- 100 percent of genotype 1b (GT1b)
patients who received VIEKIRAX + EXVIERA without ribavirin for 12
weeks, achieved SVR12 in a post-hoc analysis, regardless of whether
baseline NS5A RAVs were present1
- 97 percent of genotype 1a (GT1a)
patients, with or without baseline NS5A RAVs, who received the
regimen with ribavirin achieved SVR121
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases,
announced today data showing that patients with genotype 1 (GT1)
chronic hepatitis C virus (HCV) infection who received the
recommended regimen of AbbVie’s VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets), with or without ribavirin (RBV), achieved high sustained
virologic response rates at 12 weeks post-treatment (SVR12),
regardless of the presence of baseline resistance-associated
variants (RAVs).1 These late-breaking data from a post-hoc analysis
of five completed Phase 3 clinical trials will be presented today
at The International Liver Congress™ (ILC) 2016, in Barcelona,
Spain.
Paritaprevir is Enanta’s lead protease inhibitor identified
within the ongoing Enanta-AbbVie collaboration and is one of the
direct-acting antivirals in AbbVie’s VIEKIRAX + EXVIERA treatment
regimen for chronic hepatitis C virus (HCV).
The study found that no matter whether certain NS5A RAVs were
present, 100 percent (n=148/148) of patients with GT1b chronic HCV
infection who received VIEKIRAX + EXVIERA without RBV for 12 weeks,
achieved SVR12.1 Results also showed 97 percent of patients with
GT1a chronic HCV infection with or without baseline NS5A RAVs
(n=57/59 and n=351/361 respectively) achieved SVR12 when receiving
the recommended regimen of VIEKIRAX + EXVIERA with RBV.1 These
findings included patients new to therapy and patients previously
treated with pegylated interferon/ribavirin (pegIFN/RBV)
(treatment-experienced), as well as GT1 patients with compensated
cirrhosis.1
As the hepatitis C virus replicates, variants of the viral NS5A
protein are produced.2 The impact of these variants on treatment
response, including the possibility of becoming resistant to
therapy or achieving SVR, has yet to be fully determined.3
To understand more about the impact of variants on treatment
response, next-generation sequencing was used to assess baseline
samples for variants in NS5A, which were detected in 11 percent of
GT1a patients and 19 percent of GT1b patients, with a detection
threshold of 15 percent, consistent with the limits of detection
for variants by population sequencing.1 The post-hoc analysis was
performed on data from five completed Phase 3 studies:1 PEARL-IV
(GT1a treatment-naïve, n=90), SAPPHIRE-II (GT1a pegIFN/RBV
treatment-experienced, n=214), TURQUOISE-II (GT1a compensated
cirrhosis – 24 week treatment arm, n=118), PEARL-II (GT1b
pegIFN/RBV treatment-experienced, n=89) and TURQUOISE-III (GT1b
compensated cirrhosis, n=59). Patients who did not achieve SVR for
reasons other than virologic failure (such as early treatment
discontinuations or SVR12 data unavailable) were excluded from the
analysis.
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.
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 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’s research
and development is currently focused on four disease targets:
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic
Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors 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, developed through its
collaboration with AbbVie, include paritaprevir, which is contained
in AbbVie’s marketed DAA regimens for HCV, and ABT-493, Enanta’s
second protease inhibitor, which AbbVie is developing in phase 3
studies in combination with ABT-530, AbbVie’s NS5A inhibitor.
Enanta has also discovered a cyclophilin inhibitor, EDP-494, a
novel host-targeting mechanism for HCV, which is now in phase 1
clinical development, and EDP-305, an FXR agonist, which Enanta
plans to advance into clinical development for NASH later in 2016.
Please visit www.enanta.com for more information on Enanta’s
programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for AbbVie’s HCV
treatment regimens containing paritaprevir and Enanta’s other
research and development programs. Statements that are not
historical facts are based on management’s current expectations,
estimates, forecasts and projections about Enanta’s business and
the industry in which it operates and 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 and risks that may affect actual results include: the
efforts of AbbVie (our collaborator marketing VIEKIRAX) to market
and sell VIEKIRAX-containing regimens; the development, regulatory
and marketing efforts of others with respect to competitive HCV
treatment regimens; regulatory and reimbursement actions affecting
VIEKIRAX, any competitive regimen, or both; 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, 2015 and any
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.
____________________________________________
1Sarrazin C, et al. Effect of Baseline Resistance-Associated
Variants on SVR with the 3D Regimen plus RBV. Late Breaker Poster
#LBP503; presented at the International Liver Congress™ (ILC) The
Annual Meeting of the European Association for the Study of the
Liver (EASL) in Barcelona, April 13-17, 2016.
2 Schneider MD, et al. Antiviral therapy of hepatitis C in 2014:
do we need resistance testing? Antiviral Res. 2014
May;105:64-71.
3 American Association for the Study of Liver Diseases.
Monitoring patients who are starting hepatitis C treatment, are on
treatment, or have completed therapy, February 24,
2016, http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment
are-treatment-or-have. Accessed March 15, 2016.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160413006716/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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