Gilead Announces Full 48-Week Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chron...
April 15 2016 - 4:30AM
Business Wire
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
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version on businesswire.com: http://www.businesswire.com/news/home/20160415005142/en/
Gilead Sciences, Inc.Patrick O’Brien,
650-522-1936InvestorsorCara Miller, 650-522-1616Media
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