January 12, 2016
Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B
-- High Rates of Viral Suppression and Improved Renal and Bone Safety Parameters Compared to Viread in Phase 3 Studies --
TAF is a novel, targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improvements in surrogate laboratory markers of renal and bone safety as compared to Viread.
“Chronic hepatitis B is a potentially life-threatening disease that
impacts millions of people worldwide and often requires prolonged
The NDA for TAF is supported by 48-week data from two Phase 3 studies, which met their primary objective of non-inferiority in efficacy compared to Gilead’s Viread among treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV. In both studies, changes in renal and bone laboratory safety parameters favored the TAF regimen. Overall, patients receiving TAF experienced a significantly smaller mean percentage decrease from baseline in hip and spine bone mineral density at week 48 compared to patients receiving Viread. Additionally, the overall median change in serum creatinine from baseline to week 48 favored TAF. Rates of discontinuations due to adverse events and the most commonly reported adverse events were similar in patients receiving TAF or Viread.
Gilead plans to submit a regulatory application for TAF in the
TAF as a single agent treatment for 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 the
U.S. full prescribing information for Viread, including BOXED WARNING, is available at www.gilead.com.
Viread is a registered trademark of
For more information on
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936
Cara Miller, 650-522-1616