KUALA LUMPUR, July 23 — In conjunction with the recent International AIDS Society (IAS) Conference on HIV science, Frontier Biotechnologies has announced positive top-line results for its Phase Three 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 per cent vs 77.3 per cent).
The results of the randomised controlled, open-labelled, multicenter, non-inferiority 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.
“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,” said Dr Dong Xie, chief scientific officer and chairman of Frontier Biotechnologies.
“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,” he added.
“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.”
The Phase Three trial randomised 418 patients; more than 25 per cent of patients were female, and more than 70 per cent of patients had resistance to at least two drug classes.
Furthermore, approximately 25 per cent of patients had CD4 cell count of less than 100, indicating advanced HIV disease with highly compromised immunity, who were at high risk of opportunistic diseases and death. In other words, this was a patient population that was relatively difficult to treat.
“Today’s announcement marks an important milestone in our efforts to create a long-acting injectable for treatment-experienced PLHIV (Patients Living with HIV) and critically ill, hospitalised AIDS patients who have limited choices for antiretroviral treatment,” said Dr CJ Wang, CEO of Frontier Biotechnologies.
“ABT is the first novel HIV long-acting ART discovered in China and we look forward to working closely with global regulators and HIV medical communities to bring ABT to more PLHIV in need, as quickly as possible,” he added.
The percentage of HIV RNA <400 copies/mL subjects treated at 48 weeks was 88.1 per cent and 85.4 per cent respectively, and the viral load decreased by an average of 2.2 and 2.1 log10 copies/mL (p>0.05), CD4 increased by an average of 139.1 and 142.3 cells/µL (p>0.05).
The results showed that with a two-drug regimen of ABT (replacing two NRTIs), patients could receive rapid and durable viral suppression for 48 weeks that is not inferior to standard second-line three-drug combination therapy.
“HIV is no longer a life-threatening disease. Newer antiretroviral treatments are always welcomed, especially those with better tolerability, fewer drug-drug interactions, and in long-acting injectable formulations with less frequent dosage administration,” said Prof Adeeba Kamarulzaman, President of IAS.
“Now more than ever, we have more drug options to meet individual patient needs. ABT is one of these new options that possesses unique features to advance existing ART options,” she added.
“ABT once weekly was well tolerated in TALENT and there were no injection site reactions. The data also reinforced the advantages of ABT such as, good clinical adherence (>97 per cent) of long-acting weekly injections was also demonstrated together with good overall safety,” said Prof Wu Hao, the principal investigator of the TALENT study.
“The two-drug regimen with different targets is the future trend of ART research. It is worthy and we are looking forward to continuing to develop new HIV combinations of high efficacy and good tolerability for our patients,” he added.