BioCentury
ARTICLE | Clinical News

Asunaprevir: Additional Phase II data

April 29, 2013 7:00 AM UTC

Data from 16 treatment-naïve, non-cirrhotic patients with HCV genotype 1 infection in Part 1 of an open-label, international Phase II trial showed that an oral regimen of asunaprevir, daclatasvir and BMS-791325 for 24 weeks produced an SVR defined as undetectable HCV RNA levels (<25 IU/mL) 12 weeks after end of treatment in 94% of patients. Bristol-Myers said 1 patient withdrew consent. The SVR24 rate was 88%, with no virologic breakthroughs or relapses. In 16 patients who received asunaprevir, daclatasvir and BMS-791325 for 12 weeks in Part 1 of the trial, the SVR24 rate was 94% and the SVR36 rate was 88%. Bristol-Myers previously reported SVR12 data from the 12-week regimen in Part 1 of the trial (see BioCentury, Oct. 22, 2012 & Nov. 19, 2012). Patients received twice-daily 200 mg oral asunaprevir, once-daily 60 mg oral daclatasvir and twice-daily 75 mg oral BMS-791325 for 12 or 24 weeks in Part 1 of the trial.

In Part 2 of the trial, asunaprevir, daclatasvir and BMS-791325 for 12 weeks (n=18) led to an SVR4 and SVR12 rate of 89%, with 1 relapse and 1 virologic breakthrough. Additionally, asunaprevir, daclatasvir and BMS-791325 for 24 weeks in Part 2 of the trial (n=16) led to an SVR4 rate of 94% with 1 virologic breakthrough. In Part 2 of the trial, patients received twice-daily 200 mg asunaprevir, once-daily 60 mg daclatasvir and twice-daily 150 mg BMS-791325 for 12 and 24 weeks. There were 2 serious adverse events reported - cerebral vasoconstriction and renal calculus. The most common adverse events were headache, asthenia, diarrhea and nausea, and no grade 3/4 elevations in liver enzymes or bilirubin were observed. Data were presented at the European Association for the Study of the Liver meeting in Amsterdam. ...