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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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