NORTH CHICAGO, Ill.,
April 25, 2016 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global biopharmaceutical company,
today announced that the U.S. Food and Drug Administration (FDA)
has approved a supplemental New Drug Application (sNDA) for the use
of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets;
dasabuvir tablets) without ribavirin (RBV) in patients with
genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and
compensated cirrhosis (Child-Pugh A). The application was
previously granted priority review by the FDA, a designation given
to investigational therapies that treat a serious condition
and provide a significant improvement in safety or
effectiveness.
VIEKIRA PAK is a prescription medicine used with or without RBV
to treat adults with genotype 1 (GT1) chronic (lasting a long time)
HCV infection, and can be used in people who have a certain type of
cirrhosis (compensated). VIEKIRA PAK is not for people with
advanced cirrhosis (decompensated). Patients with cirrhosis should
talk to a doctor before taking VIEKIRA PAK.
The Centers for Disease Control and Prevention estimates that in
the United States, approximately
2.7 million people are chronically infected with HCV.1
Genotype 1 is the most common HCV in the U.S.2 Of the
total U.S. population with GT1 HCV infection, approximately 77
percent are genotype 1a (GT1a) and 23 percent are
GT1b.2
"We are constantly striving to advance clinical care for
patients living with chronic hepatitis C," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie. "This approval is especially significant because patients
with chronic HCV with compensated cirrhosis are among the tough to
treat, and in our study VIEKIRA PAK demonstrated 100 percent cure
rates in GT1b patients without the use of ribavirin."
"This provides a very useful option for people infected with
genotype 1b infection and compensated cirrhosis. The ability
to cure these individuals with just 12 weeks of treatment and
without the need for ribavirin is a great benefit," said
TURQUOISE-III lead investigator Jordan J.
Feld, MD, MPH, research director and clinician scientist,
Toronto Center for Liver Disease, Toronto, Canada. "The outstanding 100 percent
cure rate from the study confirms that this is likely to be a very
effective strategy."
The TURQUOISE-III study included in the sNDA evaluated the use
of VIEKIRA PAK without RBV for 12 weeks in GT1b patients with
compensated cirrhosis (Child-Pugh A). Results demonstrated 100
percent (N=60/60) sustained virologic response at 12 weeks
post-treatment (SVR12). Patients who achieve
SVR12 are considered cured of HCV, as the virus is no
longer detectable in the blood. No patients discontinued treatment
due to adverse events. The most commonly-reported adverse events
(≥10 percent) were fatigue (22 percent), diarrhea (20 percent),
headache (18 percent), arthralgia (10 percent), dizziness (10
percent), insomnia (10 percent) and pruritus (10
percent).3
On February 26, AbbVie announced
that the European Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) granted a positive
opinion for VIEKIRAX® (ombitasvir/ paritaprevir/ ritonavir tablets)
+ EXVIERA® (dasabuvir tablets) and this RBV-free option is now
approved for use for the treatment of chronic HCV infected GT1b
patients with compensated cirrhosis (Child-Pugh A) in Europe.
About the TURQUOISE-III Study
TURQUOISE-III is
a multi-center, open-label, single-arm Phase 3b study to evaluate
the safety and efficacy of 12 weeks of treatment with VIEKIRA PAK
without ribavirin (RBV) in adult patients (N=60) with genotype 1b
(GT1b) chronic hepatitis C virus (HCV) infection and compensated
liver cirrhosis (Child-Pugh A) who were treatment-naïve or
treatment-experienced (failed previous therapy with pegylated
interferon and RBV). The primary endpoint is the rate of sustained
virologic response 12 weeks after treatment
(SVR12).1
IMPORTANT SAFETY INFORMATION FOR VIEKIRA PAK
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®, TEGRETOL-XR®, TERIL®) • cisapride (Propulsid®)
• colchicine (Colcrys®) • dronederone (Multaq®) • efavirenz
(Atripla®, Sustiva®) • ergot containing medicines, including
ergotamine tartrate (Cafergot®, Ergomar®, Ergostat®, Medihaler®,
Migergot®, Wigraine®, Wigrettes®), dihydroergotamine mesylate
(D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®)
• ethinyl estradiol-containing medicines • gemfibrozil (LOPID®) •
lovastatin (Advicor®, Altoprev®, Mevacor®) • lurasidone (Latuda®) •
midazolam (when taken by mouth) • phenytoin (Dilantin®, Phenytek®)
• phenobarbital (Luminal®) • pimozide (Orap®) • ranolazine
(Ranexa®) • rifampin (Rifadin®, Rifamate®, Rifater®,
Rimactane®) • sildenafil citrate (Revatio®), when taken for
pulmonary artery hypertension (PAH) • simvastatin (Simcor®,
Vytorin®, Zocor®) • 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.
- 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.
Please see full Prescribing Information,
including the Medication Guide.
If people cannot afford their medication, they should
contact www.pparx.org for assistance.
Additional Information about VIEKIRA PAK®
VIEKIRA PAK® has been studied in a broad range of
genotype 1 (GT1) patients with chronic hepatitis C virus (HCV)
infection, ranging from treatment-naïve to difficult to treat
patients, such as those with compensated (mild, Child-Pugh A)
cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant
recipients with normal hepatic function and mild fibrosis, and
those who have failed previous treatment with pegylated interferon
(pegIFN) and ribavirin (RBV). VIEKIRA PAK is contraindicated in
patients with moderate to severe hepatic impairment (Child-Pugh B
and C) due to risk of potential toxicity. VIEKIRA PAK consists of
the fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor),
paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir
100mg (an HIV-1 protease inhibitor), dosed once daily with a meal,
and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase
inhibitor), dosed twice daily with a meal. VIEKIRA PAK is taken for
12 weeks, except in GT1a patients with cirrhosis and all liver
transplant recipients with normal hepatic function and mild
fibrosis, who should take it for 24 weeks. Ribavirin should be
co-administered in GT1a patients, and in all patients who have
received a liver transplant.
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.
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 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.
1 Centers for Disease Control and Prevention (CDC).
Hepatitis C FAQs for health professionals.
http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Accessed February 4, 2016.
2 Wedemeyer H. Hepatitis C. Chapter 80: In: Feldman M,
Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's
Gastrointestinal and Liver Disease. Vol 2. 10th ed.
Philadelphia, PA: Saunders
Elsevier; 2016.
3 Feld JJ 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
(2015), http://dx.doi.org/10.1016/j.jhep.2015.10.005
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