Aims: The direct acting-antivirals (DAA) glecaprevir (NS3/4A protease inhibitor; developed by AbbVie and Enanta) and pibrentasvir (NS5A inhibitor), coformulated as G/P, are a once-daily, all-oral treatment regimen with high rates of sustained virologic response at 12 weeks post-treatment (SVR12) and a favourable safety profile indicated for use in patients at any stage of chronic kidney disease (CKD). Here we report preliminary data from a Phase 3b study assessing the efficacy and safety of 8, 12, and 16 weeks of G/P treatment in patients with chronic hepatitis C virus (HCV) genotype (GT) 1-6 infection and CKD Stage 3b, 4, or 5, including those on dialysis. This study aims: to provide further evidence supporting G/P’s labeled regimen among patients with moderate or severe CKD, including efficacy of an 8-week G/P treatment duration for patients who are treatment naive and non-cirrhotic.
Methods: EXPEDITION-5 (NCT03069365) is an ongoing, Phase 3b, multicenter study evaluating the efficacy and safety of G/P in patients without cirrhosis or with compensated cirrhosis and with CKD. Patients were either treatment-naive or -experienced with interferon (IFN), pegIFN ± ribavirin (RBV), or sofosbuvir (SOF) + RBV ± pegIFN. Prior treatment with a DAA other than SOF was not permitted. Patients had an estimated glomerular filtration rate (eGFR)<45mL/min/1.73 m2 without a history of acute renal failure within 3 months prior to screening. Patients were treated with label (U.S. and E.U.) indicated treatment duration. Efficacy was evaluated by the percent of patients achieving SVR12 (HCV RNA