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-- High Cure Rates in Nearly 800 HCV Patients with Advanced Liver
BOSTON--(BUSINESS WIRE)--Nov. 11, 2014--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from
several Phase 2 and Phase 3 studies evaluating investigational uses of
Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) for the
treatment of chronic hepatitis C virus (HCV) infection in patients with
limited or no treatment options, including patients with decompensated
cirrhosis, patients with HCV recurrence following a liver transplant and
patients who failed previous treatment with other direct acting
antivirals. These data will be presented this week at the 65th
Annual Meeting of the American Association for the Study of Liver
Diseases (The Liver Meeting 2014) in Boston.
“Chronic hepatitis C patients with advanced liver disease are among the
most difficult to cure and traditionally have had limited or no
treatment options,” said Norbert Bischofberger, PhD, Executive Vice
President of Research and Development and Chief Scientific Officer,
Gilead Sciences. “The data presented this week demonstrate that Harvoni
provides high cure rates for patients with advanced liver disease, as
well as for those who failed prior treatment with other antivirals,
including sofosbuvir-based regimens.”
Harvoni was approved by the U.S. Food and Drug Administration and Health
Canada in October 2014 and is the first once-daily single tablet regimen
for the treatment of chronic HCV genotype 1 infection in adults.
Applications are pending in the European Union, Japan and New Zealand.
Advanced Liver Disease
In a pooled analysis of Phase 2 and Phase 3 open-label studies (Oral
#82) in more than 500 genotype 1 HCV infected patients with compensated
cirrhosis who received Harvoni alone or with ribavirin (RBV) for 12 or
24 weeks, 96 percent of patients achieved sustained virologic response
(SVR12). Patients who achieve SVR12 are considered cured of HCV
Two prospective analyses from a Phase 2 open-label study (Study
GS-US-337-0123) evaluating patients with decompensated cirrhosis and
those with HCV recurrence following liver transplantation also are being
presented. In the first subgroup (Oral #239), 108 genotype 1 and 4
infected patients with decompensated cirrhosis, including those with
moderate hepatic impairment (Child-Pugh-Turcotte (CPT) Class B) and
severe hepatic impairment (CPT Class C), received Harvoni plus RBV for
12 or 24 weeks. Overall, SVR12 rates were 87 percent (n=45/52) in the
12-week arm and 89 percent (n=42/47) in the 24-week arm.
The second subgroup (Oral #8) evaluated 12 or 24 weeks of Harvoni plus
RBV among 223 genotype 1 and 4 patients who developed HCV recurrence
following liver transplantation. Among non-cirrhotic patients, SVR12
rates were 96 percent (n=53/55) and 98 percent (n=55/56) following 12
and 24 weeks of treatment, respectively. For patients with compensated
cirrhosis, SVR12 rates were 96 percent for both 12 weeks (n=25/26) and
24 weeks (n=24/25) of therapy. SVR12 rates among patients with
decompensated cirrhosis were 81 percent for both 12 weeks (n=25/31) and
24 weeks (n=17/21) of therapy.
Retreatment of Patients Who Failed Prior Therapy
Study GS-US-337-0121 (Late Breaker Oral #LB-6) evaluated 155 genotype 1
patients with compensated cirrhosis who had failed prior treatment with
pegylated interferon (PegIFN)/RBV and subsequently PegIFN/RBV plus a
protease inhibitor. In this study, patients were randomized (1:1) to
receive Harvoni plus RBV for 12 weeks or Harvoni alone for 24 weeks.
Ninety-six percent (n=74/77) of those receiving Harvoni plus RBV for 12
weeks and 97 percent (n=75/77) of those receiving Harvoni for 24 weeks
In a second study (Oral #235), 51 genotype 1 patients who previously
failed SOF/PegIFN/RBV, SOF/RBV or a SOF placebo/PegIFN/RBV treatment
regimen received Harvoni plus RBV for 12 weeks. Twenty-nine percent of
study patients (n=15/51) had cirrhosis. Ninety-eight percent (n=50/51)
achieved SVR12 following 12 weeks of treatment with Harvoni plus RBV.
In all of these studies, Harvoni was well tolerated and its safety
profile was generally consistent with that observed in clinical trials
of Harvoni. Adverse events included fatigue, headache, nausea and
anemia, which was more common among patients taking RBV. Grade 3/4
laboratory abnormalities were infrequent and included decreases in
hemoglobin, which is consistent with RBV-associated anemia.
The safety and efficacy of Harvoni have not been established for the
investigational uses described above.
Additional information about these studies can be found at www.clinicaltrials.gov.
Important Safety Information About Harvoni
Warnings and Precautions
Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers:
Rifampin and St. John’s wort are not recommended for use with Harvoni as
they may significantly decrease ledipasvir and sofosbuvir plasma
Related Products Not Recommended: Harvoni is not recommended for
use with other products containing sofosbuvir (Sovaldi).
Most common (≥10 percent, all grades) adverse reactions were fatigue and
In addition to rifampin and St. John’s wort, coadministration of Harvoni
is also not recommended with carbamazepine, oxcarbazepine,
phenobarbital, phenytoin, rifabutin, rifapentine, and
tipranavir/ritonavir. Such coadministration is expected to decrease the
concentration of ledipasvir and sofosbuvir, reducing the therapeutic
effect of Harvoni.
Coadministration of Harvoni is not recommended with simeprevir due to
increased concentrations of ledipasvir and simeprevir. Coadministration
is also not recommended with rosuvastatin or co-formulated
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due
to increased concentrations of rosuvastatin and tenofovir, respectively.
Consult the full Prescribing Information for Harvoni for more
information on potentially significant drug interactions, including
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 these studies and
other ongoing and subsequent clinical trials involving Harvoni, alone or
in combination with other products, for the treatment of HCV in other
patient populations. As Harvoni is used over longer periods of time,
Gilead may find new issues such as safety or drug resistance, which may
require it to provide additional warnings or contraindications in the
label, which could reduce the market acceptance of Harvoni. 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 Quarterly
Report on Form 10-Q for the quarter ended September 30, 2014, 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
U.S. Full Prescribing Information for Harvoni is available at www.gilead.com.
Harvoni 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 (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936 (Investors)Cara
Miller, 650-522-1616 (Media)