Injectable HIV ART Is an Effective Alternative to Oral Medications
An NIAID-sponsored study concluded that injectable HIV antiretroviral therapies are effective for patients who are not effectively treated with oral medications.
On February 21, 2024, the NIH issued a press announcement revealing that long-acting injectable antiretroviral therapy (ART) using cabotegravir and rilpivirine was more effective than oral ART at suppressing human immunodeficiency virus (HIV) replication in patients who could not achieve or maintain viral suppression with oral medication.
Researchers made this conclusion during a study funded by the National Institute of Allergy and Infectious Diseases (NIAID) in collaboration with the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), ViiV Healthcare, and Advancing Clinical Therapeutics Globally (ACTG).
The study included 31 sites across the United States and Puerto Rico that enrolled patients with HIV who did not exhibit any resistance to the drugs involved. Initially, the participants were given oral ART for viral suppression, provided alongside comprehensive medication adherence support. Once patients achieved suppression, they were either transitioned to an injectable ART administered every four weeks or assigned to continue taking the oral drug.
For context, the injectible combination of extended-release cabotegravir and rilpivirine was approved by the FDA under the brand name CABENUVA in January 2021. The drug is administered as an intramuscular injection of 600 mg of cabotegravir and another intramuscular injection of 900 mg of rilpivirine for the initial dose. Subsequent doses are administered monthly, including an intramuscular injection of 400 mg of cabotegravir and another intramuscular injection of 600 mg of rilpivirine for the initial dose.
On the same day, VOCABRIA was approved in the US by the FDA. The drug is an oral 30 mg tablet of cabotegravir to be given along with oral rilpivirine. Patients are advised to take this treatment regimen for one month before beginning CABENUVA.
Recently, an independent review of study results by the Data and Safety Monitoring Board (DSMB) revealed that the long-acting injection was more effective than the oral medication for viral suppression. Upon making this discovery, the board recommended that all participants be given the option to take the injectable medication to optimize patient outcomes.
Currently, participants and their providers are being notified of this change in the study protocol and will be allowed to decide how they want to continue treatment.
