INDICATION

AIKENING^TM is a human immunodeficiency virus type 1 (HIV-1) fusion inhibitor indicated in combination with other antiretroviral agent(s) for the treatment of HIV-1 infection in treatment-experienced patients with HIV-1 replication despite ongoing antiretroviral therapy.¹

LONG-ACTING FUSION INHIBITOR

AIKENING^TM could ensure durable suppression of viral load and minimize the risk of HIV drug resistance, especially for people who have pill fatigue

The long-acting ability of AIKENING^TM is due to an incorporated 3-maleimidopropionic acid (MPA) group that specifically binds to and forms a stable conjugate with human serum albumin (HSA). The conjugate retains the biological activity of AIKENING^TM, and significantly prolongs its half-life.

As a long-acting antiretroviral therapy, AIKENING^TM may allow HIV-1-infected patients who have difficulty with daily oral therapy to maintain viral suppression within a relatively long dosing window. AIKENING^TM could ensure durable suppression of viral load and minimize the risk of HIV drug resistance, especially for people who have pill fatigue.

AIKENING^TM CLINICAL DATA

TRIAL Design

TALENT is a randomized, multicenter, open-label, phase 3 trial.^2,3

Primary endpoint: Proportion of patients with with plasma viral load (HIV-RNA) level<50 copies/mL at Week 48 by FDA snapshot algorithm

Secondary endpoints:

• Proportion of patients with plasma HIV-1 RNA level<400 copies/mL

• Changes from baseline

○ HIV-1 RNA log₁₀ copies/mL

○ CD4+ T-cell counts

PATIENT BASELINE CHARACTERISTICS

Of 374 subjects, the dominant viral subtypes were B (ABT group 49.5% vs. 2 NRTIs group 47.4%), CRF01_AE (32.4% vs. 36.5%), and CRF07_BC (8.2% vs. 3.1%).

EFFICACY DATA

AIKENING^TM was proven as effective as continuing a standard three-drug combination*

• AIKENING^TM was found to be non-inferior to a standard second line three drug regimen (upper bound of 95% CI for the treatment difference was<7%) at Week 48 for the primary endpoint (HIV-1 RNA ≤50 copies/mL).    

• Similar incidence of confirmed virologic failure across both arms was observed at Week 48.**

*In TALENT, the oral comparator consisted of 2 NRTIs + LPV/r.

**Virologic failure is defined as a confirmed viral load of more than 400 copies/mL.

AIKENING^TM showed similar incidence of confirmed virologic failure through Week 48**

High genetic barrier to resistance

• 1 of 11 patients had 1 new NRTI RAMs (K103S, G190A) at failure, but remained sensitive to NRTI and PI classes.

• 9 of 11 patients had no new RAMs.

Missing baseline drug resistance data in 1 participant, who had K103N, P225H and V82A at failure.