- MAVIRET™ is now available as a shorter, 8-week,
once-daily option for treatment-naïve, compensated cirrhotic,
chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5 and
6
- Marketing authorization is supported by 97.9 percent
cure* rate across this group of patients with no
reported virologic failures1
- Analysis evaluating MAVIRET as an 8-week, once-daily
treatment option for treatment-naïve, compensated cirrhotic, GT3
HCV patients is ongoing
NORTH CHICAGO, Illinois,
Aug. 2, 2019 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced that the European
Commission has granted 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)1, 2, 4, 5,
and 6 infection. An analysis from the same clinical trial
evaluating MAVIRET as an 8-week, once-daily treatment option for
treatment-naïve, compensated cirrhotic, GT3 HCV patients is
ongoing. MAVIRET is also currently approved as an 8-week,
pan-genotypic (GT1-6) treatment for treatment-naïve patients
without cirrhosis.2**
"MAVIRET has already had a significant impact on the lives of
hundreds of thousands of people affected by chronic HCV, and with
this approval, we are one step closer to providing more HCV
patients with an option to treat their chronic disease with a
once-daily, 8-week regimen," said Janet Hammond M.D., vice
president, general medicine and virology therapeutic area,
AbbVie.
The marketing authorization is supported by data from the
ongoing Phase 3b EXPEDITION-8 study,
which showed that with 8 weeks of MAVIRET, 97.9 percent (n=274/280)
of GT1, 2, 4, 5 and 6 patients achieved a sustained virologic
response 12 weeks after treatment (SVR12)
(ITT).1 To date, no virologic failures have been
reported in these patients and no patients have discontinued
treatment due to adverse events.1 Adverse events
(frequency >5%) reported in the study include pruritus (9.6%),
fatigue (8.6%), headache (8.2%) and nausea (6.4%).1 Six
serious adverse events (2%) have occurred during the study, none of
which were deemed to be related to
glecaprevir/pibrentasvir.1 No new safety signals were
identified in this study.1 These data were presented as
a late-breaking, oral presentation at The Liver Meeting® 2018
organized by the American Association for the Study of Liver
Diseases (AASLD) in San Francisco,
California.
The ongoing Phase 3b EXPEDITION-8
study is evaluating the safety and efficacy of MAVIRET in
treatment-naïve chronic HCV patients with compensated cirrhosis
across all major genotypes (GT1-6).1 The results have
been reported for GT1, 2, 4, 5, and 6 (n=280) patients. Enrollment
and treatment of the GT3 patient population was completed later,
therefore the analysis of this population is ongoing.
"There are still a significant number of HCV patients with
varied patient and viral characteristics who are in need of
options," said Stefan Zeuzem, M.D., chief of the department of
medicine at the J.W. Goethe University Hospital
in Frankfurt, Germany. "We
are working hard to help support achieving the World Health
Organization's goal of eliminating HCV by 2030 and having
additional patient populations eligible for shorter-term, 8-week
treatment options could help bring us closer to that goal."
About the EXPEDITION-8 Study1
EXPEDITION-8
is an ongoing non-randomized, single arm, open-label, multicenter
Phase 3b study evaluating the safety
and efficacy of glecaprevir/pibrentasvir in treatment-naïve GT1-6
chronic HCV patients with compensated cirrhosis. Analysis of the
GT3 patient population is ongoing.
The primary efficacy endpoints are the SVR12 rates in
patients with GT1, 2, 4, 5, and 6 in a per-protocol (PP) and
intent-to-treat (ITT) population versus respective historical
SVR12 rates based on the efficacy of MAVIRET for 12
weeks in treatment-naïve patients with compensated cirrhosis. The
SVR12 rates were 97.9 percent (n=274/280) and 100
percent (n=273/273) in the ITT and PP populations, respectively.
From the 280 patients with GT1, 2, 4, 5 or 6 enrolled, seven were
excluded from the SVR12 per-protocol analysis (n=273);
five patients were lost to follow up, and two patients received
less than 8 weeks of treatment (one of these two patients achieved
SVR12). The key secondary efficacy endpoints are the
percentages of GT1, 2, 3, 4, 5, and 6 patients achieving
SVR12 in a PP and ITT population.
About MAVIRET™ (glecaprevir/pibrentasvir)
MAVIRET® is
approved in the European Union for the treatment of chronic
hepatitis C virus (HCV) infection in adults and adolescents 12 to
<18 years old 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 option (GT1-6) for patients
who are new to treatment and without cirrhosis and for GT1, 2, 4, 5
and 6 patients who are new to treatment with compensated cirrhosis.
The recommended duration of therapy for treatment-naive,
compensated cirrhotic GT3 HCV patients is 12 weeks. 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).2
Glecaprevir (GLE) was discovered during the ongoing
collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ:
ENTA) 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 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.
___________________________
|
*Patients who
achieve a sustained virologic response at 12 weeks post treatment
(SVR12) are considered cured of hepatitis
C.
|
**The recommended
duration of MAVIRET is 12 weeks in liver or kidney transplant
recipients with or without cirrhosis.
|
|
1 Brown
RS, Hezode C, Wang S, et al. Preliminary Efficacy and Safety of
8-Week Glecaprevir/Pibrentasvir in Patients with HCV Genotype 1–6
Infection and Compensated Cirrhosis: The EXPEDITION-8
Study. Presented at The Liver Meeting®, the Annual Meeting of
the American Association for the Study of Liver Diseases (AASLD) in
San Francisco, U.S., November 13, 2018
|
2 MAVIRET™
tablets (glecaprevir/pibrentasvir) Summary of product
characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH
& Co. KG.
|