AASLD: Antiviral Activity of TAF Against Drug-Resistant HBV Isolates in Vitro - (01/07/16)
Gilead Announces Top-Line Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection - (01/05/16)
Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Tenofovir Alafenamide (TAF) for Patients with Chronic Hepatitis B Infection
-- High Rates of Viral Suppression and Improved Renal and Bone Safety Parameters Compared to Viread in Phase 3 Studies --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 31, 2016-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for tenofovir alafenamide (TAF) 25 mg, an investigational once-daily treatment for adults with chronic hepatitis B virus (HBV) infection.
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), which is marketed in Japan for the treatment of HBV as Tenozet® by GlaxoSmithKline. TAF has also demonstrated improvements in surrogate laboratory markers of renal and bone safety compared to TDF in clinical trials.
“With more than one million people in Japan chronically infected with hepatitis B, there is a significant need for effective new treatment options that offer a favorable safety profile,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President of Research and Development and Chief Scientific Officer. “We are pleased with the results of the Phase 3 studies, which suggest that TAF has the potential to improve the care of chronic hepatitis B patients who require lifelong treatment to manage their disease.”
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 (HBV DNA < 29 IU/mL at Week 48) compared to TDF among treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV infection. Both studies enrolled patients from a number of clinical sites in Japan. Patients randomized to the TAF arms showed a statistically significant increase in serum alanine aminotransferase normalization relative to the TDF arms when using the American Association for the Study of Liver Disease criteria. Changes in renal and bone laboratory safety parameters favored the TAF treatment arms. Overall, patients receiving TAF experienced a significantly smaller percentage decrease from baseline in hip and spine bone mineral density at Week 48 compared to patients receiving Viread. Additionally, the overall 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.
TAF as a single agent treatment for HBV is an investigational product and its safety and efficacy have not been established. 作者: StephenW 时间: 2016-3-31 20:52
在NDA的TAF是通过48周的数据来自两个3期研究，符合非劣效性的主要目标的疗效（HBV DNA <29 IU / mL的48周）之间的初治和处理 - 相比，TDF支持有经验的成年人HBeAg阴性和HBeAg阳性慢性HBV感染。这两项研究入选患者从众多日本临床场所。随机分配到TAF臂患者使用美国协会肝病标准研究时表现出相对于所述TDF臂血清谷丙转氨酶正常化有统计学显著增加。肾和骨骼实验室安全参数的变化的青睐TAF治疗武器。总体而言，接受TAF经历的患者在髋部和脊柱骨密度基线显著比例较小跌幅在48周相比，接受Viread的患者。此外，血清肌酐到48周的总体变化从基线青睐TAF。由于不良事件，最常见的不良反应停药率在接受TAF或Viread的患者相似。