China's first domestically developed anti-HIV drug clinically safe, effective: study
BEIJING, June 22 (Xinhua) -- Clinical trial results showed that China's first domestically developed drug for the treatment of HIV proved safe and effective in a simplified combination regimen.
Aikening, or albuvirtide (ABT) for injection, a novel long-acting HIV fusion inhibitor approved by China Food and Drug Administration in 2018, is used in combination with other antiretroviral drugs to treat HIV patients.
The results of a 48-week phase-3 clinical trial published recently in the Journal of Infection revealed that ABT in combining with another HIV medication Kaletra showed a good safety profile and its effectiveness was not inferior to a Kaletra-based three-drug regimen.
The ABT's developer Frontier Biotech, a Nanning-based biopharma, recruited 418 HIV patients in China who had previously received oral antiviral drugs but did not see the virus inhibited.
After administering ABT and Kaletra for four weeks, 41 percent of participants saw their plasma viral load less than 50 copy/ml, which signified the HIV viruses were "undetected," while 83 percent had been effectively treated as about 99 percent of HIV viruses in their bodies were inhibited, according to the study.
The HIV viruses were undetected for 76 percent of participants while 88 percent of them were effectively treated after the 48-week treatment, displaying its long-lasting efficacy.
The clinical trial, starting in 2013 and whose interim analysis data showed satisfying results in 2016 ahead of schedule, is the first of its kind in the world using a two-drug regimen and the first one conducted among all Asian populations.
"The envelope protein of the HIV virus can fuse with human's cell membrane and inject its genetic material into the cell," said Yao Cheng, senior medical director with Frontier Biotech. "But ABT can bond with the envelop protein before its fusion with human cells, thereby blocking the infections."
The ABT can also bond with albumin, a human protein found in plasma, to extend its stay in the body, thus having long-lasting antiviral efficacy when administrated weekly, said Yao.
Plus, no drug-resistant mutation was found in the HIV virus after the 48-week medications, according to the trial.
The Chinese company is now exploring other ABT combination regimens to provide more alternative options for infectious disease treatment.
The global anti-HIV drug market grew from 22.9 billion U.S. dollars in 2013 to 34 billion U.S. dollars in 2018 and is expected to further expand to 46.7 billion U.S. dollars by 2023.