FDA Advisory Committee Recommends Truvada for Prevention of HIV Sexual Transmiss

StephenW

FDA Advisory Committee Recommends Truvada for Prevention of HIV Sexual Transmission  Category: HIV Prevention
Published on Thursday, 10 May 2012 00:00
Written by Liz Highleyman               
                                                                                                

Image: Gilead Sciences

                                       
               
               
                On May 10, 2012, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) decisively recommended approval of Truvada -- Gilead Sciences' tenofovir/emtricitabine combination pill -- for pre-exposure prophylaxis (PrEP) to prevent sexual transmission of HIV.
         [Editor's note: this report will be updated as further details about the committee hearing and reaction to the decision become available.]
        The committee voted 19 to 3 in favor of approving Truvada PrEP for men who have sex with men, 19 to 2 (with 1 abstention) for HIV negative partners in serodiscordant couples, and 12 to 8 (with 2 abstentions) for other individuals at risk for acquiring HIV through sex
        "This brings us closer to a watershed for global HIV prevention efforts," said AVAC executive director Mitchell Warren in a press release issued immediately following the votes. "PrEP, while not a panacea, will be an essential additional part to the world’s success in ending AIDS."
        Gilead requested approvalfor the expanded indication in December 2011 based on a growing body of evidence showing that tenofovir/emtricitabine can lower the risk of HIV acquisition if taken every day.
        The iPrExstudy of gay and bisexual men (plus a small number of transgender women) and the Partners PrEP and TDF2 studies of heterosexual men and women showed that once-daily Truvada PrEP dramatically reduced the incidence of new infections.
        The data is not unanimous, however. The Fem-PrEP study of Truvada for heterosexual women was halted early because it was unable to demonstrate a preventive effect, as was an arm of the VOICEtrial testing tenofovir alone.
        Further datapresented at this year's Retrovirus conference (CROI 2012) indicated that adherence and adequate drug levels in the body are keys to PrEP's effectiveness. In Partners PrEP and iPrEx, new infections were reduced by about 90% among people with blood drug levels indicating good adherence.
        While Truvada PrEP appears highly effective -- at least for selected, high-risk populations that use it as part of a comprehensive prevention strategy that also includes condoms and risk-reduction counseling -- advocates and public health officials have raised concerns regarding the difficulty of ensuring good adherence, long-term side effects (especially bone and kidney problems), drug resistance, and cost and access.
        The Los Angeles-based AIDS Healthcare Foundation has been a vociferous critic of Truvada PrEP. "Any approach that relies on adherence for people who don't have a disease is going to fail," AHF president Michael Weinstein said in advance of today's hearing.
        Some have expressed concern that since Truvada is not 100% effective for prevention, PrEP may give people unwarranted confidence that leads them to give up safer sex practices. Studies to date, however, have not demonstrated this so-called "behavioral disinhibition."
        AVAC urged the U.S. Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and other public health agencies to quickly issue guidance on the appropriate use of Truvada PrEP for different populations, and stressed that funding for PrEP "should not detract from other essential HIV prevention and treatment efforts."
        The FDA is expected to make a decision about approval of Truvada PrEP by June 15. The agency is not required to follow its committees' recommendations but it usually does so.
        Background material about Truvada PrEP is available on the FDA web site. The FDA plans to provide an archived webcast of the advisory committee meeting on the same site.
        5/10/12
        Sources
        Associated Press. FDA advisers back approval for first pill shown to protect healthy people from AIDS virus. May 10, 2012.
        AVAC. AVAC Urges FDA Approval of PrEP Following Positive Advisory Committee Recommendation; Lays out Priorities to Ensure Access. Press release. May 10, 2012.
        Gilead Sciences. FDA Advisory Committee Supports Approval of Gilead’s Truvada for Reducing the Risk of Acquiring HIV. Press release. May 10, 2012.
        D Beasley. HIV Pill for Prevention Debated as FDA Ruling Nears. Reuters. May 9, 2012.

StephenW

FDA咨询委员会的建议预防性行为传播艾滋病毒的Truvada

详情
    分类：预防艾滋病毒
    10日（星期四）公布2012年5月00:00
    书面利兹Highleyman


图片：Gilead Sciences公司

2012年5月10日，美国食品和药物管理局（FDA）的抗病毒药物咨询委员会果断建议批准Truvada  - 暴露前预防（PrEP），以防止性传播 -  Gilead Sciences公司的替诺福韦/恩曲他滨的组合丸艾滋病毒。

[编者注：本报告将作为委员会的听证会，反应变得可用，决定进一步的细节更新]

该委员会投票19日至3赞成审批男性与男性发生性关系，19 Truvada PREP 2（1票弃权通过）为HIV阴性血清不一致夫妇中的合作伙伴，并12日至8（2票弃权）其他个人风险获得通过性交感染艾滋病毒

AVAC执行主任米切尔·沃伦说：“这使我们更接近全球艾滋病毒预防工作的一个分水岭，在之后立即发出选票的新闻稿。 “准备，而不是万能的，将是一个重要的附加部分结束艾滋病在全球的成功。”

Gilead的要求指示的基础上越来越多的证据显示，替诺福韦/恩曲他滨可降低收购艾滋病毒的风险，如果采取每天扩大，在2011年12月批准。

iPrEx同性恋和双性恋男子（加上少数的变性妇女）和合作伙伴PReP以及TDF2的异性恋男性和女性的研究，研究表明，每日一次Truvada PREP新感染者的发病率大大降低了。

，但数据并不一致。年初被终止，因为它是无法证明的预防效果，作为一个单独的语音试验测试泰诺福韦手臂的Truvada FEM-PREP异性恋女性的研究。

在今年的逆转录病毒大会（CROI 2012年）提出了进一步的数据表明，坚持和足够的药物浓度在体内Prep的有效性的关键。在合作伙伴PREP和iPrEx，减少新的感染，其中约90％的人表示良好的坚持与血药水平。

虽然Truvada PREP显得非常有效 - 至少选定，高危人群中使用它作为一个全面的预防战略，还包括避孕套和减少风险的辅导 - 倡导者和公共卫生官员已经提出关切的难度确保良好的坚持，长期的副作用（尤其是骨骼和肾脏问题），耐药性，以及成本和访问。

洛杉矶的艾滋病保健基金会一直是Truvada PREP大声疾呼评论家。 AHF的总裁迈克尔·温斯坦说：“在今天的听证会之前，”没有疾病的人坚持依靠任何方法，是要失败。

也有人担心，因为Truvada是不是100％有效预防，PREP可能会给人无端的信心，导致他们放弃安全性行为。然而，最新研究没有证明这个所谓的“行为失控。”

AVAC敦促美国疾病控制和预防中心（CDC），世界卫生组织（WHO）的，和其他公共卫生机构迅速发出对Truvada PREP的适合不同人群使用的指导，并强调，资金，为准备“应不减损其他必要的艾滋病毒预防和治疗工作。“

FDA预计使Truvada PREP 6月15日批准的决定。该机构并不需要遵循委员会的建议，但通常这样做。

Truvada PREP有关的背景材料是FDA的网站上。 FDA计划在同一网站上提供的咨询委员会会议的网络直播存档。

12年5月10日

来源

美联社。 FDA的顾问，为后面显示健康人免受艾滋病病毒的第一丸批准。 2012年5月10日。

AVAC。 AVAC敦促美国FDA批准的预科以下积极的咨询委员会的建议，勾画出优先次序，以确保访问。新闻稿。 2012年5月10日。

Gilead Sciences公司。 FDA咨询委员会支持批准Gilead公司的Truvada减少感染艾滋病毒的风险。新闻稿。 2012年5月10日。

ð比斯利。预防艾滋病毒丸辩论FDA的执政接近。路透社记者。 2012年5月9日。