Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Biktarvy® for Treatment of HIV-1 Infection

吉利德的 HIV -1药物 Biktarvy ®获日本卫生、劳动和福利部批准

2019-03-27 07:20:00 BioSpace


In the United States, Biktarvy has a Boxed Warning in its product label regarding the risk of post-treatment acute exacerbation of hepatitis B. See below for U.S. Important Safety Information as well as the Biktarvy Indication. The approval of Biktarvy is supported by data from four Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a diverse population of 2,415 participants on Biktarvy or an active comparator, including a wide range of adult age groups and races/ethnicities. Biktarvy met its primary objective of non-inferiority at 48 weeks across all four studies. Through 48 weeks, no participants in any of the four studies developed treatment-emergent virologic resistance while taking Biktarvy, no patients discontinued Biktarvy due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking Biktarvy were diarrhea, nausea and headache. “Gilead is pleased that Biktarvy, our latest HIV treatment innovation, will be made available to people living with HIV in Japan,” said John McHutchison, AO, MD, Chief Scientific Officer, and Head of Research and Development, Gilead Sciences. “In multiple clinical trials, Biktarvy has demonstrated high efficacy and a high barrier to resistance. With convenient dosing and few pre-screening or ongoing monitoring requirements, it has the potential to simplify treatment initiation, and follow-up over time.” “Gilead’s operations in Japan have expanded significantly over the years and we are pleased to now be able to bring our longstanding experience and commitment as a global leader in HIV treatment to the Japanese HIV community,” said Luc Hermans, M.D., President and Representative Director, Gilead Sciences, K.K. “Biktarvy adds an important new treatment option to our portfolio of medicines for people living with HIV in Japan.” Biktarvy does not cure HIV infection or AIDS. IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR BIKTARVY BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Biktarvy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Biktarvy. If appropriate, anti-hepatitis B therapy may be warranted.
在美国,Biktarvy因其产品标签中有关服药后乙肝急性恶化的风险而收到FDA黑盒警告。有关美国重要安全信息以及Biktarvy适应症,请参见下文。 Biktarvy的批准基于四项III期临床试验的数据:1489和1490研究针对初患艾滋病成人,1844和1878研究针对病毒得到抑制的成年人。这些试验由2,415名参加者组成,其中包括不同的年龄和种族/族裔。在四项研究中,Biktarvy在48周内都达到了不俗的主要目标。经过48周的时间,四项研究中没有一项研究的参与者在服用Biktarvy时出现了治疗突发病毒的耐药性,没有患者因为肾脏不良事件而停止服用Biktarvy,也没有出现肾近端小管病变或范可尼综合征的病例。服用比卡他韦的患者最常见的不良反应是腹泻、恶心和头痛。 “吉利德很高兴能够将我们最新的艾滋病毒创新疗法Biktarvy提供给日本艾滋病患者,” AO 医学博士、吉利德科学研究与开发总监 John McHutchison 说道。“在多个临床试验中,Biktarvy已显示出高疗效和高病毒抑制力。同时该药给药方便,预筛选和持续监测要求低,有可能简化初始治疗和随时间的跟进。” 吉利德科学总裁兼代表主任 Luc Hermans 医学博士博士说:“Biktarvy为日本艾滋病毒患者提供了一种重要的新治疗方案。” 比克托维不能治愈 HIV 感染或艾滋病。 重要的美国安全信息和Biktarvy适应症 黑盒警告: 服药后乙肝急性恶化 当同时感染HIV-1和 HBV,并停用含有emtricitabine( FTC )和/或tenofovir disoproxil fumarate( TDF )的产品时,患者出现了乙型肝炎的严重急性加重。停用Biktarvy后也可能出现这种情况。需要对同时感染HIV-1和 HBV且停用Biktarvy的患者进行密切的肝功能监测,以及临床和实验室的随访。如果适用,可采取抗乙肝治疗。