Safety and efficacy of Interferon//Ribavirin free therapy in Septuagenerians and Octogenerians with chronic Hepatitis C

Introduction: Direct acting antivirals (DAA) have revolutionized treatment of chronic hepatitis C. Renal and hepatic function decreases in elderly patients and therefore pharmacokinetics of various drugs may differ in comparison to younger population. In addition, elderly people may suffer from diverse medical conditions requiring long-term treatment and drug-drug interactions with DAA may occur. Octo- and septuagenarians are not included in clinical studies and therefore data on efficacy and safety of IFN-free treatments in elderly are missing.

Background and Aims: We included 34 cirrhotic patients > 70 years (mean age: 74.6, range 70 – 88, m/f: 15/19, median HCV RNA 1.10 × 106 IU/ml, HCV-genotype: GT-1a: 5; 1b: 26; 4: 1; missing: 1; treatment experienced: 24; median platelet count: 126 G/l; median albumin: 39.2 g/l; median bilirubin: 0.93 mg/dl; median GFR using Cockroft-Gault formula: 66.54 ml/min) were enrolled. The patients were treated with sofosbuvir (SOF) 400 mg/day combined either with daclatasvir (DCV) 60 mg/day, simeprevir (SMV) 150 mg/day, or ledipasvir 90 mg/day. HCV RNA quantification was carried out with Abbott RealTime HCV (ART) assay (LLOQ 70 years.

Results: Currently, 9 patients reached end of follow up. Full data will be available at the time of the meeting. No severe adverse events were observed. The most frequent adverse events (AE) were fatigue (27.3%), cephalea and pruritus (both 18.2%). Other less common side effects observed were insomnia (9%), mood changes (9%), but also arthralgia, nausea and cough (< 5%). No dose modifications were required.

Conclusion: IFN/RBV-free treatment regimens are safe and effective in elderly chronic hepatitis C patients with cirrhosis.