- In adult patients co-infected with genotype 1 (GT1)
hepatitis C virus (HCV) and human immunodeficiency virus type 1
(HIV-1), TURQUOISE-I, using VIEKIRA PAK with ribavirin (RBV),
demonstrated sustained virologic response rates 12 weeks
post-treatment (SVR12) of 94 percent with 12 weeks of treatment and
91 percent with 24 weeks of treatment, respectively
- TURQUOISE-I results published online today in The
Journal of the American Medical Association (JAMA)
- Additional sub-analyses of TURQUOISE-I data to be presented
this week at the Annual Conference on Retroviruses and
Opportunistic Infections (CROI)
NORTH CHICAGO, Illinois,
Feb. 23, 2015 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced that results from part
one of the Phase 2 portion of its Phase2/3 open-label study,
TURQUOISE-I, in genotype 1 chronic hepatitis C patients with human
immunodeficiency virus type 1 (HIV-1) co-infection were published
online in The Journal of the American Medical Association
(JAMA). Additional sub-analyses also will be presented in both
oral and poster presentations on Feb.
26, at the Annual Conference on Retroviruses and
Opportunistic Infections (CROI) in Seattle, Wash.
As published today in JAMA, and originally presented at
The Liver Meeting® 2014, the TURQUOISE-I study showed patients
co-infected with genotype 1 (GT1) hepatitis C virus (HCV) and HIV-1
receiving VIEKIRA PAK™ and ribavirin (RBV) for 12 weeks or 24 weeks
achieved sustained virologic response rates 12 weeks post-treatment
(SVR12) of 94 percent (n=29/31) and 91 percent
(n=29/32), respectively. The SVR12 rates were 91 percent
(n=51/56) for subjects with HCV GT1a infection and 100 percent
(n=7/7) for those with HCV GT1b infection.
"It is common for people to live with both GT1 chronic HCV and
HIV, but data supporting treatment of chronic HCV in these
co-infected patients have been limited," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie. "TURQUOISE-I is one of the few dedicated studies looking
specifically at this historically difficult-to-treat population and
we are proud to offer the HCV community an important new treatment
option."
VIEKIRA PAK is contraindicated with efavirenz (Sustiva) because
co-administration is poorly tolerated and results in liver enzyme
elevations. The ritonavir component of VIEKIRA PAK is an HIV-1
protease inhibitor and can select for HIV-1 protease inhibitor
resistance. To reduce this risk, HCV/HIV-1 co-infected patients
should also be on a suppressive antiretroviral (ART) drug regimen.
The most common adverse events occurring in at least 10 percent of
patients in TURQUOISE-I were fatigue (48%), insomnia (19%), nausea
(17%), headache (16%), itching (13%), cough (11%), irritability
(10%), and yellowing of the eyes (10%).
Sub-analyses of these data will be presented later this week at
CROI in oral and poster presentations:
- High SVR Regardless of Time to Suppression with
Paritaprevir/r/Ombitasvir & Dasabuvir + RBV
Oral
Presentation #147
February 26, 2015, 10:30-10:45 p.m. PST, Room 6AB
Analysis of time to HCV suppression in HCV/HIV co-infected patients
in TURQUOISE-I
- Hematologic Analysis of Paritaprevir/r/Ombitasvir and
Dasabuvir + RBV in TURQUOISE-I
Poster #691
February 26, 2015, 2:30-4 p.m.
PST, Poster Hall
In this analysis of the TURQUOISE-I study, certain laboratory
values in patients taking paritaprevir/r/ombitasvir and dasabuvir
with RBV were examined, including hemoglobin, CD4+ T cells,
and lymphocyte count
About TURQUOISE-I
TURQUOISE-I is an ongoing
Phase 2/3, multi-center, randomized, open-label study evaluating
the efficacy and safety of VIEKIRA PAK (ombitasvir, paritaprevir,
ritonavir (25/150/100 mg once daily) and dasabuvir (250 mg twice
daily) with RBV (weight based dosing of 1000 mg or 1200 mg per day
divided twice daily) for 12 or 24 weeks in adult patients with
chronic GT1 HCV infection with or without compensated liver
cirrhosis who are also infected with HIV-1.
Study patients were either new to therapy (treatment-naïve) or
had failed previous treatment with pegylated interferon and RBV
(treatment-experienced), had a stable immune status (CD4+ counts of
≥200 cells/mm3 or CD4+ % ≥14%). Patients were on a
stable HIV-1 ART regimen that included tenofovir disoproxil
fumarate plus emtricitabine or lamivudine, administered with
ritonavir-boosted atazanavir or raltegravir. Patients on atazanavir
stopped the ritonavir component of their HIV-1 ART regimen upon
initiating treatment with VIEKIRA PAK + RBV. Atazanavir was taken
with the morning dose of VIEKIRA PAK. The ritonavir component of
the HIV-1 ART regimen was restarted after completion of treatment
with VIEKIRA PAK and RBV. Of the five patients who were
non-responders, one experienced virologic failure, one discontinued
treatment, one experienced relapse and two patients had evidence of
HCV reinfection post-treatment. Based on the results of this study,
prescribers should follow the same dosing recommendations for
mono-infected patients as outlined in the VIEKIRA PAK prescribing
information.
Elevations in total bilirubin were the most common laboratory
abnormality, were mainly composed of indirect bilirubin, and were
not associated with elevations in commonly measured liver enzymes.
Reductions in RBV dose because of anemia or reduced hemoglobin
occurred in 10 percent of patients (n=6/63); all six patients
achieved SVR12.
About VIEKIRA PAK™
VIEKIRA PAK™
(ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets)
has been studied in a broad range of genotype 1 (GT1) patients with
chronic hepatitis C virus (HCV) infection, ranging from
treatment-naïve to some of the most difficult to treat, such as
patients 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 not recommended in patients with
moderate hepatic impairment (Child-Pugh B), and is contraindicated
in patients with severe hepatic impairment (Child-Pugh C). 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 inhibitor of an enzyme that breaks down
paritaprevir), 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.
Paritaprevir is being investigated by AbbVie for use in combination
with AbbVie's other investigational medicines for the treatment of
hepatitis C.
VIEKIRA PAK was granted priority review and designated as a
Breakthrough Therapy by the U.S. FDA, a status given to medicines
or regimens that may offer substantial improvement over available
therapies.
Full Prescribing Information, including the Medication Guide,
can be found here.
Use and Important Safety Information
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 virus (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
healthcare provider before taking VIEKIRA PAK.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA PAK in combination with ribavirin, people
should also 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 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 healthcare
provider can provide instruction on when to begin taking ethinyl
estradiol-containing medicines.
- A healthcare provider should do blood tests to check liver
function during the first 4 weeks of treatment and then as
needed.
- A healthcare provider may tell people to stop taking VIEKIRA
PAK if signs or symptoms of liver problems develop. A healthcare
provider 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, or color changes in stools.
VIEKIRA PAK must not be taken if people:
- have severe liver problems
- take any of the following medicines: alfuzosin
hydrochloride (Uroxatral®) - carbamazepine (Carbatrol®,
Epitol®, Equetro®, Tegretol®) - 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 healthcare provider before taking
VIEKIRA PAK?
- If they have: liver problems other than HCV 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 healthcare provider 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
healthcare provider should be consulted about the best way to feed
a baby if taking VIEKIRA PAK. Pregnant females who have both HCV
and HIV infection should talk with a healthcare provider 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
healthcare provider. A healthcare provider will provide
instruction on whether it is safe to take VIEKIRA PAK with other
medicines.
- When VIEKIRA PAK is finished, a healthcare provider 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
healthcare provider 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 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 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. AbbVie employs more
than 26,000 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
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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 2013 Annual Report on Form 10-K and in Item 1A,
"Risk Factors" of Part II of AbbVie's second quarter 2014
Quarterly Report on Form 10-Q, which have 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.