FDA approves injectable regimen for HIV treatment
The Food and Drug Administration (FDA) approved an injectable, complete regimen for HIV-infected adults that is administered once a month.
The FDA said this is the first time they’ve approved an injectable treatment for HIV.
The treatment is Cabenuva (cabotegravir and rilpivirine, injectable formulation) for adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”
The most common adverse reactions with Cabenuva were injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.
The FDA also approved Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.