BioCentury
ARTICLE | Clinical News

Deleobuvir: Additional Phase IIb data

June 17, 2013 7:00 AM UTC

Additional data from the open-label, international Phase IIb SOUND-C3 trial showed that 19 of 20 (95%) evaluable treatment-naïve patients with chronic HCV genotype 1b infection who received once-daily faldaprevir (BI 201335) plus twice-daily deleobuvir (BI 207127) and ribavirin for 16 weeks achieved an SVR 12 weeks after the end of treatment, including all 4 patients with liver cirrhosis. However, only 2 of 12 (17%) evaluable patients with chronic HCV genotype 1a infection and the CC genotype of the interleukin-28B (IL-28B; IFNL3) gene achieved an SVR12, which Boehringer said suggests the need for treatment of greater intensity for this patient population and confirms its decision to focus on patients with HCV genotype 1b infection in Phase III trials.

The most common adverse events were anemia, fatigue, vomiting and nausea. The trial, which has enrolled about 83 patients, consists of 3 cohorts in which patients received once-daily faldaprevir plus twice-daily deleobuvir and ribavirin for 16 or 24 weeks; or once-daily faldaprevir plus thrice-daily deleobuvir and ribavirin for 24 weeks. Data were presented at the Asian Pacific Association for the Study of the Liver meeting in Singapore. In January, Boehringer reported SVR4 data from the 20 evaluable patients (see BioCentury, Jan. 21). ...