Sofosbuvir and Ledipasvir in IBD Patients Treated With Advanced Biologics Including Ribavirin Eradicating Chronic Hepatitis C: Solataire C Trial: A Multicenter Clinical Prospective Pilot Study

Abstract

Introduction: The prevalence and concomitant treatment of chronic HCV and IBD has not been elucidated. IBD and CHC of >20 years duration may have more fibrosis due to immune suppression. Treatment of IBD often requires biological therapies to achieve longer disease-free remission, which further accelerates higher HCV replication. Thus effective therapy for IBD patients requiring immunosuppressive therapy is needed. To evaluate the role and efficacy of new NS5A + NS5B inhibitors with and without RBV in treating CHC in moderate to severe IBD requiring biologic therapy Methods: 35 patients were recruited from the Kings County Hospital Medical Center, Brooklyn. Inclusion criteria CHC with IBD, Age: >18, HCV Viral Load: > 400,000IU/mL, Genotype 1. Fibrotic Score: Metavir F1 to F4. Primary End Point: SVR12 Secondary End Point: IBD activity index, sustained control of symptoms SVR 24 and complete IBD remission at 30 weeks (endoscopy at 30 weeks). The patients were divided into two groups: Group A (n=17)- RBV 1000 mg + LDV and SOF; for 8 weeks Group B (n=18): LDV and SOF; for 12 weeks All will have base line RAV and ETRAV's and SVR 24. RAVs 5A polymorphism by Quest. Viral loads 0, 7, 14 days; 4th, 8th, 12th and 24th weeks. Results: see table. Conclusion: This study demonstrates that DAA's for HCV appear to have similar efficacy and safety in the presence of active IBD therapy withTNF Alfa antagonists while keeping the IBD in uninterrupted remission.Table 1: Results