AbbVie to Present Results from Phase 2 PEARL-I Study in Genotype 4 Chronic Hepatitis C Patients at The Liver Meeting® 2014

- Results demonstrated high response rates in adult chronic hepatitis C genotype 4 patients without cirrhosis
- Data underscore AbbVie's commitment to evaluating treatments across a range of patients with chronic hepatitis C virus infection

BOSTON, Nov. 11, 2014 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced detailed results from its open-label Phase 2b study, PEARL-I, which demonstrated 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 ribavirin (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.

"As many as 34 million people around the world are living with genotype 4 chronic hepatitis C, a population that is common in the Middle East and Africa, where it accounts for more than 80 percent of all hepatitis C cases,[i]" said Barry Bernstein, M.D., vice president, infectious disease development, AbbVie. "The data from PEARL-I represent another important step forward in realizing our commitment to advancing scientific knowledge in hepatitis C with the ultimate goal of providing treatment options to as many patients as possible."

PEARL-I studied AbbVie's all-oral, interferon-free investigational treatment combining two direct-acting antivirals (ABT-450/ritonavir and ombitasvir) with and without RBV for 12 weeks in non-cirrhotic adult patients with chronic genotype 1b (GT1b) and GT4 hepatitis C virus (HCV) infection.

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.

About AbbVie's Investigational Two Direct-Acting Antiviral HCV TreatmentAbbVie's proposed all-oral antiviral treatment consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (25mg) dosed once daily, co-administered with weight-based ribavirin (1000mg or 1200mg in divided doses twice daily). The combination of two direct-acting antivirals, each with distinct mechanisms of action, targets and inhibits specific HCV proteins in the viral replication process.

About AbbVie's HCV Clinical Development Program The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with and without ribavirin with the goal of achieving high sustained virologic response rates in as many patients as possible. AbbVie's development programs combining two direct-acting antivirals are studying additional hepatitis C virus (HCV) genotypes.

ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

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