Gilead success in late-stage hepatitis B trials
pharmafile | January 5, 2016 | News story | Research and Development, Sales and Marketing | Gilead, hepatitis B, phase III
Two Phase III trials evaluating Gilead treatments in chronic hepatitis B virus (HBV) infection have met their primary objectives, showing they are no less effective than Viread.
The trials found tenofovir alafenamide (TAF) demonstrated non-inferiority to Gilead’s (tenofovir disoproxil fumarate, or TDF).
Studies 108 and 110 involved treatment-naive and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV, and met their primary endpoints, based on the percentage of patients with HBV DNA levels below a threshold of 29 IU/mL after 48 weeks of therapy. In addition, TAF demonstrated improved renal and bone safety, and a significantly smaller mean percentage decrease from baseline in hip and spine bone mineral density, in the laboratory compared to Viread.
In Study 108, in HBeAg-negative patients, 94% of patients receiving TAF and 92.9% of patients receiving Viread achieved low HBV levels at week 48. In Study 110, evaluating HBeAg-positive patients, 63.9% of TAF patients and 66.8% of Viread patients achieved low HBV levels in the same timeframe.
Gilead said that based on the results of the two studies, it plans to submit regulatory applications for TAF for chronic HBV in the US and the European Union in Q1 2016. It is already approved in these regions, as part of Gilead’s combination treatment Genvoya, as a treatment for certain HIV infections.
“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,” says Norbert Bischofberger, executive vice president of research and development and chief scientific officer at 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.”
Joel Levy
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