November 12, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
AbbVie may have another blockbuster drug on its hands, after it said this week that patients in a Phase II study of its new liver drug ribavirin saw a cure rate of 97 percent in non-cirrhotic liver transplant patients with recurrent genotype 1 hepatitis C virus
Results from AbbVie‘s ongoing open-label Phase 2 study, CORAL-I, were presented yesterday at industry event The Liver Meeting during an oral session and published online in The New England Journal of Medicine. They found that non-cirrhotic liver transplant patients with recurrent GT1 HCV and new to treatment after transplantation achieved a sustained virologic response (SVR) rate of 97.1 percent and a SVR post-treatment of 97.1 percent after 24 weeks.
“Recurrence of HCV infection in the new graft post-liver transplantation is universal in those that have the virus prior to transplantation, and can be associated with an aggressive disease course,” said Paul Kwo, medical director of liver transplantation and professor of medicine, Indiana University School of Medicine, in a statement. “The high SVR rates seen in CORAL-I are promising and offer valuable information as we continue to assess this regimen within this specific patient population.”
The company also announced results from studies in chronic hepatitis C patients with human immunodeficiency virus type 1 (HIV-1) co-infection (TURQUOISE-I) and liver transplant recipients (CORAL-I).
The Phase 2 portion of AbbVie‘s Phase 2/3 open-label study, TURQUOISE-I, showed patients co-infected with GT1 HDV and HIV-1 receiving ribavirin for 12 weeks or 24 weeks achieved sustained virologic response rates 12 weeks post-treatment of 93.5 percent and 90.6 percent respectively. Those response rates have enormous significance for the two diseases, which have been tricky to treat effectively.
“Patients living with both chronic HCV and HIV have been historically considered more difficult to treat,” said Barry Bernstein, vice president, infectious disease development, AbbVie, said. “TURQUOISE-I is one of the few dedicated studies looking specifically at this population, who are seen in everyday clinical practice. These data will help us gain a better understanding of how our investigational treatment works in this subpopulation of genotype 1 patients.”
