Lenacapavir approved in the EU and UK to treat multidrug resistant HIV
1 September 2022. Related: Antiretrovirals.
Simon Collins, HIV i-Base
On 22 August 2022, the EMA approved lenacapavir in Europe as a treatment for multi drug HIV resistance. [1]
This was also approved by the MHRA in the UK a few days later. [2]
Lenacapavir is the first capsid inhibitor to be approved as an HIV treatment. It is an extremely long-acting formulation and is given as a single subcutaneous injection, every six months.
However, it is essential to only use lenacapavir as part of a combination that includes other active HIV drugs.
If lenacapavir is used as virtual monotherapy, resistance can quickly develop. This shows the importance of good adherence to other drugs in the combinations.
Earlier reports in HTB have reported on the development of this exciting compound. Most recently this included 52-week results in both treatment-experienced and -naive studies, at CROI earlier this year. [3, 4]
Although the current approval is only for multidrug resistant cases, it is also being studied in other populations, including as first-line ART.
comment
Lenacapavir is a remarkable new drug with an exciting PK profile that allows 6-monthly dosing.
Until other compounds with similar long-acting properties are available, it will still need to be used with other HIV drugs that require more frequent dosing. However, Gilead are also developing long-acting monoclonal antibodies and other compounds to use in combination with lenacapavir.
The current indication is for multidrug resistance, which has been prioritised due to the greater need in this group. Additional support for adherence to the oral drugs used to treat MDR HIV is vital.
Low adherence and the resulting drug resistance to lenacapavir is described in the few cases of treatment failure in the registrational CAPELLA study, just published in JID. [5]
References
- Gilead PR. Gilead announces first global regulatory approval of Sunlenca (Lenacapavir), the only twice-yearly HIV treatment option. (22 August 2022).
https://www.gilead.com/news-and-press/press-room/press-releases/2022/8/gilead-announces-first-global-regulatory-approval-of-sunlencalenacapavir-
the-only-twiceyearly-hiv-treatment-option - UK approval for Gilead HIV drug with blockbuster potential. (26 August 2022).
https://www.thepharmaletter.com/article/uk-approval-for-gilead-hiv-drug-with-blockbuster-potential - CROI 2022: Lenacapavir: 54 week results in treatment-naive participants of CALIBRATE study
https://i-base.info/htb/42313 - CROI 2022: Lenacapavir in treatment-experienced participants, and as PrEP in macaques
https://i-base.info/htb/42128 - Margot NA et al. Resistance analyses in highly treatment-experienced people with HIV treated with the novel capsid HIV inhibitor lenacapavir, Journal of Infectious Diseases, 2022; jiac364,
https://doi.org/10.1093/infdis/jiac364
This report was first published on 22 August 2022.