8 at week 1 (53%), 2 at week 2 (18%) and 2 at week 4 (18%). Elevation of bilirubin occurred in 8 patients with an increase to 1.3 to 3.4 in 4 patients (1.5-2.5 times the baseline level) without associated transaminase elevation. Three-month treatment has been completed in 8 patients (53%) with all scheduled to complete treatment before August. Two patients had treatment extended to 4 months due to N/V during the first month in one and the other for hospitalization due to recurrent lymphoma. Virologic relapse occurred in 2 patient with D168 T/A mutation and prior DAA treatment. Conclusion: The availability of interferon free treatment regimens for HCV represents a major advance in treatment and offers a chance for cure in patients who were previously ineligible for IFN therapy. In this community clinic, the response rates and side effect profile are similar to the clinical trial experience. Several patients experienced bilirubin elevation that required close monitoring; however, these were not accompanied by clinical decompensation. All patients have achieved undetectable virus on treatment and are within 1 month of completing treatment. Further description of SVR/relapse rates will be available for presentation.