NORTH CHICAGO, Ill.,
March 6, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced that the European Commission has approved a change
to the marketing authorization for MAVIRET®
(glecaprevir/pibrentasvir) to shorten once-daily treatment duration
from 12 to 8 weeks in treatment-naïve, compensated cirrhotic,
chronic hepatitis C (HCV) patients with genotype (GT) 3 infection.
MAVIRET was already indicated as an 8-week, pan-genotypic (GT1-6),
once-daily regimen for treatment-naïve HCV patients without
cirrhosis, and as an 8-week, once-daily regimen for treatment-naïve
GT 1, 2, 4, 5 and 6 HCV patients with compensated
cirrhosis.1*
"A shorter treatment duration means that more patients with HCV
can be treated with an 8-week course of MAVIRET in the absence of
initial tests to determine their genotype or degree of fibrosis or
cirrhosis," said Janet Hammond M.D.,
Ph.D., vice president, general medicine and virology therapeutic
area, AbbVie. "The ability to streamline pre-treatment assessment
for people with HCV represents a paradigm shift in the way the
disease is treated, potentially accelerating the care cascade and
allowing us to make greater strides towards achieving the World
Health Organization's goal of eliminating HCV by 2030."
The EC approval is supported by data from the Phase 3b EXPEDITION-8 study. The Phase 3b EXPEDITION-8 study evaluated the safety and
efficacy of MAVIRET in treatment-naïve chronic HCV patients with
compensated cirrhosis across all major genotypes (GT1-6). The
results have been reported for GT1, 2, 3, 4, 5, and 6 (n=343)
patients2 and showed that with 8 weeks of MAVIRET, 97.7
percent (n=335/343) of GT1- 6 patients achieved a sustained
virologic response 12 weeks after treatment (SVR12)
(ITT). For patients with GT3, the SVR12 rate was 95.2%
(n= 60/63) (ITT).**
To date, one virologic failure has been reported and no patients
have discontinued treatment due to adverse events. In the study,
most patients that did not achieve SVR12** were lost to
follow up versus experiencing treatment failure, and no new safety
signals were identified.2
"Despite hepatitis C now being curable, there are millions of
people in Europe who are
chronically infected with the virus. Many of these patients have
never received treatment, often because they have been unable to
navigate the practical and clinical complexities of the treatment
journey," said Stefan Zeuzem, M.D., chief of the department of
medicine at the J.W. Goethe University Hospital
in Frankfurt, Germany. "A
shorter-duration therapeutic option and simplified pre-treatment
approach can eliminate the need for extra tests and help
significantly more people overcome their very real treatment
barriers."
In the World Health Organization (WHO) European Region, 14
million people are estimated to be chronically infected with the
hepatitis C virus and many of them are unaware that they are
infected.3 Each year 112,500 people die from
hepatitis C-related liver disease.3
About the EXPEDITION-8
Study2
EXPEDITION-8 is a single-arm,
open-label, Phase 3b study in treatment-naïve, GT1-6
chronic HCV patients with compensated cirrhosis (n=343) who
received MAVIRET for 8 weeks.
The primary efficacy endpoints were SVR12** in
patients with GT1, 2, 4, 5, and 6 in a per-protocol (PP) and
intent-to-treat (ITT) population versus historical
SVR12** rates based on the efficacy of MAVIRET for 12
weeks in treatment-naïve patients with compensated cirrhosis. The
key secondary efficacy endpoints were the percentages of GT1-6
patients achieving SVR12** in a PP and ITT
population.
Additional information on the clinical trials for MAVIRET is
available at www.clinicaltrials.gov/.
About MAVIRET®
(glecaprevir/pibrentasvir)1
MAVIRET is
approved in the European Union for the treatment of chronic
hepatitis C virus (HCV) infection in adults and adolescents aged 12
to <18 years across all major genotypes (GT1-6). MAVIRET is a
pan-genotypic, once-daily, ribavirin-free treatment that combines
glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir
(40mg), an NS5A inhibitor, dosed once-daily as three oral
tablets.
MAVIRET is an 8-week, pan-genotypic (GT 1-6) option for patients
without cirrhosis or with compensated cirrhosis and who are new to
treatment.* MAVIRET is also approved as a treatment for patients
with specific treatment challenges, including those with
compensated cirrhosis across all major genotypes, and those who
previously had limited treatment options, such as patients with
severe chronic kidney disease (CKD) or those with genotype 3
chronic HCV infection. MAVIRET is a pan-genotypic treatment
approved for use in patients across all stages of CKD.
MAVIRET is contraindicated in patients with severe hepatic
impairment (Child-Pugh C) and is not recommended in patients with
moderate hepatic impairment (Child-Pugh B).
Glecaprevir (GLE) was discovered during the ongoing
collaboration between AbbVie and Enanta Pharmaceuticals for HCV
protease inhibitors and regimens that include protease
inhibitors.
EU Indication
MAVIRET is indicated for the treatment
of chronic hepatitis C virus (HCV) infection in adults and
adolescents aged 12 to <18 years old.
Important EU Safety Information
Contraindications:
MAVIRET is contraindicated in
patients with severe hepatic impairment (Child-Pugh C). Concomitant
use with atazanavir containing products, atorvastatin, simvastatin,
dabigatran etexilate, ethinyl oestradiol-containing products,
strong P-gp and CYP3A inducers, such as rifampicin, carbamazepine,
St. John's wort, phenobarbital,
phenytoin, and primidone.
Special warnings and precautions for use:
Hepatitis
B virus reactivation
Cases of hepatitis B virus (HBV)
reactivation, some of them fatal, have been reported during or
after treatment with direct-acting antiviral agents. HBV screening
should be performed in all patients before initiation of
treatment.
Hepatic impairment
MAVIRET is not recommended in
patients with moderate hepatic impairment (Child-Pugh B).
Patients who failed a prior regimen containing an NS5A-
and/or an NS3/4A-inhibitor
MAVIRET is not recommended for
the re-treatment of patients with prior exposure to NS3A/4A and/or
NS5A-inhibitors.
Use in diabetic patients
Diabetics may experience
improved glucose control and potential symptomatic hypoglycaemia
after initiating HCV direct acting antiviral treatment. Glucose
levels should be closely monitored, particularly within the first 3
months of treatment.
Adverse Reactions
Most common (≥10%) adverse reactions
for MAVIRET were headache and fatigue.
This is not a complete summary of all safety information. See
MAVIRET full summary of product characteristics (SmPC) 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 and
development-based biopharmaceutical company committed to developing
innovative advanced therapies for some of the world's most complex
and critical conditions. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to
markedly improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on
Twitter, Facebook, LinkedIn or Instagram.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, competition from
other products, challenges to intellectual property, difficulties
inherent in the research and development process, adverse
litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
* The recommended duration of MAVIRET is 12 weeks in liver or
kidney transplant recipients without cirrhosis or with compensated
cirrhosis.
** Sustained virologic response (SVR12), defined as HCV RNA less
than lower limit of quantification (LLOQ) at 12 weeks after the end
of treatment, was the primary endpoint in all the studies.
1 MAVIRET® tablets
(glecaprevir/pibrentasvir) Summary of product characteristics.
Maidenhead, UK. AbbVie, Ltd.
2 Brown RS et al. Glecaprevir/pibrentasvir for 8
weeks in treatment-naïve patients with chronic HCV genotypes 1–6
and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol (2019)
the HCV cure rate. (ref 1)
3 Hepatitis C in the WHO European Region. WHO Fact Sheet
July 2019. Available at:
http://www.euro.who.int/__data/assets/pdf_file/0009/377253/Fact-Sheet-Hepatitis-C_2019_ENG.PDF?ua=1
Last accessed February 2020
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