AbbVie Announces New Data on VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Patients with Chronic Hepatitis C Virus Infection With or Without Compensated Cirrhosis

- Ongoing TOPAZ-II study evaluates long-term treatment outcomes in genotype 1a and genotype 1b chronic HCV patients with or without compensated cirrhosis

- Patients treated with VIEKIRA PAK, with or without ribavirin, achieved 95 percent sustained virologic response rates at 12 weeks post-treatment (SVR12)  

NORTH CHICAGO, Illinois, Nov. 14, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today 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.¹ Results show that 95 percent (n=586/615) 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, a secondary endpoint for the study.¹ These data were presented today at The Liver Meeting® 2015, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.

The TOPAZ-II study, a multicenter trial in the U.S., 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, according to the dosing recommendations found in the U.S. full prescribing information.¹

"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.