AbbVie 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) at The Liver Meeting 2014.
New, detailed results from part one of the Phase 2 portion of AbbVie’s Phase 2/3 open-label study, TURQUOISE-I, showed patients co-infected with genotype 1 (GT1) hepatitis C virus (HCV) and HIV-1 receiving AbbVie’s investigational treatment and ribavirin (RBV) for 12 weeks or 24 weeks achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 93.5% and 90.6%, respectively. These data were presented today, November 11, as a “Poster of Distinction.”
“Patients living with both chronic HCV and HIV have been historically considered more difficult to treat,” said Barry Bernstein, M.D., vice president, infectious disease development, AbbVie. “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.”
Additionally, results from the first cohort of AbbVie’s ongoing open-label Phase 2 study, CORAL-I, were presented today during an oral session and published online in The New England Journal of Medicine. Results showed that non-cirrhotic liver transplant patients with recurrent GT1 HCV and new to treatment after transplantation achieved a SVR12 rate of 97.1% (n=33/34) and a sustained virologic response rate 24 weeks post-treatment of 97.1% after 24 weeks of treatment.
“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,” explained Dr. Paul Kwo, medical director of liver transplantation and professor of medicine, Indiana University School of Medicine. “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.”
Filed Under: Drug Discovery