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 results from part one of the Phase 2 portion of AbbVie’s 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, Washington.
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™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets)
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.
Paritaprevir is Enanta’s lead protease inhibitor identified within the
ongoing Enanta-AbbVie collaboration and is one of the three
direct-acting antivirals in the TURQUOISE-I treatment regimen. AbbVie is
responsible for all development and commercialization activities for
regimens that contain paritaprevir.
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,
2:30-4:00 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.
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 and
ABT-493 are protease inhibitors identified through the collaboration.
AbbVie is Abbott’s successor under the agreement and is responsible for
all development and commercialization activities for paritaprevir, as
well as ABT-493, the collaboration’s next-generation protease inhibitor.
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. 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 paritaprevir-containing, VIEKIRA
PAK + ribavirin in patients co-infected with GT1 HCV and HIV-1.
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 regimens
containing paritaprevir, market acceptance of VIEKIRA PAK in the U.S.
and other markets, the impact of competitive products on the use and
sales of those regimens, and regulatory actions affecting clinical
development of paritaprevir and clinical development of competitive
product candidates in jurisdictions beyond the U.S. and Europe. 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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