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 - Seite 2

"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."

About the TOPAZ-II Study

TOPAZ-II is an ongoing, single arm, open-label, Phase 3b multicenter study in the U.S. evaluating the safety and efficacy of 12 or 24 weeks of treatment with VIEKIRA PAK, with or without ribavirin, in treatment-naïve or pegIFN/RBV treatment-experienced, adult patients with GT1 chronic HCV infection with or without compensated cirrhosis.¹ Patients in the TOPAZ-II study will be followed up for a period of five years post-treatment to evaluate the long-term impact of SVR₁₂ on progression of liver disease.

The trial includes 615 patients, 115 (19 percent) with compensated cirrhosis and 500 (81 percent) without cirrhosis.¹ On-treatment virologic failure was experienced by 0.8 percent (n=5/615) of study patients, while 1.9 percent (n=11/590) experienced relapse. One percent (n=6/615) of patients prematurely discontinued treatment due to adverse events.¹ Four percent (n=25/615) experienced serious adverse events. Ribavirin dosage was reduced due to anemia in 30/474 (6.3 percent) patients or due to hemoglobin decreases in 20/474 (4.2 percent) patients who received RBV. The most commonly-reported adverse events (in ≥10 percent of patients) were fatigue, nausea, headache, pruritus and insomnia.¹

Genotype 1 subjects who were either treatment-naïve or previously treated with IFN or pegIFN/RBV received VIEKIRA PAK. Subjects with GT1a and all GT1 subjects with compensated cirrhosis also received RBV. The treatment duration was 12 weeks for all subjects except GT1a subjects with compensated cirrhosis who received treatment for 24 weeks. Treatment for 12 weeks was considered for some of these patients based on prior treatment history.¹ The primary endpoint is the incidence of all-cause death, liver-related death, liver decompensation, liver transplantation, hepatocellular carcinoma, and the composite of any of the above outcomes observed during the post-treatment period. Key secondary endpoints included the percentage of subjects with SVR₁₂ (HCV undetectable in the blood 12 weeks following the final dose of the study drug), on-treatment virologic failure and post-treatment relapse.¹