Virologic Response Rates to Fixed-Dose Combination Ledipasvir/Sofosbuvir for 8 or 12 Weeks With Baseline Viral Load

Abstract

Introduction: Ledipasvir/Sofosbuvir (LDV/SOF) is approved to treat patients infected with hepatitis C virus (HCV) genotype 1 (GT1). Based on the LDV/SOF U.S Prescribing Information, 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL. A post-hoc analysis of the phase 3, ION-3 study, showed that patients with baseline viral load < 6 million IU/ml achieved high response rates with 8 or 12 weeks of LDV/SOF, 97% and 96% SVR12, respectively. Here we evaluate traditional negative predictors of response in patients with baseline viral loads < 6 million IU/ml who received LDV/SOF for 8 weeks or 12 weeks. Methods: This was a retrospective analysis of all patients treated with LDV/SOF for 8 or 12 weeks in the ION-3 trial, who had a baseline viral load < 6 million IU/mL. SVR12 rates are compared for patients with and without traditional negative predictors of response, including: age, gender, race, GT1 subtype, BMI, IL28B status, and fibrosis status based on biopsy and/or Fibrotest score. Results: Two-hundred forty-nine HCV GT1, treatment naïve, non-cirrhotic patients, with baseline viral load < 6 million IU/mL were included in the analysis. SVR12 data for patients who received LDV/SOF for 8 vs 12 weeks are reported in table 1. Conclusion: High response rates were achieved in treatment naïve, non-cirrhotic, GT1 patients with baseline HCV RNA < 6 million IU/mL patients treated with either 8 or 12 weeks of LDV/SOF, regardless of the presence of baseline characteristics traditionally associated with a poor response to IFN-based regimens. These results suggest that 8 weeks of LDV/SOF provides a safe, simple and efficacious treatment option for this patient group.Table 1: Virologic Response Rates in Traditional Negative Predictive Factors