– Studies Highlight Progress with Approved
Therapies and Investigational Pangenotypic Regimens, Including
Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857
–
Gilead Sciences, Inc. (NASDAQ: GILD) today announced results
from several Phase 2 and Phase 3 studies evaluating its two
investigational, pangenotypic, fixed-dose combination therapies for
the treatment of chronic hepatitis C virus (HCV) infection, as well
as new data highlighting the potential use of Harvoni®
(ledipasvir/sofosbuvir) in adolescents aged 12 to 17. Data were
presented this week at The International Liver CongressTM 2016 in
Barcelona, Spain.
“The data presented this week continue to underscore the high
cure rates and safety of our sofosbuvir-based HCV therapies, and
support their utility across all patient HCV genotypes and disease
stages,” said Norbert Bischofberger, PhD, Executive Vice President
of Research and Development and Chief Scientific Officer at Gilead.
“We are pleased to have the opportunity to further characterize the
pangenotypic profiles of our two new investigational fixed-dose
combinations, sofosbuvir/velpatasvir and sofosbuvir/velpatasvir
plus GS-9857, and to highlight results from the first study to
evaluate interferon-free HCV therapy in adolescents.”
Sofosbuvir/Velpatasvir
(SOF/VEL)
Results from the open-label, Phase 3 ASTRAL-5 study (PS104), led
by David L. Wyles, MD, Associate Professor of Medicine, Division of
Infectious Diseases, University of California, San Diego,
California, evaluating once-daily SOF/VEL for 12 weeks among
patients with HCV genotype 1-6 who are co-infected with HIV
demonstrated that SOF/VEL was well-tolerated and resulted in high
SVR12 rates. The SVR12 rate was 95 percent (n=99/104) overall, and
100 percent (n=19/19) and 97 percent (n=28/29) in patients with
cirrhosis and prior treatment-failure, respectively. Two patients
relapsed, while three patients were lost to follow up or withdrew
consent. Two patients achieved SVR4 but have not yet returned for
the post-treatment week 12 visit. The most common adverse events
(>10 percent) were fatigue and headache.
SOF/VEL is currently being evaluated by regulatory agencies in
the United States, Europe and Canada.
Sofosbuvir/Velpatasvir (SOF/VEL) Plus
GS-9857
Data from three Phase 2 trials evaluating SOF/VEL plus GS-9857,
a pangenotypic protease inhibitor, (Studies GS-US-367-1168 and
GS-US-367-1169 and TRILOGY-3) also were selected for
presentation.
Studies 1168 and 1169
Studies 1168 and 1169 evaluated 6 and 8 weeks of SOF/VEL plus
GS-9857, with or without ribavirin (RBV), among treatment-naïve
patients and 12 weeks of SOF/VEL plus GS-9857 among patients who
failed prior treatment including those previously exposed to a
direct acting antiviral (DAA) regimen. Study 1168 evaluated 197
genotype 1 patients and Study 1169 evaluated 128 genotype 2-6
patients.
•
Treatment-naïve patients: Poster
SAT-138 highlighted combined safety and efficacy results from
Studies 1168 and 1169 evaluating SOF/VEL plus GS-9857, with or
without ribavirin, in genotype 1-6, treatment-naïve patients, with
and without cirrhosis. SVR12 rates were:
SOF/VEL plus
GS-9857 SOF/VEL plus GS-9857 with RBV 6 weeks
8 weeks 8 weeks SVR12 79% (n=53/67) 96% (n=95/99) 81% (n=25/31)
The most common adverse events (>10
percent) across the three study arms were headache, nausea,
fatigue, diarrhea and anemia.
•
Treatment-experienced patients: Oral
presentation PS008 highlighted combined safety and efficacy results
from Studies 1168 and 1169 evaluating 12 weeks of SOF/VEL plus
GS-9857 in genotype 1-6, treatment-experienced
patients. Twenty-seven percent of patients were NS5A
inhibitor-experienced, 52 percent were non-NS5A inhibitor,
DAA-experienced and 21 percent failed interferon-based treatment
without a DAA. Overall, the SVR12 rate was 99 percent
(n=127/128). One genotype 3 patient with cirrhosis who had failed
prior treatment with sofosbuvir plus pegylated interferon/ribavirin
relapsed. Frequently reported adverse events (>10 percent) were
headache, fatigue, diarrhea and nausea.
Studies 1168 and 1169 were led by Edward J. Gane, MD, Auckland
City Hospital, Auckland, New Zealand (SAT-138); and Eric Lawitz,
MD, Texas Liver Institute, University of Texas Health Science
Center, San Antonio, Texas (PS008), respectively.
TRILOGY-3
A late-breaker oral presentation (PS021) featuring data from a
Phase 2 trial, led by Dr. Lawitz, evaluated 12 weeks of a
fixed-dose combination of SOF/VEL/GS-9857, with or without RBV,
among genotype 1, DAA-experienced, HCV-infected patients, including
patients with cirrhosis. One hundred percent (n=24/24) of patients
receiving 12 weeks of therapy with SOF/VEL/GS-9857 and 96 percent
(n=24/25) of patients receiving SOF/VEL/GS-9857 plus RBV achieved
SVR12. Among the 49 patients in this trial, 41 percent had prior
exposure to an NS5A inhibitor and 47 percent previously received at
least two classes of DAA. The most common adverse events (>10
percent) across both treatment arms were fatigue and anemia.
Based on these data a fixed-dose combination of SOF/VEL/GS-9857
is being evaluated in four Phase 3 studies (POLARIS-1, POLARIS-2,
POLARIS-3 and POLARIS-4). SOF/VEL/GS-9857 has been granted a
Breakthrough Therapy designation by the U.S. Food and Drug
Administration for the treatment of chronic genotype 1 HCV patients
who have previously failed an NS5A inhibitor-containing
regimen.
Harvoni
Harvoni is the first single tablet HCV regimen approved in the
United States for use in a broad range of patient populations,
including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV
genotype 1 and 4 liver transplant recipients and genotype
1-infected patients with decompensated cirrhosis.
Data from an evaluation of Harvoni in genotype 1 HCV-infected
adolescents aged 12 to 17 have been selected for presentation in a
late breaker oral session (LB-4597). Presented by Sanjay Bansal,
MD, MRCPCH, Kings College Hospital, London, United Kingdom, and led
by Kathleen B. Schwarz, MD, Pediatric Liver Center, Johns Hopkins
University School of Medicine, Baltimore, Maryland, the Phase 2
study demonstrated that Harvoni is well tolerated and results in
high SVR12 in this population. Of the 100 patients enrolled, 97
percent (n=97/100) achieved SVR12. The three patients who did not
achieve SVR12 were lost to follow up; no patients experienced
virologic failure. The most common adverse events were headache,
diarrhea and fatigue. Further evaluation of Harvoni in a pediatric
population of children aged 3 to 11 is ongoing.
Further information about the clinical studies described above
can be found at www.clinicaltrials.gov.
Uses for Harvoni in certain HCV patient populations highlighted
above are investigational and have not been determined to be safe
or efficacious. SOF/VEL and SOF/VEL/GS-9857 are investigational
products and have not been determined to be safe or
efficacious.
Important Safety Information for
Harvoni
Contraindications
If Harvoni is used in combination with ribavirin (RBV), all
contraindications, warnings and precautions, in particular
pregnancy avoidance, and adverse reactions to RBV also apply. Refer
to RBV prescribing information.
Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Coadministered
with Amiodarone: Amiodarone is not recommended for use with
Harvoni due to the risk of symptomatic bradycardia, particularly in
patients also taking beta blockers or with underlying cardiac
comorbidities and/or with advanced liver disease. In patients
without alternative, viable treatment options, cardiac monitoring
is recommended. Patients should seek immediate medical evaluation
if they develop signs or symptoms of bradycardia.
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 concentrations.
Related Products Not Recommended: Harvoni is not
recommended for use with other products containing sofosbuvir
(Sovaldi).
Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue,
headache and asthenia.
Drug Interactions
In addition to rifampin and St. John’s wort, co-administration
of Harvoni is also not recommended with carbamazepine,
oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine,
and tipranavir/ritonavir. Such co-administration is expected to
decrease the concentration of ledipasvir and sofosbuvir, reducing
the therapeutic effect of Harvoni.
Co-administration of Harvoni is not recommended with simeprevir
due to increased concentrations of ledipasvir and simeprevir.
Co-administration 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
clinical comments.
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. Gilead has
operations in more than 30 countries worldwide, with headquarters
in Foster City, California.
Forward-Looking
Statement
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 risk that Gilead may observe unfavorable results from
additional clinical trials involving SOF/VEL, SOF/VEL/GS-9857 and
Harvoni in certain patient populations, including adolescents aged
12 to 18. In addition, the regulatory filings for SOF/VEL and
SOF/VEL/GS-9857 may not be approved by regulatory agencies, and
marketing approvals, if granted, may have significant limitations
on their use. 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, 2015, 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 Harvoni
is available at www.gilead.com.
Harvoni is a registered trademark of Gilead
Sciences, Inc. or its related companies.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160416005005/en/
Gilead Sciences, Inc.InvestorsPatrick O’Brien,
650-522-1936orMediaCara Miller, 650-522-1616
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