AbbVie announced that new, detailed results from its hepatitis C development program were presented Saturday at the International Liver Congress (ILC) 2014. Data from a pivotal Phase 3 study, TURQUOISE-II, featured in the ILC press conference on Saturday, were presented as late-breaking. Additionally, results from the study have been published online in The New England Journal of Medicine.
TURQUOISE-II is a global, multi-center, randomized, open-label study evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie’s regimen with ribavirin (RBV) in adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection with compensated liver cirrhosis. Patients achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 91.8% and 95.9% in the 12-week and 24-week treatment arms, respectively. Patients in the study were either new to therapy or treatment-experienced (failed previous treatment with pegylated interferon and RBV).
“Results from the TURQUOISE-II study demonstrate that high SVR12 rates can be achieved in GT1 patients with compensated liver cirrhosis in both 12-week and 24-week treatment durations,” said Fred Poordad, lead clinical investigator for TURQUOISE-II and clinical professor of medicine at the University of Texas Health Science Center at San Antonio. “These data are encouraging, as cirrhotic patients are often a difficult-to-treat population in the HCV community.”
Discontinuation rates due to adverse events were 1.9% (four patients) and 2.3% (four patients) in the 12-week and 24-week arms, respectively. The most commonly reported adverse events (>10 percent in either arm) in TURQUOISE-II were fatigue, headache, nausea, pruritus, insomnia, diarrhea, asthenia, rash, cough, irritability, anemia and dyspnea.
On-treatment virologic failure occurred in one patient (0.5%) in the 12-week arm and three patients (1.7%) in the 24-week arm. In addition, 12 patients (5.9%) in the 12-week arm and one patient (0.6%) in the 24-week arm experienced relapse within 12 weeks post-treatment.
“We designed our comprehensive HCV clinical trial program to generate important information about treating a range of GT1 patients,” said Scott Brun, vice president, pharmaceutical development, AbbVie. “These data will help the medical community better understand the use of our regimen for specific patient types they encounter with GT1 infection in actual practice.”
Date: April 12, 2014