LP05 : Daclatasvir plus sofosbuvir with or without ribavirin in patients with HCV genotype 3 infection: Interim analysis of a french multicenter compassionate use program

Abstract

Introduction: Treatment options for HCV genotype 3 (GT3) patients are limited. The combination daclatasvir (DCV) and sofosbuvir (SOF) for 12 weeks is associated with high SVR rate in genotype 3 non cirrhotic patients (96% SVR12) and a lower response in cirrhotic (63% SVR12). GT3 cirrhotic remain a difficult to treat population and may benefit from the addition of ribavirin (RBV) or extended treatment duration. This analysis reports interim results from a French multicenter compassionate use program of DCV+SOF±RBV in patients with HCV genotype 3 chronic infection. Material and Methods: The ATU has been managing over 4000 HCV patients from 221 French centers. Patients received DCV+SOF QD for 12 or 24 weeks, with RBV added at the physician's discretion. Results: 601 HCV genotype 3 patients with severe fibrosis (F3) or cirrhosis (F4), or HCV extrahepatic manifestations or postliver transplant HCV recurrence or indication for liver or kidney transplantation enrolled in the program. Most patients were male (75%), HCV mono-infected (83%), cirrhotic (77%), and treatment experienced (73%). The median age was 54.3 years (27-83). 64% and 15% planned to receive DCV+SOF for 24 weeks with or without RBV, respectively, 4% and 17% planned to receive DCV+SOF for 12 weeks with or without RBV, respectively. Baseline median HCVRNA level was 6.07 (1.20-7.62) log10 IU/mL, platelets count 118.5x109/L (31- 387) and albumin was 39.0 g/L (13-56). Treatment discontinuations were related to adverse event in 1 patient, death in 2 patients and patient's decision in 1 patient. The table below shows the interim results in the first 106 patients without liver transplant who reached the week 4 post-treatment visit according to treatment schedule, fibrosis stage and patient status. Efficacy and safety data will be updated in larger population. Conclusions: This preliminary analysis is consistent with previous findings and demonstrates that12 weeks of DCV+SOF in GT3 patients results in a high SVR4 in non cirrhotic patient population. Cirrhotic patients appeared to benefit from the extended treatment duration to 24 weeks.