The following data were presented at the European Association for the Study of the liver meeting in Berlin.
Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported Phase II data showing that its oral protease inhibitor, BI 201335, produced a sustained viral response (SVR) in 71 percent to 83 percent of treatment-naïve patients with hepatitis C virus (HCV) genotype 1 when given in combination with standard of care (SOC) pegylated interferon and ribavirin. A second Phase II trial showed an SVR in 28 percent to 41 percent of treatment-experienced patients who received BI 201335 plus SOC.
Medivir AB, of Huddinge, Sweden, and partner Tibotec Pharmaceuticals, a unit of New Brunswick, N.J.-based Johnson & Johnson, said results of a planned week 24 interim analysis from the Phase IIb ASPIRE study of TMC435 in treatment-experienced hepatitis C virus (HCV) patients showed patients achieved greater virologic response following treatment with TMC435-containing regimens compared to placebo. The 150-mg dose group showed the highest response, particularly in null responders. In that group, HCV RNA levels were undetectable at week 24 for between 82 percent and 91 percent of the patients. TMC435 is an oral HCV protease inhibitor.
Merck & Co. Inc., of Whitehouse Station, N.J., reported final results from a Phase III study of Victrelis (boceprevir), its oral protease inhibitor for hepatitis C virus (HCV), in combination with standard of care (SOC) peginterferon alfa-2a and ribavirin, with data showing that, over the 48-week treatment period, two-thirds (64 percent) of treatment-failed patients with HCV genotype 1 receiving the triple-drug therapy achieved sustained virologic response (SVR) vs. 21 percent receiving SOC alone. Data also identified potential predictors for the likelihood of achieving SVR based on a patient's response during a four-week lead-in with SOC alone prior to the additional of boceprevir and showed that the addition of boceprevir to the treatment regimen improved SVR rates regardless of whether patients had good or poor response during lead-in treatment. In pre-specified analyses of the pivotal Phase III studies, researchers found that IL28B status was a strong baseline predictor of viral response at treatment weeks four and eight and SVR among patients receiving boceprevir.