NORTH CHICAGO, Ill.,
Oct. 11, 2017 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global research and development
based biopharmaceutical company, today announced that it will
present new data evaluating MAVYRET™ (glecaprevir/pibrentasvir),
its once-daily, ribavirin-free treatment for adults with chronic
hepatitis C virus (HCV) infection across all major genotypes
(GT1-6), at the annual meeting of the American Association for the
Study of Liver Diseases (AASLD). Sixteen AbbVie scientific
abstracts have been accepted, including two oral presentations
studying the use of MAVYRET in patients across genotypes (GT1-6)
with compensated cirrhosis and treatment-naïve patients with
genotype 3 (GT3) HCV. These populations have historically had
limited treatment options. A third oral presentation evaluates
adherence to treatment with MAVYRET in the clinical development
program. The Liver Meeting® 2017 will take place in
Washington, D.C., from
October 20 – 24, 2017.
"AbbVie's data presentations at this year's The Liver Meeting
reinforce our commitment to people living with hepatitis C," said
Janet Hammond, M.D., Ph.D., vice
president, infectious diseases development, AbbVie. "These data add
to a robust collection of clinical trial results to further enhance
scientific knowledge of MAVYRET's safety and efficacy across a
number of patient populations."
Researchers will also present data obtained from the MAVYRET
clinical program evaluating patients with cardiovascular, metabolic
and renal conditions as well as data on HCV patient
preferences.
"On the heels of AASLD's newly released HCV treatment guidance,
we are excited to see additional data on MAVYRET across a broad
range of patients," said Fred Poordad, M.D., vice president,
academic and clinical affairs, Texas Liver Institute and professor
of medicine, University of Texas
Health, San Antonio. "The updated
recommendations on available treatments, including the use of
MAVYRET in the majority of patients, serve as an additional source
of information to help physicians make treatment decisions."
Select AbbVie clinical presentations include:
MAVYRET Abstracts
- Adherence to Pangenotypic Glecaprevir/Pibrentasvir
Treatment and SVR12 in HCV-Infected Patients: An
Integrated Analysis of the Phase 2/3 Clinical Trial Program
- Abstract 198; Oral Presentation; Monday,
October 23, 2017; 4:15 p.m.
ET
- Efficacy and Safety of Glecaprevir/Pibrentasvir for 8 or
12 Weeks in Treatment-Naïve Patients with Chronic HCV Genotype 3:
An Integrated Phase 2/3 Analysis - Abstract 62; Oral
Presentation; Sunday, October 22,
2017; 1:15 p.m. ET
- Efficacy, Safety, and Pharmacokinetics of
Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6
Hepatitis C Virus Infection and Compensated Cirrhosis: An
Integrated Analysis - Abstract 74; Oral Presentation;
Sunday, October 22, 2017;
3:15 p.m. ET
- Efficacy and Safety of Glecaprevir/Pibrentasvir in
Patients Infected with HCV GT1-3 by Renal Impairment Status: A
Pooled Analysis of Two Phase 3 Japanese Trials - Abstract
1179; Poster Session; Saturday, October 21,
2017; 2:00 – 7:00 p.m. ET
- Safety and Efficacy of Glecaprevir/Pibrentasvir in
Patients With Chronic Hepatitis C Genotypes 1–6 and Recent Drug
Use - Abstract 1182; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
- Safety and Efficacy of Glecaprevir/Pibrentasvir in
Patients Aged 65 Years or Older With Chronic Hepatitis C: A Pooled
Analysis of Phase 2 and 3 Clinical Trials - Abstract 1188;
Poster Session; Saturday, October 21,
2017; 2:00 – 7:00 p.m. ET
- Impact of Hepatitis C Treatment With Glecaprevir +
Pibrentasvir on Patient`s Health-Related Quality of Life: Results
From Phase 3 CERTAIN Trials - Abstract 1187; Poster
Session; Saturday, October 21, 2017;
2:00 – 7:00 p.m. ET
- Exposure-Safety Response Relationship for Glecaprevir and
Pibrentasvir in Hepatitis C Virus-Infected Subjects in Phase 2 and
3 Studies - Abstract 1189; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
- Exposure-Response Analyses of Virologic Response to
Glecaprevir and Pibrentasvir in HCV Subjects from Phase 2 and 3
Studies - Abstract 1185; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
- Glecaprevir and Pibrentasvir Exposures in Hepatitis C
Virus-Infected Subjects in Phase 2 and 3 Studies - Abstract
1190; Poster Session; Saturday, October 21,
2017; 2:00 – 7:00 p.m. ET
HCV Health Outcomes Abstract
- Assessing Patient Preferences for and Relative Importance
of Features of New Direct Acting Antiviral (DAA) Treatments for
Chronic Hepatitis C Virus (HCV) Infections - Abstract 741;
Poster Session; Friday, October 20,
2017; 8:00 a.m. – 5:30 p.m. ET
The full AASLD 2017 scientific program can be found at
www.aasld.org.
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 of hepatitis C virus with MAVYRET.
Hepatitis B virus becoming 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:
-
- atazanavir (Evotaz®, Reyataz®)
- rifampin (Rifadin®, Rifamate®,
Rifater®, Rimactane®)
What should people tell a doctor before taking
MAVYRET?
- If they have ever had hepatitis B virus infection, liver
problems other than hep C infection, 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 www.pparx.org for
assistance.
About AbbVie
AbbVie is a global, research-driven
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 or LinkedIn.
Forward-Looking Statements
Some statements in this
news release may be 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," in
AbbVie's 2015 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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