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

Other data to be presented on MK-5172 at AASLD include results from a preclinical study evaluating the antiviral activities of MK-5172 in combination with MK-8742, an oral HCV NS5A inhibitor in Phase I development.

Indications and Usage for VICTRELIS (boceprevir)

VICTRELIS is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa and ribavirin (PR), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

The following points should be considered when initiating VICTRELIS for treatment of chronic HCV infection:

• VICTRELIS must not be used as monotherapy and should only be used in combination with PR.
• VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
• VICTRELIS in combination with PR has not been studied in patients documented to be historical null responders [less than a 2 log ₁₀ HCV-RNA decline by treatment week (TW) 12] during prior therapy with PR. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log ₁₀ HCV-RNA decline in viral load at TW 4 with PR alone are predicted to have a null response (less than a 2 log ₁₀ viral load decline by TW 12) to PR therapy.
• Poorly interferon responsive patients who were treated with VICTRELIS in combination with PR have a lower likelihood of achieving a sustained virologic response (SVR), and higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to PR.

About the Study

This Phase II, multi-center, double-blind, randomized, active-controlled, dose ranging, response-guided therapy (RGT) study is designed to examine the safety and antiviral activity of MK-5172 administered with peginterferon alfa-2b (1.5 µg/kg/week) and an investigational, weight-based dose of ribavirin (600-1,400 mg/day) (PR) in non-cirrhotic, treatment-naïve, adult patients with chronic HCV genotype 1 infection. In the study, 332 patients were enrolled in two cohorts: the Vanguard Cohort of 136 patients, followed by a Second Cohort of 196 patients. In both cohorts, patients were randomized to one of four MK-5172 treatment arms (100 mg QD, 200 mg QD, 400 mg QD, 800 mg QD). All patients received MK-5172 in combination with PR for 12 weeks followed by PR for 12 or 36 weeks, depending on treatment response at TW 4. If the patient's virus (HCV RNA) was target not detected (TND; <10 IU/mL) at TW 4, then the patient was able to stop all therapy at TW 24. If the patient's virus was target detected unquantifiable (TD(u); <25 IU/mL) or target detected quantifiable (TD(q)) at TW 4, then the patient stopped all therapy at TW 48. In the control arm, patients received a 4-week lead-in of PR followed by the addition of VICTRELIS (boceprevir) administered per the U.S. Prescribing Information.

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