BI 201335: Additional Phase IIb data

Data from a subgroup of 37 patients with compensated liver cirrhosis in the open-label Phase IIb SOUND-C2 trial in 362 treatment-naïve patients with chronic HCV genotype 1 infection showed that 60% and 56% of patients with HCV genotype 1a and 1b infection, respectively, who received once-daily 120 mg BI 201335 plus thrice-daily 600 mg BI 207127 and ribavirin for 16 or 28 weeks achieved an SVR 12 weeks after the end of treatment (n=21). The data include patients who achieved an SVR 4 weeks after the end of treatment in the 40-week treatment arm as SVR 12 data for the cohort are not yet available. Additionally, 29% and 83% of patients with HCV genotype 1a and 1b infection, respectively, who received once-daily 120 mg BI 201335 plus twice-daily 600 mg BI 207127 and ribavirin for 28 weeks achieved an SVR 12 weeks after the end of treatment (n=13). Furthermore, 0% and 33% of patients with HCV genotype 1a and 1b infection, respectively, who received once-daily 120 mg BI 201335 plus thrice-daily 600 mg BI 207127 without ribavirin for 28 weeks achieved an SVR 12 weeks after the end of treatment (n=3). Data will be presented at the European Association for the Study of the Liver meeting in Barcelona this month. ...