2014年9月13日讯 /生物谷BIOON/ --根据美国药品研究与制造商协会（PhRMA）发布的最新报告，目前，在美国有44种在研的药物和疫苗，开发用于艾滋病毒/艾滋病（HIV/AIDS）的治疗和预防。在另一份名为《HIV/AIDS治疗创新的价值》的报告中，PhRMA强调了HIV/AIDS药物的研发进展及其对临床治疗的影响。
新药研发仍然是一项危险的投资，而且过程漫长。平均而言，一种新药从研发到上市，需投入12亿美元和10-15年时间。尽管存在诸多风险，但制药公司仍在继续努力研发新的、更有效的药物和疫苗，用于治疗和预防、甚至可能治愈HIV/AIDS。
自1981年美国疾病控制和预防中心（CDC）发现首批5例HIV/AIDS病例以来，HIV/AIDS临床治疗已取得了多项重大进步。抗逆转录病毒药物（ART）自1995年上市之后，在美国，HIV/AIDS相关死亡已降低83%，HIV/AIDS相关住院率已下降32%。这些药物正在帮助改善患者的综合护理，并帮助降低治疗相关费用。根据芝加哥大学的一项研究显示，与20世纪80年代相比，目前HIV/AIDS患者的寿命已延长15年。
在过去的35年里，HIV/AIDS已经从死刑变成一种慢性、可控的疾病，这在很大程度上归功于生物制药研究所取得的巨大进步。然而，尽管已取得了长足进展，但科学界和业界仍在继续与HIV/AIDS作斗争，主要专注于改进治疗方案以及研发更有效的药物及预防性疫苗，在研的44种药物和疫苗中，包括25种抗病毒药物、16种疫苗、3种细胞/基因疗法，其中包括：一类首创的细胞膜附着抑制剂，旨在阻止HIV突破细胞膜；一类基因/细胞修饰疗法，旨在修饰患者自身的T细胞，使其能够抵抗HIV感染；一类治疗性疫苗，旨在诱导免疫保护性T细胞反应，阻止HIV感染。这些新药和疫苗，使实现HIV/AIDS治愈的希望也比以往任何时候都大得多。
目前，在美国，有94项临床试验正在调查HIV药物和疫苗，其中43项尚未开始招募患者或正在招募患者。根据报告，暴露前预防（PrEP）能够有效阻止病毒的传播，目前国际指南已推荐将药物应用于PrEP，作为HIV/AIDS综合防治计划的一部分。根据联合国HIV/AIDS联合规划署，在全球范围内，约有3500万人感染HIV，但新发感染自2001年以来已降低了38%。（生物谷Bioon.com）
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英文原文：PhRMA: 44 medicines and vaccines for HIV/AIDS treatment and prevention in development
New Medicines in Development Give Hope to Patients with HIV/AIDS
Washington, D.C. (September 10, 2014) — America’s biopharmaceutical research companies are currently developing 44 medicines and vaccines for HIV/AIDS treatment and prevention, according to the latest Medicines in Development report by the Pharmaceutical Research and Manufacturers of America (PhRMA). A second report, a PhRMA-sponsored white paper by Boston Healthcare Associates, Inc. (BHA), “The Value of Innovation in HIV/AIDS Therapy ” highlights the progress in HIV/AIDS treatment and its impact on patients afflicted with the disease.
Both reports are being released in conjunction with PhRMA’s 2014 Research & Hope Awards, which will honor researchers and patient advocates for their role in improving HIV/AIDS research and care.
Multiple medical advancements have taken place since 1981, when the Centers for Disease Control and Prevention identified the first five cases of HIV/AIDS. Since anti-retroviral treatments (ART) were approved in 1995, HIV/AIDS-related deaths in the United States have dropped by 83 percent, resulting in a 32 percent decline in HIV/AIDS-related hospitalizations. These medicines are improving overall care for patients and are helping to prevent costs associated with treating the disease. According to a University of Chicago study, HIV/AIDS patients today live 15 years longer than in the 1980s.
“Over the past 35 years, HIV/AIDS has gone from a death sentence to a chronic, manageable disease thanks in large part to advances in biopharmaceutical research,” said PhRMA President and CEO John J. Castellani. “Despite the progress that has been made, researchers are continuing the fight against HIV/AIDS and, with more than 40 medicines in the pipeline, there is more hope than ever that a cure can be achieved.”
Currently, biopharmaceutical companies are focused on improved treatment regimens, more effective therapies and preventive vaccines that are either in clinical trials or awaiting review by the Food and Drug Administration . The 44 medicines and vaccines in the development pipeline include 25 antivirals, 16 vaccines and three cell/gene therapies. Examples include:
- A first-in-class medicine intended to prevent HIV from breaking through the cell membrane;
- A cell therapy that modifies a patient’s own cells in an attempt to make them resistant to HIV; and,
- A therapeutic vaccine designed to induce responses from T cells that play a role in immune protection against viral infections.
Today, there are 94 active clinical trials for HIV medicines and vaccines in the United States. Of those, 43 have not yet started recruiting patients or have recently begun seeking participants. Therapies being investigated involve attachment inhibitors, gene modification and inducing T cell responses, among others. The development of new, innovative therapies would not be possible without the patients who volunteer to participate in clinical trials. These trials, in combination with the promising new scientific approaches researchers are using, build on the progress against HIV infection.
According to the Value of Innovation in HIV/AIDS Therapy report, advances in treatment, including the Pre-Exposure Prophylactic (PrEP) method, have built upon each other over time, yielding better results for patients through use of medicines earlier and in combination. Recent research has revealed that many of these therapies are effective in preventing the transmission of the virus. Both national and international guidelines now recommend PrEP use of medicines as part of a comprehensive HIV prevention plan in populations that are disproportionately impacted by HIV.
