Sofosbuvir（GS-7977），GS-5885和利巴韦林治疗初治基因型1丙型肝

StephenW

Gilead Announces 100 Percent Sustained Virologic Response Rate (SVR4) for an Interferon-Free Regimen of Sofosbuvir (GS-7977), GS-5885 and Ribavirin in Treatment-Naïve Genotype 1 Hepatitis C Infected Patients

From the PharmaLive.com News Archive - Nov. 10, 2012

- Phase 3 Study with a Fixed-Dose Combination Tablet of Sofosbuvir and GS-5885 Now Underway -

BOSTON--(BUSINESS WIRE)--Nov 10, 2012 - Gilead Sciences (Nasdaq: GILD) today announced interim data from the ongoing Phase 2 ELECTRON study examining a 12-week course of therapy with the investigational nucleotide sofosbuvir (formerly referred to as GS-7977), the NS5A inhibitor GS-5885 and ribavirin in patients with genotype 1 chronic hepatitis C virus (HCV) infection. Among treatment-naïve patients receiving this combination, 100 percent (n=25/25) remained HCV RNA undetectable four weeks after completing therapy (SVR4). These data will be presented on Tuesday, November 13th at the 63rd annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2012) in Boston.

“These results indicate that adding GS-5885 to sofosbuvir-based regimens may enhance SVR rates, potentially offering HCV genotype 1 infected patients a convenient 12-week course of oral therapy,” said Professor Edward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and principal investigator of the ELECTRON study. “Along with other data from the ELECTRON study, these results add to the growing body of evidence supporting the potential for effective sofosbuvir-based all-oral regimens.”

Gilead recently initiated the first Phase 3 trial (ION-I) evaluating a fixed-dose combination of sofosbuvir and GS-5885 in treatment-naïve genotype 1 patients. This four-arm study is evaluating the fixed-dose combination with and without ribavirin for 12-and 24-week durations in 800 patients, 20 percent of whom have evidence of cirrhosis.

Data from five additional arms of the ELECTRON study examining sofosbuvir-based therapy in various patient populations also will be presented:

StephenW

Gilead公司宣布，无干扰素Sofosbuvir（GS-7977），GS-5885和利巴韦林治疗初治基因型1丙型肝炎病毒感染者，100％的持续病毒学应答率（SVR4）

，从PharmaLive.com新闻存档 -  2012年11月10号

- 一个固定剂量复方制剂的片剂Sofosbuvir和GS-5885目前正在进行的第三期研究 -

波士顿 - （美国商业资讯） -  11月10，2012  -  Gilead Sciences公司（纳斯达克股票代码：GILD）今天公布的中期数据，从目前的第2阶段，ELECTRON研究，研究为期12周的治疗过程中，研究的核苷酸sofosbuvir（以前被称为GS-7977），NS5A抑制剂GS-5885和利巴韦林治疗基因1型慢性丙型肝炎病毒（HCV）感染患者。在治疗初治患者接受这样的组合，100％（N = 25/25）保持HCV RNA检测不到四个星期后完成治疗（SVR4）。这些数据将在周二，11月13日在第63届会议的美国协会在波士顿的肝病（肝会议2012年）的研究。

“这些结果表明，GS-5885 sofosbuvir为基础的方案，可提高SVR率，有可能提供HCV基因1型感染患者一个方便的口服治疗12周的课程，说：”爱德华·盖恩教授，医学博士，副主任，肝病，中国肝移植单位，在新西兰奥克兰市医院的电子研究的主要研究者。 “随着其他数据的电子研究，这些结果增加了越来越多的证据支持的潜力，有效sofosbuvir口服治疗。”

Gilead公司最近发起了第一阶段的3期临床试验评价固定剂量组合的sofosbuvir和GS-5885（ION-I）在治疗初治基因1型患者。这四臂的研究，评估和利巴韦林固定剂量组合为12和24周的持续时间在800例患者，其中20％有肝硬化的证据。

从5个额外
组的ELECTRON研究sofosbuvir为基础的治疗在不同的患者人群中的数据也将提交：