Filing Supported by Data from the Phase 3 OPTIMIST-1 and -2
Clinical Trials Evaluating OLYSIO® Combination Therapy in Hepatitis C
Patients with and without Cirrhosis
TITUSVILLE, N.J., July 23, 2015
/PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP
(Janssen), today announced the submission of a supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration (FDA) to
update the label for once-daily, all-oral OLYSIO® (simeprevir). OLYSIO®
is a hepatitis C virus (HCV) NS3/4A protease inhibitor, currently
approved for use with sofosbuvir for adults with genotype 1 chronic
hepatitis C (CHC) infection as a 12-week treatment for patients without
cirrhosis or a 24-week treatment regimen for patients with cirrhosis.
Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor marketed by
Gilead Sciences, Inc.
OLYSIO® was approved in November 2014
in combination with sofosbuvir based on the Phase 2 COSMOS clinical
trial. This sNDA is based on results from the Phase 3 OPTIMIST-1 and
OPTIMIST-2 trials, which evaluated 12 and eight weeks of therapy for
treatment-naive and treatment-experienced genotype 1 CHC adult patients
without cirrhosis, and 12 weeks of therapy for treatment-naive and
treatment-experienced genotype 1 CHC adult patients with cirrhosis.
contributed significantly to the care of people living with hepatitis
C. The availability of multiple treatment options is important to help
offer an opportunity for cure, and we believe OLYSIO® will continue to play a meaningful role going forward," said Richard Nettles,
M.D., vice president, Medical Affairs, Janssen Therapeutics. "We're
pleased to submit the data from the Phase 3 OPTIMIST trials, which adds
to the body of clinical information about this combination in patients
with and without cirrhosis."
Results from the OPTIMIST trials were presented in April 2015 at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) in Vienna.
About the OPTIMIST TrialsOPTIMIST-1 is
a Phase 3, randomized, open-label trial to investigate the efficacy and
safety of the all-oral regimen of simeprevir and sofosbuvir (SMV/SOF)
among treatment-naive and treatment-experienced genotype 1 CHC patients
without cirrhosis. The primary study endpoint is sustained virologic
response (SVR) at 12 weeks after treatment (SVR12) with 12 and eight
weeks of treatment with SMV/SOF versus a historical control (patients
previously treated with approved regimens containing a direct-acting
antiviral, pegylated interferon and ribavirin).
- Ninety-seven (97) percent of patients treated with SMV/SOF for 12
weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate
of 87 percent among the historical control.
- SVR12 rates of 100 percent were seen among patients with IL28B CC
genotype (n=43/43) and those with baseline NS5A and NS3 Q80K
- Patients treated with eight weeks of SMV/SOF achieved an SVR12 rate
of 83 percent (n=128/155), which was not superior to the SVR12 rate of
83 percent in the historical control.
- High SVR12 rates were seen among patients with baseline HCV RNA <
4 million IU/mL (96 percent; n=46/48), IL28B CC genotype (93 percent;
n=38/41), patients with genotype 1b CHC (92 percent; n=36/39) and
patients without baseline NS5A and Q80K polymorphisms (89 percent;
- The most frequently reported adverse events in the 12- and
eight-week treatment arms were headache (14 and 17 percent,
respectively), fatigue (12 and 15 percent, respectively) and nausea (15
and 9 percent, respectively).
is a Phase 3, open-label, single-arm trial to investigate the efficacy
and safety of SMV/SOF in treatment-naive and treatment-experienced
genotype 1 CHC patients with cirrhosis. The primary endpoint is SVR12
with SMV/SOF versus a historical control.
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- Twelve (12) weeks of treatment with SMV/SOF resulted in SVR12 rates
of 84 percent (n=86/103), which was superior to the SVR12 rate of 70
percent in the historical control.
- Higher SVR12 rates were seen in patients with baseline NS5A
polymorphisms with or without NS3 Q80K polymorphisms (100 percent;
n=13/13), patients with albumin ≥4 g/dL (94 percent; n=47/50) and
treatment-naïve patients (88 percent; n=44/50).
- The most common adverse events were fatigue (20 percent), headache (20 percent) and nausea (11 percent).
Labels: New Drug Application (NDA), Simeprevir + sofosbuvir, Sovaldi + Olysio