FDA Approval Granted for First Long-acting Injectable HIV Therapy

The US Food and Drug Administration has approved cabotegravir and rilpivirine, injectable formulation (Cabenuva; ViiV Healthcare) as a complete regimen for the treatment of HIV-1 infection in adults. according to a statement from the company.

Cabotegravir and rilpivirine, injectable formulation is the first extended-release injectable drug regimen for adults with HIV that is administered once per month, according to a press release from the company. The formulation is approved as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

The approval is based on 2 pivotal phase 3 trials (ATLAS, FLAIR) that enrolled 1182 participants with HIV who were virologically suppressed. During a lead-in period of 1 month, participants were treated with oral formulations of cabotegravir and rilpivirine to assess tolerability of each drug.

Cabotegravir and rilpivirine, injectable formulation in both studies maintained viral suppression as effectively as a daily oral 3-drug regimen and there was no clinically relevant change from baseline in CD4+ cell counts. Patient preference data collected during both studies found the injectable formulation preferred by 9 out of 10 participants over their previous daily oral therapy.

“Among the scientific community, we recognize the innovation behind Cabenuva is truly meaningful,” said David Wohl, MD, professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill, North Carolina, in the ViiV news release. “Not only is it the first, complete long-acting regimen, which allows for a dramatic reduction in the frequency of dosing, but it also was preferred by most clinical trial participants when compared to their prior oral daily regimens."

ViiV Healthcare Head of North America Lynn Baxter emphasized in the same news release that the approval of Cabotegravir and rilpivirine, injectable formulation reduces the number of treatment dosing days for adults living with HIV from 365 to 12.

The most common adverse effects associated with cabotegravir and rilpivirine, injectable formulation were injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. Additionally, the regimen should not be used in individuals with known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in those who are not virally suppressed.

Shipment of cabotegravir and rilpivirine, injectable formulation to distributors in the US is slated to begin in February 2021.