On June 10, 2022, the Journal Of Infection (ISSN: 0163-4453, eISSN: 1532-2742), an authoritative international medical journal, published online the 48-week final results of Phase III clinical TALENT study on Frontier Biotech’s long-acting anti-HIV fusion inhibitor Albuvirtide (ABT). In 2018, based on the 24-week interim results of the TALENT study, the National Medical Products Administration of China approved the marketing of Albuvirtide in China.
Results showed that HIV-1 patients who failed initial treatment achieved rapid and durable viral suppression after treatment with a two-drug regimen using ABT as the core to replace two NRTIs. The treatment effect for 48 weeks of treatment was not inferior to standard second-line three-drug combinations. ABT has the advantages of a high drug resistance barrier, no injection site reactions, good compliance to long-term weekly injection, and an overall good safety profile.
The TALENT study is the world’s first Phase III clinical trial using a two-drug formulation containing a long-acting injectable drug to treat HIV-infected patients who failed initial treatment; the first Phase III clinical trial of an original new HIV drug in China; and the first clinical trial registered for a new HIV drug in an all-Asian population.
The study was a randomized controlled, open, multicenter, and non-inferiority clinical study enrolling 418 HIV-infected patients who failed first-line antiviral therapy and were subject to 1:1 random allocation to receive ABT + Kaletra (ABT group) and ABT + two optimized nucleoside antivirals (NRTI) + Kaletra (NRTIs group), respectively. Clinical trial results showed that the ABT group and NRTIs group had 75.7% and 77.3% of subjects with HIV viral load successfully suppressed to <50 copies/mL, respectively, with a difference of -1.6%, 95% CI of -10.1 to 6.9%. According to the pre-set non-inferiority criterion of -12%, the ABT group was non-inferior to the NRTIs group.
In addition, a cohort study of HIV post-exposure prophylaxis (PEP) in China showed that ABT+DTG or ABT+TDF+3TC for post-exposure prophylaxis was significantly better tolerated and of higher patient compliance than the oral regimen DTG+TDF+3TC, and no study subjects were tested HIV-positive at the end of the study.
More treatment combinations with ABT are currently under trial. As the only new long-acting anti-HIV fusion inhibitor to be injected weekly, Albuvirtide will become an effective option and complement to clinical treatment and prevention of HIV with its efficacy, safety and high resistance barrier.
l Reference: https://www.sciencedirect.com/science/article/abs/pii/S0163445322003413
l About Journal of Infection:
Journal of Infection (ISSN: 0163-4453, eISSN: 1532-2742), founded in 1997, is an authoritative international medical journal published by the publisher Elsevier and edited by Professor Robert Read of the Department of Clinical and Experimental Sciences, University of Southampton, UK. The content involves original papers on all aspects of infection - clinical, microbiological and epidemiological. The Journal seeks to bring together knowledge from all specialties of infection research and clinical practice and to present the latest research in the ever-changing field of infection. Each issue provides editorials describing current or controversial topics of interest, high-quality reviews, and content covering the latest developments in specific areas, epidemiological reports on hospital and general community studies, etc.