- EU label expansion supported by high cure rates shown in
TURQUOISE-III study, a dedicated Phase 3b study of VIEKIRAX +
EXVIERA without ribavirin for 12 weeks
- 100 percent SVR(12) (n=60/60) achieved in genotype 1b patients
with compensated cirrhosis (Child-Pugh A); no patients discontinued
treatment due to adverse events
NORTH CHICAGO, Illinois,
Feb. 26, 2016 /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 the use of VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV)
infected genotype 1b (GT1b) patients with compensated cirrhosis
(Child-Pugh A).
"This positive CHMP opinion brings us one step closer to
delivering a ribavirin-free treatment option for GT1b patients with
compensated cirrhosis that has demonstrated high cure rates with no
treatment discontinuations in our clinical trial," said
Michael Severino, M.D., executive
vice president, research and development and chief scientific
officer, AbbVie. "This milestone reinforces our continued
commitment to provide additional treatment options for the HCV
community, and we look forward to the final decision by the
European Commission."
Approximately 160 million people worldwide are infected with
HCV.1 Genotype 1 is the most common type of HCV
genotype, accounting for 60 percent of cases worldwide.2
In Europe, the most prevalent
genotype is 1b, accounting for 47 percent of the nine million
people infected with chronic HCV.3,4
The CHMP opinion of the Type-II variation application for
VIEKIRAX + EXVIERA is supported by data from the Phase 3b
TURQUOISE-III study, which is part of AbbVie's larger clinical
program investigating efficacy and safety in a broad range of GT1
patients. TURQUOISE-III is a dedicated Phase 3 study of VIEKIRAX +
EXVIERA without RBV for 12 weeks in GT1b patients with compensated
cirrhosis. Results from the TURQUOISE-III study showed 100 percent
(n=60/60) of GT1b chronic HCV infected patients with compensated
cirrhosis (Child-Pugh A) achieved sustained virologic response at
12 weeks post-treatment (SVR12) with VIEKIRAX + EXVIERA
without RBV for 12 weeks.5 No patients discontinued
treatment due to adverse events. The most commonly reported adverse
events (>10 percent) were fatigue (22 percent), diarrhea (20
percent) and headache (18 percent).5
On January 7, AbbVie announced
that its supplemental New Drug Application (sNDA) for VIEKIRA PAK®
was accepted and granted priority review by the U.S. Food and Drug
Administration (FDA).
About 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 are 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 and GT4 patients with compensated cirrhosis,
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 VIEKIRA PAK
USE
VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets;
dasabuvir tablets) is a prescription medicine used with or without
ribavirin to treat adults with genotype 1 chronic (lasting a long
time) hepatitis C (hep C) virus infection, including people who
have a certain type of cirrhosis (compensated).
VIEKIRA is not for people with advanced cirrhosis
(decompensated). If people have cirrhosis, they should talk to a
healthcare provider before taking VIEKIRA.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA PAK in combination with ribavirin, people
should read the Medication Guide that comes with ribavirin,
especially the important pregnancy information.
What is the most important information to know about VIEKIRA
PAK?
- VIEKIRA PAK may cause severe liver problems, especially in
people with certain types of cirrhosis. These severe liver problems
can lead to the need for a liver transplant, or can lead to
death.
- VIEKIRA PAK can cause increases in liver function blood test
results, especially if people use ethinyl estradiol-containing
medicines (such as some birth control products).
- Ethinyl estradiol-containing medicines (combination birth
control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho
Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal rings such as
NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®)
must be stopped before starting treatment with VIEKIRA PAK. If
these medicines are used as a method of birth control, another
method must be used during treatment with VIEKIRA PAK, and for
about 2 weeks after treatment with VIEKIRA PAK ends. A doctor can
provide instruction on when to begin taking ethinyl
estradiol-containing medicines.
- A doctor should do blood tests to check liver function during
the first 4 weeks of treatment and then as needed.
- A doctor may tell people to stop taking VIEKIRA PAK if signs or
symptoms of liver problems develop. A doctor must be notified right
away if any of the following symptoms develop or if they worsen
during treatment with VIEKIRA PAK: tiredness, weakness, loss of
appetite, nausea, vomiting, yellowing of the skin or eyes, color
changes in stools, confusion, or swelling of the stomach area.
VIEKIRA PAK must not be taken if people:
- have certain liver problems
- take any of the following medicines: alfuzosin
hydrochloride (Uroxatral®) • carbamazepine (Carbatrol®, Epitol®,
Equetro®, Tegretol®) • colchicine (Colcrys®) • efavirenz (Sustiva®,
Atripla®) • ergot containing medicines, including ergotamine
tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®,
Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®,
Migranal®), methylergonovine (Ergotrate®, Methergine®) • ethinyl
estradiol-containing medicines • gemfibrozil (Lopid®) • lovastatin
(Advicor®, Altoprev®, Mevacor®) • midazolam (when taken by mouth) •
phenytoin (Dilantin®, Phenytek®) • phenobarbital (Luminal®) •
pimozide (Orap®) • rifampin (Rifadin®, Rifamate®, Rifater®,
Rimactane®) • sildenafil citrate (Revatio®), when taken for
pulmonary artery hypertension (PAH) • simvastatin (Zocor®,
Vytorin®, Simcor®) • St. John's
wort (Hypericum perforatum) or a product that contains St. John's wort • triazolam (Halcion®)
- have had a severe skin rash after taking ritonavir
(Norvir®)
What should people tell a doctor before taking VIEKIRA
PAK?
- If they have: liver problems other than hep C infection, HIV
infection, or any other medical conditions.
- If they have had a liver transplant. If they take the medicines
tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®,
Sandimmune®), a doctor should check blood levels and, if needed,
may change the dose of these medicines or how often they are taken,
both during and after treatment with VIEKIRA PAK.
- If they are pregnant or plan to become pregnant or if they are
breastfeeding or plan to breastfeed. It is not known if VIEKIRA PAK
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
VIEKIRA PAK. Pregnant females who have both hep C and HIV infection
should talk with a doctor about enrolling in the antiretroviral
pregnancy registry.
- About all the medicines they take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. Some medicines interact with VIEKIRA PAK.
- A new medicine must not be started without telling a
doctor. A doctor will provide instruction on whether it is safe
to take VIEKIRA PAK with other medicines.
- When VIEKIRA PAK is finished, a doctor should be consulted on
what to do if one of the usual medicines taken was stopped or if
the dose changed during VIEKIRA PAK treatment.
What are the common side effects of VIEKIRA PAK?
- For VIEKIRA PAK used with ribavirin, side effects
include tiredness, nausea, itching, skin reactions such as redness
or rash, sleep problems, and feeling weak.
- For VIEKIRA PAK used without ribavirin, side effects
include nausea, itching, and sleep problems.
These are not all of the possible side effects of VIEKIRA PAK. 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 VIEKIRA
PAK. For more information, talk with a doctor.
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.
Click here for full Prescribing Information, including
the Medication Guide.
If people cannot afford their medication, they should
contact www.pparx.org for assistance.
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.
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 2014 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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2 Global Alert and Response (GAR): Hepatitis C. World
Health Organization Web site.
http://www.who.int/csr/disease/hepatitis/Hepc.pdf. Published 2003.
Accessed February, 2016.
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 Feld JJ, Moreno C, Trinh R, et al. Sustained virologic
response of 100% in HCV genotype 1b patients with cirrhosis
receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks. J
Hepatol. 2016 Feb; 64(2):301-7.