Full Press Release Details
NORTH CHICAGO, Ill. , March 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV ), a global biopharmaceutical company, today announced that 25 abstracts have been accepted for presentation at The International Liver Congress™ (ILC) 2016 in Barcelona, Spain , April 13-17 , including real-world data that support clinical trial results seen in AbbVie's development program with VIEKIRAX ® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA ® (dasabuvir tablets). Abstracts presented will further expand scientific knowledge of VIEKIRAX and EXVIERA in genotype 1 (GT1) and genotype 4 (GT4) chronic hepatitis C virus (HCV) infected patients, including those with compensated cirrhosis (Child-Pugh A).
Additionally, data will be presented from AbbVie's HCV pipeline program, investigating its pan-genotypic, once-daily, ribavirin-free regimen of ABT-493 and ABT-530 in patients with genotypes 1-6 (GT1-6) chronic HCV infection, including data on treatment durations of as short as eight weeks in genotypes 1-3 (GT1-3) treatment-naïve patients without cirrhosis.
"We are pleased to present encouraging results which further investigate the potential of a pan-genotypic treatment that could reach even more people with HCV and reflect AbbVie's continued commitment to people living with this disease," said Michael Severino , M.D., executive vice president of research and development and chief scientific officer, AbbVie. "We are also further expanding our understanding of VIEKIRAX and EXVIERA with the new real-world evidence and clinical data we are generating."
Real-World Evidence Abstracts Evaluating VIEKIRAX and EXVIERA
Clinical Trial Data Abstracts for VIEKIRAX and EXVIERA
HCV Pipeline Abstracts for ABT-493 and ABT-530
The full ILC 2016 scientific program can be found at http://ilc-congress.eu/ .
About AbbVie's HCV Clinical Development Program AbbVie's HCV clinical development program is intended to advance scientific knowledge and the clinical care of people with chronic HCV infection by investigating pan-genotypic (genotypes 1-6), all-oral, ribavirin-free, once-daily treatment for 12 weeks. An eight-week treatment duration with ABT-493 and ABT-530 will be investigated across all genotypes in our comprehensive Phase 2/Phase 3 clinical trial program, which focuses on areas of ongoing need in HCV.
AbbVie's investigational regimen includes 300 mg ABT-493, an NS3/4A protease inhibitor, and 120 mg ABT-530, an NS5A inhibitor.
ABT-493 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA ) for HCV protease inhibitors and regimens that include protease inhibitors.
About VIEKIRAX and EXVIERA VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA ) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov .
EU Indication VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of CHC in adults.
Important EU Safety Information Contraindications : VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.
Special warnings and precautions for use : VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis Viekirax and Exviera are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis should be monitored for signs and symptoms of hepatic decompensation, including hepatic laboratory testing at baseline and during treatment.
ALT elevations Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirin Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when VIEKIRAX with or without EXVIERA is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Use with concomitant medicinal products Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.
Adverse Reactions Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu .
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com . Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.