BARCELONA, April 16, 2016 /PRNewswire/ -- AbbVie (NYSE:
ABBV), a global biopharmaceutical company, today announced that
with eight weeks of treatment, 97-98 percent of genotype 1-3
(GT1-3) chronic hepatitis C virus (HCV) infected patients without
cirrhosis treated with AbbVie's investigational, once-daily,
ribavirin (RBV)-free, pan-genotypic regimen of ABT-493 and ABT-530
achieved sustained virologic response at 12 weeks post-treatment
(SVR12).1,2 Results for GT1 (n=33/34), GT2
(n=53/54) and treatment-naïve GT3 (n=28/29) patients were based on
an Intent-to-Treat (ITT) analysis.1,2 Additionally, 100
percent (n=34/34) of genotype 4-6 (GT4-6) chronic HCV infected
patients without cirrhosis achieved SVR12 with 12 weeks
of treatment.4 These new data from the Phase 2
SURVEYOR-1 and SURVEYOR-2 studies will be presented at The
International Liver Congress™ (ILC) 2016 in Barcelona, Spain.
"These results move us closer to our ultimate goal of providing
a treatment option for as many hepatitis C patients as possible. We
will continue to examine our investigational, pan-genotypic regimen
through our dedicated clinical trial program, including an
eight-week duration across all genotypes," said Rob Scott, M.D., vice president, development and
chief medical officer, AbbVie.
In separate late-breaking data from the SURVEYOR-2 study, 100
percent of GT3 chronic HCV infected patients with compensated
cirrhosis (Child-Pugh A) new to therapy achieved SVR12
with 12 weeks of treatment both with and without RBV (n=24/24 in
each arm).3 No patients discontinued treatment due to
adverse events.3 Data in GT3 chronic HCV infected
patients with and without cirrhosis were featured in the official
ILC 2016 press program.
"The recent evolution in hepatitis C treatment has resulted in
high cure rates for many patients with specific genotypes, but
there remain distinct areas of unmet need," said Paul Kwo, M.D., professor of medicine at the
Indiana University School of Medicine.
"These new data show us the potential of ABT-493 and ABT-530 in
genotype 3 patients new to therapy even with the added complication
of compensated cirrhosis."
In a pooled analysis of 531 patients across both SURVEYOR
studies, of five treatment regimens of ABT-493 and ABT-530
evaluated, the most commonly reported adverse events were fatigue
(18 percent), headache (17 percent), nausea (13 percent) and
diarrhea (10 percent).5 Three patients across all study
arms evaluated to date, two of whom received RBV, discontinued
study drugs early due to adverse events.5
Overview of
SURVEYOR-1 and SURVEYOR-2 Clinical Data Presented at
ILC:
|
Patient
Profile/Study
|
Patient number
(n)/
Patient
Population
|
Duration of
Treatment
|
Treatment
Regimen
|
SVR12
Rates
ITT*
|
GT1
Non-cirrhotic1
SURVEYOR-1
|
n=34
Treatment-naïve=85%
pegIFN/RBV treatment
experienced=15%
|
8 weeks
|
ABT-493 (300mg) +
ABT-530 (120mg) once daily
|
97%
(n=33/34)
|
GT2
Non-cirrhotic1
SURVEYOR-2
|
n=54
Treatment-naïve=87%
pegIFN/RBV
treatment
experienced=13%
|
8 weeks
|
ABT-493 (300mg) +
ABT-530 (120mg) once daily
|
98%
(n=53/54)
|
GT3
Non-cirrhotic2
SURVEYOR-2
|
n=29
Treatment-naïve
=100%
|
8 weeks
|
ABT-493 (300mg) +
ABT-530 (120mg) once daily
|
97%
(n=28/29)
|
GT3
Cirrhotic3
(Child-Pugh
A)
SURVEYOR-2
|
n=24
Treatment-naïve=
100%
|
12 weeks
|
ABT-493 (300mg) +
ABT-530 (120mg) without RBV
once daily
|
100%
(n=24/24)
|
n=24
Treatment-naïve=100%
|
12 weeks
|
ABT-493 (300mg) +
ABT-530 (120mg) +
RBV
(800mg)
once daily
|
100%
(n=24/24)
|
GT
4,5,6
Non-cirrhotic4
SURVEYOR-1
|
n=34
(GT4=22; GT5=1;
GT6=11)
Treatment-naïve=85%
pegIFN/RBV treatment
experienced=15%
|
12 weeks
|
ABT-493 (300mg) +
ABT-530 (120mg) once daily
|
100%
(n=34/34)
|
*
|
Intent-to-treat (ITT)
population is defined as all patients who received at least one
dose of the study drugs
|
About SURVEYOR-11,4,5
SURVEYOR-1 is an
ongoing Phase 2 two-part study designed to evaluate the safety and
efficacy of ABT-493 and ABT-530, with and without RBV, for eight to
12 weeks, in cirrhotic and non-cirrhotic adult genotype 1 patients,
and non-cirrhotic adult patients with genotypes 4, 5 or 6 chronic
HCV infection who were new to therapy or did not respond to
previous treatment with pegylated interferon (pegIFN)/RBV (null
responder).
About SURVEYOR-21,2,3,5
SURVEYOR-2 is an
ongoing Phase 2, four-part study designed to evaluate the safety
and efficacy of ABT-493 and ABT-530, with or without RBV, in adult
patients with genotypes 2, 3, 4, 5 or 6 chronic HCV infection who
were new to therapy or had failed previous treatment with pegylated
interferon (pegIFN)/RBV.
The primary endpoint of both studies is the percentage of
subjects achieving SVR12.
Safety and efficacy data for Part 1 of the studies were
presented at The Liver Meeting® 2015, the Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD) in
San Francisco.
About pooled safety analysis of SURVEYOR-1 and
SURVEYOR-25
531 patients were included in this safety analysis: 26 percent GT1,
24 percent GT2, 43 percent GT3, and 6 percent with GT4, 5 or 6
infection. Patients across genotypes received ABT-493/ABT-530 at
five doses: 300/120mg (n=258), 300/120mg with RBV (n=27), 200/120mg
(n=121), 200/120mg with RBV (n=56), and 200/40mg (n=69).
About AbbVie's HCV Clinical Development Program
AbbVie's HCV clinical development program is intended to advance
scientific knowledge and the clinical care of people with chronic
HCV infection by investigating pan-genotypic (genotypes 1-6),
all-oral, ribavirin-free, once-daily treatment for 12 weeks. An
eight-week treatment duration with ABT-493 and ABT-530 will be
investigated across all genotypes in our comprehensive Phase
2/Phase 3 clinical trial program, which focuses on areas of ongoing
need in HCV.
AbbVie's investigational regimen includes 300mg ABT-493, an
NS3/4A protease inhibitor, and 120mg ABT-530, an NS5A
inhibitor.
ABT-493 was discovered during the ongoing collaboration between
AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease
inhibitors and regimens that include protease inhibitors.
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.
1 Poordad, F et al. High SVR Rates with the
Combination of ABT-493 + ABT-530 for 8 Weeks in Non-Cirrhotic
Patients with HCV Genotype 1 or 2 Infection. Poster presentation
#SAT-157; presented at The International Liver Congress™ (ILC), the
Annual Meeting of the European Association for the Study of the
Liver (EASL) in Barcelona, Spain,
April 13-17, 2016.
2 Muir, A et al. High SVR Rates with ABT-493 + ABT-530
Co-Administered for 8 Weeks in Non-Cirrhotic Patients with HCV
Genotype 3 Infection. Oral presentation #PS098; presented at The
International Liver Congress™ (ILC), the Annual Meeting of the
European Association for the Study of the Liver (EASL) in
Barcelona, Spain, April 13-17, 2016.
3 Kwo, P et al. 100% SVR12 with ABT-493 And
ABT-530 with or without Ribavirin in Treatment-Naïve HCV Genotype
3-Infected Patients with Cirrhosis; Late Breaker presentation
#LB01; presented at The International Liver Congress™ (ILC), the
Annual Meeting of the European Association for the Study of the
Liver (EASL) in Barcelona, Spain,
April 13-17, 2016
4 Gane, E et al. 100% SVR4 and Favorable
Safety of ABT-493 + ABT-530 Administered for 12 Weeks in
Non-Cirrhotic Patients with Genotypes 4,5, or 6 Infection
(SURVEYOR-I). Poster presentation #SAT-137; presented at The
International Liver Congress™ (ILC), the Annual Meeting of the
European Association for the Study of the Liver (EASL) in
Barcelona, Spain, April 13-17, 2016.
5 Kwo, P et al. Safety of ABT-493 and ABT-530
Co-Administered in Patients with HCV Genotype 1-6 Infection:
Results From the SURVEYOR-I and SURVEYOR-II Studies; Poster
presentation #SAT-239; presented at The International Liver
Congress™ (ILC), the Annual Meeting of the European Association for
the Study of the Liver (EASL) in Barcelona, Spain, April
13-17, 2016.
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SOURCE AbbVie