That’s why the National Institute of Allergy and Infectious Diseases (NIAID) sponsored a study of long-acting antiretroviral therapy (ART) with cabotegravir and rilpivirine, marketed as Cabenuva, in patients who had been unable to maintain viral suppression through an oral daily regimen. The long-acting combo was superior in suppressing HIV replication compared to daily oral ART, according to interim data from the randomized trial.
In a press release, NIAID announced that upon review of the findings, an independent Data and Safety Monitoring Board (DSMB) recommended halting randomization and invited all eligible study participants to take long-acting ART.
NIAID is part of the National Institutes of Health and sponsored the study in collaboration with the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), ViiV Healthcare, and ACTG, a global, NIH-funded clinical trials network that designed and implemented the study. NIH accepted the DSMB’s recommendation.
About 70% of people with HIV in the United States who take oral ART achieve viral suppression, according to data from the CDC. Viral suppression protects people with HIV from progressing to advanced disease and prevents HIV transmission to others, according to the report.
In 2021, the FDA approved cabotegravir and rilpivirine as an ART regimen for people with a consistent history of viral suppression. The NIAID study was launched in 2019 to better understand how the regimen would work in patients with previous challenges taking daily oral ART as prescribed and who had not consistently maintained viral suppression.
The study is ongoing across 31 sites in the United States, including Puerto Rico. Participants were screened to ensure that the HIV in their blood was not resistant to the study drugs and that they met other health and safety criteria. Once enrolled, the participants received comprehensive and incentivized adherence support while taking daily oral ART to achieve viral suppression. Researchers randomized participants who achieved viral suppression to receive long-acting injectable ART every 4 weeks or to continue taking standard-of-care daily oral ART, with frequent health monitoring.
In February, the study DSMB conducted a planned review of interim data and found that long-acting cabotegravir and rilpivirine administered every 4 weeks had superior efficacy to daily oral ART. The DSMB recommended that all participants should have the opportunity to choose long-acting ART to ensure the best possible health outcomes in the study.
At the time of the announcement, study participants were being notified of these findings, and those currently taking daily oral ART had the option of deciding with their providers which ART method best suits their needs. All study participants will be monitored for another year.
ViiV Healthcare and Johnson & Johnson provided medications for this study. Cabenuva is administered as two intramuscular injections by a healthcare professional once monthly or every 2 months.
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