AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C

NORTH CHICAGO, Ill., Sept. 23, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new data showing high response rates with just eight weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) treatment. In the Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12).1 These data were presented today at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, in Paris, France and included in the newly published 'EASL Recommendations on Treatment of Hepatitis C.' VIEKIRAX + EXVIERA is currently approved in the European Union for GT1b patients without cirrhosis or with compensated cirrhosis for 12 weeks.

AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C

NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. VIEKIRA XR is a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). VIEKIRA XR is not for people with decompensated cirrhosis.

CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A)

NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the use of 12 weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin (RBV) in genotype 4 (GT4) chronic hepatitis C virus (HCV) infected adult patients with compensated cirrhosis (Child-Pugh A). VIEKIRAX with RBV is currently approved in the European Union for GT4 patients with compensated cirrhosis for 24 weeks.

World Health Assembly Commits to Eliminate Viral Hepatitis Threat by 2030

The World Health Assembly adopted the World Health Organization (WHO) viral hepatitis strategy to reduce mortality rates, increase screening and treatment for hepatitis B and C.

World Health Assembly Commits to Eliminate Viral Hepatitis Threat by 2030

The World Health Assembly adopted the World Health Organization (WHO) viral hepatitis strategy to reduce mortality rates, increase screening and treatment for hepatitis B and C.

World Health Assembly Commits to Eliminate Viral Hepatitis Threat by 2030

The World Health Assembly adopted the World Health Organization (WHO) viral hepatitis strategy to reduce mortality rates, increase screening and treatment for hepatitis B and C.

AbbVie Receives U.S. FDA Approval of Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis

NORTH CHICAGO, Ill., April 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A). The application was previously granted priority review by the FDA, a designation given to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness. 

AbbVie Presents New Phase 2 Data for Investigational, Once-Daily, Ribavirin-Free, Pan-Genotypic Regimen of ABT-493 and ABT-530 for Hepatitis C Genotypes 1-6

BARCELONA, April 16, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that with eight weeks of treatment, 97-98 percent of genotype 1-3 (GT1-3) chronic hepatitis C virus (HCV) infected patients without cirrhosis treated with AbbVie's investigational, once-daily, ribavirin (RBV)-free, pan-genotypic regimen of ABT-493 and ABT-530 achieved sustained virologic response at 12 weeks post-treatment (SVR12).1,2 Results for GT1 (n=33/34), GT2 (n=53/54) and treatment-naïve GT3 (n=28/29) patients were based on an Intent-to-Treat (ITT) analysis.1,2 Additionally, 100 percent (n=34/34) of genotype 4-6 (GT4-6) chronic HCV infected patients without cirrhosis achieved SVR12 with 12 weeks of treatment.4 These new data from the Phase 2 SURVEYOR-1 and SURVEYOR-2 studies will be presented at The International Liver Congress™ (ILC) 2016 in Barcelona, Spain.

AbbVie's Investigational, Pan-Genotypic Regimen of ABT-493 and ABT-530 Shows High SVR Rates in Genotype 1 Hepatitis C Patients Who Failed Previous Therapy with Direct-Acting Antivirals

BARCELONA, April 15, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that 91 percent (n=20/22) of genotype 1 (GT1) chronic hepatitis C virus (HCV) infected patients who failed previous therapy with direct-acting antivirals (DAAs) achieved SVR12 with 12 weeks of ABT-493 and ABT-530 with ribavirin (RBV) in the primary intent-to-treat analysis. Additionally, 86 percent (n=19/22) of GT1 patients who received ABT-493 and ABT-530 without RBV, achieved SVR12.1 SVR12 was achieved in 95 percent of patients with and without RBV (n=20/21, n=19/20; respectively) in a modified intent-to-treat analysis, excluding patients who did not achieve SVR for reasons other than virologic failure.

AbbVie Announces Real-World Data with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) from Large German Hepatitis C-Registry

BARCELONA, Spain, April 15, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new real-world data showing 96 percent of genotype 1 (GT1) patients (n=486/505 assessable for analysis) and 100 percent (n=53/53) of genotype 4 (GT4) patients achieved sustained virologic response at 12 weeks post-treatment (SVR12).1 These data support results seen in Phase 3 clinical trials for chronic GT1 or GT4 hepatitis C virus (HCV) infected patients treated with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV).