Injectable Extended-Release HIV Regimen Gets Milestone FDA Approval

The FDA has announced its approval of the first injectable extended-release regimen for adults who have HIV-1 infections. For patients who meet the criteria for the regimen, Cabenuva can reduce the number of dosing days to only 12 per year, according to ViiV Healthcare, which says the regimen can replace antiretroviral regimens in eligible adults.

According to ViiV Healthcare, Cabenuva is the 'first and only complete long-acting regimen' for adults that has received FDA approval to treat HIV-1. The regimen is provided as two injectables in a co-pack, one being Janssen's rilpivirine and the other ViiV's cabotegravir. The regimen is dosed once per month, meaning there are only 12 dosing days per year rather than 365.

The company says the regimen is intended for adults who have HIV-1, who are on a stable regimen and virologically suppressed, and who don't have any history of failed treatment. ViiV Healthcare says the FDA approval was granted based on two studies across 16 countries that included more than 1,100 people.

ViiV Healthcare states that nine of the 10 people given Cabenuva preferred it over a daily regimen. With this approval in place, ViiV says it will start shipping the injectable regimen to certain distributors and its wholesalers in the United States next month.

As part of this, the FDA says it also approved the tablet formation called Vocabria, which has to be taken with the oral version of rilpivirine called Edurant for one month before the injections; this is to make sure the patient can tolerate the medications before making the switch from their previous regimen.