AIM To evaluate sustained viral response(SVR) of 8-wk ledipasvir/sofosbuvir therapy among non-cirrhotic, genotype-1 hepatitis C virus(HCV) patients with RNA < 6 million IU/m L.METHODS We performed a retrospective cohort study to examine SVR rates, predictors of treatment failure and safety analysis of 8-wk ledipasvir/sofosbuvir(LDV/SOF) therapy among non-cirrhotic, genotype 1 HCV patients with viral load < 6 million IU/m L. Primary outcome was an achievement of SVR at 12 wk after treatment. Secondary outcomes were identifying predictors of treatment failure and adverse events during treatment.RESULTS Total 736 patients: 55% males, 51% Caucasians and 65% were genotype 1a. Non-cirrhotic state of 53% was determined by clinical judgment(imaging, AST, platelet count) and 47% had documented liver fibrosis testing(biopsy, vibration-controlled transient elastography, serum biomarkers). Overall SVR12 was 96%. No difference in SVR12 was seen between patients whose non-cirrhotic state was determined by clinical judgment and patients who had fibrosis testing. Age groups, gender, ethnicity and genotype 1 subtype did not predict SVR. Non-cirrhotic state determined by clinical judgment based on simple, non-invasive tests were not associated with lower SVR [OR = 1.02, 95%CI: 0.48-2.17, P = 0.962]. The AUROC for hepatitis C RNA viral load was 0.734(P < 0.001, 95%CI: 0.66-0.82). HCV RNA 2.2 million IU/m L was identified as the cutoff value with sensitivity 73% and specificity 64%. HCV RNA < 2.2 million IU/m L was associated with significantly higher SVR 98% with OR = 0.22(95%CI: 0.1-0.49, P < 0.001) compared to SVR 92% in HCV RNA ≥ 2.2 million IU/m L. No death or morbidities were reported.CONCLUSION Our outcomes validate safety and effectiveness of 8-wk LDV/SOF therapy in non-cirrhotic, untreated HCV genotype 1 patients with HCV RNA < 6 million IU/m L. AIM To run sustained viral response (SVR) of 8-wk ledipasvir / sofosbuvir therapy among non-cirrhotic, genotype-1 hepatitis C virus (HCV) patients with RNA <6 million IU / m L. METHODS We performed a retrospective cohort study to examine SVR rates, predictors of treatment failure and safety analysis of 8-wk ledipasvir / sofosbuvir (LDV / SOF) therapy among non-cirrhotic, genotype 1 HCV patients with viral load <6 million IU / m L. Primary outcome was an achievement of SVR at 12 wk after treatment. Secondary outcomes were identified predictors of treatment failure and adverse events during treatment. RESULTS Total 736 patients: 55% males, 51% Caucasians and 65% were genotype 1a. Non-cirrhotic state of 53% was determined by Overall SVR12 was 96%. No difference in SVR12 was seen between patients whose non-cirrhotic state (clinical, AST, platelet count) and 47% had documented liver fibrosis testing (biopsy, was determi ned by clinical judgment and patients who had fibrosis testing. Age groups, gender, ethnicity and genotype 1 subtype did not predict SVR. Non-cirrhotic state determined by clinical judgment based on simple, non-invasive tests were not associated with lower SVR [OR = 1.02, 95% CI: 0.48-2.17, P = 0.962] The AUROC for hepatitis C RNA viral load was 0.734 (P <0.001, 95% CI: 0.66-0.82). HCV RNA 2.2 million IU / mL was identified as cutoff value with sensitivity 73% and specificity 64% compared to SVR 98% with OR = 0.22 (95% CI: 0.1-0.49, P <0.001) 92% in HCV RNA ≥ 2.2 million IU / m L. No death or morbidities were reported. CONCLUSION Our results validate safety and effectiveness of 8-wk LDV / SOF therapy in non-cirrhotic, untreated HCV genotype 1 patients with HCV RNA <6 million IU / m L.