ViiV Healthcare’s HIV treatment Cabenuva has been approved by the U.S. Food and Drug Administration for use every two months, meaning patients only have to receive an injectable dose six times per year.
Cabenuva was first approved last year for use once a month, reducing antiretroviral treatments from once per day to only 12 times per year. Cabenuva (cabotegravir, rilpivirine) has been designed to replace antiretroviral regimens currently used by some HIV-positive adults whose disease is virologically suppressed.
ViiV Healthcare, established through a partnership of GlaxoSmithKline, Pfizer and Shinogi Limited, is laser-focused on developing new therapeutics for HIV, a disease that has been present in society for the past 41 years. The recent FDA approval for Cabenuva allows for monthly or every other month dosing.
The latest approval was based on data from the Phase IIIb ATLAS-2M study that showed dosing of Cabenuva every other month was non-inferior to monthly dosing. The study also found that rates of virologic suppression were similar for dosing monthly or every two months. This was a key secondary endpoint of the Phase IIIb study. Cabenuva continued to show a safe profile in HIV patients with adverse events primarily limited to injection site reaction, fatigue, dizziness, and musculoskeletal pain.
Lynn Baxter, head of North America at ViiV Healthcare, expressed excitement about the latest approval for Cabenuva.
“Today’s approval is a remarkable achievement given where HIV treatment was just a decade ago. We know some people living with HIV struggle with taking daily oral pills, and Cabenuva may allow them to maintain viral suppression while significantly reducing dosing to as few as six times a year,” Baxter said in a statement.
Cabenuva is comprised of ViiV Healthcare’s cabotegravir extended-release injectable suspension and Janssen’s rilpivirine extended-release injectable suspension. The drug is a complete regimen for HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure.
“In clinical trials, approximately nine out of every ten trial participants preferred long-acting cabotegravir and rilpivirine dosed every two months compared to daily oral cabotegravir and rilpivirine taken as the oral lead-in per trial protocol. This preference data highlights the meaningful impact long-acting regimens can have on the treatment experience for the HIV community,” Dr. Turner Overton, a professor in the Department of Medicine at the University of Alabama at Birmingham and ATLAS-2M primary investigator said in a statement.
Cabenuva is the first and only complete long-acting HIV treatment regimen, and the FDA first approved it in January 2021 as a once-monthly treatment for HIV-1 in virologically suppressed adults.Cabenuva contains ViiV Healthcare’s cabotegravir extended-release (ER) injectable suspension in a single-dose vial and rilpivirine ER injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, 1 of the Janssen Pharmaceutical Companies of Johnson & Johnson.
By 2030, the goal is to reduce infections by at least 90%, for an estimated 250,000 total HIV infections averted. The current administration has taken up the cause and pledged to meet the goal.
The approval is based on the global ATLAS-2M phase 3b trial results, which demonstrated that every-2-month dosing was non-inferior to once monthly dosing. Non-inferiority was determined by comparing the proportion of individuals with plasma HIV-1 RN ≥ 50 c/ml using the FDA snapshot algorithm at week 48.
It showed that the every-2-month dosing arm and once-monthly dosing arm were similar in effectiveness. The study results also showed that rates of virologic suppression, a key secondary endpoint, were similar for every-2-month dosing and once-monthly dosing.
The most common adverse reactions observed after receiving the injection were dizziness, fatigue, headaches, injection site reactions, musculoskeletal pain, nausea, pyrexia, rash, and sleep disorders.
Multiple approaches are being made to combat HIV, including gene therapies by companies like American Gene Technologies and other treatments by Merck and Gilead Sciences.
In the every-2-month arm, rates of serious adverse events and withdrawals because of adverse events were low and similar to those experienced in the once monthly arm.
Individuals’ preference data were collected from individuals in the clinical trial who received long-acting cabotegravir and rilpivirine.
In a pooled analysis of this intent-to-threat exposed population with no prior experience with long-acting cabotegravir and rilpivirine, 327 individuals completed a single-item question at week 48, and 92% of them preferred every-2-month injections compared with 1% who preferred oral cabotegravir and rilpivirine that was taken as the required oral lead-in.
ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting HIV treatment. GSK. News release. February 1, 2022. Accessed February 1, 2022. https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-us-fda-approval-of-cabenuva-cabotegravir-rilpivirine-for-use-every-two-months-expanding-the-label-of-the-first-and-only-complete-long-acting-hiv-treatment/