NORTH CHICAGO, Ill., Feb. 27, 2017 /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 (EMA) has granted a positive opinion for a shorter, eight-week treatment of VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) as an option for previously untreated adult patients
with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and minimal to moderate fibrosis*.
VIEKIRAX + EXVIERA is currently approved in the European Union for use as a 12-week treatment for GT1b chronic HCV-infected
patients without cirrhosis or with compensated cirrhosis.
"AbbVie continuously strives to expand the utility of our HCV treatments, including investigating a shorter path to virologic
cure for people living with HCV," said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie. "With this positive CHMP opinion, we will bring an eight-week treatment
option for the many HCV patients with GT1b."
Approximately 160 million people worldwide are infected with HCV, with GT1b being the most common subtype
globally.2 ,5 In Europe, this subtype accounts for 47 percent of the nine
million people infected with chronic HCV across the continent.3 , 4
"Nearly half of the people living with chronic hepatitis C in Europe are infected with
genotype 1b," said Dr. Tania Mara Welzel, M.H.Sc., study author and Medical Lead of the Clinical
Study Center at the Department of Medicine at J.W. Goethe University in Frankfurt, Germany. "VIEKIRAX + EXVIERA has demonstrated high cure rates with only eight weeks of treatment in GT1b
patients with minimal to moderate fibrosis."
The CHMP positive opinion is supported by data from the dedicated Phase 3b GARNET study. Results showed that with eight weeks
of treatment with VIEKIRAX + EXVIERA, 98 percent (n=160/163) of previously untreated GT1b chronic HCV infected patients without
cirrhosis achieved sustained virologic response at 12 weeks post-treatment (SVR12).1 The most commonly
reported adverse events, occurring at rate equal to or greater than 5 percent, were headache (21 percent), fatigue (17 percent),
nasopharyngitis (8 percent), pruritus (8 percent), nausea (6 percent) and asthenia (5 percent).
* When assessing severity of liver disease using non-invasive methods, additional blood tests improve accuracy and should
be undertaken prior to 8-week treatment in all patients with moderate fibrosis.
About the GARNET Study 1
The Phase 3b GARNET study is a multicenter, open-label, single-arm study investigating the safety and efficacy
of eight weeks of treatment with VIEKIRAX + EXVIERA without ribavirin in treatment-naïve patients with GT1b chronic HCV infection
without cirrhosis.1 The study enrolled 166 patients across 20 sites around the world. Of the 166 patients
enrolled, 163 patients had GT1b chronic HCV infection without cirrhosis and three patients with other HCV genotypes were excluded
from the efficacy analysis. The primary endpoint is the percentage of patients who achieved SVR12.
Two patients experienced post-treatment relapse and one discontinued due to noncompliance. Less than one percent of patients
experienced serious adverse events or clinically significant (Grade ≥3) laboratory abnormalities. One patient discontinued
treatment on Day 45 due to an adverse event but achieved SVR12.
Additional information about the GARNET study can be found on www.clinicaltrials.gov.
VIEKIRAX® + 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 is 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 patients with compensated
cirrhosis (Child-Pugh A), 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.
1 Welzel, T. et al. GARNET: High SVR Rates Following Eight-Week Treatment with Ombitasvir/Paritaprevir/Ritonavir +
Dasabuvir for Patients with HCV Genotype 1b Infection. Presented at the European Association for the Study of the Liver Special
Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, Paris,
France on September 23-24, 2016.
2 Gower E. et al. Global epidemiology and genotype distribution of the hepatitis C virus infection. Journal of
Hepatology Update: Hepatitis C, 2014; 61: S45-S57.
3 O'Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's
Gastrointestinal and Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1. Philadelphia,
PA: Saunders Elsevier. 2010:1313-1335.
4 Hatzakis A. et al. The state of hepatitis B and C in Europe: report from the
hepatitis B and C summit conference. Journal of Viral Hepatitis, 2011; 18 (Suppl. 1): 1-16.
5 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15.
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