Safety Findings

In the MK-5172 arms of the study, there were two transient liver abnormalities observed – early elevations in total bilirubin before TW 4, associated with normalization of alanine aminotransferase/aspartate aminotransferase (ALT/AST) levels, and late elevations in liver transaminases (ALT/AST) occurring after TW 4.

Patients with Early Total Bilirubin Elevations
                     
    Arm 1   Arm 2   Arm 3 (N=67)   Arm 4 (N=65)   Arm 5
  MK-5172   MK-5172   VC   SC*   VC   SC*   BOC
 

100 mg+ PR

200 mg+ PR

MK-5172
MK-5172 MK-5172 MK-5172

800 mg tid+ PR
 

 

 

400 mg+ PR

400 mg+ PR

800 mg+ PR

800 mg+ PR

 
 
    (n=66)   (n=68)   (n=24)   (n=43)   (n=29)   (n=36)   (n=66)

TotalBilirubin >2 x ULN
  1 (1.5%)   8 (11.8%)   2 (8.3%)   4 (9.3%)   2 (6.9%)   7 (19.2%)   2 (3.0%)
 

PR, peginterferon alfa-2b + ribavirin; ULN, upper limit of normal.

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