NORTH CHICAGO, Ill.,
Nov. 13, 2018 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced new data for its pan-genotypic chronic hepatitis C
virus (HCV) treatment, MAVYRET™ (glecaprevir/pibrentasvir), in
treatment-naïve patients with compensated cirrhosis. Results from
the Phase 3b EXPEDITION-8 study
showed that with 8 weeks of MAVYRET, 100 percent (n=273/273) of
genotype 1, 2, 4, 5 and 6 patients achieved a sustained virologic
response 12 weeks after treatment (SVR12) per protocol
analysis.1
These data are being presented today 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.
"Current guidelines recommend a 12-week pan-genotypic regimen
for people who have hepatitis C, are treatment-naïve and have
compensated cirrhosis," said Robert S.
Brown, Jr., M.D., the Gladys and
Roland Harriman professor of medicine, Weill Cornell Medical
College. "We are interested in investigating shorter treatment
options, which may simplify care for patients with compensated
cirrhosis while providing high cure rates."
This analysis is part of the ongoing Phase 3b EXPEDITION-8 study evaluating the safety and
efficacy of MAVYRET in treatment-naïve chronic HCV patients with
compensated cirrhosis across all major genotypes
(GT1-6).1 The study includes two cohorts; cohort one
with genotype 1, 2, 4, 5, 6 chronic HCV-infected patients, and
cohort two with genotype 3 (GT3) chronic HCV-infected
patients.1
"MAVYRET is already having a significant impact on people living
with HCV. However, there are still groups of patients who may
benefit from a shorter treatment option," said Janet Hammond, M.D., Ph.D., vice president,
infectious diseases development, AbbVie. "We continue to
investigate and understand the value of an 8-week treatment regimen
for patients, something we recognize as an important step towards
HCV elimination."
To date, no virologic failures have been reported in cohort one
of the study and no patients have discontinued treatment due to
adverse events.1 Adverse events (>5%) reported
of the study populations 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.
Data from the ongoing EXPEDITION-8 Phase 3b study will be presented as a late-breaking,
oral presentation during the Late-breaking Abstract Oral Session II
on November 13 at 8:30 a.m. PST.
MAVYRET is approved in the U.S. as a 12-week pan-genotypic
treatment for treatment-naïve patients with compensated
cirrhosis.2
*Patients who achieve a sustained virologic response at 12
weeks post treatment (SVR12) are considered cured of
hepatitis C.
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. The study
investigated two cohorts of patients:
- Cohort one: treatment-naïve genotype 1, 2, 4, 5, 6
patients with compensated cirrhosis (n=280)
- Cohort two: treatment-naïve GT3 patients with
compensated cirrhosis (n=60)
The primary endpoint is the percentage of patients achieving
SVR12 in a per-protocol analysis and the secondary
endpoints are on-treatment virologic failure and relapse rates. For
cohort one, 280 patients were enrolled and seven patients 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).
Additional information on the clinical trials for MAVYRET is
available at www.clinicaltrials.gov/.
About MAVYRET™ (glecaprevir/pibrentasvir)
MAVYRET™ is
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of chronic hepatitis C virus (HCV) infection in adults
across all major genotypes (GT1-6). MAVYRET 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, taken with
food.
MAVYRET is an 8-week, pan-genotypic option for patients without
cirrhosis and who are new to treatment, who comprise the majority
of people living with HCV. MAVYRET is also approved as a treatment
for patients with specific treatment challenges, including those
(GT1) not cured by prior treatment experience to either a protease
inhibitor or NS5A inhibitor (but not both), and in patients with
limited treatment options, such as those with severe chronic kidney
disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is a
pan-genotypic treatment approved for use in patients across all
stages of CKD.
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.
Full prescribing information can be found here.
Use and Important Safety Information
USE
MAVYRET™ (glecaprevir and pibrentasvir) tablets
are a prescription medicine used to treat adults with chronic
(lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3,
4, 5, or 6 infection without cirrhosis or with compensated
cirrhosis.
IMPORTANT SAFETY INFORMATION
What is the most important information to know about
MAVYRET?
Hepatitis B virus reactivation: Before starting treatment
with MAVYRET, a doctor will do blood tests to check for hepatitis B
virus infection. If people have ever had hepatitis B virus
infection, the hepatitis B virus could become active again during
or after treatment for hepatitis C virus with MAVYRET. Hepatitis B
virus that becomes active again (called reactivation) may cause
serious liver problems including liver failure and death. A doctor
will monitor people if they are at risk for hepatitis B virus
reactivation during treatment and after they stop taking
MAVYRET.
MAVYRET must not be taken if people:
- Have certain liver problems
- Are taking the medicines:
-
What should people tell a doctor before taking
MAVYRET?
- If they have had hepatitis B virus infection, have liver
problems other than hep C infection, have HIV-1 infection, have had
a liver or a kidney transplant, or any other medical
conditions.
- If they are pregnant or plan to become pregnant, or if they are
breastfeeding or plan to breastfeed. It is not known if MAVYRET
will harm a person's unborn baby or pass into breast milk. A doctor
should be consulted about the best way to feed a baby if taking
MAVYRET.
About all the medicines they take, including prescription
and over-the-counter medicines, vitamins, and herbal supplements.
MAVYRET and other medicines may affect each other. This can cause
people to have too much or not enough MAVYRET or other medicines in
their body. This may affect the way MAVYRET or other medicines
work, or may cause side effects.
- A new medicine must not be started without telling a
doctor. A doctor will provide instruction on whether it is safe
to take MAVYRET with other medicines.
What are the common side effects of MAVYRET?
- The most common side effects of MAVYRET are headache and
tiredness.
These are not all of the possible side effects of MAVYRET. A
doctor should be notified if there is any side effect that is
bothersome or that does not go away.
This is the most important information to know about MAVYRET.
For more information, people should talk to a doctor or
healthcare provider.
People are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Please see full Prescribing Information,
including the Patient Information.
If people cannot afford their medication, they should contact
http://www.pparx.org for assistance.
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.
For more information, please visit
www.abbvie.com/HCV.
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, challenges to
intellectual property, competition from other products,
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 2017 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.
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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.
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2 MAVYRET™
tablets (glecaprevir/pibrentasvir) Prescribing Information.
Chicago, U.S. AbbVie Inc.
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SOURCE AbbVie