Sofosbuvir/Ledipasvir Fixed-Dose Combination for the Treatment of HCV Infected Patients with Compensated and Decompensated Liver Disease: Real-Life Experience: 809

Introduction: High rates of sustained virologic response have been observed among patients with hepatitis C virus (HCV) infection treated with the nucleotide polymerase inhibitor sofosbuvir (SOF) combined with the NS5A inhibitor ledipasvir (LDV). We have enrolled 293 patients with HCV genotype 1 and 4 infection in a clinical protocol of all oral exclusive treatment recently accomplished in the Portuguese guidelines for hepatitis C treatment. Methods: Genotype 1 and 4 HCV infected patients were treated with a fixed-dose combination of SOF 400mg plus LDV 90mg with or without ribavirin (RBV). They were stratified according to HCV genotype, degree of fibrosis, viral load and prior treatment response. Viremia was sequentially evaluated at baseline, week 4, 12 and, in the prolonged regimen, at week 24, all with follow-up blood sampling at week 12 post treatment. Results: A total of 293 patients (mean age 55.9±12.3) were evaluated: 61% males, 49% genotype 1a, 39% genotype 1b and 12% genotype 4. Thirty-seven (13%) patients were treated with RBV. One hundred and sixty (55%) patients were prior treatment non-responders/relapsers and 37% had cirrhosis. Among patients with cirrhosis, 19% had decompensated cirrhosis. Rapid virologic response (undetectable viremia at week 4) was achieved in 89% of the patients and all (100%) had undetectable viremia at the end of treatment (week 12 or 24, as applicable). Sustained virologic response at week 12-post treatment was achieved in 99% of the patients. Treatment was well-tolerated (side effects in 26% of patients, most commonly headaches, fatigue and insomnia) and only one patient discontinued treatment, at week 7, due to symptomatic bradicardia (with concomitant use of amiodarone). One patient died due to complications related to cirrhosis. No significant laboratory abnormalities were observed and ALT values normalized in 89% of the patients at the end of treatment. Conclusion: In real life experience, SOF/LDV was highly effective (99% of sustained virologic response), safe and well tolerated in genotype 1 and 4 HCV-infected patients, independently of the degree of fibrosis, viral load and prior treatment response.