FDA approves first long-acting injectable regimen for HIV
The FDA approved the first long-acting injectable regimen for HIV treatment, Cabenuva, which includes shots of cabotegravir and rilpivirine given just once a month.
The regimen has been shown to be noninferior to daily three-drug oral regimens in clinical trials. It was approved as a replacement for current antiretroviral regimens in patients with HIV who are virologically suppressed, on a stable regimen, have no history of treatment failure and no suspected or known resistance to cabotegravir (ViiV Healthcare) or rilpivirine (Janssen Pharmaceuticals).
“HIV drug development has made a clear priority of convenience and safety. We’ve come a great distance since the early days of triple therapy, with handfuls of pills taken multiple times a day and often with significant side effects to current one-pill, once-a-day multidrug regimens,” Infectious Disease News Chief Medical Editor Paul A. Volberding, MD, professor of medicine and director of the AIDS Research Institute at the University of California, San Francisco, told Healio.
“We now have another option, and one favored by many patients, in an injectable two-drug, long-acting regimen given once a month,” Volberding said. “This has been shown to maintain full viral suppression with minimal side effects and is an important addition to our treatment options. This is good news for persons living with HIV.”
Patients prescribed the new regimen will initially take a 1-month, daily oral lead-in consisting of ViiV’s Vocabria (cabotegravir in tablet formation) — which also received FDA approval — and oral rilpivirine to ensure the medications are well tolerated.
After that, they will receive a one-time dose consisting of 600 mg cabotegravir and 900 mg rilpivirine at a cost of $5,940, a ViiV spokesperson told Healio. Subsequent monthly injections of 400 mg cabotegravir and 600 mg rilpivirine will cost $3,960.
The spokesperson said the cost of the monthly two-shot therapy is “within the top range” of daily oral therapies on the market.
The FDA initially declined to approve Cabenuva in 2019 because of concerns related to chemistry, manufacturing and controls, but not safety.
The approval is based on data from the phase 3 ATLAS and FLAIR trials, which collectively enrolled more than 1,100 patients in 16 countries. The injectable regimen was found to be as effective in maintaining viral suppression as continuing an oral three-drug regimen. Additionally, nine of 10 patients preferred Cabenuva over daily oral therapy.
The most common adverse reactions in both studies were pyrexia, fatigue, injection site reactions, headache, nausea, musculoskeletal pain, sleep disorders, rash and dizziness.
“This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”
In November, the FDA designated long-acting cabotegravir a breakthrough therapy for HIV PrEP after data from several studies showed it was effective at preventing infection among transgender women, men who have sex with men and cisgender women.