BARCELONA, April 15, 2016 /PRNewswire/ -- AbbVie (NYSE:
ABBV), a global biopharmaceutical company, today announced that 91
percent (n=20/22) of genotype 1 (GT1) chronic hepatitis C virus
(HCV) infected patients who failed previous therapy with
direct-acting antivirals (DAAs) achieved SVR12 with 12
weeks of ABT-493 and ABT-530 with ribavirin (RBV) in the primary
intent-to-treat analysis. Additionally, 86 percent (n=19/22) of GT1
patients who received ABT-493 and ABT-530 without RBV, achieved
SVR12.1 SVR12 was achieved in 95
percent of patients with and without RBV (n=20/21, n=19/20;
respectively) in a modified intent-to-treat analysis, excluding
patients who did not achieve SVR for reasons other than virologic
failure.
The results were evaluated in the ongoing MAGELLAN-1 study of
AbbVie's once-daily, investigational, pan-genotypic regimen of
co-formulated ABT-493 (300mg) and ABT-530 (120mg) for the
retreatment of non-cirrhotic patients with GT1 chronic HCV who have
failed previous therapy with DAAs. These data will be presented
today at The International Liver Congress™ (ILC) 2016 in
Barcelona, Spain.
"Retreatment options for those patients who have previously
failed therapy are limited, and present a particular challenge for
treating physicians," said Fred Poordad, M.D., vice president of
academic and clinical affairs at The Texas Liver Institute in
San Antonio. "The high SVR rates
seen in the ongoing MAGELLAN-1 study are significant as they show
promise in addressing this particular clinical challenge."
No patients discontinued treatment due to adverse events, and
two patients experienced virologic failure, one from each
arm.1 The most common adverse events (≥10 percent of
patients overall; n=44) were headache (30 percent), fatigue (27
percent) and nausea (20 percent).1
"While high virologic cure rates have been demonstrated in
clinical studies with current DAA regimens, we recognize that not
all patients achieve a cure," said Rob
Scott, M.D., vice president, development and chief medical
officer, AbbVie. "Through our ongoing clinical development program,
we are striving to give HCV patients a potential option for
retreatment."
About MAGELLAN-11
MAGELLAN-1 is an ongoing Phase 2, randomized, open-label
multicenter study to evaluate the efficacy, safety and
pharmacokinetics of ABT-493 and ABT-530, with and without RBV, in
adults with GT1 and genotypes 4-6 chronic HCV infection who failed
a prior DAA-containing therapy.
In Part 1 of the study, 50 GT1 patients without cirrhosis who
previously failed therapy containing a protease inhibitor and/or
NS5A inhibitor, with or without a NS5B polymerase inhibitor, were
randomized to receive once-daily ABT-493 and ABT-530 at doses of
200/80mg (Arm A), 300/120mg with 800mg RBV (Arm B), or 300/120mg
without RBV (Arm C), for 12 weeks. The primary efficacy endpoint
was SVR12. Patients who failed previous treatment for
reasons other than breakthrough or relapse were excluded. Deep
sequencing (Illumina MiSeq) revealed pre-existing
resistance-associated variants (RAVs) in 41 patients (82 percent),
15 in NS3, 10 in NS5A, and 16 with RAVs in both targets. Data
presented at ILC 2016 were based on an analysis of the
intent-to-treat population.
Data from the first six patients enrolled in Arm A (once-daily
ABT-493 and ABT-530 at doses of 200/80mg) showed 100 percent
achieved SVR12. Additional patients were enrolled and
received study drug at the higher doses of the combination, which
will be used in Phase 3 clinical trials, 300/120mg ABT-493/ABT-530
with and without 800mg RBV. There were no grade 3 or 4 laboratory
abnormalities.
Part 2 of the study is underway to examine once-daily ABT-493
(300mg) and ABT-530 (120mg) without RBV in a larger group of DAA
treatment-experienced patients, including those with compensated
cirrhosis and in genotypes 4-6.
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 Efficacy of ABT-493 and
ABT-530 in HCV Genotype 1 Infected Patients Who Have Failed
Direct-Acting Antiviral-Containing Regimens: The MAGELLAN-I Study.
Oral presentation #GS11; 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