罗氏（Roche）7月22日宣布，FDA已接受并授予安维汀（Avastin，通用名：bevacizumab，贝伐单抗）补充生物制品许可申请（sBLA）优先审查资格。该sBLA寻求批准Avastin联合化疗用于复发性铂耐药卵巢癌的治疗。
sBLA的提交，是基于在复发性铂耐药卵巢癌患者中开展的III期AURELIA试验的积极数据。AURELIA是一项多中心、随机、开放标签III期研究，涉及361例既往接受过不超过2种抗癌疗法的铂耐药复发性上皮性卵巢、原发性腹膜或输卵管癌患者。研究中，患者随机分配至6个治疗组（紫杉醇、替康或脂质体阿霉素，有或无Avastin）。数据表明，Avastin联合化疗使疾病恶化风险降低了52%（无进展生存期PFS，平均PFS:6.7个月 vs 3.4个月，p＜0.001），达到了研究的主要终点。总生存期（OS）次要终点则未表现出统计学意义的显著改善（平均OS：16.7个月 vs 13.3个月，p＜0.174）。
关于安维汀（Avastin）：
Avastin（通用名：bevacizumab，贝伐单抗）是罗氏（Roche）旗下基因泰克（Genentech）开发的一种单克隆抗体，可特异性结合并抑制VEGF（血管内皮生长因子）的生物效应。VEGF（血管内皮生长因子）是肿瘤血管生成的关键驱动因素，而血管生成为肿瘤生长并扩散（转移）所需要。Avastin的精确作用方式使其能够与化疗和其它方式的抗癌治疗有效结合。Avastin可抑制肿瘤生长、延长生存期，且对化疗副作用的影响有限。
迄今为止，Avastin在欧洲获批的适应症包括：晚期乳腺癌、晚期结直肠癌、晚期非小细胞肺癌、晚期肾细胞癌、晚期卵巢癌；Avastin在美国获批的适应症包括：结直肠癌、非小细胞肺癌、肾细胞癌、复发性成胶质细胞瘤。
此外，Avastin已获全球110国家批准，用于卵巢癌的一线治疗。
英文原文：FDA grants Roche¡ˉs Avastin Priority Review for recurrent platinum-resistant ovarian cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
¡°The majority of women with ovarian cancer will become resistant to platinum therapy and a quarter of women will have platinum-resistant disease at the time of a first recurrence. New treatment options are needed,¡± said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ¡°We look forward to working with the FDA to bring this potential option to women with this difficult-to-treat cancer as soon as possible.¡±
The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide ¡°significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.¡±1 The sBLA for Avastin plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from the Phase III AURELIA trial with an FDA action date of November 19, 2014.
about the AURELIA Study2
AURELIA is a company-sponsored, multicentre, randomised, open-label, Phase III study in 361 women with platinum-resistant recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer who had received no more than two anticancer regimens prior to enrolment in the trial. Participants were randomised to one of six treatment arms (paclitaxel, topotecan or liposomal doxorubicin with or without Avastin). Study data showed:
The study met its primary endpoint and showed that Avastin plus chemotherapy reduced the risk of disease worsening (progression-free survival, PFS) by 52 percent compared to chemotherapy alone (median PFS: 6.7 months vs. 3.4 months; Hazard Ratio (HR)=0.48, p<0.001). No statistically significant difference was seen in the secondary endpoint of overall survival (median OS: 16.6 months vs. 13.3 months; HR=0.85, p<0.174).2
Women in the Avastin plus paclitaxel arm (n=60) experienced a 54 percent reduction in the risk of their disease worsening (median PFS: 10.4 months vs. 3.9 months; HR=0.46, 95% CI 0.30-0.71)3 and a 35 percent reduction in the risk of death (median OS: 22.4 months vs. 13.2 months; HR=0.65, 95% CI 0.42-1.02).4
The study showed women who received Avastin plus chemotherapy had a significantly higher rate of tumour shrinkage (objective response rate, ORR) compared to chemotherapy alone when evaluated by the RECIST criteria (27.3 percent vs. 11.8 percent, respectively; p=0.001).2
Grade 3-5 adverse events occurring at a higher incidence (> 2 percent) in women receiving Avastin plus chemotherapy compared to women receiving chemotherapy alone were hypertension (high blood pressure; 7 percent vs. 1 percent), proteinuria (too much protein in the urine; 2 percent vs. 0 percent) and gastrointestinal perforations (a hole in the stomach or intestine; 2 percent vs. 0 percent).2
about Ovarian Cancer
Ovarian cancer causes more deaths than any other gynaecological cancer.5 In 2014, nearly 22,000 women will be diagnosed with ovarian cancer in the United States and more than 14,000 will die from the disease.6 Patients are said to have ¡®platinum-resistant¡ˉ disease if the disease worsens within six months of completing platinum-based chemotherapy. One quarter of those who relapse after initial treatment - more than 4,300 women - will have platinum-resistant cancer, the most difficult-to-treat form of the disease.2,6
Worldwide, ovarian cancer is the seventh most commonly diagnosed cancer in women, with an estimated 230,000 cases diagnosed around the world every year and there are approximately 150,000 deaths from the disease making it the deadliest of all gynaecological cancers.5
about Avastin ¨C 10 years of transforming cancer care
With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.
Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer, and is available in the U.S. for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. In addition, Avastin is approved in the U.S. and over 60 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.
Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over 1.4 million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.
about Avastin ¨C mechanism of action
An independent blood supply is critical for a tumour to grow beyond a certain size (2mm) and spread (metastasise) to other parts of the body. Tumours develop their own blood supply in a process called angiogenesis by releasing vascular endothelial growth factor (VEGF) ¨C a key driver for tumour growth. Avastin is an antibody that precisely targets and inhibits VEGF. Precise VEGF inhibition by Avastin allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.
about Roche
Headquartered in basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world¡ˉs largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche¡ˉs personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
FDA认定勃林格殷格翰尼达尼布为首个IPF领域突破性治疗药物 发布日期：2014-07-23 来源：新药汇
美国食品和药品管理局（FDA）首次授予勃林格殷格翰公司用于治疗特发性肺纤维化（IPF）的在研药物尼达尼布以突破性治疗药物的地位。
德国勃林格殷格翰公司于2014年7月17日宣布，美国食品和药品管理局（FDA）首次授予用于治疗特发性肺纤维化（IPF）的药物尼达尼布(Nintedanib) 以突破性治疗药物的地位。IPF是一种危害大、且具有致命性威胁的疾病。尼达尼布是一种在研治疗药物，目前正在接受FDA和欧洲药品管理局（EMA）的注册审核。对于尼达尼布在美国获得突破性药物认证的消息，中华医学会全国间质病学组组长、北京朝阳医院呼吸与危重症医学科代华平教授表示：“目前对于特发性肺纤维化的治疗，临床上尚无特效药物，FDA的认证使得尼达尼布的研发速度大大加快，有望为治疗特发性肺纤维化带来重大进展，这对广大特发性肺纤维化的患者来说是鼓舞人心的消息。”FDA于2012年建立了突破性治疗药物认定机制，目的就在于推动并加速那些用于治疗严重的或危及生命的治疗方法的研发和审批进程，但前提条件是，已有早期临床证据显示该治疗方法在一个或多个临床终点方面明显优于现有的治疗方法。 特发性肺纤维化是一种病因不明，以肺部的进行性纤维化损害为特征的慢性进展性疾病，是最为常见的特发性间质性肺炎 。目前尚无预防方法或除肺移植外国际公认的有确切疗效的治疗方法。该在全球范围的患病率达到14-43例/每100000人 。据此估算我国现有的特发性肺纤维化患者在60万人左右。由于进展快、预后差，该疾病的致残率和致死率极高。患者平均预期寿命为诊断后的3-5 年，或自症状出现后的4-6 年 。长期以来，特发性肺纤维化与其他间质性肺炎一样，被认为是一种肺部炎性疾病。但随着对其发病机制研究的深入，治疗策略已从抗炎为主，转向对特发性肺纤维化的病理生理各个具体环节进行干预。尼达尼布是勃林格殷格翰公司针对特发性肺纤维化（IPF）开发的在研小分子酪氨酸激酶抑制剂（TKI）。该药针对已被证实在肺纤维化病理机制中具有潜在影响的生长因子受体发挥作用。其中最为重要的就是血小板源性生长因子受体（PDGFR）、成纤维细胞生长因子受体（FGFR）和血管内皮生长因子受体（VEGFR）。通过阻断这些参与纤维化进程的信号转导通路，尼达尼布被认为有望能够通过减少肺功能下降速度、从而减缓IPF疾病进展。已有的两项全球性III期临床试验（INPULSIS™-1 研究和INPULSIS™-2研究）针对尼达尼布治疗IPF的疗效和安全性进行了评估，上述研究所获得的结果已于2014年5月份在全球性学术大会美国胸科学会（ATS）年会上公布、并在NEJM杂志上发表。尼达尼布是获得临床证据一致证实的、可通过显著减少肺功能年下降率（减少幅度达50%）从而延缓IPF疾病进展的、首个IPF靶向治疗药物。该药对于疾病进展的影响进一步获得了数据汇总分析结果的支持，上述汇总分析结果显示出急性加重发生风险降低38% （p=0.08）的阳性趋势、同时显示确诊的急性加重或可疑的急性加重的发生风险可显著降低68%（p=0.005）。“对于尼达尼布能在美国被授予突破性治疗药物的地位，我们感到非常兴奋，我们希望由此能使IPF患者尽快获得这一治疗药物。目前尚无任何一种药物获得FDA批准用于治疗IPF。我们承诺与药监当局保持密切合作，从而使尼达尼布能用于罹患这一严重的、威胁生命的肺部疾病的人群。”勃林格殷格翰公司首席医学官Klaus Dugi教授如此说道。公司目前还在针对尼达尼布作为癌症治疗选择开展临床研发工作，包括非小细胞肺癌、卵巢癌、结直肠癌和肝细胞肝癌。
关于尼达尼布* 尼达尼布*是勃林格殷格翰公司针对特发性肺纤维化（IPF）开发的在研小分子酪氨酸激酶抑制剂（TKI）5。该药针对已被证实在肺纤维化病理机制中具有潜在影响的生长因子受体发挥作用，其中最为重要的就是血小板源性生长因子受体（PDGFR）、成纤维细胞生长因子受体（FGFR）和血管内皮生长因子受体（VEGFR）6，7。通过阻断这些参与纤维化进程的信号转导通路，尼达尼布*被认为有望能够通过减少肺功能下降速度、从而减缓IPF疾病进展7，8。公司目前还在针对尼达尼布*作为癌症治疗选择开展临床研发工作，包括非小细胞肺癌、卵巢癌、结直肠癌和肝细胞肝癌。 关于勃林格殷格翰公司 勃林格殷格翰公司是全球排名前20位的制药公司之一。总部位于德国殷格翰，在全球拥有142家子公司和超过47400名员工。自从1885年成立以来，这家家族企业一直致力于研发、制造及推广各种对人类和动物具有极高治疗价值的创新药品。 作为公司文化的核心成分，勃林格殷格翰始终承诺担负社会责任，包括在全球范围内参与社会公益项目（例如，发起“创造更多健康”活动）以及对员工的关爱。尊重、机会同等以及保持工作与生活的平衡等要素为互相合作奠定了基础。公司做的每一件事，都从保护环境和保持可持续性发展的角度出发。 在2013年，勃林格殷格翰公司纯销总额达到141亿欧元，公司将纯销总额的19.5%投入于研发。新研究再次证明鱼油能预防阿尔兹海默症 发布日期：2014-07-23 来源：福布斯中文网
当你读完本文的时候，阿尔兹海默症又将新增三例。仅在美国就有500多万阿尔兹海默症患者（全球有4，400万）。该病每分钟增加一例，目前无法彻底治愈。现在，一项新的研究再次证明，鱼油补充品是预防阿尔兹海默症的最佳措施之一，至少对那些没有该病遗传风险的人来说是如此。
罗德岛医院（Rhode Island Hospital）的研究人员对年龄介于55至90岁的三组老年人进行了神经心理测试和脑核磁共振成像检查，每六个月进行一次。第一组是229位没有患病迹象的老年人，第二组是397位存在中度认知障碍的老年人，第三组是193位阿尔兹海默症患者。他们都是阿尔兹海默症神经成像计划（Alzheimer’s Disease Neuroimaging Initiative）的参与者。该计划始于2003年，在2010年结束。研究结果显示，尚未患上阿尔兹海默症的老年人在服用鱼油后，认知退化和脑萎缩的程度明显低于没有服用鱼油的老年人。认知退化是通过阿尔兹海默症评定量表（Alzheimer’s Disease Assessment Scale）和简易精神状态检查（Mini Mental State Exam）进行衡量的。（遗憾的是，这项研究没有具体说明鱼油的服用量和补充品中EPA和DHA的含量。）研究结果令人振奋，但需要注意一点：服用鱼油只对没有阿尔兹海默症主要遗传风险因素（也就是APOE ε4基因）的人有效。研究人员认为，携带APOE ε4基因的人无法代谢DHA。DHA是鱼油中的脂肪酸，被认为有助于促进认知功能。但研究人员补充说，即使是那些拥有遗传标记的人，如果到中年时或者在更早之前就开始补充鱼油，那么仍然有可能预防阿尔兹海默症。如果把APOE ε4基因比喻成电灯开关，那么提早服用鱼油可以预防开关被打开。这至少有了希望。考虑到阿尔兹海默症（美国第六大致死因素）目前仍然无法被治愈，有可能对该病起到预防作用的鱼油将继续成为认知研究领域的热点。这项研究发表在期刊《阿尔兹海默症与痴呆》（Alzheimer’s & Dementia）上。（生物谷Bioon.com）
GSK和辉瑞合资公司ViiV Healthcare在第20届国际艾滋病大会公布III期MODERN研究48周结果分析数据 发布日期：2014-07-23 来源：新药汇
ViiV Healthcare在第20届国际艾滋病大会公布III期MODERN研究的48周数据，该项研究中，HIV两药疗法（MVC+DRV/r）疗效不及三药疗法（FTC/TDF+DRV/r），未达非劣性终点。
葛兰素史克（GSK）和辉瑞（Pfizer）合资公司ViiV Healthcare 7月22日在澳大利亚墨尔本举行的第20届国际艾滋病大会上公布了III期MODERN研究48周结果的分析数据，该项研究在抗逆转录病毒药物初治（antiretroviral-naïve）HIV患者中开展，将maraviroc（MVC，马拉韦罗，商品名Celsentri/Selzentry，一种口服CCR5进入抑制剂）+达芦那韦/利托那韦剂量（darunavir/ritonavir，DRV/r）组合疗法与恩曲他滨/替诺福韦（emtricitabine/tenofovir，FTC/TDF）+DRV/r组合疗法进行了对比。数据表明，48周时，MVC+DRV/r治疗组FTC/TDF+DRV/r治疗组分别有77.3%和86.8%（95% CI：-15.0%至-4.4%）的患者实现病毒学抑制（HIV-1 RNA＜50拷贝/mL），该项研究未能达到-10%的非劣性终点。MODERN是一项双盲、双模拟、非劣性、96周III期研究，在抗逆转录病毒药物初治HIV患者中开展，旨在调查一种实验性两药方案（MVC+DRV/r）是否能提供三药方案（FTC/TDF+DRV/r）相当的抗病毒活性。研究中，MVC受试组有更多的患者因缺乏疗效而停药（MVC+DRV/r vs FTC/TDF+DRV/r，8.3% vs 2.0%）且有更多的患者达到方案定义的治疗失败（MVC+DRV/r vs FTC/TDF+DRV/r，10.1% vs 3.2%）。研究中，各组治疗失败的患者中未见病毒耐药报道。进一步的次要终点分析数据将提交至未来的科学会议。ViiV首席科学和医疗官John Pottage博士称，尽管这种实验性两药方案劣效于三药方案，但马拉韦罗（maraviroc）在与其他抗逆转录病毒药物联合用于CCR5-嗜性HIV患者时仍是一个有价值的抗逆转录病毒疗法。关于ViiV Healthcare：ViiV医疗保健公司是葛兰素史克（GSK）和辉瑞（Pfizer）于2009年联合成立的HIV/AIDS药物研发公司，目前，GSK持有ViiV 76.5%的股份，辉瑞持有10%的股份，日本盐野义（Shionogi）持有10%的股份。英文原文：ViiV Healthcare presents phase III data comparing once-daily maraviroc in combination with darunavir/ritonavir with emtricitabine/tenofovir plus darunavir/ritonavir in treatment-naïve adults with HIV-1An investigational two drug-regimen of maraviroc dosed once daily, combined with darunavir/ritonavir (DRV/r) showed inferior efficacy compared to emtricitabine/tenofovir (FTC/TDF) with DRV/r.ViiV Healthcare today presented, at the 20th International AIDS Congress in Melbourne, Australia, the analysis of the 48-week results from the phase III MODERN study comparing maraviroc (MVC; marketed as Celsentri® /Selzentry®) dosed once daily with darunavir/ritonavir (DRV/r) to emtricitabine/tenofovir (FTC /TDF) with DRV/r in antiretroviral-naïve subjects. The study did not meet the -10% non-inferiority endpoint. The proportion of study participants who were virologically suppressed (HIV-1 RNA <50 copies/mL) at week 48 was 77.3% for MVC+DRV/r compared to 86.8% for FTC /TDF +DRV/r (95% confidence interval -15.0% to -4.4%).MODERN was designed as a double-blind, double dummy non-inferiority 96-week study, intended to determine if an investigational two-drug regimen of once-daily MVC (a CCR5 receptor antagonist) and DRV/r (a boosted protease inhibitor) could provide comparable antiviral activity when compared to a three-drug regimen consisting of two once-daily nucleosides (FTC /TDF) and DRV/r in antiretroviral-naïve subjects. More MVC subjects discontinued due to lack of efficacy (8.3% for MVC+DRV/r vs 2.0% for FTC /TDF +DRV/r) and there were more protocol defined treatment failures in the maraviroc arm (10.1% for MVC and 3.2% for FTC /TDF). There were no reports of viral resistance in subjects who failed in either arm of the study.The secondary endpoints included safety and tolerability of maraviroc as well as the utility of genotypic and phenotypic testing and tropism change. There were no new or unique safety findings, and discontinuations due to adverse events were 4.8% for MVC+DRV/r and 4.5% for FTC /TDF +DRV/r. Category C events, grade 3/4 adverse events and laboratory abnormalities were similar between the two treatment arms.The study was also designed to compare the performance of a genotypic tropism test with the phenotypic tropism test Trofile® (ESTA, Monogram Biosciences) to determine whether patients had R5-tropic HIV-1 virus and were therefore eligible for maraviroc treatment. This was the first trial to compare the treatment outcomes of patients prospectively randomized to either a genotypic or phenotypic tropism test. The proportion of subjects meeting the primary endpoint were comparable between the two arms in predicting a clinical response (for the MVC arm, difference was 6.86% in favour of genotyping, 95% confidence interval -1.28% to 15.0%; for FTC /TDF, difference was 0.3%, 95% confidence interval -6.4% to 6.9%).“Although this investigational two-drug regimen was inferior to the three-drug regimen in this study, maraviroc remains a valuable antiretroviral therapy when used in combination with other antiretrovirals and dosed twice daily in adults with confirmed CCR5-tropic HIV.” said Dr. John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare.ViiV Healthcare decided to terminate the MODERN study in October 2013 following a preliminary review of the 48-week primary clinical efficacy data by the study’s external Independent Data Monitoring Committee (IDMC). This decision was not based on any new or unique drug-related safety events. The results presented today are the first analysis of the 48-week primary endpoint of this study. Further analyses of the secondary objectives will be presented at future conferences. “ViiV Healthcare is committed to supporting innovative clinical programmes to better understand our therapies and the potential they could offer to people living with HIV.” said Dr. Dominique Limet, Chief Executive Officer, ViiV Healthcare. “The treatment of HIV has come a long way, but it is essential that we continue to pursue effective novel treatment strategies that minimise toxicity while maximising tolerability and convenience to meet our objective of delivering advances in care and treatment for all people living with HIV.”about the MODERN study‘Maraviroc once daily with Darunavir Enhanced by Ritonavir in a Novel regimen’ (MODERN) was a Phase III, 96-week, multi-centre, randomised, double-blind, comparative study. The study started in 2011 and was carried out in 797 HIV-1 infected antiretroviral-naïve adults with HIV-1 RNA >1000 copies/mL (cpm) and without reported viral resistance from over 120 sites in the E.U., U.S., Australia and Canada. At baseline, the median age of subjects was 37 for MVC+DRV/r vs. 35 for FTC /TDF +DRV/r (9.1% vs. 8.5% were female respectively, and 81.3% in both arms were ethnically white).Subjects with HIV-1 RNA >100 000cpm at baseline was 20.5% vs. 20.7% for MVC+DRV/r and FTC /TDF +DRV/r respectively.As per the protocol, the primary endpoint for MODERN was the proportion of patients with HIV-1 RNA <50 copies/mL at week 48. Secondary objectives included the proportion of patients with HIV-1 RNA below the limits of assay detection at week 96; change in CD4+ cell counts through 48 and 96 weeks; assessment of the safety and tolerability of maraviroc including the effects on peripheral fat distribution and trunk to limb fat ratio; the effects on bone mineral density and tropism change and evolution of viral resistance.MODERN was also the first large Phase III trial to prospectively compare the performance of a genotypic test with a phenotypic test to identify patients with CCR5 tropic virus to determine eligibility for maraviroc. Patients were randomised to undergo screening with either the genotypic or phenotypic test. Genotypic tropism testing in the MODERN study was provided by Siemens Healthcare Diagnostics and phenotypic testing (Trofile®) by Monogram Biosciences.about maravirocMaraviroc is an oral CCR5 entry inhibitor. It is approved in the U.S, under the name Selzentry®, for both treatment-naïve and treatment-experienced adult patients with CCR5-tropic HIV-1 virus in combination with other anti-HIV medicines. Selzentry® is known as Celsentri® outside of the U.S. wher it is indicated for appropriate treatment-experienced patients. Tropism testing with a highly sensitive tropism assay is required for the appropriate use of Selzentry®/Celsentri®.
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