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|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 --
“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
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
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
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.
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
Viread is a registered trademark of
For more information on
Gilead Sciences, Inc.
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