Enanta Pharmaceuticals Announces AbbVie's Investigational, Pan-Genotypic Regimen Of Glecaprevir/Pibrentasvir (G/P) Shows High SVR Rates In Chronic Hepatitis C Patients With Severe Chronic Kidney Disease
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR 12) with AbbVie's investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR 12 was achieved in 100 percent (n=102/102) of severe CKD patients. The mITT analysis excludes patients who did not achieve SVR for reasons other than virologic failure. These new data from the Phase 3 EXPEDITION-4 study, evaluating patients with chronic HCV infection across all major genotypes (GT1-6) and severe CKD, will be presented as a late-breaker today at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston. The EXPEDITION-4 results are the latest to be released from registrational studies in AbbVie's G/P clinical development program, designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing areas of continued unmet need. Glecaprevir (GLE), an NS3/4A protease inhibitor, is Enanta's second protease inhibitor being developed through its collaboration with AbbVie. G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg) and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets. HCV is common among people with severe CKD, reaching prevalence of up to 80 percent in some regions of the world. 1 In the U.S., it is estimated that over 500,000 people have both chronic HCV and CKD 2. Some chronic HCV infected patients with severe CKD, particularly those with GT2 and GT3 HCV infection, currently don't have access to direct-acting antivirals (DAAs). The development of new, safe and effective regimens to treat HCV in these patients remains a critical unmet medical need. 3 The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney disease, including 85 patients (82 percent) who were receiving dialysis at enrollment and 20 patients (19 percent) who had compensated cirrhosis. The study also included those who were not cured with previous treatment with sofosbuvir (SOF) plus ribavirin (RBV) or with interferon (IFN) plus RBV, with or without SOF (44 patients, 42 percent).