China approves albuvirtide: a once-weekly injectable entry inhibitor

29 June 2018. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 6 June 2018, without news from the US FDA, a press release from Frontier Biotech announced the approval of a new HIV drug in China that is given by once-weekly injection. [1]

This is a rare example of an HIV treatment not being first approved in either the US or Europe.

Albuviride is an HIV fusion inhibitor that works at an early stage of the HIV lifecycle by blocking attachment to CD4 cells. It has a similar structure and mechanism to an earlier HIV fusion inhibitor called enfuvirtide (T-20, Fuzeon) that was developed for people who had run out of treatment options.

Enfuvirtide was approved in 2003 but has been very rarely used for the last ten years because later drugs have become more effective and have an easier safety profile than the twice-daily subcutaneous injections it required.

Although there is little information about the results of the completed phase 3 studies that would have contributed to approval by the Chinese FDA, early results were presented at a UK conference in 2016. [2, 3]

These reported good efficacy compared to the second-line treatment option that is currently available in China, an older protease inhibitor lopinavir/r. HIV positive people in China do not have access to integrase inhibitors that are now routinely recommended as first-line treatment in the US and Europe, and that also overcome drug resistance to many other widely used HIV drugs.

From a safety perspective, albuvirtide was also not associated with the injection site reactions that limited the use of enfuvirtide.

Unfortunately the press release on approval in China still only refers to interim results from these studies.

Albuvirtide injection are marketed by Frontier Biotech with the trade name Aikening. There are plans to extend access outside of China, although further details have not been publicised.

In July 2017, the company announced a licensing agreement with with Rockerfeller University in the US to coformulated albuvirtide with the broadly neutralising monoclonal antibody 3BNC117.

References

1. Frontier Biotech press release. Frontier Biotech receives marketing authorization from China FDA for Aikening (albuvirtide for injection), China’s first new drug for the treatment of HIV. (06 June 12018).
   http://www.frontierbiotech.com/en/news
2. Collins S. Once-weekly albuvirtide infusion: early results of T-20-like compound. HTB November 2016.
   https://i-base.info/htb/31017
3. Wu H et al. Efficacy and safety of long-acting HIV fusion inhibitor albuvirtide in antiretroviral- experienced adults with HIV-1: interim 48-week results from the randomised, controlled, phase 3, non-inferiority TALENT study. Glasgow Congress on HIV Therapy, 23-26 October 2016 (Glasgow 2016). Oral abstract O336. Webcast: https://vimeo.com/189136480
4. Frontier Biotech licenses 3BNC117, a novel broad-spectrum HIV neutralizing antibody. (25 July 2017)
   https://www.firstwordpharma.com/node/1491015