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27.11.2016
«Китай: Инъекционный АРВ-препарат длительного действия Albuvirtide близок к одобрению» | http://www.hiv-2020.ru/news.php |
Как передает Global Times, китайский фармрегулятор 23 ноября изучил результаты клинических исследований нового инъекционного АРВ-препарата длительного действия Albuvirtide. Это заключительный этап рассмотрения перед официальным одобрением лекарственного средства. Согласно данным, опубликованным ранее, в отличие от распространенных сегодня лекарств от ВИЧ-инфекции, которые требуется пить ежедневно, новая инъекция подавляет вирус на семь дней. О разработке инновационного ингибитора слияния Albuvirtide стало известно в конце октября. Действующее вещество связывается с белком крови альбумином и продлевает период полувыведения. Благодаря этому вирусная нагрузка снижается на срок от шести до десяти дней. По результатам клинических испытаний препарат показал эффективность у 80,4% пациентов в экспериментальной группе. В случае одобрения Albuvirtide может появиться на китайском рынке уже в конце года.
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«China to approve 1st long-acting injection to treat HIV/AIDS» | http://www.globaltimes.cn/content/1020133.shtml |
China's national drug authority on Wednesday examined clinical research results on a domestically produced anti-HIV drug in its final phase prior to officially approving the drug.
Once approved, the new-generation drug, named Albuvirtide for Injection, is expected to be the world's first long-acting injection for HIV treatment.
Developed by the Nanjing-based Frontier Biotechnologies Inc, the medicine can block fusion of the viral and host cell membranes, interrupting the HIV life cycle in its earliest stage. It has been put into phase-3 clinical trials in 12 clinical centers across the country since February 2014, the Xinhua News Agency reported.
The drug is a fusion inhibitor that should be used with antiretroviral drugs to treat people suffering from HIV who have received antiviral therapy, the company's website said.
According to the website, it is the world's first long-acting anti-HIV drug that has entered phase-3 clinical trials, which, with a molecular mechanism of action, is effective on both the HIV-1 virus and other resistant viruses.
The China Food and Drug Administration on Wednesday verified medium-term experimental data of the drug's phase-3 clinical trials in the Beijing Youan Hospital (BYH), which took charge of conducting national clinical trials of the drug.
"Medium-term experimental data shows that one primary and three secondary endpoints of the trial have all achieved expectations, with the HIV concentration of 80.4 percent of patients in the experimental groups being reduced to less than 50 copies per milliliter, the detection sensitivity of HIV," BYH infectious diseases center dean Wu Hao was quoted as saying by Xinhua.
Wu said that the drug, which is applied once a week, is much more effective and safer than current drugs in that it does less harm to the kidneys.
The data was collected between the 24th and 48th weeks of the trials that include 83 experimental groups and 92 control groups, read a company document sent to the Global Times.
There has been no report about the drug's side effects. Li Dun, a professor at the Tsinghua University Center for the Study of Contemporary China, noted that the side effects, if there are any, should be made public.
According to the company's government affairs manager, Zhang Xuelin, the drug is likely to be promoted in the market at the end of the year, and will be included in the free HIV treatment directory of the Chinese Center for Disease Control and Prevention (CDC) within two years.
"Current HIV treatments used in China are either generic or imported, and were developed one or two decades ago and are comparatively ineffective under current conditions," Zhang said.
Six in every 10,000 people in China are affected with HIV/AIDS. Over 570,000 people in China had been found to be HIV positive by the end of 2015, and an estimated 32 percent of those infected remain undiscovered, said Liang Xiaofeng, deputy director of the CDC at a forum in October.
Liang noted that China has taken measures, such as expanding the scope of medical examinations, to deal with the disease.
"The country has reduced HIV treatment costs and expanded the scope of free treatment to support people living with HIV," Peng Xiaohui, a sexologist at Wuhan's Central China Normal University, told the Global Times. Peng said the average cost for treating HIV-positive people has been reduced from 30,000 yuan ($4,337) to between 3,000 and 5,000 yuan per year.
Current cocktail therapy widely used in HIV treatments can only bring the HIV virus under temporary control but cannot cure the disease.
Experts said that an HIV/AIDS vaccine developed by Chinese scientists completed its safety testing stage during the 2014 National Conference on HIV/AIDS in Beijing in October 2014.
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