June 17, 2013

Journal of Hepatology
Volume 59, Issue 1 , Pages 11-17, July 2013

Eric Lawitz,, Maribel Rodriguez-Torres,, Albrecht Stoehr,, Edward J. Gane,, Lawrence Serfaty,, Sanhita Bhanja,, Richard J. Barnard,Di An,, Jacqueline Gress,, Peggy Hwang., Niloufar Mobashery

Received 26 November 2012; received in revised form 4 February 2013; accepted 12 February 2013. published online 22 February 2013.

Abstract

Background & Aims

MK-7009 (vaniprevir) is a non-covalent competitive inhibitor of the hepatitis C virus (HCV) NS3/4A protease. This report presents the primary analysis results (safety and sustained viral response) of a phase 2b study of MK-7009 given in combination with peginterferon (PegIFN) alfa2a 180μg weekly and ribavirin (RBV) 1000–1200mg/day, for 24–48weeks to non-cirrhotic patients who have failed previous PegIFN and RBV treatment.

Methods

We present results of a randomized, placebo-controlled, double-blind study of MK-7009 administered for 24–48weeks in combination with PegIFN and RBV in 4 regimens to at least 40 patients per arm. Stratification by prior response to PegIFN and RBV was as follows: null response, partial response, breakthrough and relapse. HCV RNA was determined by Roche Cobas Taqman with a lower limit of detection (LLoD) of 10IU/ml and a lower limit of quantification (LLoQ) of 25IU/ml.

Results

SVR24 in patients on MK-7009+PegIFN and ribavirin (P/R) was statistically superior to placebo+P/R in all treatment groups (p<0.001). MK-7009 at 300mg b.i.d. and 600mg b.i.d. is generally well tolerated for use for up to 48weeks of therapy. Patients in MK-7009 regimens had higher rates of gastrointestinal adverse events as compared to control (mostly mild to moderate). There were no significant differences in rates of anemia and rash between the MK-7009 regimens and control.

Conclusions

In conclusion, patients treated with MK-7009 plus P/R experienced significant improvement in SVR compared to P/R control in a population of GT 1 experienced patients.

Keywords: Vaniprevir, HCV, Direct-acting antivirals

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