On July 18, 2021 local time, the 11th International AIDS Society (IAS) Conference on HIV Science was held in Berlin, Germany. At this conference, Frontier Biotech (stock code: 688221.SH) released the key research results of its Phase III clinical study (TALENT study) on the long-acting anti-HIV-1 fusion inhibitor, Aikening® (generic name: Albuvirtide/ ABT).
The TALENT study is the world’s first Phase III clinical trial, using a two-drug formulation containing a long-acting infusion therapy, to treat HIV-infected patients who failed initial treatment. It is the first proprietary anti-HIV drug studied in a Phase III clinical trial in China and the first clinical study conducted in an Asian population.
The study was a randomized, controlled, open, multicenter and non-inferiority clinical study. The study population included HIV-1-infected patients who failed first-line antiretroviral therapy (ART). Eligible subjects were randomly assigned to the two-drug combination therapy, ABT group (ABT+LPV/r) and standard second-line three-drug combination therapy, NRTIs (control) group (LPV/r+2NRTIs) for 48 weeks of treatment and follow-up.
The study enrolled 418 subjects that were comparatively difficult to treat. 15% of the subjects had viral load >100,000 copies/mL and approximately 25% of the subjects had CD4 cell count <100 units/µL at baseline. More than 25% of the subjects were females. Data presented at IAS 2021 virtual meeting and showed that the TALENT study achieved its primary endpoint by demonstrating non-inferiority based on the predefined margin of 12%. At 48 weeks, the percentage of HIV RNA<50 copies/mL subjects in the ABT group and the NRTIs group was 75.7% and 77.3% respectively, with the two-sided 95% CI of the intergroup difference value being -10.1-6.9%. The percentage of subjects with HIV RNA<400 copies/mL after the 48-week therapy was 88.1% and 85.4% respectively. The viral load decreased by 2.2 and 2.1 log10 copies/mL (p>0.05) on average compared to baseline levels and CD4 cell count increased by 139.1 and 142.3 units/µL (p>0.05) on average. ABT has a high barrier to resistance and there was no drug-resistant mutation related to gp41 detected in the subjects who failed the 48-week therapy.
Result showed that rapid and sustained viral suppression after treatment with a two-drug regimen using ABT in second-line setting and ABT was able to replace two NRTIs backbone components. Overall safety was good that no reported injection site reactions and the once-weekly infusion regimen demonstrated good compliance.
The future direction of HIV research will mainly focus on two-drug combinations targeting different HIV virus lifecycle targets. Research and development of new anti-HIV combination regimens, providing high efficacy and low toxicities, is worth waiting for.