BARCELONA, Spain, April 14, 2016 /PRNewswire/ -- AbbVie (NYSE:
ABBV), a global biopharmaceutical company, today announced data
showing that patients with genotype 1 (GT1) chronic hepatitis C
virus (HCV) infection who received the recommended regimen of
VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA®
(dasabuvir tablets), with or without ribavirin (RBV), achieved high
sustained virologic response rates at 48 weeks post-treatment
(SVR48), regardless of the presence of baseline
resistance-associated variants (RAVs).1 These
late-breaking data from a post-hoc analysis of five completed Phase
3 clinical trials will be presented today at The International
Liver Congress™ (ILC) 2016 in Barcelona,
Spain.
The study found that no matter whether certain RAVs, called
NS5A, were present, 100 percent (n=148/148) of patients with
genotype 1b (GT1b) chronic HCV infection, who received VIEKIRAX +
EXVIERA without RBV for 12 weeks, achieved
SVR48.1 Results also showed 97 percent of
patients with genotype 1a (GT1a) chronic HCV infection with or
without baseline NS5A RAVs (n=57/59 and
n=351/361 respectively) achieved SVR48 when
receiving the recommended regimen of VIEKIRAX + EXVIERA with
RBV.1 These findings included both patients new to
therapy and pegylated interferon/ribavirin (pegIFN/RBV)
treatment-experienced, as well as those with compensated
cirrhosis.1
"These results show that high virologic cure rates were achieved
in HCV genotype 1a and 1b infected patients no matter their NS5A
RAV status when treated with VIEKIRAX plus EXVIERA with and without
ribavirin as recommended, a regimen which contains the NS5A
inhibitor ombitasvir," said Christoph
Sarrazin, M.D., professor of medicine at J.W. Goethe University Hospital in Frankfurt, Germany.
As the hepatitis C virus replicates, variants of the viral NS5A
protein are produced.2 The impact of these variants on
treatment response, including the possibility of becoming resistant
to therapy or achieving SVR, has yet to be fully
determined.3
"It's important that we understand emerging issues in treating
people with chronic HCV, including RAVs, so that we can meet the
needs of patients and physicians," said Rob
Scott, M.D., vice president, development and chief medical
officer, AbbVie. "As we learn more about the role of resistance to
direct-acting antiviral regimens, it is vital to further
investigate treatment options that are not affected by baseline
RAVs."
To understand more about the impact of variants on treatment
response, next-generation sequencing was used to assess baseline
samples for variants in NS5A, which were detected in 11 percent of
GT1a patients and 19 percent of GT1b patients, with a detection
threshold of 15 percent, consistent with the limits of detection
for variants by population sequencing.1 The post-hoc
analysis was performed on data from five completed Phase 3
studies:1 PEARL-IV (GT1a treatment-naïve, n=90),
SAPPHIRE-II (GT1a pegIFN/RBV treatment-experienced, n=214),
TURQUOISE-II (GT1a compensated cirrhosis – 24 week treatment arm,
n=118), PEARL-II (GT1b pegIFN/RBV treatment-experienced, n=89) and
TURQUOISE-III (GT1b compensated cirrhosis, n=59). Patients who did
not achieve SVR for reasons other than virologic failure (such as
early treatment discontinuations or SVR12 data
unavailable) were excluded from the analysis.
About VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is
approved in the European Union for the treatment of genotype 1
(GT1) chronic hepatitis C virus (HCV) infection, including patients
with compensated cirrhosis. VIEKIRAX is approved in the European
Union for the treatment of genotype 4 (GT4) chronic HCV
infection.
VIEKIRAX tablets consist of the fixed-dose combination of
paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg
with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA
tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase
inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or
without ribavirin (RBV), dosed twice daily based on patient type.
VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV,
except in genotype 1a and GT4 patients with compensated cirrhosis,
who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration
between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for
hepatitis C protease inhibitors and regimens that include protease
inhibitors. Paritaprevir has been developed by AbbVie for use in
combination with AbbVie's other investigational medicines for the
treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development
program can be found on www.clinicaltrials.gov.
EU Indication
VIEKIRAX is indicated in combination
with other medicinal products for the treatment of chronic
hepatitis C (CHC) in adults. EXVIERA is indicated in combination
with other medicinal products for the treatment of CHC in
adults.
Important EU Safety Information
Contraindications:
VIEKIRAX + EXVIERA are
contraindicated in patients with severe hepatic impairment
(Child-Pugh C). Patients taking ethinyl estradiol-containing
medicinal products must discontinue them and switch to an
alternative method of contraception prior to initiating VIEKIRAX +
EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive
CYP3A substrates or strong inhibitors of CYP3A. Do not give
VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do
not give EXVIERA with certain drugs that are strong inhibitors of
CYP2C8.
Special warnings and precautions for use:
VIEKIRAX and
EXVIERA are not recommended as monotherapy and should be used in
combination with other medicinal products for the treatment of
hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in
Patients with Cirrhosis
VIEKIRAX and EXVIERA are not
recommended in patients with moderate hepatic impairment
(Child-Pugh B). Patients with cirrhosis should be monitored for
signs and symptoms of hepatic decompensation, including hepatic
laboratory testing at baseline and during treatment.
ALT elevations
Transient elevations of ALT to >5x
ULN without concomitant elevations of bilirubin occurred in
clinical trials with VIEKIRAX + EXVIERA and were more frequent in a
subgroup who were using ethinyl estradiol-containing
contraceptives.
Pregnancy and concomitant use with ribavirin
Extreme
caution must be taken to avoid pregnancy in female patients and
female partners of male patients when VIEKIRAX with or without
EXVIERA is taken in combination with ribavirin, see section 4.6 and
refer to the Summary of Product Characteristics for ribavirin for
additional information.
Use with concomitant medicinal products
Use caution
when administering VIEKIRAX with fluticasone or other
glucocorticoids that are metabolized by CYP3A4. A reduction in
colchicine dosage or interruption in colchicine is recommended in
patients with normal renal or hepatic function. VIEKIRAX with or
without EXVIERA is expected to increase exposure of statins so
certain statins need to be discontinued or dosages reduced. Low
dose ritonavir, which is part of VIEKIRAX, may select for PI
resistance in HIV co-infected patients without ongoing
antiretroviral therapy. HIV co-infected patients without
suppressive antiretroviral therapy should not be treated with
VIEKIRAX.
Adverse Reactions
Most common (>20 percent) adverse
reactions for VIEKIRAX + EXVIERA with RBV were fatigue and
nausea.
Full summary of product characteristics is available
at www.ema.europa.eu
Globally, prescribing information varies; refer to the
individual country product label for
complete 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. 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 Sarrazin C, et al. Effect of Baseline
Resistance-Associated Variants on SVR With the 3D Regimen Plus RBV.
Late Breaker Poster #LBP503; presented at the International Liver
CongressTM (ILC), the Annual Meeting of the European
Association for the Study of the Liver (EASL) in Barcelona, April
13-17, 2016.
2 Schneider MD, et al. Antiviral therapy of hepatitis C
in 2014: Do we need resistance testing? Antiviral Res. 2014
May;105:64-71.
3 American Association for the Study of Liver Diseases.
Monitoring patients who are starting hepatitis C treatment, are on
treatment, or have completed therapy, February 24,
2016, http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have.
Accessed March 15, 2016.
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SOURCE AbbVie