Approximately 2 million new HIV infections occur each year around the globe, with nearly 40,000 new cases in the US alone. With no current cure, affected individuals rely on antiretroviral therapy (ART) to help them treat their infections and to live longer and healthier lives. Better antiviral treatments continue to become available and are growing in their ability to reduce the amount of viral load in the body. This helps keep an HIV infection from advancing into AIDS. New therapies such as the first-ever monthly injectable greatly expand the horizon for HIV treatment.
Approved in early 2021, Cabenuva (cabotegravir and rilpivirine, injectable formulation)
is a complete regimen for the treatment of HIV-1 infection in adults. Cabotegravir is an integrase inhibitor, and by blocking the HIV enzyme integrase, interrupts the HIV replication cycle, thereby reducing the viral load in a body. Rilpivirine is a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor and also combats replication of HIV. Administered as two co-packaged injections, Cabenuva is used to replace the current stable antiretroviral regimen of a virologically suppressed patient, who has no history of treatment failure, and has no resistance to either cabotegravir or rilpivirine. As the first FDA-approved monthly, injectable, complete regimen for HIV-infected adults, Cabenuva represents an innovative treatment option for many patients. A tablet formulation of cabotegravir was also approved concurrently, marketed as Vocabria
. In order to ensure each of the medications in Cabenuva are well-tolerated in a patient, an oral lead-in regimen of Vocabria and Edurant (rilpivirine)
is required for one month prior to starting treatment with the long-acting injectable formulation.
The FDA approval of Cabenuva was based on evidence from two clinical trials, FLAIR
, which included 1182 adults who were infected with HIV-1. In the FLAIR study, previously untreated individuals received an approved antiretroviral therapy for 20 weeks. The patients who achieved a viral load of fewer than 50 copies/mL were then randomized to either continue Cabenuva (receiving lead-in dosing with tablets for the first 4 weeks) or to remain on the initial antiretroviral therapy for an additional 44 weeks. In the ATLAS study, ART-experienced patients who were able to achieve a viral load of fewer than 50 copies/mL were randomized to receive either Cabenuva (receiving lead-in dosing with tablets for the first 4 weeks) or to remain on their initial therapy for an additional 44 weeks.
Approval and availability of this novel treatment option can offer improved outcomes for some patients. The monthly administration may relieve pill fatigue or anxiety for those coping with concern about stigma associated with taking HIV medications and improve overall adherence. Patients should continue to be counseled about how important medication adherence is. Attending all scheduled visits for injections is vital for maintaining viral suppression, preventing resistance to the treatment, and reducing the risk of losing virologic response. If a patient misses a monthly injection or if the injection is delayed by more than 7 days and oral therapy has not been taken in the interim, the patient needs to be reassessed to determine if it is appropriate to resume injection dosing. For many patients, advancements such as the cabotegravir and rilpivirine injectable regimen and the benefits it brings can transform their lives and relationship with HIV.