China-based Frontier Biotechnologies Inc. (SHA: 688221) has released Phase III trial data for albuvirtide, China’s first homegrown innovative HIV therapy. The non-inferiority “TALENT” study assessed the performance of the long-acting HIV fusion inhibitor albuvirtide in combination with Kaletra (ritonavir-boosted lopinavir) in 418 Chinese patients with HIV-1 over 48 weeks. The results, published by the Journal of Infection, show that the combination regimen produced a good safety profile with effectiveness non-inferior to the Kaletra three-drug based regimen.
Clinical Trial Results
The study demonstrated that 41% of participants achieved plasma viral loads of less than 50 copies/ml, indicating undetectable HIV virus levels. Additionally, 83% of participants saw approximately 99% of the HIV virus in their bodies inhibited. These results highlight the potential of albuvirtide as an effective treatment option for HIV patients.
Drug Mechanism and Development
Albuvirtide is described as the world’s first long-acting HIV drug, acting as a cell fusion inhibitor that prevents HIV from fusing with healthy cells. It is designed to bind strongly to human blood protein albumin, extending its half-life to enable once weekly or biweekly dosing by intravenous infusion. Importantly, no drug-resistance mutations were found during the study.
Development Milestones
The TALENT study was initiated in 2013, with positive interim data reported in 2016. Albuvirtide made history as the world’s first two-drug HIV treatment regimen when it received market approval in China in June 2018. The drug was approved for clinical trials in the US in August 2018 and secured its first Latin America market approval in Ecuador in February 2021.-Fineline Info & Tech
