Eight weeks duration of ledipasvir/sofosbuvir (LDV/SOF) can be considered in genotype 1 hepatitis C virus (HCV) infected patients who are treatment naive, non-cirrhotic and have pre-treatment viral load < 6 million IU/ml. The effectiveness of this regimen, however, has not been fully confirmed by real-world experience. Using data from real-world cohorts, we aimed to determine the effectiveness of 8 weeks of LDV/SOF treatment, examine variables associated with relapse after treatment with this regimen, and compare the effectiveness of 8 weeks and 12 weeks of LDV/SOF treatment. To evaluate the effectiveness of 8 weeks of therapy and characteristics associated with relapse, we utilized individual patient data from IFI Institut für Interdisziplinäre Medizin (IFI), Burmans pharmacy, and Kaiser Permanente Southern California. All patients had fibrosis staging assessed with biopsy, transient elastography or serum biomarkers. We also performed a systematic review and meta-analysis of 6 additional real world cohorts, to compare effectiveness of 8 weeks to 12 weeks duration. In our pooled data analysis, 634 patients were treated for 8 weeks with LDV/SOF, of which all patients had outcomes of cure or relapse, without loss to follow-up. Per protocol sustained virologic response (SVR)12 rates were 98.1% (622/634) in the full cohort and 97.9% (571/583) among treatment eligible patients. Exact logistic regression revealed no specific patient characteristics associated with relapse. Our meta-analysis of 6 additional real world cohorts, comprised of 5,637 patients, demonstrated similar risk for relapse between 8 weeks and 12 weeks of LDV/SOF (RR=0.99, 95% CI 0.98-1.00).
An 8-week duration of treatment with LDV/SOF is highly effective in properly selected patients. Greater utilization of this regimen is recommended. This article is protected by copyright. All rights reserved.