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Findings from Two Phase 3 Studies of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients
Date:4/23/2013

hallenging to cure," said Maria Beumont , M.D., medical leader for simeprevir, Janssen. "Janssen is committed to advancing hepatitis C therapy for even the most difficult-to-cure patients."

The most common adverse events seen in patients receiving simeprevir in QUEST-1 were fatigue (42 percent versus 41 percent for placebo), itch (26 percent versus 16 percent for placebo), and headache (33 percent versus 39 percent for placebo). The most common adverse events seen in patients receiving simeprevir in QUEST-2 were fatigue (37 percent versus 42 percent for placebo), itch (25 percent versus 25 percent for placebo), headache (39 percent versus 37 percent for placebo), fever (31 percent versus 40 percent for placebo), and influenza-like illness (26 percent versus 26 percent for placebo). In QUEST-1, in both the simeprevir and placebo arms, 3 percent of patients discontinued treatment due to an adverse event. In QUEST-2, 2 percent of patients in the simeprevir arm and 1 percent of patients in the placebo arm discontinued treatment due to an adverse event.

About QUEST-1 and QUEST-2

QUEST-1 and QUEST-2 are global, Phase 3, randomized, double-blind, placebo controlled clinical trials assessing the efficacy, safety and tolerability of simeprevir plus pegylated interferon and ribavirin versus pegylated interferon and ribavirin alone in treatment-naive adult patients with genotype 1 chronic hepatitis C with compensated liver disease, including all stages of liver fibrosis.

In the QUEST-1 and QUEST-2 trials, 394 and 391 patients, respectively, were randomized to receive one 150 mg capsule of simeprevir or placebo once daily plus pegylated interferon and ribavirin for 12 weeks, followed by pegylated interferon and ribavirin alone for either 12 or 36 weeks based on RGT criteria. Patients in the simeprevir arm were considered to have met RGT criteria if their HCV RNA levels were <25 IU/mL (detectable or undetectable) at we
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SOURCE Janssen R&D Ireland
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