19 July 2021 | News
The first long-acting injectable (Aikening) proves safe and efficacious
Photo Credit: Freepik
In conjunction with the IAS Conference on HIV Science, Germany's Frontier Biotechnologies has announced positive top-line results for its phase 3 TALENT study, which demonstrated that an ABT-based two-drug treatment arm was non-inferior to a lopinavir (LPV)-based three-drug arm (75.7% vs 77.3%).
The results of the study showed successful achievement of the primary endpoint, with a good proportion of patients on the ABT regimen with HIV RNA less than 50 copies/mL at 48 weeks. The drug demonstrated efficacy against major strains of HIV, including resistant strains.
Additionally, the subjects who experienced virological failure at 48 weeks did not present with treatment-emergent resistant associated mutations with gp41. The high genetic barrier to resistance of ABT+LPV/r meant no further resistance developed against these agents, which is important to avoid compromising future drug options for these treatment-experienced HIV patients.
Dr Dong Xie, Chief Scientific Officer, Chairman, Frontier Biotechnologies said, “IAS is the world’s most influential meeting on HIV science. It leads the collective response on every front of the global HIV community. Frontier Biotechnologies is delighted to break the TALENT study results, through the investigators, at this prestigious meeting. ABT+LPV/r (Albuvirtide plus boosted Lopinavir combination) is a preferred two-drug regimen as ABT is active against most HIV strains, including resistant strains, and has a high resistance barrier, while LPV/r is widely available in China. This is a robust example of a combination of two classes of drugs with different mechanisms of action providing a combination of complementary efficacies. Two NRTIs were replaced with Aikening® as the core, and rapid and persistent viral suppression was achieved in patients who failed initial treatment.”
ABT once weekly is reportedly well-tolerated during the study and there were no injection site reactions. The two-drug regimen with different targets is the future trend of ART research. Researchers are looking forward to continuing to develop new HIV combinations of high efficacy and good tolerability for the patients.