US FDA Approves Now First and Only Long-Acting HIV Treatment

The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. ViiV Healthcare is the marketing authorization holder for CABENUVA in the U.S.               

CABENUVA was approved by the U.S. FDA in January 2021 as a once-monthly, complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml).1 CABENUVA is comprised of two separate injectable medicines, rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, and ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single dose vial. Prior to initiating treatment of CABENUVA, oral dosing of rilpivirine and cabotegravir should be administered for approximately one month to assess the tolerability of each therapy. The U.S. FDA Approval allows CABENUVA to be dosed monthly or every two months.

“The expanded label approval for CABENUVA—to be administered every two months—marks an important step forward in advancing the treatment landscape for people living with HIV,” said Candice Long, President, Infectious Diseases & Vaccines, Janssen Therapeutics, a Division of Janssen Products, LP. “With this milestone, adults living with HIV have a treatment option that further reduces the frequency of medication.”

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“An important goal for us in HIV is alleviating the need for daily medication, which can serve as a constant reminder for people living with the condition,” said James Merson, Ph.D., Global Therapeutic Area Head, Infectious Diseases, Janssen Research & Development, LLC. “With this new treatment option that reduces CABENUVA dosing frequency to just six times per year, we are revolutionizing HIV therapy for people living with HIV in the U.S.”

The U.S. FDA approval of long-acting rilpivirine and cabotegravir for use every two months is based on the global ATLAS-2M phase 3b trial results, which demonstrated that every-two-month dosing was non-inferior to once-monthly dosing.2 Non-inferiority was determined by comparing the proportion of participants with plasma HIV-1 RNA ≥ 50 c/ml using the U.S. FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed population), which showed that the every-two-month arm (9/522 [1.7%]) and once-monthly arm (5/523 [1.0%]) were similarly effective (adjusted difference: 0.8%, 95% confidence interval [CI]: -0.6%, 2.2%). The study also found that rates of virologic suppression, a key secondary endpoint, were similar for every-two-month dosing (492/522 [94.3%]) and once-monthly dosing (489/523 [93.5%]) (adjusted difference: 0.8%, 95% CI: -2.1%, 3.7%). The most common adverse reactions (Grades 1 to 4) observed in ≥2% of participants receiving long-acting rilpivirine and cabotegravir were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. In ATLAS-2M, the type and frequency of adverse reactions reported in participants receiving long-acting rilpivirine and cabotegravir once monthly or every two months for 48 weeks were similar. In the every-two-month arm, rates of serious adverse events (SAEs: 27/522[5.2%]) and withdrawals due to adverse events (AEs: 12/522 [2.3%]) were low and similar to those experienced in the once-monthly arm (SAEs: 19/523 [3.6%], withdrawals due to AEs 13/523 [2.5%]).2

“Every clinician wants to be able to provide a patient with a treatment that is right for them, and there are a number of factors that go into that decision,” said Tony Mills, MD*, CEO of Men’s Health Foundation in Los Angeles, CA. “With this approval, there is an important added option for physicians to address patient’s preferences for less frequent dosing.”

The once-monthly version of rilpivirine and cabotegravir injectable treatment has also been approved by the European Commission, Health Canada, the Australia Therapeutic Goods Administration, and the Swiss Agency for Therapeutic Products. The every-two-months version has also been approved by the European Commission, Health Canada, and the Swiss Agency for Therapeutic Products. Regulatory reviews continue with additional submissions planned throughout 2022.