The First and Only All-Oral Interferon-Free Treatment for Genotype
4 Chronic Hepatitis C in the U.S.
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Approval is supported by data from the PEARL-I study, which
demonstrated 100 percent sustained virologic response rate at 12 weeks
post-treatment (SVR12) in Genotype 4 HCV
patients who received TECHNIVIE and ribavirin for 12 weeks
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All-oral, two-direct-acting antiviral, interferon-free treatment
regimen contains paritaprevir, Enanta’s lead protease inhibitor
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
that the U.S. Food and Drug Administration (FDA) approved AbbVie’s
TECHNIVIE™ (ombitasvir, paritaprevir and ritonavir) tablets in
combination with ribavirin (RBV) for the treatment of non-cirrhotic
adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection.
TECHNIVIE is the first and only all-oral, interferon-free, direct-acting
antiviral treatment approved in the U.S. for adult patients with GT4
chronic HCV infection.
“The approval of TECHNIVIE is an important advancement in the care of
patients with genotype 4 HCV,” commented Jay R. Luly, President and CEO.
“These difficult-to-treat patients now have a treatment option with high
cure rates available to them and we are proud to have paritaprevir be
part of this regimen.”
Paritaprevir is Enanta’s lead protease inhibitor identified within the
ongoing Enanta-AbbVie collaboration and is one of the two direct-acting
antivirals (2-DAA) in AbbVie’s TECHNIVIE. Forty five percent of AbbVie’s
worldwide net sales of the 2-DAA regimen will be included in the
paritaprevir net sales on which Enanta is eligible to receive annually
tiered royalties, ranging from the low double digits up to twenty
percent. AbbVie is responsible for all worldwide development and
commercialization of TECHNIVIE and other HCV treatment regimens.
Paritaprevir/ritonavir and ombitasvir, AbbVie’s NS5A inhibitor, are also
included in AbbVie’s VIEKIRA PAK™, which was approved in the
U.S. in late 2014 for patients with GT1 HCV infection.
The Centers for Disease Control and Prevention (CDC) estimates that 2.7
million people have chronic HCV infection in the U.S.1 There
are six major HCV genotypes (GT1-6). While genotype 1 (GT1) is the most
prevalent form of HCV in the U.S., accounting for approximately 74
percent of all cases2, GT4 infection is estimated to account
for approximately 1.1 percent of HCV infections in the U.S.3
About the PEARL-I Study
This approval of TECHNIVIE is based on data from the PEARL-I study,
which demonstrated 100 percent sustained virologic response rates at 12
weeks post-treatment (SVR12) in patients who received
TECHNIVIE and RBV for 12 weeks. PEARL-I is an open-label Phase 2b study
that evaluated the efficacy and safety of TECHNIVIE in GT4 chronic HCV
patients without cirrhosis. The study included GT4 patients who were new
to therapy (n=42/42) or who had failed previous treatment with pegylated
interferon (pegIFN) and RBV (n=49/49). Additionally, 91 percent of
patients who were new to therapy achieved SVR12 (n=40/44)
after taking TECHNIVIE without RBV. In the treatment-naïve group without
RBV, on-treatment virologic breakthrough was reported in one patient
(two percent), and two patients (five percent) experienced
post-treatment relapse. There were no virologic failures in the other
treatment arms.
There were no discontinuations due to adverse events in these patients.
The most commonly reported treatment-emergent adverse events (greater
than 10 percent in any group) observed in patients receiving TECHNIVIE
or TECHNIVIE with RBV, respectively, were asthenia (weakness) (25-29
percent), fatigue (7-15 percent), nausea (9-14 percent) and insomnia
(5-13 percent). Four patients who received TECHNIVIE with RBV
experienced decreased hemoglobin (anemia) which required RBV dose
reductions; however, none of these patients required blood transfusions
or medication to boost their red blood cell production. All patients
treated with TECHNIVIE and RBV achieved SVR12.
About TECHNIVIE
TECHNIVIE is an all-oral antiviral treatment consisting of the
fixed-dose combination of paritaprevir/ritonavir (150/100mg)
co-formulated with ombitasvir (25mg) dosed once daily and taken with a
meal, which is co-administered with weight-based RBV (1000mg or 1200mg
in divided doses, twice daily), taken with food. The combination of two
direct-acting antivirals, each with distinct mechanisms of action,
targets and inhibits specific HCV proteins in the viral replication
process.
Important Safety Information4
USE
TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir) tablets is a
prescription medicine used with ribavirin to treat adults with genotype
4 chronic (lasting a long time) hepatitis C (hep C) virus infection
without cirrhosis.
TECHNIVIE is not for people with certain types of liver problems.
IMPORTANT SAFETY INFORMATION
TECHNIVIE is taken 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 TECHNIVIE?
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TECHNIVIE 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 TECHNIVIE. If these medicines are used
as a method of birth control, another method must be used during
treatment with TECHNIVIE, and for about 2 weeks after treatment
with TECHNIVIE 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 TECHNIVIE 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 TECHNIVIE: tiredness, weakness, loss of appetite, nausea,
vomiting, yellowing of the skin or eyes, or color changes in stools.
TECHNIVIE must not be taken if people:
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have severe liver problems
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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 • 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®)
Before taking TECHNIVIE people should tell a doctor about all their
medical conditions, including:
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if they have liver problems other than hep C infection or have HIV
infection.
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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
TECHNIVIE.
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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 TECHNIVIE 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 TECHNIVIE.
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all the medicines they take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. Some
medicines interact with TECHNIVIE.
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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
TECHNIVIE with other medicines.
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when TECHNIVIE 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 TECHNIVIE treatment.
What are the common side effects of TECHNIVIE?
TECHNIVIE with ribavirin side effects include feeling weak,
tiredness, nausea, and sleep problems. These are not all of the possible
side effects of TECHNIVIE. 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 TECHNIVIE. 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.
For full Prescribing Information, click here or visit
rxabbvie.com/pdf/technivie_pi.pdf.
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 is discovering, and in some cases
developing, novel inhibitors designed for use against the hepatitis C
virus (HCV). These inhibitors include members of the direct acting
antiviral (DAA) inhibitor classes – protease (partnered with AbbVie),
NS5A, and nucleotide polymerase – as well as a host-targeted antiviral
(HTA) inhibitor class targeted against cyclophilin. Enanta’s lead
protease inhibitor, paritaprevir, is part of AbbVie’s recently approved
HCV treatment regimens. In addition, Enanta has a preclinical program in
non-alcoholic steatohepatitis, or NASH, which is a condition that
results in liver inflammation and damage caused by a buildup of fat in
the liver.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including with
respect to the prospects for AbbVie’s TECHNIVIE. 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
commercialization of TECHNIVIE; the level of market acceptance and the
pricing and rate of reimbursement for TECHNIVIE; the impact of
competitive products on the use and sales of TECHNIVIE; 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.
1 Centers for Disease Control and Prevention. Hepatitis C
FAQs for Health Professionals. Centers for Disease Control and
Prevention website. http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm.
2 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
3 Manos MM, Shvachko VA, Murphy RC, et al. Distribution of
hepatitis C virus genotypes in a diverse US integrated healthcare
population. J Med Virol. 2012 Nov; 84(11):1744-50.
4 TECHNIVIE [package insert]. North Chicago, IL: AbbVie Inc.
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