The first drug developed in China for the treatment of HIV (human immunodeficiency virus) proved to be safe and effective in the results of the clinical trialsthe Xinhua news agency reported last Wednesday.
The albuvirtide (ABT), the generic name it has received, belongs to the group of anti-HIV drugs called fusion inhibitors, which block the virus from entering certain cells of the immune system.
The results of the phase III clinical trial, which has lasted for 48 weeks, were published in the Journal of Infection and showed that the combination of ABT with the antiretroviral drug Kaletra revealed a good safety profile.
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For the trials, the pharmaceutical company Frontier Biotech, developer of ABT, enrolled 418 HIV patients in China who had previously failed to suppress the virus with oral antiviral drugs.
After taking ABT and Kaletra for four weeks, 41% of the participants saw their plasma viral load fall below 50 copies/mL, meaning HIV viruses were “undetected”, while 83% % had been effectively treated, as about 99% of the HIV viruses in their bodies were inhibited, according to the study.
The clinical trial, which began in 2013, is the first of its kind in the world using a two-drug regimen and the first conducted with an all-Asian sample.
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In May 2018, ABT received the new drug certificate from the State Administration of Medicines in China, so that in October of the same year it will be included as one of the main antiretroviral drugs available in the Chinese guidelines for diagnosis and HIV treatment.
According to the National Health Commission, in 2020, about 1.25 million patients were living with HIV in China, a country where around 80,000 people contract the virus each year.
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