|[April 10, 2014]
Gilead Announces Results from Study of Sovaldi® for Retreatment of Chronic Hepatitis C in Patients Not Cured with Prior Antiviral Therapy
LONDON --(Business Wire)--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from an
open-label clinical trial (Study GS-US-334-0109) evaluating once-daily
Sovaldi® (sofosbuvir) 400 mg tablets for the retreatment of
chronic hepatitis C virus (HCV) infection among patients who failed
prior therapy. These data will be presented in two oral sessions at the
49th Annual Meeting of the European Association for the Study of the
Liver (The International Liver Congress 2014) in London.
In Study GS-US-334-0109 (Oral #55), patients with genotype 1 HCV
infection (n=80) received 12 weeks of treatment with once-daily Sovaldi
plus weight-based ribavirin (RBV) twice-daily (1,000 or 1,200 mg/day)
and pegylated interferon (peg-IFN; 180 µg/week). Patients in the study
had failed prior regimens containing peg-IFN, RBV and an investigational
NS3 protease inhibitor, with or without investigational direct-acting
antivirals (DAAs) (NS5A and/or non-nucleoside NS5B inhibitors).
Forty-five percent of patients (n=36) had received more than one course
of prior therapy, and 90 percent (n=72) had at least one viral mutation
associated with HCV NS3, NS5A or NS5B drug resistance.
Among the 50 patients for whom sustained virologic response data was
available 12 weeks after the end of treatment (SVR12), 74 percent
(n=37/50) achieved SVR12. Additionally, 80 percent (n=28/35) of patients
with baseline resistance against two or more DAAs achieved SVR12.
"This study demonstrates that Sovaldi-based regimens can achieve high
cure rates even among hepatitis C patients who previously failed therapy
with baseline resistance to at least two DAAs," said Stanislas Pol, MD,
PhD, Professor of Hepatology and Gastroenterology, Paris Descartes (News - Alert)
University, Paris, France, and a principal investigator. "Importantly,
Sovaldi has now demonstrated efficacy among genotype 1 HCV infected
patients who failed prior treatment with three or four drug regimens and
have developed viral resistance to some of the components of those
In a separate presentation (Oral #8), retreatment with Sovaldi in
genotype 2 (n=11) or genotype 3 (n=96) HCV infected patients who
previously failed treatment with 12 or 16 weeks of Sovaldi plus RBV in
the Phase 3 studies FISSION, FUSION and POSITRON was evaluated.
Thirty-six percent of these patients (39/107) had cirrhosis. Patients
were retreated either with a 12-week regimen of Sovaldi, RBV and
peg-IFN, or a 24-week, interferon-free regimen of Sovaldi plus RBV. The
choice of regimen was determined by study investigators.
Among patients with available SVR12 data, 63 percent (n=25/40) of those
who received the 24-week all-oral regimen and 92 percent (n=24/26) of
those who received the 12-week regimen of Sovaldi, RBV, and peg-IFN
"These data support initial findings from the Phase 3 trials, which
demonstrate that Sovaldi is an effective treatment option and one that
may also be particularly important for genotype 2 and 3 patients who
failed a previous sofosbuvir-based regimen," said Rafael Esteban, MD,
Head of the Internal Medicine and Liver Unit, Hospital Universitari Vall
d'Hebron and Professor of Medicine, Universitat Autónoma de Barcelona,
Barcelona, Spain and a principal investigator for the study
Sovaldi was well tolerated in Study GS-US-334-0109. The most common
adverse events were consistent with the safety profiles of peg-IFN
and/or RBV. Additional information about the study can be found at www.clinicaltrials.gov.
Sovaldi is an oral nucleotide analog inhibitor of the HCV NS5B
polymerase enzyme, which plays an essential role in HCV replication.
Sovaldi is a direct-acting agent, meaning that it interferes directly
with the HCV life cycle by suppressing viral replication.
Sovaldi was approved in the United States on December 8, 2013
and in the European Union on January 17. In the United States, Sovaldi
is approved for the treatment of chronic hepatitis C infection as a
component of a combination antiviral treatment regimen. Efficacy has
been established in subjects with HCV genotype 1, 2, 3 or 4 infection,
including those with hepatocellular carcinoma meeting Milan criteria
(awaiting liver transplantation) and those with HCV/HIV-1 co-infection.
Treatment response varies based on baseline host and viral factors.
Monotherapy is not recommended for treatment of chronic hepatitis C.
Study GS-US-334-0109 evaluated investigational uses of Sovaldi, for
which safety and efficacy have not yet been established.
IMPORTANT SAFETY INFORMATION
Sovaldi combination treatment with ribavirin or with peginterferon alfa
plus ribavirin is contraindicated in women who are pregnant or may
become pregnant and men whose female partners are pregnant because of
the risk for birth defects and fetal death associated with ribavirin.
Contraindications to peginterferon alfa and ribavirin also apply to
Sovaldi combination treatment. Refer to the prescribing information of
peginterferon alfa and ribavirin for a list of their contraindications.
Warnings and Precautions
Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin:
Ribavirin therapy should not be started unless a report of a negative
pregnancy test has been obtained immediately prior to initiation of
therapy. Female patients of childbearing potential and their male
partners must use two forms of non-hormonal contraception during
treatment and for at least 6 months after treatment has concluded.
Routine monthly pregnancy tests must be performed during this time.
Refer to the prescribing information for ribavirin.
Use with Potent P-gp Inducers: Rifampin and St. John's wort
should not be used with Sovaldi as they may significantly decrease
sofosbuvir plasma concentration, reducing its therapeutic effect.
Most common (=20 percent, all grades) adverse reactions for:
Sovaldi + peginterferon alfa + ribavirin combination therapy were
fatigue, headache, nausea, insomnia, and anemia
Sovaldi + ribavirin combination therapy were fatigue, and headache
In addition to rifampin and St. John's wort, coadministration of Sovaldi
is not recommended with carbamazepine, oxcarbazepine, phenobarbital,
phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such
coadministration is expected to decrease the concentration of
sofosbuvir, reducing its therapeutic effect.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company's mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility of unfavorable longer-term results from clinical trials
evaluating Sovaldi for the treatment or retreatment of HCV, and the risk
that healthcare providers, payers or insurers may not recognize the
benefits of Sovaldi. As Sovaldi is used over longer periods of time by
treatment-experienced patients with underlying health problems taking
numerous other medicines, Gilead may find new issues such as safety,
resistance or drug interaction issues, which may require it to provide
additional warnings or contraindications in the label, which could
reduce the market acceptance of Sovaldi. These risks, uncertainties and
other factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is cautioned
not to rely on these forward-looking statements. These and other risks
are described in detail in Gilead's Annual Report on Form 10-K for the
year ended December 31, 2013, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
U.S. full prescribing information for Sovaldi is available at www.gilead.com.
Sovaldi is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company's
website at www.gilead.com,
follow Gilead on Twitter (News - Alert) (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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