April 15, 2016
Gilead Announces Full 48-Week Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 15, 2016--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed 48-week
results from two large Phase 3 clinical trials (Studies 108 and 110)
evaluating once-daily tenofovir alafenamide (TAF) 25 mg in
treatment-naïve and treatment-experienced adults with HBeAg-negative and
HBeAg-positive chronic hepatitis B virus (HBV) infection. Data were
presented this week during two oral sessions (GS06 and GS12) at The
International Liver Congress™ 2016 in Barcelona, Spain.
Both studies met their primary endpoints of non-inferiority to Gilead’s
Viread® (tenofovir disoproxil fumarate, TDF) 300 mg based on
the percentage of patients with HBV DNA levels below 29 IU/mL at 48
weeks of therapy. In addition, TAF demonstrated improved renal and bone
laboratory safety parameters compared to Viread. Discontinuations due to
adverse events were uncommon in both treatment arms. The most commonly
reported adverse events in both studies included headache, upper
respiratory tract infection, nasopharyngitis and cough, and occurred at
similar rates in patients receiving either TAF or Viread. A summary of
the topline study results was disclosed in a press release dated January
5, 2016.
“Chronic hepatitis B infection is a life-threatening disease that can
lead to liver failure, liver cancer and death,” said Norbert
Bischofberger, PhD, Executive Vice President, Research and Development
and Chief Scientific Officer, Gilead Sciences. “With millions of people
living with the disease, it remains a significant health concern
worldwide. The TAF Phase 3 results presented this week demonstrate its
potential to advance the treatment of HBV – offering a similar efficacy
profile to Viread with improved bone and renal safety parameters.”
About Studies 108 and 110
Studies 108 and 110, led by Maria Buti, MD, PhD, Liver Unit, Hospital
General Universitario Vall d'Hebron, Barcelona, Spain, and Henry L.Y.
Chan, MD, Head, Division of Gastroenterology and Hepatology, The Chinese
University of Hong Kong, respectively, are randomized, double-blind,
96-week clinical trials among 1,298 treatment-naïve and
treatment-experienced patients with chronic HBV infection. In Study 108,
425 HBeAg-negative patients were randomized 2:1 to receive TAF (n=285)
or Viread (n=140). In Study 110, 873 HBeAg-positive patients were
randomized 2:1 to receive TAF (n=581) or Viread (n=292).
The primary efficacy endpoint of both studies is the proportion of
subjects with plasma HBV DNA levels below 29 IU/mL. Key secondary
endpoints include change from baseline in bone mineral density at the
hip and spine at week 48, and change from baseline in serum creatinine
at week 48. Other secondary endpoints include alanine aminotransferases
(ALT, an enzyme that serves as a measure of liver damage) normalization
and change from baseline in eGFR at week 48.
Based on the results of Studies 108 and 110, Gilead submitted a New Drug
Application to the U.S. Food and Drug Administration (FDA) for TAF and
the FDA has set a target review date under the Prescription Drug User
Fee Act (PDUFA) of November 11, 2016. Gilead also has submitted
regulatory applications for TAF in the European Union and Japan.
TAF as a single-agent for chronic HBV is an investigational product and
its safety and efficacy have not been established.
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. 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 the regulatory filings for TAF for chronic HBV may not be
approved by the regulatory authorities in the United States, the
European Union and Japan, and marketing approvals, if granted, may have
significant limitations on their use. As a result, TAF may never be
successfully commercialized. Further, there is a possibility of
unfavorable results from other clinical trials involving TAF regimens
for the treatment of HBV. 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 statement.
U.S. full prescribing information for Viread, including BOXED
WARNING, is available at www.gilead.com.
Viread 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
View source version on businesswire.com: http://www.businesswire.com/news/home/20160415005142/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936
Investors
or
Cara
Miller, 650-522-1616
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