Enanta Announces Results From Phase 2b PEARL-I Study In Genotype 4 Chronic Hepatitis C Patients At The Liver Meeting 2014

anta Pharmaceuticals, Inc., ENTA a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced detailed results from AbbVie's open-label, Phase 2b PEARL-I study in patients with genotype 4 (GT4) chronic hepatitis C virus (HCV). PEARL-I studied AbbVie's all-oral, interferon-free investigational treatment combining two direct-acting antivirals (ABT-450/ritonavir and ombitasvir) with or without ribavirin (RBV) for 12 weeks in non-cirrhotic adult patients with chronic genotype 1b (GT1b) and GT4 hepatitis C virus (HCV) infection. Results showed that 100 percent of genotype 4 (GT4) patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49) achieved sustained virologic response rates at 12 weeks post-treatment (SVR12) after taking AbbVie's investigational treatment with RBV. Additionally, 90.9 percent of patients who were new to therapy achieved SVR12 (n=40/44) after taking the treatment without RBV. These data will be presented today during a poster session at The Liver Meeting® 2014. There were no discontinuations due to adverse events in PEARL-I. The most commonly reported treatment-emergent adverse events (greater than 15 percent in any group) were headache (29-33 percent), asthenia (weakness) (24-33 percent), fatigue (7-18 percent), nausea (9-17 percent) and insomnia (5-16 percent). One patient had a grade 3 liver function test elevation (AST> five times the upper limit of normal), which was asymptomatic and resolved during continued dosing. Four patients with hemoglobin decreases (anemia) required RBV dose reductions; however, none of these patients required blood transfusions or medication to boost their red blood cell production. In the treatment-naïve group without RBV, on-treatment virologic breakthrough was reported in one patient (2 percent) and two patients (5 percent) experienced post-treatment relapse. There were no virologic failures in the other treatment arms. As many as 34 million people around the world are living with genotype 4 chronic HCV infection, the most common HCV genotype in the Middle East and Africa, where it accounts for more than eighty percent of all hepatitis C cases1.