January 05, 2016
Gilead Announces Top-Line Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection
-- U.S. and EU Filings Planned for Q1 2016 --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 5, 2016--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that two Phase 3
clinical trials (Studies 108 and 110) evaluating investigational use of
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 met their primary objectives.
The studies demonstrated that TAF was non-inferior to Gilead’s Viread®
(tenofovir disoproxil fumarate, TDF) 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.
“An estimated 350 million people are living with chronic hepatitis B
worldwide, and Viread is an effective treatment option for those
appropriate to receive therapy,” said Norbert Bischofberger, PhD,
Executive Vice President, Research and Development and Chief Scientific
Officer, Gilead Sciences. “We are pleased that the TAF Phase 3 study
results reflect high efficacy and improved renal and bone safety
parameters similar to those seen in clinical studies evaluating
TAF-based regimens for HIV. Like HIV, HBV is a chronic condition that
requires prolonged therapy and we look forward to the opportunity to
offer patients an improved option that has the potential to advance the
long-term treatment of HBV.”
In Study 108, evaluating HBeAg-negative patients, 94.0 percent
(n=268/285) of patients receiving TAF and 92.9 percent (n=130/140; CI
-3.6 percent to +7.2 percent, p=0.47) of patients receiving Viread
achieved HBV DNA below 29 IU/mL at week 48. In Study 110, evaluating
HBeAg-positive patients, 63.9 percent (n=371/581) of TAF patients and
66.8 percent (n=195/292; CI -9.8 percent to +2.6 percent, p=0.25) of
Viread patients achieved HBV DNA below 29 IU/mL at week 48. Two criteria
were used to evaluate normalization of serum ALT levels: a central
laboratory cut-off value and the American Association for the Study of
Liver Diseases (AASLD) criteria. In both studies, treatment with TAF
showed a statistically significant increase in ALT normalization
relative to the Viread arms when using the AASLD criteria. The ALT
normalization was not statistically significant using the central
laboratory cut-off value, which defines normalization at a higher ALT
level. Discontinuations due to adverse events were uncommon in both
treatment arms (0.7 percent (n=2) for TAF vs. 0.7 percent (n=1) for
Viread in Study 108, and 1.0 percent (n=6) for TAF vs. 1.0 percent (n=3)
for Viread in Study 110). 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.
Changes in bone and renal laboratory parameters favored the TAF regimen.
In both studies, patients receiving TAF experienced a significantly
smaller mean percentage decrease from baseline in hip and spine bone
mineral density at week 48 (p<0.001) compared to patients receiving
Viread. Smaller increases in serum creatinine were observed in patients
receiving TAF in Study 110 (p=0.02). Additionally, the median change in
estimated glomerular filtration rate (eGFR) from baseline to week 48
favored TAF in both studies (p<0.01).
Based on the results of Studies 108 and 110, Gilead plans to submit
regulatory applications for TAF for chronic HBV in the United States and
the European Union in the first quarter of 2016. Gilead also plans to
submit data from both studies for presentation to a scientific
conference in 2016.
About Studies 108 and 110
Studies 108 and 110 are randomized, double-blind, 96-week clinical
trials among 1,298 treatment-naïve and treatment-experienced patients
with chronic HBV. 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 the 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 ALT normalization and
change from baseline in eGFR at week 48.
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,
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 be unable to submit regulatory applications for TAF
for chronic HBV treatment in the United States and the European Union in
the currently anticipated timelines. In addition, the regulatory filings
may not be approved by the regulatory authorities, 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 Quarterly
Report on Form 10-Q for the quarter ended September 30, 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
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
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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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Miller, 650-522-1616 (Media)