It’s worthwhile to first take into account the FDA’s guidance from January: Cabenuva was developed 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.” That means if you’ve built up HIV drug resistance, you could be disqualified from this treatment.
Based on what we know so far, it remains to be seen whether the injectable will be prescribed for people who are newly diagnosed or not yet virally suppressed. Katerina Christopoulos, M.D., M.P.H., an infectious-disease physician focused on HIV care and an associate professor of medicine at the University of California San Francisco, said she would not recommend long-acting injectables in people who have not yet reached undetectable status. “Switching to injectables after a shorter period of suppression could be an option, depending on the needs of the patient,” said Christopoulos. “But right now, this is a data-free zone. So, if providers choose to pursue this option in the real world, we need to track and share clinical outcomes.”
Jay Gladstein, M.D., chief medical officer and site medical director at APLA Health in Los Angeles, agreed that there is not enough data to safely put “treatment-naive” patients—those who have not taken oral therapy before—on Cabenuva.
“If a patient gets one dose of Cabenuva but then doesn’t return for their next injection, they end up with a prolonged ‘tail’ of [antiretroviral medications] in their system,” said Gladstein. That tail could make a patient resistant to the drug. According to Gladstein, with treatment-naive or rapid-start patients, there is no way to know how adherent or non-adherent they will be. “With orals in rapid start, non-adherence is less of a big deal,” he added. “If they don’t continue after a few doses, no great harm. The drugs are out of their system in a few days.”
For people interested in Cabenuva, but who are unsure if it’s the right option, both Gladstein and Christopoulos agreed it’s important they start the conversation with their doctors sooner rather than later.