Janssen’s HIV drug SYMTUZA yields positive results in DIAMOND trial

杨森HIV药物 SYMTUZA III期研究取得积极进展,有望成为治疗艾滋新选择

2019-04-15 18:25:17 pharmbr


标签: 医药/器械
Janssen Pharmaceutical said that a phase 3 trial evaluating SYMTUZA showed that a high percentage of HIV patients recorded an undetectable viral load through 48 weeks after rapid initiation of the drug. The trial, called DIAMOND, is the first prospective phase 3 trial which is assessing the rapid initiation of a single-tablet regimen (STR) SYMTUZA for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The trial involved 109 patients who were enrolled within 14 days of going through an HIV diagnosis and then started on the once-daily STR of the drug before the release of laboratory or baseline resistance test results. According to Janssen, 97 of the enrolled patients completed the 48-week study, which represents almost 90%. In the primary intent-to-treat (ITT) analysis, 84% of patients registered undetectable viral loads, while 8% of patients had virologic failure at 48 weeks. The company said that, in an observed analysis, which excluded those with missing data, 96% of patients showed undetectable viral loads. Janssen stated that 100% of patients registered viral loads of less than 200 c/mL at Week 48, with none of the patients having to stop SYMTUZA treatment based on efficacy reasons. The company said that the drug was well-tolerated with no serious related adverse events (AEs) recorded. Janssen Scientific Affairs, Janssen Infectious Diseases, medical affairs vice president Richard Nettles said: “The DIAMOND study mirrors real clinical scenarios that physicians face today – including the need to start treatment before lab or baseline resistance test results are available – and highlights the benefits this model of care can bring to those newly diagnosed with HIV. “SYMTUZA is the only single-tablet regimen proven in a Phase 3 clinical trial studying the rapid initiation of treatment, further demonstrating it as a treatment option for people new to HIV therapy.” The Janssen drug was approved in the US in July 2018 for the treatment of HIV-1 infection in treatment-naïve and certain virologically suppressed adults. In Europe, the drug was approved for the treatment of HIV-1 infection in adults and adolescents aged 12 years and over with body weight of at least 40kg.
杨森(Janssen) Pharmaceuticals 表示,一项评估 SYMTUZA 的3期试验显示,在快速启动该药物48周后,很高比例的艾滋病患者记录了无法检测的病毒载量。 这项名为 DIAMOND 的试验是第一个前瞻性的第三阶段试验,它正在评估快速启动单药片养生法 SYMTUZA 治疗成人免疫缺陷病毒1型( HIV-1)感染。 试验涉及109名患者,他们在接受艾滋病毒诊断后14天内登记,然后在释放实验室或基线耐药性测试结果之前开始每天进行一次的药物 STR 试验。 根据杨森(Janssen)的数据,97名被纳入研究的患者完成了48周的研究,这几乎占90%。在最初的意图治疗( ITT )分析中,84%的患者出现了无法检测的病毒载量,而8%的患者在48周时出现了病毒学失败。 该公司表示,在一项观察分析中,96%的患者显示病毒载量无法检测。 杨森(Janssen)说,在48周时,100%的患者的病毒载量少于200 c / mL ,没有患者因疗效原因而停止 SYMTUZA 治疗。 该公司表示,该药物耐受性良好,没有严重相关不良事件( AE )的记录。 Janssen Scientific Affairs ,杨森(Janssen) Infective Diseases ,医学事务副总裁理查德•内特尔( Richard Nettles )表示:“ DIAMOND 的研究反映了医生们今天面临的真实临床情况,包括在实验室或基线耐药性测试结果公布之前就开始治疗的必要性,并强调了这种护理模式可以给新诊断的艾滋病患者带来的好处。 “ SYMTUZA 是唯一一种在研究快速启动治疗的3期临床试验中得到证实的单片疗法,进一步证明它是 HIV 治疗新患者的治疗选择。” 杨森(Janssen)药物于2018年7月在美国获得批准用于治疗纳伊韦和某些病毒抑制成人中的 HIV-1感染。在欧洲,该药物被批准用于治疗12岁及以上体重至少40公斤的成年人和青少年的 HIV-1感染。