研究显示抗艾新药比克塔维有效性高于现有疗法

2020-11-02 来源:腾讯新闻   关键字:Biktarvy 防艾 艾滋

研究显示抗艾新药比克塔维有效性高于现有疗法

  原标题:艾滋病新药比克塔维(Biktarvy)有效性高于现有治疗方法

  多项研究显示,抗艾滋病药物比克塔维(Biktarvy)有效性高于现有治疗方法。

  在亚洲与艾滋病毒(HIV)的斗争有一个好消息,在涉及63名亚洲成年人的多项研究,Biktarvy显示出100%的病毒抑制作用,这意味着医生现在有更多选择来治疗患者。

  但是,Biktarvy目前仅在亚洲中国香港,新加坡,韩国,中国台湾和泰国得到批准,这意味着其他亚洲国家和地区的人不允许使用该治疗。

  美国生物制药公司吉利德科学公司(Gilead Sciences)在COVID-19危机期间声名大噪,当时该公司的药物瑞德西韦(Remdesivir)被用于有严重症状的患者,知名度最高的患者是美国总统特朗普。

  现在,该公司这款HIV药物已在多项临床试验中显示出高疗效,零耐药性,良好的安全性和耐受性。

  吉利德科学公司亚洲艾滋病医学事务主任李光业博士说,有关Biktarvy的其他数据可以进一步支持医疗提供者为亚洲的艾滋病毒患者做出适当的治疗选择。

  吉利德在给媒体的电子邮件中说:“由于给药方便,几乎没有预先筛查或持续的监测要求,因此它有可能简化治疗的开始和后续跟进,从而达到更好的药物依从性。”

  吉利德补充说:“亚洲拥有超过500万艾滋病毒感染者,2019年记录了30万例新病例。尽管如此,亚洲艾滋病患者在艾滋病临床试验中的比例仍然很大程度上偏低。”

  “虽然我们继续面临诊断延迟和病人因接受检查和护理而流失的挑战,但这项在亚洲成年人中进行的研究结果为Biktarvy在这一重要患者群体中的安全性、耐受性和有效性提供了重要的长期数据。”

  Biktarvy是一种联合药物(比格列韦50毫克/恩曲他滨200毫克/替诺福韦阿拉芬酰胺25毫克片剂,B/F/ TAF),是每天一次的片剂方案,用于治疗体重至少55磅的成人和儿童的艾滋病毒感染。

  抗逆转录病毒药物通过控制病毒的生长并改善免疫系统来帮助降低病毒载量。一些药品制造商将一些HIV药物合在一片药中,以便患者可以轻松服用。固定剂量组合中包括核苷酸逆转录酶抑制剂(NRTIs),非核苷逆转录酶抑制剂(NNRTIs),蛋白酶抑制剂(PIs)和整合酶链转移抑制剂(INSTI)。

  吉利德说,对亚洲人群进行的三项研究的分析“证明了在病毒学抑制的艾滋病毒感染者中,从基于机构的抗逆转录病毒疗法转向B/F/TAF,或通过两种NRTIs基线方案提高PI的疗效。”

  吉利德在媒体发布会上说:“在分析中,转换为B/F/ TAF的63名亚洲成年人中,100%保持了病毒学抑制,没有出现紧急的耐药性,相比之下,使用基线方案组的95.9%的人,最多持续48周。B/F/TAF在亚洲受试者中耐受性良好,没有不良事件导致其停用。”

  该研究结果在2020年亚太艾滋病与合并感染会议上公布。子分析只是Gilead正在进行的针对亚洲患者的研究的一小部分。该公司表示,它将致力于进行更多的研究,以进一步证明Biktarvy在不同年龄、不同国家和不同疾病背景下对亚洲患者的临床益处。

  由于Biktarvy可能会引起副作用,因此鼓励艾滋病患者向医生透露自己的所有医疗状况、服用的所有药物以及怀孕和哺乳情况。

  在亚洲以外,Biktarvy被批准在美国和欧盟使用。吉利德说:“它认识到在世界上欠发达的地区对艾滋病毒的治疗需求更大。”

  该公司解释说:“我们已经制定了创新计划和合作伙伴关系,例如药品专利池,自愿许可等,以扩大全球获得吉利德的艾滋病毒疗法的渠道,特别是在那些需求高但支付能力低的国家。”

  Gilead reveals HIV drug Biktarvy ‘demonstrates efficacy' in HIV battle

  Multiple studies show higher effectiveness than existing treatments.

  There is some good news in the fight against HIV in Asia with multiple studies involving 63 Asian adults showing 100% viral suppression, which means doctors now have more options to treat their patients with.

  However, Biktarvy is currently only approved in Asia in Hong Kong, Singapore, South Korea, Taiwan, and Thailand, which means those in other Asian countries such as the Philippines are not allowed to access the treatment.

  American biopharmaceutical company Gilead Sciences shot to fame during the COVID-19 crisis when its Remdesivir drug was prescribed to patients with severe symptoms, with its highest profile patient being US President Donald Trump.

  Now, its HIV drug has shown high efficacy with zero resistance and good safety and tolerability in multiple clinical trials.

  Dr Kuan-Yeh Lee, director of HIV Medical Affairs Asia of Gilead Sciences, said the additional data on Biktarvy can further support healthcare providers in making the appropriate treatment choice for HIV patients in Asia.

  “With convenient dosing and few pre-screening or ongoing monitoring requirements, it has the potential to simplify treatment initiation and follow-up over time and achieve better drug adherence,” Gilead said in an email to Healthcare Asia.

  “Asia is home to over 5 million people living with HIV, with 300,000 new cases recorded in 2019. Despite that, Asian HIV patients remain largely underrepresented in HIV clinical trials,” Gilead added. “While we continue to face challenges with late diagnosis and leakage of patients from getting tested and care, the findings from this study conducted among Asian adults yield important long-term data on the safety, tolerability, and efficacy of Biktarvy in this important patient population.”

  Biktarvy is a combination drug (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) taken as a once-a-day tablet regimen for the treatment of HIV infection in adults and children who weigh at least 55 pounds.

  Antiretroviral drugs help lower viral load by controlling the growth of the virus and improve the immune system. Some drug manufacturers combine some HIV medicines in one pill, so that patients can easily take it. Among the fixed-dose combinations are Nucleotide Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), Protease Inhibitors (PIs), and Integrase Strand Transfer Inhibitor (INSTI).

  According to Gilead, analysis from three studies in Asian population “demonstrated efficacy of switching to B/F/TAF from INSTI-based antiretroviral therapy, or a boosted PI with two NRTIs baseline regimens, among virologically suppressed Asian adults living with HIV.”

  “In the analysis, 100 percent of the 63 Asian adults who switched to B/F/TAF maintained virologic suppression with no emergent resistance, versus 95.9 percent in those stay on baseline regimen group, through a maximum of 48 weeks. B/F/TAF was well tolerated with no adverse events leading to discontinuation among Asian participants in the studies,” Gilead said in a media release.

  The research results were revealed at the 2020 Asia Pacific AIDS & Co-Infections Conference. The sub-analyses are just a small part of Gilead’s ongoing studies focusing on Asian patients. The company said it is committed to conducting more studies to further demonstrate the clinical benefits of Biktarvy for patients in Asia, across ages, countries, and disease profiles.

  HIV patients are encouraged to disclose to their doctor all their medical conditions, all the medications they take, and their pregnancy and breastfeeding as Biktarvy may cause side effects.

  Outside Asia, Biktarvy is approved for use in the United States and the European Union. Gilead said it “recognises that there is a greater need for HIV treatment in the less-developed parts of the world.”

  “We have put in place innovative programs and partnerships such as Medicines Patent Pool, Voluntary Licensing to expand global access to Gilead’s HIV therapies, especially in countries where need is high, but the ability to pay is low,” the company explained.

  (来源:腾讯新闻 chinameditour)

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  研究显示抗艾新药比克塔维有效性高于现有疗法

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