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北京时间·🕒 发布 07-28 19:08:36时区推断·⟳ 抓取 07-28 19:09:06·⚡ 决策 07-29 08:02:27 +12h53m·90.4 天前
Atea丙肝组合疗法在905人三期C-BEYOND试验达到主要终点
bemnifosbuvir/ruzasvir在905名初治慢性HCV患者中达到主要终点，SVR为93.9%，对照sofosbuvir/velpatasvir为94.8%，统计上满足非劣效。
📄 原文Investing.com↗ 原文
Atea’s hepatitis C drug meets primary endpoint in phase 3 trial
Oil extends slide as U.S.-Iran talks raise hopes of lasting de-escalation BOSTON - Atea Pharmaceuticals Inc. (NASDAQ:AV…
不做 Atea Pharmaceuticals（AVIR.US）
三期非劣效阳性但疗效数值未优于成熟对照，第二三期仍待2027年初读出，商业化增量不够清晰。
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研究档案
🔎 新鲜度:最早出现 2026-07-28 · 扩散 medium · price-in 风险 medium ↗
关键理由
- bemnifosbuvir/ruzasvir在905名初治慢性HCV患者中达到主要终点，SVR为93.9%，对照sofosbuvir/velpatasvir为94.8%，统计上满足非劣效。
- 无肝硬化721人中8周疗程SVR为93.5%，对照12周疗程为94.6%，体现疗程缩短潜力；但美国HCV已有成熟DAA竞争格局。
- 公司第二个三期C-FORWARD超过880人，预计2027年初读出，当前单项非劣效结果尚不足以完整支撑全球提交和商业化量级。
主要风险
- 疗效数值低于对照但落在5%非劣效界值内，商业化需面对成熟竞品、定价和支付壁垒。
原文全文
展开原文 · 1,999 字
Oil extends slide as U.S.-Iran talks raise hopes of lasting de-escalation
BOSTON - Atea Pharmaceuticals Inc. (NASDAQ:AVIR) announced today that its experimental hepatitis C treatment bemnifosbuvir/ruzasvir met the primary endpoint in a phase 3 trial, demonstrating statistical non-inferiority compared to sofosbuvir/velpatasvir, according to a press release statement.
The C-BEYOND trial, conducted at approximately 120 sites in the U.S. and Canada, enrolled 905 treatment-naive patients with chronic hepatitis C virus infection. In the modified intent-to-treat analysis, bemnifosbuvir/ruzasvir achieved a 93.9% sustained virologic response rate versus 94.8% for sofosbuvir/velpatasvir at week 24. The 95% confidence interval for the difference in response rates fell within the prespecified 5% margin.
Among patients without cirrhosis, who comprised 721 participants, bemnifosbuvir/ruzasvir administered for eight weeks achieved a 93.5% response rate compared to 94.6% for the 12-week sofosbuvir/velpatasvir regimen. In patients with cirrhosis, both treatments were administered for 12 weeks and achieved identical 95.4% response rates.
The company stated that bemnifosbuvir/ruzasvir was generally safe and well tolerated with no drug-related serious adverse events or drug-related early treatment discontinuations. Safety profiles were comparable between treatment arms.
Approximately four million people in the U.S. are estimated to have hepatitis C, with 80-90% not having cirrhosis. The company noted that new diagnoses continue to outpace annual cures.
Atea’s second phase 3 trial, C-FORWARD, enrolled more than 880 patients at approximately 120 sites in 17 countries outside North America. The company expects to report results from that trial in early 2027.
The company plans to present detailed results at future medical conferences and submit findings to peer-reviewed journals.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
BOSTON - Atea Pharmaceuticals Inc. (NASDAQ:AVIR) announced today that its experimental hepatitis C treatment bemnifosbuvir/ruzasvir met the primary endpoint in a phase 3 trial, demonstrating statistical non-inferiority compared to sofosbuvir/velpatasvir, according to a press release statement.
The C-BEYOND trial, conducted at approximately 120 sites in the U.S. and Canada, enrolled 905 treatment-naive patients with chronic hepatitis C virus infection. In the modified intent-to-treat analysis, bemnifosbuvir/ruzasvir achieved a 93.9% sustained virologic response rate versus 94.8% for sofosbuvir/velpatasvir at week 24. The 95% confidence interval for the difference in response rates fell within the prespecified 5% margin.
Among patients without cirrhosis, who comprised 721 participants, bemnifosbuvir/ruzasvir administered for eight weeks achieved a 93.5% response rate compared to 94.6% for the 12-week sofosbuvir/velpatasvir regimen. In patients with cirrhosis, both treatments were administered for 12 weeks and achieved identical 95.4% response rates.
The company stated that bemnifosbuvir/ruzasvir was generally safe and well tolerated with no drug-related serious adverse events or drug-related early treatment discontinuations. Safety profiles were comparable between treatment arms.
Approximately four million people in the U.S. are estimated to have hepatitis C, with 80-90% not having cirrhosis. The company noted that new diagnoses continue to outpace annual cures.
Atea’s second phase 3 trial, C-FORWARD, enrolled more than 880 patients at approximately 120 sites in 17 countries outside North America. The company expects to report results from that trial in early 2027.
The company plans to present detailed results at future medical conferences and submit findings to peer-reviewed journals.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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