NORTH CHICAGO, Ill.,
Jan. 7, 2016 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global biopharmaceutical company,
today announced that the U.S. Food and Drug Administration (FDA)
has accepted its supplemental New Drug Application (sNDA) and
granted priority review for VIEKIRA PAK® (ombitasvir,
paritaprevir, and ritonavir tablets; dasabuvir tablets) without
ribavirin (RBV) in patients with genotype 1b (GT1b) chronic
hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh
A). The current dosing recommendation for patients with GT1b
and compensated cirrhosis is to administer RBV with VIEKIRA PAK for
12 weeks. The FDA grants priority review designation to
investigational therapies that treat a serious condition and, if
approved, would provide a significant improvement in safety or
effectiveness.
VIEKIRA PAK is a prescription medicine used with or without
ribavirin to treat adults with genotype 1 (GT1) chronic HCV
infection, including people who have a certain type of cirrhosis
(compensated). VIEKIRA PAK is not for people with advanced
cirrhosis (decompensated). If people have cirrhosis, they should
talk to a doctor before taking VIEKIRA PAK.
"We are pleased that the FDA has granted priority review for
VIEKIRA PAK without ribavirin as a therapy for treating GT1b
chronic hepatitis C patients who have compensated cirrhosis," said
Michael Severino, M.D., executive
vice president, research and development and chief scientific
officer, AbbVie. "The filing of this sNDA further underscores
AbbVie's commitment to patients living with chronic HCV
infection."
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). 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).1
The Centers for Disease Control and Prevention (CDC) estimates
that in the United States, 2.7
million people are chronically infected with HCV.2
Genotype 1 is the most common HCV in the U.S.3 Of the
total U.S. population with GT1 HCV infection, approximately 77
percent are genotype 1a (GT1a) and 23 percent are
GT1b.3
About the TURQUOISE-III Study
TURQUOISE-III is a
multi-center, open-label 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
About VIEKIRA PAK
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.
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, who should take
it for 24 weeks. Ribavirin should be co-administered in GT1a
patients, and in all patients who have cirrhosis or who have
received a liver transplant.
Paritaprevir was discovered during the ongoing collaboration
between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV
protease inhibitors and regimens that include protease
inhibitors.
About AbbVie's HCV Clinical Development
Program
AbbVie's HCV clinical development program is
intended to advance scientific knowledge and clinical care by
investigating interferon-free, all-oral treatments with and without
ribavirin with the goal of achieving high sustained virologic
response rates in as many patients as possible.
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] 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
[2] Centers for Disease Control and Prevention (CDC). Hepatitis C
FAQs for health professionals.
http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Accessed December 17, 2015.
[3] 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.
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