NORTH CHICAGO, Ill.,
Jan. 9, 2017 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a global biopharmaceutical company, today announced
high SVR12 rates with 8 weeks of treatment with its
investigational, pan-genotypic, ribavirin (RBV)-free regimen of
glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese
patients with genotype 1 (GT1) chronic hepatitis C virus (HCV)
infection without cirrhosis. In top-line results from the Phase 3
CERTAIN-1 study, 99 percent (n=105/106) of patients without
cirrhosis, which represents the majority of HCV patients, and
without the Y93H variant achieved sustained virologic response at
12 weeks post treatment (SVR12). The only patient in
whom SVR12 was not documented in this intent to treat
(ITT) population was lost to follow-up. All 23 patients with
the Y93H variant were assigned to the G/P arm and achieved
SVR12.
These data are the first to be released from registrational
studies in Japan as part of
AbbVie's global G/P clinical development program, designed to
investigate a faster path to virologic cure* for all major HCV
genotypes and with the goal of addressing treatment areas of
continued unmet need.
"These initial data in GT1-infected patients, which is the most
common type of hepatitis C in Japan, may help to further advance our
understanding on how we care for patients in this country," said
Stefan Zeuzem, M.D., Chief of the
Department of Medicine at the Goethe
University Hospital in Frankfurt,
Germany. "In the CERTAIN-1 study with the G/P regimen, we
see for the first time that 8 weeks of treatment achieved high cure
rates in these GT1-infected Japanese patients without cirrhosis."
Japan has one of the highest
rates of hepatitis C infection in the industrialized
world.2 Approximately 1 million people are living with
hepatitis C in Japan, with 60 to
70 percent of those infected with GT1 chronic HCV.1,3
Patients included in the CERTAIN-1 study were further
representative of the HCV-infected patient population in
Japan, where the prevalence of HCV
infection increases with age, by including a majority of patients
over 65 years of age.4
"Due to patient characteristics and virological considerations,
people living with HCV in Japan
have specific treatment challenges and needs," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie. "AbbVie's dedicated G/P registrational clinical development
program in Japan reflects our
continued commitment to make a real difference in the lives of
Japanese patients."
The CERTAIN-1 study compared the safety and efficacy of 8 weeks
of treatment with the investigational G/P regimen, to 12 weeks of
ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), in GT1 chronic
HCV-infected patients. The primary endpoint of the study was met,
as 8 weeks of G/P was shown to be non-inferior to 12 weeks of
OBV/PTV/r (100 percent SVR12; n=52).
Additionally, in substudy 1 evaluating GT1 patients (treated
with G/P) without cirrhosis and who are new to treatment with
direct-acting antivirals (DAA), no patients discontinued treatment
due to adverse events (AEs). In patients treated with OBV/PTV/r,
there was one who discontinued treatment due to AEs. In patients
receiving the G/P regimen, the most common AEs, occurring at a rate
greater than 5 percent, were nasopharyngitis (inflammation of the
throat and nasal passages) and pruritus (itchiness).
About the CERTAIN-1 Study
The CERTAIN-1 study is a
Phase 3, multicenter study evaluating the efficacy, safety and
pharmacokinetics (PK) of G/P in Japanese adults. Substudy 1 is
randomized, open-label, active-controlled, in genotype 1 (GT1)
chronic HCV-infected patients without cirrhosis and who are new to
DAA treatment. Patients who tested negative for Y93H resistance
associated variant received either 8 weeks of G/P or 12 weeks of
OBV/PTV/r (2:1 randomization ratio). All Y93H positive patients
were assigned to receive 8 weeks of G/P and all (n=23/23) achieved
SVR12. The primary objectives were safety and
non-inferiority of G/P compared to OBV/PTV/r.
Substudy 2 is a non-randomized, open-label study evaluating
GT1-6 HCV patients with specific treatment challenges, including
those with compensated cirrhosis (Child-Pugh A), chronic kidney
disease (CKD) and those who were not cured with previous DAA
treatment.
Additional data will be presented at an upcoming scientific
congress.
About AbbVie's G/P Clinical Development Program
AbbVie's glecaprevir/pibrentasvir (G/P) clinical development
program was designed to investigate a faster path to virologic
cure* for all major HCV genotypes (GT1-6) and with the goal of
addressing treatment areas of continued unmet need. In Japan, AbbVie studied the G/P regimen in
additional dedicated clinical trials due to patient and viral
characteristics specific to the Japanese HCV patient
population.
G/P is an investigational, pan-genotypic regimen that is being
evaluated as a potential cure in 8 weeks for HCV patients without
cirrhosis and who are new to treatment with direct-acting
antivirals (DAA), who make up the majority of HCV patients. AbbVie
is also studying G/P in patients with specific treatment
challenges, such as genotype 3, patients who were not cured with
previous DAA treatment and those with chronic kidney disease,
including patients on dialysis.
G/P is an investigational, once-daily regimen that combines two
distinct antiviral agents in a fixed-dose combination of
glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir
(120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral
tablets.
Glecaprevir (GLE) was discovered during the ongoing
collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ:
ENTA) for HCV protease inhibitors and regimens that include
protease inhibitors.
G/P is an investigational product and its safety and efficacy
have not been established in Japan.
*Patients with a sustained virologic response at 12
weeks post treatment (SVR12) are considered cured of
hepatitis C.
About VIEKIRAX in Japan
VIEKIRAX
(ombitasvir/paritaprevir/ritonavir) is indicated for the
improvement of viremia in chronic hepatitis C or compensated
hepatic cirrhosis C in patients of serogroup 1 (genotype 1) and for
chronic hepatitis C in patients of serogroup 2 (genotype 2).
Summary of Safety Information
Contraindications
VIEKIRAX is contraindicated in patients with a history of known
hypersensitivity to an ingredient in VIEKIRAX, patients with
moderate and more severe hepatic impairment (Child-Pugh B and C) or
patients being treated with the following drugs: azelnidipine,
triazolam, iv midazolam, blonanserin, pimozide, ergotamine
tartrate, dihydroergotamine mesilate, ergometrine maleate,
methylergometrine maleate, sildenafil citrate [Revatio], tadalafil
[Adcirca], rivaroxaban, vardenafil hydrochloride hydrate,
riociguat, simvastatin, atorvastatin calcium hydrate,
carbamazepine, phenytoin, fosphenytoin sodium hydrate,
phenobarbital, rifampin, efavirenz, foods containing St. John's
Wort (Hypericum perforatum), ethinyl estradiol-containing medicinal
products. Patients receiving colchicine with renal or hepatic
impairment.
Precautions for Use
Positive result for HCV RNA should be confirmed before
administering VIEKIRAX and decompensated cirrhosis should be
excluded.
For genotype 2, since efficacy varies due to subtype and prior
treatment experience with or without IFN the benefit-risk of
VIEKIRAX treatment should be considered. Since VIEKIRAX is
coadministered with ribavirin in genotype 2, precautions for use of
the package insert of ribavirin must be confirmed.
When VIEKIRAX is used for patients co-infected with HIV/HCV,
administer VIEKIRAX only to patients whose virological suppression
has been achieved by anti-HIV therapy as ritonavir may cause
resistance against a HIV protease inhibitor.
During the administration of VIEKIRAX, perform liver function
tests regularly because hepatic function disorder may occur.
While HCV viral load is decreased, HBV reactivation in patients
who are chronic infection of HBV or patients who have a history of
HBV infection has been reported after initiation of HCV DAA
treatment.
Renal function tests should be performed prior to an initiation
and periodically after initiation of VIEKIRAX.
Co-administration of VIEKIRAX with drugs that are substrates of
CYP3A4, P-gp, BCRP, OATP1B1 or OATP1B3 may result in increased
plasma concentrations of such drugs, potentially requiring dose
adjustment or clinical monitoring.
The safety of VIEKIRAX in pregnant women has not been
established. VIEKIRAX should be used in pregnant women and women
who may possibly be pregnant only if the expected therapeutic
benefits outweigh the possible risks associated with treatment.
VIEKIRAX in combination with ribavirin must not be used in patients
who are pregnant or may be pregnant.
Do not administer VIEKIRAX to nursing mothers. If VIEKIRAX is
administered to a nursing mother by necessity, breast feeding must
be discontinued during treatment.
Safety and effectiveness have not been established in
children.
Adverse Reactions
Common adverse reactions in Phase 3 clinical trials of VIEKIRAX
in Japan in GT1b patients included
peripheral edema in 15 subjects (4.1%), headache in 12 subjects
(3.3%) and nausea in 10 subjects (2.8%); and anemia in 36 subjects
(22.5%), blood bilirubin increased in 29 subjects (18.1%) and
pruritus in 14 subjects (8.8%) in GT2 patients.
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. Together with its wholly-owned
subsidiary, Pharmacyclics, AbbVie employs more than 28,000 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
Some statements in this
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," of
AbbVie's 2015 Annual Report on Form 10-K, which has 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.
1 National Center for Global Health and Medicine.
Hepatitis C. Assessed January 2017.
Available from:
http://www.kanen.ncgm.go.jp/cont/010/c_gata.html
2 Gower, E. Global epidemiology and genotype
distribution of the hepatitis C virus infection. Journal of
Hepatology 2014; 61: S45-S57, Table 2.
3 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol
2013; 10: 553-562. Available from:
http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html
4 Chung H, Taisuke U, Masatoshi K. Changing Trends in
Hepatitis C Infection over the Past 50 Years in Japan. Intervirology 2010; 53:39–43.
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