EU approves cabotegravir as injectable PrEP

1 October 2023. Related: HIV prevention and transmission.

Simon Collins, HIV i-Base

On 19 September 2023, ViiV Healthcare issued a press release that the European Union had approved cabotegravir as HIV pre-exposure prophylaxis (PrEP).

Approval includes both the two-monthly injection and oral tablet formulations of cabotegravir. Injections are given every two months.

The indication is for use by adults and adolescents (age 12 and older), weighing at least 35 kg who are at high risk of sexual exposure to HIV.

However, the long half-life of the injections means that significant levels of cabotegravir can continue at detectable levels for more than a year. People who continue to need PrEP after using cabotegravir injections are recommended to switch to oral PrEP for the following year.

Injectable cabotegravir is produced by ViiV Healthcare and marketed under the trade name Apretude.

No details about pricing were included in the announcement.

Reference

ViiV Healthcare press statement. European Commission authorises ViiV Healthcare’s Apretude(cabotegravir long-acting and tablets) for HIV prevention. (19 September 2023).
https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2023/september/european-commission-authorises-viiv-healthcare/

This report was first posted on 19 September 2023.