March 30, 2016

AbbVie to Present Data on VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) and Investigational, Pan-Genotypic Regimen at The International Liver Congress™ 2016

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- Real-world and Phase 3/3b clinical trial data to be presented on VIEKIRAX® and EXVIERA® in genotype 1 and genotype 4 chronic hepatitis C virus infected patients
- New data from AbbVie's investigational, pan-genotypic regimen of ABT-493 and ABT-530 will also be presented

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

  • Real-World Safety and Effectiveness of Ombitasvir/Paritaprevir/r With Dasabuvir and/or Ribavirin in the German Hepatitis C Registry; Hinrichsen, H et al. Oral Presentation, General Session 2 and Awards 1: Friday, April 15 at 08:30am–08:45am CEST; #GS07
  • Real-World Data on the Use of Ribavirin With Ombitasvir/Paritaprevir/r With or Without Dasabuvir in HCV Genotype 1 or 4-Infected Patients From the German Hepatitis C Registry; Welzel, T M et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-276
  • Late-Breaking Abstract: Analysis of the Real-World Effectiveness of Direct Acting Antiviral Treatments for Hepatitis C in a Large Population; McCombs, JS et al. Late breaker posters: Thursday, April 14 at 08:00am-Saturday, April 16 at 18:00pm CEST; #LBP510

Clinical Trial Data Abstracts for VIEKIRAX and EXVIERA

  • Late-Breaking Abstract: Effect of Baseline Resistance-Associated Variants on SVR With the 3D Regimen With and Without RBV in GT1a and GT1b-infected Patients; Sarrazin, C et al. Late breaker posters: Thursday, April 14 at 08:00am-Saturday, April 16 at 18:00pm CEST; #LBP503
  • Efficacy and Safety of Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir Without Ribavirin in Patients With HCV Genotype 1b With or Without Compensated Cirrhosis: Pooled Analysis Across 5 Clinical Trials; Welzel, T M et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-273
  • A Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir in Non-Cirrhotic Adult Asians With HCV Genotype 1b; Lou, Y et al. Poster Presentation, Clinical trials in progress: Thursday, April 14 at 08:00am-18:00pm CEST; #THU-489
  • High SVR Rates in Patients With Genotype 4 Chronic Hepatitis C Infection and Compensated Cirrhosis With Ombitasvir/Paritaprevir/Ritonavir Co-Administered With Ribavirin (AGATE-I); Asselah, T et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-278
  • Improvement in Markers of Liver Fibrosis and Function in HCV Genotype 4-infected Patients With Compensated Cirrhosis Receiving Ombitasvir/Paritaprevir/Ritonavir With Ribavirin (AGATE-I); Hassanein, T I et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-277
  • Ombitasvir/Paritaprevir/Ritonavir With Ribavirin Achieves High Sustained Virologic Response (SVR) Rates in Egyptian Adults With Chronic HCV Genotype 4 Infection (AGATE-II); Waked, I et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-166
  • Ombitasvir/Paritaprevir/r, Dasabuvir, and Sofosbuvir Treatment of Patients With HCV Genotype 1-Infection Who Failed a Prior Course of DAA Therapy: The QUARTZ-I Study; Poordad, F et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-156
  • Reductions in Lifetime Risks of Liver-Related Morbidity and Mortality Associated With Novel Direct-Acting Antiviral Regimens Recommended for Treating Genotype 4 Non-Cirrhotic Hepatitis C Patients in the United States; Saab, S et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-108
  • Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir, With or Without Ribavirin, in Adults Treated With the Regimen Approved in Australia, Canada, New Zealand, and Switzerland; Gane, E et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-136
  • Sustained Virologic Response Predicts Fibrosis Regression Measured by FibroTest in HCV-infected Patients; Forns, X et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-283

HCV Pipeline Abstracts for ABT-493 and ABT-530

  • High Efficacy of ABT-493 and ABT-530 in HCV Genotype 1 Infected Patients Who Have Failed Direct-Acting Antiviral-Containing Regimens: The MAGELLAN-I Study; Poordad, F et al. Oral Presentation, General Session 2 and Awards 1: Friday, April 15 at 10:00am–10:15am CEST; #GS11
  • Late-Breaking Abstract: 100% SVR4 With ABT-493 and ABT-530 With or Without Ribavirin in Treatment-Naïve HCV Genotype 3-Infected Patients With Cirrhosis. Oral Presentation, Late-breaker session: Saturday, April 16 at 16:00pm-16:15pm CEST; #LB01
  • High SVR Rates With the Combination of ABT-493 + ABT-530 for 8 Weeks in Non-Cirrhotic Patients With HCV Genotype 1 or 2 Infection; Poordad, F et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-157
  • High SVR Rates With ABT-493 + ABT-530 Co-Administered for 8 Weeks in Non-Cirrhotic Patients With HCV Genotype 3 Infection; Muir, A et al. Oral Presentation, Viral Hepatitis C 2 Session: Saturday, April 16 at 11:45am–12:00pm CEST; #PS098
  • High Efficacy and Favorable Safety of ABT-493 and ABT-530 Co-Administration for 12 Weeks in HCV Genotype 1-Infected Patients With Cirrhosis (SURVEYOR-I); Gane, E et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-135
  • 100% SVR4 and Favorable Safety of ABT-493 + ABT-530 Administered for 12 Weeks in Non-Cirrhotic Patients With Genotypes 4, 5, or 6 Infection (SURVEYOR-I); Gane, E et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-137
  • Safety of ABT-493 and ABT-530 Co-Administered in Patients with HCV Genotype 1 – 6 Infection: Results From the SURVEYOR-I and SURVEYOR-II Studies; Kwo, P et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-239
  • ENDURANCE-3: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered With Daclatasvir in Adults With HCV Genotype 3 Infection; Foster, G et al. Poster Presentation, Clinical trials in progress: Thursday, April 14 at 08:00am-18:00pm CEST; #THU-482
  • Pharmacokinetics, Safety, and Tolerability of Next Generation Direct Acting Antivirals ABT-493 and ABT-530 in Subjects With Hepatic Impairment; Kosloski, M P. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (new compounds, resistance): Thursday, April 14 at 08:00am-18:00pm CEST; #THU-230
  • Pharmacokinetics, Safety, and Tolerability of Next Generation Direct-Acting Antivirals ABT-493 and ABT-530 in Subjects With Hepatic Impairment; Kosloski, M P. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (new compounds, resistance): Thursday, April 14 at 08:00am-18:00pm CEST; #THU-231
  • Analysis of HCV Genotype 2 and 3 Variants in Patients Treated With Combination Therapy of Next Generation HCV Direct-Acting Antiviral Agents ABT-493 and ABT-530; Ng, T. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (new compounds, resistance): Thursday, April 14 at 08:00am-18:00pm CEST; #THU-240
  • ABT-493 and ABT-530 Combination Demonstrated Minimal Potential for CYP-Mediated Drug-Drug Interactions; Kosloski, M P. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (new compounds, resistance): Thursday, April 14 at 08:00am-18:00pm CEST; #THU-229

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.

 

SOURCE AbbVie

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