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Combination of Vaniprevir With Peginterferon and Ribavirin Significantly Increases the Rate of SVR in Treatment-Experienced Patients With Chronic HCV.

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Presentation on theme: "Combination of Vaniprevir With Peginterferon and Ribavirin Significantly Increases the Rate of SVR in Treatment-Experienced Patients With Chronic HCV."— Presentation transcript:

1 Combination of Vaniprevir With Peginterferon and Ribavirin Significantly Increases the Rate of SVR in Treatment-Experienced Patients With Chronic HCV Genotype 1 Infection and Cirrhosis  Maribel Rodriguez–Torres, Albrecht Stoehr, Edward J. Gane, Lawrence Serfaty, Eric Lawitz, Amy Zhou, Michael Bourque, Sanhita Bhanja, Julie Strizki, Richard J.O. Barnard, Peggy M.T. Hwang, Mark J. DiNubile, Niloufar Mobashery  Clinical Gastroenterology and Hepatology  Volume 12, Issue 6, Pages e5 (June 2014) DOI: /j.cgh Copyright © 2014 AGA Institute Terms and Conditions

2 Supplementary Figure 1 Dosing arms for the MK-7009 P009 phase 2B trial in treatment-experienced patients with chronic HCV–genotype 1 infection. After stratification by type of previous failure, patients were randomized to 1 of 4 regimens combining vaniprevir with P/R (arms 1–4) or the control arm (arm 5) using P/R alone. Noncirrhotic and cirrhotic subjects were assigned separately to the same 5 treatment arms. Futility rules effective at or after week 12 included the following: (1) less than a 2-log decrease in baseline HCV RNA level by week 12 (null response); (2) decreased but still quantifiable HCV RNA levels at week 24 or persistently detectable but unquantifiable HCV RNA levels at weeks 24 and 28 (partial response); and (3) a log increase from nadir HCV RNA level at or after week 12 or an HCV RNA level greater than 100 IU/mL at or after week 12 after becoming undetectable (breakthrough). Clinical Gastroenterology and Hepatology  , e5DOI: ( /j.cgh ) Copyright © 2014 AGA Institute Terms and Conditions

3 Supplementary Figure 2 Patient accounting in the cirrhotic cohort. A CONSORT diagram shows the disposition of cirrhotic patients for the entire study. Patients who discontinued study medication did not necessarily drop out of the study. All treated patients had postrandomization HCV RNA measurements and, therefore, were eligible for the efficacy analyses. However, 4 vaniprevir recipients were excluded per protocol from the primary mITT efficacy analysis because of withdrawal from the study at a time when their HCV RNA level was undetectable. Bid indicates patients were instructed to take vaniprevir (V) at approximately 12-hour intervals. Clinical Gastroenterology and Hepatology  , e5DOI: ( /j.cgh ) Copyright © 2014 AGA Institute Terms and Conditions


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