AbbVie Demonstrates 96 percent SVR(12) in its Phase III Study of Treatment-Experienced Patients with Genotype 1 Hepatitis C

PR Newswire/Les Echos/ 
AbbVie Demonstrates 96 percent SVR(12) in its Phase III Study of  
Treatment-Experienced Patients with Genotype 1 Hepatitis C 
-Results further confirm phase II studies, with consistent virologic response
 and tolerability profile-
-SAPPHIRE-II is the second of six phase III trials studying the investigational
 3D regimen-
-Future data anticipated from AbbVie's clinical trials examines 3D regimen 
 with and without ribavirin, as well as treatment of hepatitis C in patients 
 with cirrhosis-
NORTH CHICAGO, Ill., Dec. 10, 2013 -- AbbVie (NYSE: ABBV) released phase III
results for the investigational three direct-acting-antiviral (3D) regimen plus
ribavirin in patients with chronic, genotype 1 (GT1) hepatitis C virus (HCV)
infection. In the 394-patient SAPPHIRE-II study, 96 percent of patients who
previously failed pegylated interferon and ribavirin treatment, including
approximately 49 percent of who were prior null responders, achieved sustained
virologic response at 12 weeks (SVR12) with the regimen. The majority of
patients were GT1a, considered a difficult-to-treat subtype, and the SVR12
rates of GT1a and GT1b were 96 percent and 97 percent, respectively. Virologic
relapse or breakthrough was noted in 2 percent of patients receiving the 3D 
regimen plus ribavirin. In addition, the discontinuation rate due to adverse 
events was 1 percent. 
Globally, approximately 160 million people are chronically infected with
hepatitis C[1]. AbbVie's multinational HCV program is the largest all-oral,
interferon-free clinical program in GT1 patients being conducted to date[2]. 
GT1 (with subtypes 1a and 1b) is the most prevalent genotype worldwide, with a
higher prevalence of 1a in the U.S. and 1b in Europe. 
"SAPPHIRE-II demonstrates that treatment-experienced genotype 1 HCV patients
achieved high rates of virologic response with AbbVie's interferon-free,
all-oral 3D regimen plus ribavirin," said Scott Brun, M.D., vice president,
pharmaceutical development, AbbVie. "Completion of the two placebo-controlled
SAPPHIRE studies is an important step in AbbVie's HCV clinical development
program. We look forward to the results of studies looking at AbbVie's 3D
regimen with and without ribavirin in different patients, as well as data from
our dedicated study in patients with cirrhosis." 
About Study M13-098 (SAPPHIRE-II) 
Following SAPPHIRE-I, SAPPHIRE-II is the second placebo-controlled trial and
the second of six phase III trials supporting AbbVie's investigational 3D 
regimen for the treatment of GT1 hepatitis C patients. AbbVie will disclose 
detailed SAPPHIRE-II results at future scientific congresses and in 
publications. 
SAPPHIRE-II is a global, multi-center, randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of 12 weeks of
treatment with ABT-333 (250mg), ribavirin (weight-based), both dosed twice
daily, and the fixed-dose combination of ABT-450/ritonavir (150/100mg)
co-formulated with ABT-267 (25mg) and dosed once daily in non-cirrhotic, GT1a
and GT1b HCV-infected, treatment-experienced adult patients who previously
failed treatment with pegylated interferon and ribavirin. 
The study population consisted of 394 GT1 treatment-experienced patients with 
no evidence of liver cirrhosis with 297 patients randomized to the 3D regimen 
plus ribavirin for 12 weeks, and 97 patients randomized to placebo for the 
initial 12 weeks. Patients initially randomized to placebo for the first 12 
weeks then received open-label treatment with the 3D regimen plus ribavirin for
12 weeks. In the study, 49 percent of patients were prior null responders to 
pegylated interferon and ribavirin, generally considered among the most 
difficult to treat successfully. 
Following 12 weeks of treatment with AbbVie's 3D regimen plus ribavirin, 96
percent (n=286/297) of patients achieved SVR12 based on intent-to-treat 
analysis where patients with missing values for any reason were considered 
treatment failures. The SVR12 rates in GT1a and GT1b patients were 96 percent 
(166/173) and 97 percent (119/123), respectively. One subject had HCV genotype 
1 and achieved SVR12, but was unable to be subgenotyped. 
The most commonly reported adverse events in both the 3D and placebo arms were
headache, fatigue and nausea. Discontinuations due to adverse events were
reported in three (1 percent) patients receiving the 3D regimen and no patients
receiving placebo. Virologic relapse or breakthrough was noted in 2 percent of
patients receiving the 3D regimen plus ribavirin. 
Additional information about AbbVie's phase III studies can be found on
www.clinicaltrials.gov. 
AbbVie's HCV Development Program 
The clinical program supporting our 3D regimen includes more than 2,300 GT1
patients in more than 25 countries around the world. The AbbVie HCV clinical
development program is intended to advance scientific knowledge and clinical
care by investigating an interferon-free, all-oral 3D regimen with or 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 nonresponders to interferon-based therapy or patients with advanced
liver fibrosis or cirrhosis.
Results from the remaining four studies in AbbVie's phase III program will be
available in the coming months, supporting regulatory submissions starting in
the second quarter of 2014. 
Overview of AbbVie's phase III clinical program is as follows: 
Study       Patients (N)          Treatment Regimen          Treatment Duration
SAPPHIRE-I  GT1, treatment-naive  * ABT-450/r(b) +ABT-267(c) 12 weeks 


            (631)                 * ABT-333
                                  * Ribavirin
                                  * Placebo                  12 weeks, 
                                                             then active
                                                             treatment 


                                                         for 12 weeks 
SAPPHIRE-II  GT1, treatment-      * ABT-450/r +ABT-267       12 weeks 


             experienced          * ABT-333      
             (394)                * Ribavirin
                                    * Placebo                  12 weeks, 
                                                             then active
                                                             treatment 


                                                         for 12 weeks 
PEARL-II     GT1(b), treatment-   * ABT-450/r +ABT-267       12 weeks 


             experienced          * ABT-333
             (210 (a))            * Ribavirin
                                     * ABT-450/r +ABT-267       12 weeks 


                              * ABT-333   
PEARL-III    GT1b, treatment-     * ABT-450/r +ABT-267       12 weeks 


                               
             naive                * ABT-333
             (400 (a))            * Ribavirin
                                    * ABT-450/r +ABT-267       12 weeks 
                                  * ABT-333
                                  * Placebo 

PEARL-IV     GT1b, treatment-     * ABT-450/r +ABT-267       12 weeks 
                               
             naive                * ABT-333
             (300 (a))            * Ribavirin
                                    * ABT-450/r +ABT-267       12 weeks 
                                  * ABT-333


                              * Placebo  
TURQUOISE-II GT1b, treatment-     * ABT-450/r +ABT-267       12 weeks 


                               
             naive with           * ABT-333
             compensated          * Ribavirin
             cirrhosis) 
             (380 (a)) 
                    
                                  * ABT-450/r +ABT-267       24 weeks
                                  * ABT-333


                              * Ribavirin 
(a) projected study population 
(b) ABT-450/ritonavir 
(c) ABT-267 is co-formulated with ABT-450/r, administered as two pills once 
daily 
The 3D regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A
inhibitor ABT- 267, and non-nucleoside polymerase inhibitor ABT-333. 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 investigational 3D regimen with
and without ribavirin for HCV GT1 was designated as a Breakthrough Therapy by
the U.S. Food and Drug Administration (FDA). 
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
of HCV. 
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 use. 
There are special safety considerations when prescribing these drugs in 
approved populations. 
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, automimmune
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. 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. In 2013, AbbVie employs approximately 21,000 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. 
[1] Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol 
Infect. 2011; 17(2):107-15.
[2] Comparison based on review of data from clinicaltrials.gov for phase 3a 
programs of Gilead, BMS and BI as of November 15, 2013
 

SOURCE AbbVie Inc. 
CONTACT: Media: Elizabeth Hoff, +1 (847) 935-4236, elizabeth.hoff@abbvie.com, 
or Javier Boix, +1 (847) 937-6113, javier.boix@abbvie.com, or For Investor
Relations: Elizabeth Shea, +1 (847) 935-2211, elizabeth.shea@abbvie.com 
                  
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-0- Dec/10/2013 14:07 GMT
 
 
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