FDA Approves Cabenuva for 2 Month Dosing to Treat HIV-1

The FDA has approved cabotegravir and rilpivirine (Cabenuva, ViiV Healthcare) for every-2-month dosing treatment of HIV-1 in virologically suppressed adults on a stable regimen, with no history of prior treatments not working and with no known or suspected resistance to either cabotegravir or rilpivirine, ViiV said in a statement.

Virologically suppressed adults are defined as HIV-1 RNA less than 50 copies per c/ml.

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.

“Many people living with HIV face challenges with daily therapies and are interested in alternative dosing options. In clinical trials, approximately 9 out of every 10 trial participants preferred long-acting cabotegravir and rilpivirine dosed every2 months compared to daily oral cabotegravir and rilpivirine taken as the oral lead-in per trial protocol,” Turner Overton, MD, professor in the department of medicine at the University of Alabama at Birmingham, said in the statement. “This preference data highlights the meaningful impact long-acting regimens can have on the treatment experience for the HIV community.”.

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.

In ATLAS-2M, the frequency and type of adverse reactions reported for individuals receiving long-acting cabotegravir and rilpivirine once monthly or every 2 months for 48 weeks were similar.

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.

Reference

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/