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Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
Date:5/21/2013

PROMISE were fatigue (32 percent versus 42 percent), headache (32 percent versus 36 percent) and influenza-like illness (30 percent versus 20 percent), respectively. In addition, rash (19 percent versus 14 percent), itching (24 percent versus 17 percent), neutropenia (15 percent versus 17 percent), anemia (11 percent versus 6 percent), increased bilirubin (6 percent versus 2 percent), and photosensitivity conditions (4 percent versus none) were also observed. One patient in the simeprevir arm and no patients in the placebo arm discontinued treatment due to an adverse event.

Digestive Disease Week® (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at the Orange County Convention Center, Orlando, Florida. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

About PROMISE
PROMISE is a global, Phase 3, randomized, double-blind, placebo-controlled clinical trial assessing the efficacy, safety and tolerability of simeprevir plus pegylated interferon and ribavirin versus pegylated interferon and ribavirin alone in adult patients with genotype 1 chronic hepatitis C with compensated liver disease, including all stages of liver fibrosis, who relapsed after previous interferon-based therapy.

In the PROMISE trial, 393 patients were randomized to receive one 150 mg capsule of simeprevir or placebo once dai
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SOURCE Janssen R&D Ireland
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