FDA OKs Long-Acting Injectable Drug Regimen for HIV Treatment

Officials with the FDA have approved cabotegravir and rilpivirine, injectable formulation (Cabenuva; ViiV Healthcare) as a complete regimen for the treatment of HIV-1 infection in adults.

Cabotegravir and rilpivirine, injectable formulation is the first extended-release injectable drug regimen adults with HIV that is administered once per month, according to the FDA. It is indicated for treatment in adults to replace a current antiretroviral (ARV) regimen in those who are virologically suppressed on a stable ARV regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Additionally, the FDA has approved cabotegravir, tablet formulation (Vocabria; ViiV Healthcare), which should be taken in combination with oral rilpivirine (Edurant; Janssen) for 1 month prior to starting treatment with cabotegravir and rilpivirine, injectable formulation.

Cabotegravir and rilpivirine, injectable formulation was evaluated through 2 randomized, open-label, controlled clinical trials involving 1182 adults with HIV who were virologically suppressed before treatment initiation. Prior to administering treatment with the complete injectable regimen, oral dosing of cabotegravir and rilpivirine was administered for approximately 1 month to assess tolerability.

In both studies, treatment with cabotegravir and rilpivirine, injectable formulation resulted in continued virologic suppression and no clinically relevant change from baseline in CD4+ cell counts. According to patient preference data, 9 out of 10 patients indicated preference for the injectable regimen over their previous daily oral therapy.

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.

“Among the scientific community, we recognize the innovation behind Cabenuva is truly meaningful,” David Wohl, MD, professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill, North Carolina, said in a statement. “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. The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV."

ViiV Healthcare will begin shipping cabotegravir and rilpivirine, injectable formulation to wholesalers and specialty distributors in the United States in February 2021, according to the company.

Reference

1. ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine, the first and only complete long-acting regimen for HIV treatment. News release. ViiV Healthcare; January 21, 2021. Accessed January 22, 2021. https://viivhealthcare.com/en-us/us-news/us-articles/2021/viiv-healthcare-announces-fda-approval-of-cabenuva--cabotegravir/