Tu1041 Experience With Sofosbuvir-Based Antiviral Therapy in Septuagenarians and Octogenarians

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Background: The interferon-free antiviral regimen, Sofosbuvir (SOF) and Simeprevir (SMV), is well tolerated and achieves high sustained virologic response (SVR) rates when treating patients with compensated hepatitis C genotype 1 (HCV GT1) infection. However, the safety and efficacy of a Simeprevir containing regimen in decompensated cirrhosis is unclear. Aim & Methods: We aim to report the safety, tolerability and efficacy of SOF+SMV to treat decompensated HCV GT1 cirrhosis in a single center cohort study. Results: 31 patients with decompensated HCV GT1 cirrhosis met criteria to be considered for treatment. 22 patients have received SOF+SMV to date: 55% male, 50% subtype 1a, 41% with HCV RNA >800,000 IU/mL, 68% who previously failed or did not tolerate interferon-based treatments. Additionally 82% were classified as Child-Pugh score (CPS) B cirrhosis and 18% as CPS C cirrhosis. Median MELD score was 11 (range 6 19). Complications prior to treatment include ascites (60%), hepatic encephalopathy (60%) and hepatic hydrothorax (9%). All patients had estimated GFR >30 mL/min. Patients have been followed for a median of 12 weeks (range 2 48 weeks). Of the 17 patients who completed 4 weeks of treatment, 14 (82%) achieved HCV RNA levels below the limit of quantification; and of the 14 patients who completed treatment, 12 (86%) achieved HCV RNA levels below the limit of detection (table). One patient with CPS C10 cirrhosis never achieved undetectable HCV RNA, and one patient with CPS C10 cirrhosis had treatment stopped due to severe adverse events of worsening ascites, encephalopathy and spontaneous bacterial peritonitis. To date, HCV RNA data is available post-treatment in 6 patients, of which one patient relapsed. 5 of 14 patients by end of treatment (36%) developed signs of worsening portal hypertension including: worsening ascites (2/14), worsening hepatic encephalopathy (1/14), worsening hepatic hydrothorax (1/14) and variceal bleed (1/14). Two of these patients required hospital admission. Conclusions: The interferon-free antiviral regimen SOF+SMV combination achieves virological response rate at end of treatment. However, during treatment, patients may be at risk for complications of worsening portal hypertension. Complete SVR12 data will be reported at the meeting. Virological Response Rates