- Presentations Include First Results For Lead Hepatitis C
Candidate GS-7977 In Treatment-Naïve Genotype 1 Patients -
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that 30 abstracts
examining the company's products and investigational agents for
hepatitis B and C have been selected for presentation at the 47th
Annual Meeting of the European Association for the Study of the Liver
(International Liver Congress 2012) taking place April 18-22 in
Barcelona, Spain. The abstracts describe clinical and preclinical data
for a number of investigational chronic hepatitis C compounds, as well
as new long-term data for Viread® (tenofovir disoproxil
fumarate) for chronic hepatitis B.
Presentations will include data from several studies examining Gilead's
late-stage nucleotide analog polymerase inhibitor, GS-7977, in
treatment-naïve genotype 1 hepatitis C patients. Genotype 1 is the most
prevalent strain of the hepatitis C virus (HCV), and also the hardest to
treat with existing therapies. Data from ELECTRON (Poster #1113) and
ATOMIC (Oral Abstract #1) will be presented and both studies have been
selected for inclusion in official EASL Press Office activities.
In addition to GS-7977, Gilead is advancing multiple oral compounds with
different mechanisms of action with the goal of creating an efficacious,
well tolerated and convenient all-oral treatment regimen for chronic
HCV. Notably, data will be presented for two of these compounds, GS-5885
(an NS5A inhibitor) and GS-9669 (a non-nucleoside polymerase inhibitor):
Interim efficacy and safety results for a Phase 2 study (Study 120)
examining 12 weeks of treatment with GS-5885, GS-9451, tegobuvir
(GS-9190) and ribavirin. Based on the results of this trial and other
studies involving more than 800 patients treated with GS-5885 for at
least 12 weeks, Gilead has selected a 90 mg dose of GS-5885 for
further clinical development (Latebreaker Poster #1421).
Results of a three-day, Phase 1, ascending-dose study, which
demonstrate the potent antiviral activity of GS-9669, a non-nucleoside
polymerase inhibitor, when administered once-daily (Poster #1189).
Seven abstracts at the International Liver Congress will highlight the
safety and efficacy profile of Viread, the most-prescribed treatment
for chronic hepatitis B in the United States and major countries
of Europe. Notably, new data further characterize Viread's
well-established renal safety profile:
The VIREAL prospective cohort study reports on 115 chronic hepatitis B
patients with reduced renal function at baseline, the majority of whom
either remained stable or improved after 48 weeks of treatment with
Viread (Poster #531).
Abstracts for Gilead's presentations can currently be accessed on the
EASL website, with the exception of the ELECTRON and ATOMIC studies,
which are embargoed until Thursday, April 19, 2012 due to their
inclusion in the press program of the International Liver Congress.
Gilead will issue press releases describing the data from these studies.
Further information about these studies can also be found at www.clinicaltrials.gov.
GS-7977, GS-5885, GS-9669, GS-9451 and tegobuvir (GS-9190) are
investigational products and their safety and efficacy have not yet been
Important Information About Viread for Chronic
Viread (tenofovir disoproxil fumarate) is indicated for the treatment of
chronic hepatitis B in adults. The following points should be considered
when initiating therapy with Viread for the treatment of HBV infection:
This indication is based primarily on data from the treatment of
nucleoside-treatment-naïve patients, and a smaller number of patients
who had previously received lamivudine or adefovir. Patients were adults
with HBeAg-positive and HBeAg-negative chronic hepatitis B with
compensated liver disease. Viread was evaluated in a limited number of
subjects with chronic hepatitis B and decompensated liver disease. The
number of patients in clinical trials who had lamivudine- or
adefovir-associated substitutions at baseline was too small to reach
conclusions of efficacy.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal
cases, have been reported with the use of nucleos(t)ide analogs,
including Viread, in combination with other antiretrovirals.
Severe acute exacerbations of hepatitis have been reported in
HBV-infected patients who have discontinued anti-hepatitis B therapy,
including Viread. Hepatic function should be monitored closely with both
clinical and laboratory follow-up for at least several months in
patients who discontinue anti-hepatitis B therapy, including Viread. If
appropriate, resumption of anti-hepatitis B therapy may be warranted.
New onset or worsening of renal impairment including cases of acute
renal failure and Fanconi syndrome has been reported with the use of
Viread. It is recommended to assess creatinine clearance (CrCl) before
initiating treatment with Viread and monitor CrCl and serum phosphorus
in patients at risk, including those who have previously experienced
renal events while receiving Hepsera®. Administering Viread
with concurrent or recent use of nephrotoxic drugs should be avoided.
Viread should not be used with other tenofovir-containing products
(e.g., Atripla®, Complera®, Truvada®).
Viread should not be administered in combination with Hepsera.
Due to the risk of development of HIV-1 resistance, Viread should only
be used as part of an appropriate antiretroviral combination regimen in
HIV-infected patients with or without HBV coinfection. HIV antibody
testing should be offered to all HBV-infected patients before initiating
therapy with Viread.
Decreases in bone mineral density (BMD) have been observed in
HIV-infected patients. It is recommended that BMD monitoring be
considered for patients with a history of pathologic fracture or who are
at risk for osteopenia. The bone effects of Viread have not been studied
in patients with chronic HBV infection. Cases of osteomalacia
(associated with proximal renal tubulopathy and which may contribute to
fractures) have been reported in association with the use of Viread.
In controlled clinical trials in patients with chronic hepatitis B with
compensated liver disease, the most common adverse reaction (all grades)
was nausea, observed in 9 percent of patients taking Viread at week 48.
Other adverse reactions observed at week 48 in greater than 5 percent of
patients treated with Viread include abdominal pain, diarrhea, headache,
dizziness, fatigue, nasopharyngitis, back pain and skin rash.
In HBV-infected patients with decompensated liver disease, the most
common adverse reactions (all grades) reported in greater-than or equal
to 10 percent of patients treated with Viread were abdominal pain (22
percent), nausea (20 percent), insomnia (18 percent), pruritus (16
percent), vomiting (13 percent), dizziness (13 percent), and pyrexia (11
Coadministration of Viread with didanosine increases didanosine
concentrations. Use with caution and monitor for evidence of didanosine
toxicity (e.g., pancreatitis, neuropathy). Didanosine should be
discontinued in patients who develop didanosine-associated adverse
reactions. In adults weighing >60 kg, the didanosine dose should be
reduced to 250 mg when it is coadministered with Viread. Data are not
available to recommend a dose adjustment of didanosine for patients
weighing <60 kg. Coadministration of Viread with atazanavir decreases
atazanavir concentrations and increases tenofovir concentrations. Use
atazanavir with Viread only with additional ritonavir; monitor for
evidence of tenofovir toxicity. Coadministration of Viread with
lopinavir/ritonavir increases tenofovir concentrations. Monitor for
evidence of tenofovir toxicity.
The recommended dose for the treatment of chronic hepatitis B is 300 mg
once daily taken orally without regard to food. The dosing interval of
Viread should be adjusted and renal function closely monitored in
patients with moderate and severe renal impairment.
The parent compound of Viread was discovered through a collaborative
research effort between Dr. Antonin Holy, Institute for Organic
Chemistry and Biochemistry, Academy of Sciences of the Czech Republic
(IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical
Research, Katholic University in Leuven, Belgium.
Please see full Prescribing Information for Viread, Atripla,
Complera, Truvada and Hepsera (including BOXED WARNINGS).
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 America, Europe and Asia
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 subsequent results in studies examining
GS-7977, GS-5885, GS-9669, GS-9451 and tegobuvir (GS-9190). As a result,
these compounds may never be successfully commercialized. In addition,
Gilead may make a strategic decision to discontinue development of these
compounds if, for example, Gilead believes commercialization will be
difficult relative to other opportunities in its pipeline. Further,
Gilead may be unable to develop an all-oral antiviral regimen for HCV
genotype 1 patients or a pangenotypic regimen for all HCV patients.
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, 2011, 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
U.S. full prescribing information for Viread is available at www.Viread.com.
full prescribing information for Atripla is available at www.Atripla.com.
full prescribing information for Complera is available at www.Complera.com.
full prescribing information for Truvada is available at www.Truvada.com.
full prescribing information for Hepsera is available at www.Hepsera.com.
Viread, Complera, Truvada and Hepsera are registered trademarks of
Gilead Sciences, Inc.
Atripla is a registered trademark of
Bristol-Myers Squibb & Gilead Sciences, LLC.
For more information on Gilead Sciences, please visit the company's
website at www.gilead.com
or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Susan Hubbard, 650-868-5215 (Investors)
O?Brien, 650-522-1936 (Investors)
Miller, 650-576-7849 (Media)