Interim Phase II Data Of Merck's Investigational MK-5172 In Combination Therapy In Chronic Hepatitis C Virus Genotype 1 Infection To Be Presented At The American Association For The Study Of Liver Diseases (AASLD) Annual Meeting

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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