研究人员设计了一种新型 HIV 药物，可以帮助在没有其他治疗选择的患者中对抗晚期、耐药性 HIV 感染。
至少有 40 万人与 艾滋病毒 till mid-2018. 艾滋病毒 (Human Immunodeficiency Virus) is a retrovirus which attacks the crucial immune cells of our body (CD4 cells) that are integral to our immune system. This virus which is then found in all body tissues is transmitted from one human to another through body fluids of the infected person. AIDS (Acquired Immunodeficiency Syndrome) is caused by HIV and this disease alters one’s immune system making the person prone to 感染 和 疾病. Despite our understanding of HIV and significant research in this area, prevention, care and efficient treatment of HIV infection remains a challenge. If HIV is left untreated, the virus attacks the immune system and can cause various life-threatening infections and cancers. Effective treatment of 艾滋病毒 with HIV drugs which are able to control the spread of the virus is available and patients with 艾滋病毒 can still lead healthy lives and lower the risk of transmission to others. Unfortunately, no cure exists for 艾滋病毒 到目前为止。
当前抗 HIV 药物的挑战
桥梁 药物 therapies available for HIV treatment – called antiretroviral therapy (ART) – involve taking medicines that slow the progression of the virus in the body. These existing drug therapies also have multitude of challenges attached to them particularly in middle-and-low-income countries. There is always a delay in starting the treatment because first serious symptoms show up only when the virus has spread in the body. Known drugs also have considerable side effects. Also, drug resistance is a grave problem – when HIV medicines that previously controlled a person’s infection are not effective against new, drug-resistant HIV. So, HIV medicines cannot prevent drug-resistant HIV from multiplying and such an acquired drug resistance can cause 艾滋病毒 treatment to completely fail. The existing drug therapies also do not work for some individuals as they have no effect on the virus and in turn lead to drug resistance and worse condition of the disease. Many HIV drugs are known to target the virus effectively, however despite extensive research no new class of 艾滋病毒 drugs has been discovered in the past decade.
一种针对新机制的新型抗 HIV 药物
In March 2018, US Food and Drug Administration has approved a new drug called ‘ibalizumab’ which targets the primary receptor protein which is responsible for entry of 艾滋病毒 virus into the immune cells called CD4 T cells. The drug which is a monoclonal antibody targets this particular mechanism for the very first time in which the entry itself of the virus into the target cells can be prevented. The study describing phase III clinical trials is published in 新英格兰医学杂志. 患有多重耐药性 HIV 的参与者在多个地点参加了这项研究。 这些患者患有晚期形式的 HIV 感染，并且具有抗药性的病毒，几乎没有治疗可能。
The patients were given a dosage of ibalizumab (by directly injecting into the bloodstream) in addition to the HIV drugs they were already taking, for a period of one week. After this period, they were given ibalizumab combined with known effective drugs for a period of six months. It was observed that after a week’s time itself, 83% patients exhibited suppression in amount of HIV virus (called the viral load) detected in their blood. After 25 weeks, 43 percent of the patients had viral load which was below the detectable limit. Alongside CD4 T cells – a known marker for immune strength – increased in the body. Viral suppression remained steady from week 24 till week 48 post start of the treatment. The trial conducted differed from previous trials for anti-艾滋病毒 drugs. Firstly, sample size was proportionate with population having multi-drug resistant HIV infection. The main assessment on how exactly the virus was getting depleted was done between 7 to 14 days of the start of the treatment. Patients also received their own personalised medication regime. Finally, durability and safety testing were done after 24 weeks (unlike 48 weeks in previous trials). Some adverse events were noted in the participants, like diarrhoea was most common. Authors pointed out that most adverse events were not directly linked to the drug ibalizumab. A small set of patients were enrolled because of the uncommonness of multi-drug resistant 艾滋病毒 and this is being labelled ‘adequate’ by some experts.
A combination of existing 艾滋病毒 medicines and this new drug ibalizumab looks like a good strategy for patients who have already undergone different drug therapies and are essentially left with no further options of treatment while having developed multi-drug resistance. The new drug effectively reduces the virus and boosts immunity in patients in such patients. The mechanism targeted by this drug is unique and therefore this drug cannot interact negatively with other drugs or medicines. It has to be intravenously injected once every two weeks and it persists more than currently available 艾滋病毒 drugs which are required to be taken orally every day. This is a new class of medicine having a unique mode of delivery.
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来源（S）
鸸鹋 B 等。 2018. Ibalizumab 治疗多药耐药 HIV-3 的第 1 期研究。 新英格兰医学杂志.
https://doi.org/10.1056/NEJMoa1711460
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