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AbbVie announces new data for Viekira Pak in HCV
16 November 2015 • Author: Victoria White
AbbVie has announced new data from its ongoing Phase 3b TOPAZ-II study evaluating Viekira Pak (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets), with or without ribavirin (RBV), in adult patients with genotype 1a (GT1a) or genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection.
Results from the study show that 95% of patients in the TOPAZ-II trial achieved a sustained virologic response at 12 weeks post-treatment (SVR12) after 12 or 24 weeks of treatment.
The TOPAZ-II study evaluates the impact of SVR12 on the progression of liver diseases over the course of five years in a diverse patient population, including genotype 1 (GT1) HCV patients with or without cirrhosis and those who were treatment-naïve or pegylated interferon (pegIFN)/RBV treatment-experienced. Patients were treated with Viekira Pak, with or without RBV.
Patients achieved high sustained virologic response rates with Viekira Pak
“The preliminary data from TOPAZ-II show that a diverse population of genotype 1 HCV patients, including those with compensated cirrhosis, have been effectively treated with Viekira Pak,” said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. “These data show both GT1a and GT1b patients achieved high sustained virologic response rates when treated with Viekira Pak, with or without ribavirin, for 12 or 24 weeks, which reinforces efficacy data from previous studies.”
Viekira Pak, with or without RBV, is indicated for the treatment of patients with GT1 chronic HCV infection, including those with compensated cirrhosis (Child-Pugh A). Viekira Pak is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity.
“If left untreated over a period of 20 to 30 years, approximately five to 20 percent of chronic hepatitis C patients may develop cirrhosis of the liver,” said Nancy Reau, M.D., chief, Section of Hepatology, and associate director, Solid Organ Transplantation,Rush University Medical Center. “These results add to the body of medical information about the treatment of patients with genotype 1 chronic hepatitis C infection, and future data from this study will inform the impact of treatment with VIEKIRA PAK on liver disease progression.”
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