IAS 2021: Phase-III results from Frontier’s long-acting Aikening (albuvirtide)

Chinese biotech company, Frontier Biotechnologies, presented the results of a Phase-III clinic trial examining their new long-acting HIV fusion inhibitor, Aikening (albuvirtide).

TALENT Research

The TALENT study is the world’s first clinical trial of two-component therapy containing a long-lasting injection drug to treat people living with HIV who have not previously taken HIV therapy. Researchers also noted that this was the final clinic trial of a new HIV drug targeted exclusively at Asian groups. 

The study was attended by people living with HIV who had a viral load above 1000 copies/ml and had not yet started antiretroviral therapy (ART). In total 418 people took part in the study, 25% of them were women.

Group one received 320mg albuvirtide weekly and lopinavir/ritonavir. 

Group two received standard combination ART formed of two nucleoside reverse transcriptase inhibitors and lopinavir/ritonavir. 

Both groups received antiviral treatment for 48 weeks followed by observation.

Results

After 48 weeks of treatment, the percentage of participants with HIV RNA <50 copies/ml in the albuvirtide group and the control group was 75.7% and 77.3%, respectively. The researchers said, that according to the set value (the set threshold of lack of efficiency - 12%), the Aikening group was not inferior to the control group.

Albuvirtide has a high stability barrier: no drug resistance mutations associated with gp41 have been detected in participants.

During the 48 weeks of study in the albuvirtide group, no irritations were recorded at the injection site.

Two participants in the control group had serious side effects related to taking medication. But there were no such side effects in the albuvirtide group.

Undesirable drug-related adverse events were extremely rare and similar in both groups - usually diarrhoea, nausea and increased triglycerides.

Conclusions

Studies found that a two-drug scheme, including injected albuvirtide as the main drug replacing two NRTIs, can provide rapid and lasting suppression of the virus. Treatment for 48 weeks appears to be as good as standard three-component second-row treatment at this time. The drug has a high barrier of drug resistance, no reaction at the injection site and showed high overall safety.

This data only takes us to 48 weeks however, and with some studies like BRIGHTE, passing the 96 week mark there may be more to see when it comes to albuvirtide.