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AbbVie’s ongoing TOPAZ-II study evaluates long-term treatment
outcomes in genotype 1a and genotype 1b chronic HCV patients with or
without compensated cirrhosis
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Patients treated with VIEKIRA PAK, with or without ribavirin,
achieved 95 percent sustained virologic response rates at 12 weeks
post-treatment (SVR12)
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VIEKIRA PAK contains Enanta’s lead protease inhibitor, Paritaprevir
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA) a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
new data from AbbVie’s ongoing Phase 3b TOPAZ-II study evaluating
VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir
tablets), taken with or without ribavirin (RBV), in adult patients with
genotype 1a (GT1a) or genotype 1b (GT1b) chronic hepatitis C virus (HCV)
infection.1 Interim data show that 95 percent (n=586/615) of
patients in the TOPAZ-II trial achieved a sustained virological response
at 12 weeks post-treatment after 12 or 24 weeks of treatment, a
secondary endpoint for the study.1 These data were presented
today at The Liver Meeting® 2015, the Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD) in San Francisco.
Paritaprevir is Enanta’s lead protease inhibitor identified within the
ongoing Enanta-AbbVie collaboration and is one of the three DAAs in
AbbVie’s VIEKIRA PAK.
The TOPAZ-II study, a multicenter trial in the U.S., evaluates the
impact of SVR12 on the progression of liver diseases over the
course of five years in a diverse patient population, including GT1 HCV
patients with or without cirrhosis and those who were treatment-naïve or
pegylated interferon (pegIFN)/RBV treatment-experienced. Patients were
treated with VIEKIRA PAK with or without RBV, according to the dosing
recommendations found in the U.S. prescribing information.1
VIEKIRA PAK with or without RBV is indicated for the treatment of
patients with GT1 chronic HCV infection, including those with
compensated cirrhosis (Child-Pugh A). VIEKIRA PAK is contraindicated in
patients with moderate to severe hepatic impairment (Child-Pugh B and C)
due to risk of potential toxicity.
About the TOPAZ-II Study
TOPAZ-II is an ongoing, single arm, open-label, Phase 3b multicenter
study in the U.S. evaluating the safety and efficacy of 12 or 24 weeks
of treatment with VIEKIRA PAK, with or without ribavirin, in
treatment-naïve or pegIFN/RBV treatment-experienced, adult patients with
GT1 chronic HCV infection with or without compensated cirrhosis.1 Patients
in the TOPAZ-II study will be followed up for a period of five years
post-treatment to evaluate the long-term impact of SVR12 on
progression of liver disease.
The trial includes 615 patients, 115 (19 percent) with compensated
cirrhosis and 500 (81 percent) without cirrhosis.1
On-treatment virologic failure was experienced by 0.8 percent (n=5/615)
of study patients, while 1.9 percent (n=11/590) experienced relapse. One
percent (n=6/615) of patients prematurely discontinued treatment due to
adverse events.1 Four percent (n=25/615) experienced serious
adverse events. Ribavirin dosage was reduced due to anemia in 30/474
(6.3 percent) patients or due to hemoglobin decreases in 20/474 (4.2
percent) patients who received RBV. The most commonly-reported adverse
events (in ≥10 percent of patients) were fatigue, nausea, headache,
pruritus and insomnia. 1
Genotype 1 subjects who were either treatment-naïve or previously
treated with IFN or pegIFN/ RBV received VIEKIRA PAK. Subjects with GT1a
and all GT1 subjects with compensated cirrhosis also received RBV. The
treatment duration was 12 weeks for all subjects except GT1a subjects
with compensated cirrhosis who received treatment for 24 weeks.
Treatment for 12 weeks was considered for some of these patients based
on prior treatment history.1 The primary endpoint is the
incidence of all-cause death, liver-related death, liver decompensation,
liver transplantation, hepatocellular carcinoma, and the composite of
any of the above outcomes observed during the post-treatment period. Key
secondary endpoints included the percentage of subjects with SVR12
(HCV undetectable in the blood 12 weeks following the final dose of the
study drug), on-treatment virologic failure and post-treatment relapse.1
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 doctor before taking
VIEKIRA.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA 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?
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VIEKIRA 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.
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VIEKIRA can cause increases in liver function blood test results,
especially if people use ethinyl estradiol-containing medicines (such
as some birth control products).
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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. If these
medicines are used as a method of birth control, another method
must be used during treatment with VIEKIRA, and for about 2 weeks
after treatment with VIEKIRA ends. A doctor can provide
instruction on when to begin taking ethinyl estradiol-containing
medicines.
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A doctor should do blood tests to check liver function during the
first 4 weeks of treatment and then as needed.
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A doctor may tell people to stop taking VIEKIRA 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: 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 must not be taken if people:
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have certain liver problems
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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®)
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have had a severe skin rash after taking ritonavir (Norvir®)
What should people tell a doctor before taking VIEKIRA?
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If they have: liver problems other than hep C infection, HIV
infection, or any other medical conditions.
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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.
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If they are pregnant or plan to become pregnant or if they are
breastfeeding or plan to breastfeed. It is not known if VIEKIRA 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.
Pregnant females who have both hep C and HIV infection should talk
with a doctor about enrolling in the antiretroviral pregnancy registry.
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About all the medicines they take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. Some medicines interact with VIEKIRA.
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A new medicine must not be started without telling a doctor.
A doctor will provide instruction on whether it is safe to take
VIEKIRA with other medicines.
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When VIEKIRA 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 treatment.
What are the common side effects of VIEKIRA?
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For VIEKIRA used with ribavirin, side effects include
tiredness, nausea, itching, skin reactions such as redness or rash,
sleep problems, and feeling weak.
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For VIEKIRA used without ribavirin, side effects include
nausea, itching, and sleep problems.
These are not all of the possible side effects of VIEKIRA. 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. 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.
Visit AbbVie’s website 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-naive 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.
Protease Inhibitor Collaboration with AbbVie
In December 2006, Enanta and Abbott announced a worldwide agreement to
collaborate on the discovery, development and commercialization of HCV
NS3 and NS3/4A protease inhibitors and HCV-protease-inhibitor-containing
drug combinations. Paritaprevir is a protease inhibitor identified
through the collaboration, as I is ABT-493, Enanta’s next-generation
protease inhibitor that is completing Phase 2 development as part of
AbbVie’s investigational next-generation regimen for HCV. AbbVie is
Abbott’s successor under the agreement and is responsible for all
development and commercialization activities for paritaprevir , as well
as ABT-493.
About Enanta
Enanta Pharmaceuticals is a research and development-focused
biotechnology company that uses its robust chemistry-driven approach and
drug discovery capabilities to create small molecule drugs for viral
infections and liver diseases. Enanta has developed novel protease and
NS5A inhibitors that are members of the direct-acting-antiviral (DAA)
inhibitor classes designed for use against the hepatitis C virus (HCV).
Enanta’s protease inhibitors partnered with AbbVie include paritaprevir,
which is contained in AbbVie’s marketed DAA regimens for HCV, and
ABT-493, Enanta’s next-generation protease inhibitor completing phase 2
development in combination with ABT-530, AbbVie’s next-generation NS5A
inhibitor. Enanta also has a program to develop a host-targeted
antiviral (HTA) inhibitor class for HCV targeted against cyclophilin, as
well as another DAA program to develop nucleotide polymerase inhibitors.
In addition, Enanta has a preclinical program in non-alcoholic
steatohepatitis, or NASH, which is a condition that results in liver
inflammation and liver damage caused by a buildup of fat in the liver.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s VIEKIRA PAK and
other treatment regimens for HCV containing paritaprevir. Statements
that are not historical facts are based on our management’s current
expectations, estimates, forecasts and projections about our business
and the industry in which we operate and our management’s beliefs and
assumptions. The statements contained in this release are not guarantees
of future performance and involve certain risks, uncertainties and
assumptions, which are difficult to predict. Therefore, actual outcomes
and results may differ materially from what is expressed in such
forward-looking statements. Important factors that may affect actual
results include the efforts of AbbVie (our collaborator on paritaprevir)
regarding clinical development of paritaprevir-containing regimens;
regulatory approvals and other regulatory actions regarding
paritaprevir-containing regimens; the impact of competitive products on
the regulatory requirements, use and sales of any
paritaprevir-containing regimen; and other risk factors described or
referred to in “Risk Factors” in Enanta’s most recent Form 10-K for the
fiscal year ended September 30, 2014 and other periodic reports filed
more recently with the Securities and Exchange Commission. Enanta
cautions investors not to place undue reliance on the forward-looking
statements contained in this release. These statements speak only as of
the date of this release, and Enanta undertakes no obligation to update
or revise these statements, except as may be required by law.
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1 Reau, N., et al. Preliminary Safety and Efficacy Results
from TOPAZ-II: A Phase 3b Study Evaluating Long-Term Clinical Outcomes
in HCV Genotype 1-infected Patients Receiving Ombitasvir/Paritaprevir/r
and Dasabuvir +/-Ribavirin. Poster #1065; presented at The Liver
Meeting®, the Annual Meeting of the American Association for the Study
of Liver Diseases (AASLD) in San Francisco, November 13-17, 2015.
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