On January 2, the U.S. Food and Drug Administration approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in 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. This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month.
Before, 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.
HIV-1 is the most common type of Human Immunodeficiency Virus. It attacks your body’s immune system. The virus destroys CD4 cells. These cells help your body fight infections. HIV-1 can severely damage your immune system and lead to Acquired Immune Deficiency Syndrome (AIDS).
HIV-1 treatment may reduce the amount of HIV-1 in your blood (called “viral load”). Treatment may also help to increase the number of CD4 cells in your blood. These cells help fight off other infections. An HIV-1 drug is more likely to be effective when it works at the same time with other HIV-1 drugs. Your treatment can only work if you take your medicines when and how your health care team tells you.
Approximately 1.2 million people in the U.S. are living with HIV today. About 14 percent of them (1 in 7) don’t know it and need testing. HIV continues to have a disproportionate impact on certain populations, particularly racial and ethnic minorities and gay and bisexual men.
HIV and AIDS remain a persistent problem for the United States and countries around the world. While great progress has been made in preventing and treating HIV, there is still much to do.
The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with Cabenuva. Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed.
The most common adverse reactions with Cabenuva were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/milliliter).
“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. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”