Sofosbuvir and Ledipasvir in Attainment of SVR12 in Sickle Cell Disease (SCD) Sub-population With Chronic Hepatitis C (CHC): A Single-Center, Prospective, Open-Label Clinical Pilot Stud: SLASH C Trial

Abstract

Introduction: CHC is no longer a clinical challenge in the era of DAA's. CHC and SCD contributes added challenges (sickle cell hepatopathy, splenic dysfunction, accelerated fibrosis secondary to anemia, iron overload and LPS induced mitochondrial injury). Historical management with IFN and RBV causes fatal hemolysis, severe anemia and sepsis. This study evaluates the safety, efficacy and eradication of hepatitis C in this sub-group population with SCD Methods: 24 patients were recruited from three sickle cell centers in NYC. Inclusion criteria: CHC (Geno specific with variation, diagnosed between 1998-2014) with SCD in remission (with sickle cell history > 30 years). All patients were placed LDV 90 mg + SOF 400 mg a day; with food for 12 weeks. Patient characteristics: to be included in the poster/slides. Medications allowed: Hydroxyurea, Tylenol, MS Contin, Methadone, Antibiotics (Levofloxacin, Doxycycline, Colchicine, Metronidazole), epoetin alpha. Exclusion: Decompensated cirrhotics, HIV, HBV, Sepsis, brittle SCD with frequent flares, uncontrolled DM, cardiomyopathy, CHF NYHA class III-IV, CKD, chronic osteomyelitis, active IVDU, Daily alcohol > 30 grams, Deferoxamine for 12 weeks. Side events: Nausea- 9/24, constipation 6/24, diarrhea 2/24, headache 6/24, abdominal pain 3/24, renal colic 1/24, insomnia 8/24, anemia 2/24, hyperbilirubinemia 4/24, UTI 3/24 Results: see table Conclusion: This study demonstrates that LDV and SOF combination in SCD patients with CHC is safe and well tolerated; with an SVR12 of 91.67% (22/24) with 8.3% (2/24) viral failure (in concomitant genotypes; 1a/4c and 1a/3c).Table 1: Results