In AbbVie's Interferon-free late-stage studies of 6 phase 3 trials most HCV genotype 1 participants achieved an impressive 99% cure rates in 12 weeks. AbbVie said it will file for regulatory approval early in the second quarter, expecting to launch in late 2014.
AbbVie Completes Largest Phase III Program of an All-Oral, Interferon-Free Therapy for the Treatment of HCV Genotype 1
- Ninety-nine percent SVR(12) rates with and without ribavirin in certain patient types
- Even in difficult-to-treat patients (cirrhotic patients) achieved 92-96 percent SVR(12) rates
- AbbVie expects U.S. launch in 2014
NORTH CHICAGO, Ill., 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 (SVR12) and tolerability in these GT1 patients.
AbbVie Phase III Clinical Program Results
Study
|
Patients
|
Treatment Regimen
|
SVR12
|
PEARL-II
(12 weeks)
|
GT1b treatment-experienced
(N=179)
|
AbbVie regimen + RBV (n=88)
|
97%
(85/88)
|
AbbVie regimen only (n=91)
|
100%
(91/91)
| ||
PEARL-III
(12 weeks)
|
GT1b treatment-naive
(N=419)
|
AbbVie regimen + RBV (n=210)
|
99%
(209/210)
|
AbbVie regimen only (n=209)
|
99%
(207/209)
| ||
PEARL-IV
(12 weeks)
|
GT1a treatment-naive
(N=305)
|
AbbVie regimen + RBV (n=100)
|
97%
(97/100)
|
AbbVie regimen only (n=205)
|
90%
(185/205)
| ||
TURQUOISE-II
(12 & 24 weeks)
|
GT1 treatment-naive
and treatment-experienced with compensated cirrhosis
(N=380)
|
AbbVie regimen + RBV, 12 weeks (n=208)
|
92%
(191/208)
|
AbbVie regimen + RBV, 24 weeks (n=172)
|
96%
(165/172)
| ||
SAPPHIRE-I
(12 weeks)
|
GT1 treatment-naive
(N=631)
|
AbbVie regimen + RBV (n=473)
|
96%
(455/473)
|
SAPPHIRE-II
(12 weeks)
|
GT1 treatment-experienced
(N=394)
|
AbbVie regimen + RBV (n=297)
|
96%
(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 promising."
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
publications.
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 SVR12, while 97 percent (n=85/88) achieved SVR12 in the ribavirin-containing arm.
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 SVR12, while 97 percent (n=85/88) achieved SVR12 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 SVR12.
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 SVR12.
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 SVR12.
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 SVR12.
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 SVR12. Following 24 weeks of treatment, 96 percent of patients (n=165/172) achieved SVR12.
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 SVR12. Following 24 weeks of treatment, 96 percent of patients (n=165/172) achieved SVR12.
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 arm.
Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.
Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.
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.
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.
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 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.
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, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score ≥ 6.
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
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.
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.
[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 www.clinicaltrials.gov for phase 3a programs of Gilead, BMS and BI as of November 15, 2013.
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