Elderly subjects have been historically underrepresented in clinical trials involving antiviral hepatitis C therapies. The aim of this analysis was to retrospectively evaluate the safety and efficacy of ledipasvir/sofosbuvir (LDV/SOF) by age groups of <65 years versus 65 years among subjects enrolled in phase 3 trials. Four open-label phase 3 clinical trials evaluated the safety and efficacy of LDV/SOF with or without ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C virus. Sustained virological response at 12 weeks, treatment-emergent adverse events (AEs), and graded laboratory abnormalities were analyzed according to age group. Of the 2293 subjects enrolled in four phase 3 trials, 264 (12%) were 65 years of age, of whom 24 were aged 75 years. Sustained virological response at 12 weeks was achieved by 97% (1965/ 2029) of subjects aged <65 years and 98% (258/264) of subjects aged 65 years. The most common AEs in both LDV/ SOF groups that occurred in 10% of subjects were headache and fatigue. The rate of study discontinuation due to AEs was similar in the two age cohorts. The use of RBV in 1042 (45%) subjects increased the number of AEs, treatmentrelated AEs, and AEs leading to study drug modification/interruption, particularly among elderly subjects. Conclusions: LDV/SOF with or without RBV was highly effective for treatment of genotype 1 chronic hepatitis C virusin subjects aged 65 and older. Addition of RBV did not increase sustained virological response at 12 weeks rates but led to higher rates of AEs, especially in elderly subjects. (HEPATOLOGY 2016;63:1112-1119 C hronic hepatitis C viral (HCV) infection is an important cause of morbidity and mortality in infected individuals worldwide.(1) The World Health Organization estimates that the worldwide prevalence of HCV infection is 2.2%, representing 123 million people.(2) Globally, HCV accounts for 27% of liver cirrhosis and 25% of hepatocellular carcinoma cases.(3) Although the rate of HCV is decreasing overall due to attrition from mortality, (4,5) the rate of HCV-related cirrhosis is anticipated to increase by Abbreviations: AE, adverse event; CI, confidence interval; eGFR, estimated glomerular filtration rate; HCV, hepatitis C virus; LDV/SOF, ledipasvir/sofosbuvir; RAV, resistance-associated variant; RBV, ribavirin; SVR12, sustained virological response at 12 weeks

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