AbbVie Completes Largest Phase III Program of an All-Oral, Interferon-Free
Therapy for the Treatment of Hepatitis C Genotype 1
NORTH CHICAGO, Illinois, Jan. 31, 2014
- Ninety-nine percent SVR(12)rates with and without ribavirin in certain
- Even in difficult-to-treat patients (cirrhotic patients) achieved 92-96
percent SVR(12) rates
- AbbVie expects U.S. launch in 2014
NORTH CHICAGO, Illinois, Jan. 31, 2014 /PRNewswire/ --AbbVie (NYSE: ABBV)
announced the completion of its phase III clinical program and released
results of four additional studies designed to assess AbbVie's investigational
all-oral, interferon-free therapy with and without ribavirin (RBV) in patients
with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. These results
described below confirm previously reported AbbVie data and further
demonstrate high sustained virologic response rates 12 weeks post treatment
(SVR  ) and tolerability in these GT1 patients.
AbbVie Phase III Clinical Program Results
Study Patients Regimen SVR 
PEARL-II (12 GT1b treatment-experienced AbbVie regimen
weeks) (N=179) + RBV (n=88) 97% (85/88)
only (n=91) 100% (91/91)
PEARL-III (12 GT1b treatment-naive (N=419) AbbVie regimen 99%
weeks) + RBV (n=210) (209/210)
AbbVie regimen 99%
only (n=209) (207/209)
PEARL-IV (12 GT1a treatment-naive (N=305) AbbVie regimen
weeks) + RBV (n=100) 97% (97/100)
AbbVie regimen 90%
only (n=205) (185/205)
TURQUOISE-II (12 GT1 treatment-naive and AbbVie regimen
& 24 weeks) treatment-experienced with + RBV, 12 92%
compensated cirrhosis (N=380) weeks (n=208) (191/208)
+ RBV, 24 96%
weeks (n=172) (165/172)
SAPPHIRE-I (12 GT1 treatment-naive (N=631) AbbVie regimen 96%
weeks) + RBV (n=473) (455/473)
SAPPHIRE-II (12 GT1 treatment-experienced AbbVie regimen 96%
weeks) (N=394) + RBV (n=297) (286/297)
"The outcomes of AbbVie's comprehensive phase III studies in 2,300 patients
across 25 countries demonstrate how our investigational regimen performs
across a broad spectrum of genotype 1 patients, including those with
compensated liver cirrhosis," said Scott Brun, M.D., vice president,
pharmaceutical development, AbbVie. "The high rates of response and
tolerability of our regimen, coupled with the low rates of discontinuation are
The AbbVie investigational regimen consists of the fixed-dose combination of
ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once
daily, and ABT-333 (250mg) with or without ribavirin (weight-based), dosed
twice daily. The combination of three different mechanisms of action
interrupts the HCV replication process with the goal of optimizing SVR rates
across different patient populations. In May of 2013, AbbVie's regimen with
and without ribavirin for HCV GT1 was designated as a Breakthrough Therapy by
the U.S. Food and Drug Administration (FDA). AbbVie is on track to begin major
regulatory submissions early in the second quarter of 2014. AbbVie will
disclose detailed study results at future scientific congresses and in
About Study M13-389 (PEARL-II) PEARL-II is a global, multi-center, randomized,
open-label, controlled study to evaluate the efficacy and safety of 12 weeks
of treatment with AbbVie's regimen with and without ribavirin in
non-cirrhotic, GT1b HCV-infected, treatment-experienced adult patients.
The study population consisted of 179 GT1b treatment-experienced patients with
no evidence of liver cirrhosis: 91 patients randomized to the regimen without
ribavirin for 12 weeks, and 88 patients randomized to the regimen with
ribavirin for 12 weeks. In the ribavirin-free arm, 100 percent (n=91/91) of
patients achieved SVR  , while 97 percent (n=85/88) achieved SVR  in
the ribavirin-containing arm.
The most commonly reported adverse events were fatigue and headache.
Discontinuations due to adverse events were reported in none of the patients
in the ribavirin-free arm and two (2 percent) patients in the
ribavirin-containing arm. There were no patients in either arm of the study
that experienced virologic relapse or breakthrough.
About Study M13-961 (PEARL-III) PEARL-III is a global, multi-center,
randomized, double-blind, placebo-controlled study to evaluate the efficacy
and safety of 12 weeks of treatment with AbbVie's regimen with and without
ribavirin in non-cirrhotic, GT1b HCV-infected, treatment-naive adult patients.
The study population consisted of 419 GT1b treatment-naive patients with no
evidence of liver cirrhosis: 209 patients randomized to the regimen without
ribavirin for 12 weeks, and 210 patients randomized to the regimen with
ribavirin for 12 weeks. Following 12 weeks of treatment, 99 percent receiving
the regimen without ribavirin (n=207/209) and 99 percent receiving the regimen
with ribavirin (n=209/210) achieved SVR  .
The most commonly reported adverse events were headache and fatigue. No
patient discontinued study drug due to adverse events. Virologic relapse or
breakthrough was noted in none of the patients receiving the regimen without
ribavirin and 0.5 percent of patients receiving the regimen with ribavirin.
About Study M14-002 (PEARL-IV) PEARL-IV is a global, multi-center, randomized,
double-blind, placebo-controlled study to evaluate the efficacy and safety of
12 weeks of treatment with AbbVie's regimen with and without ribavirin in
non-cirrhotic, GT1a HCV-infected, treatment-naive adult patients.
The study population consisted of 305 GT1a treatment-naive patients with no
evidence of liver cirrhosis: 205 patients randomized to the regimen without
ribavirin for 12 weeks, and 100 patients randomized to the regimen with
ribavirin for 12 weeks. Following 12 weeks of treatment, 90 percent of
patients receiving the regimen without ribavirin (n=185/205) and 97 percent
receiving the regimen with ribavirin (n=97/100) achieved SVR  .
The most commonly reported adverse events were fatigue, headache and nausea.
Discontinuations due to adverse events were reported in two (1 percent)
patients receiving the regimen without ribavirin and no patients in the
ribavirin-containing arm. Virologic relapse or breakthrough was noted in 8
percent of patients receiving the regimen without ribavirin and 2 percent of
patients receiving the regimen with ribavirin.
About Study M13-099 (TURQUOISE-II) TURQUOISE-II is the first phase III study
completed exclusively in GT1 cirrhotic patients investigating an all-oral,
interferon-free regimen. It is a global, multi-center, randomized, open-label
study evaluating the efficacy and safety of 12 or 24 weeks of treatment with
AbbVie's regimen with ribavirin in cirrhotic, GT1a and GT1b HCV-infected,
treatment-naive and treatment-experienced adult patients.
The study population consisted of 380 GT1a and GT1b, treatment-naive and
treatment-experienced patients with compensated cirrhosis: 208 patients
randomized to the regimen with ribavirin for 12 weeks, and 172 patients
randomized to the regimen with ribavirin for 24 weeks. Following 12 weeks of
treatment, 92 percent of patients (n=191/208) achieved SVR  . Following 24
weeks of treatment, 96 percent of patients (n=165/172) achieved SVR  .
The most commonly reported adverse events were fatigue, headache and nausea.
Discontinuations due to adverse events were reported in four (2 percent)
patients receiving the regimen with ribavirin for 12 weeks and four (2
percent) patients in the 24-week arm. Virologic relapse or breakthrough was
noted in 6 percent of patients in the 12-week arm and 2 percent in the 24-week
Additional information about AbbVie's phase III studies can be found on
Globally, approximately 160 million people are chronically infected with
hepatitis C. AbbVie's multinational HCV program is the largest all-oral,
interferon-free clinical program in GT1 patients being conducted to date.
GT1 (with subtypes 1a and 1b) is the most prevalent genotype worldwide.
AbbVie's HCV Development Program The AbbVie HCV clinical development program
is intended to advance scientific knowledge and clinical care by investigating
an interferon-free, all-oral regimen with and without ribavirin with the goal
of producing high SVR rates in as many patients as possible, including those
that typically do not respond well to treatment, such as previous
non-responders to interferon-based therapy or patients with advanced liver
fibrosis or cirrhosis.
ABT-450 was discovered during the ongoing collaboration between AbbVie and
Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens
that include protease inhibitors. ABT-450 is being developed by AbbVie for use
in combination with AbbVie's other investigational medicines for the treatment
Safety Information for Ribavirin and Ritonavir Ribavirin and ritonavir are not
approved for the investigational use discussed above, and no conclusions can
or should be drawn regarding the safety or efficacy of these products for this
There are special safety considerations when prescribing these drugs in
Ritonavir must not be used with certain medications due to significant
drug-drug interactions and in patients with known hypersensitivity to
ritonavir or any of its excipients.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis
C virus and must not be used alone for this use. Ribavirin causes significant
teratogenic effects and must not be used in women who are pregnant or
breast-feeding and in men whose female partners are pregnant. Ribavirin must
not be used in patients with a history of severe pre-existing cardiac disease,
severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune
hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in
HIV/HCV co-infected patients with cirrhosis and Child-Pugh score ≥ 6.
See approved product labels for more information.
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. AbbVie employs approximately 25,000
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," in AbbVie's 2012 Annual Report on Form
10-K/A, 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.
 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol
Infect. 2011; 17(2):107-15.
 Comparison based on review of data from www.clinicaltrials.gov for phase
3a programs of Gilead, BMS and BI as of November 15, 2013.
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