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

BOC, boceprevir; PR, peginterferon alfa-2b + ribavirin; SC, second cohort; VC, vanguard cohort.

*Patients receiving the 400 mg and 800 mg doses in the SC were down-dosed to receive 100 mg in an open-label fashion. Down dosing occurred in the SC at various time points while on MK-5172. No patients were dosed down in the VC.

Of those patients with bilirubin elevation, 92 percent (22/24) occurred within the first seven to 23 days of therapy, and their bilirubin levels decreased from peak levels despite continued dosing.

Patients With Late ALT/AST Elevations

Arm 1

Arm 2

Arm 3 (N=67)

Arm 4 (N=65)

Arm 5

Parameter

MK-5172

MK-5172

VC

SC*

VC

SC*

MK-5172

100 mg+ PR

200 mg+ PR

MK-5172

MK-5172

MK-5172

MK-5172

400 mg+ PR

400 mg+ PR

800 mg+ PR

800 mg+ PR

100 mg+ PR

(n=66)

(n=68)

(n=24)

(n=43)

(n=29)

(n=36)

(n=66)

Patientswith LateALT/AST> 2x ULN

1 (2%)

6 (9%)

5 (21%)

8 (19%)

7 (24%)

8 (22%)

1 (2%)

ALT, alanine aminotransferase; AST, aspartate aminotransferase; PR, peginterferon alfa-2b + ribavirin; ULN, upper limit of normal.

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